79C3C34C52B45572883A05D425EB0F82
45 CFR 46 (Common Rule)
https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000062: Find issues of the CFR (including issues Research
p.000062: prior to 1996) at a local Federal
p.000062: depository library.
p.000062: §46.201 To what do these regulations apply?
p.000062: [A2] §46.202 Definitions.
p.000062: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of children.
p.000062: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000062: §46.409 Wards.
p.000062:
p.000062: Subpart E—Registration of Institutional Review Boards
p.000062:
p.000062: §46.501 What IRBs must be registered?
p.000062: §46.502 What information must be provided when registering an IRB?
p.000062: §46.503 When must an IRB be registered?
p.000062: §46.504 How must an IRB be registered?
p.000062: §46.505 When must IRB registration information be renewed or updated?
p.000062:
p.000062:
...
p.000063: and the organization operating the IRB shall document the institution's reliance on the IRB for oversight of the
p.000063: research and the responsibilities that each entity will undertake to ensure compliance with the requirements of
p.000063: this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-
p.000063: wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not
p.000063: affiliated with the institution, or as set forth in a research protocol).
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.104 Exempt research.
p.000063:
p.000063: (a) Unless otherwise required by law or by department or agency heads, research activities in which the only
p.000063: involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are
p.000063: exempt from the requirements of this policy, except that such activities must comply with the requirements of
p.000063: this section and as specified in each category.
p.000063:
p.000063: (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D:
p.000063: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C,
p.000063: and D, is as follows:
p.000063:
p.000063: (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the
p.000063: conditions of the exemption are met.
p.000063:
p.000063: (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for
p.000063: research aimed at involving a broader subject population that only incidentally includes prisoners.
p.000063:
p.000063: (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to
p.000063: research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this
p.000063: section only may apply to research subject to subpart D involving educational tests or the observation of public
p.000063: behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this
p.000063: section may not be applied to research subject to subpart D.
p.000063:
p.000063: (c) [Reserved]
p.000063:
p.000063: (d) Except as described in paragraph (a) of this section, the following categories of human subjects research
p.000063: are exempt from this policy:
p.000063:
p.000063: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves
p.000063: normal educational practices that are not likely to adversely impact students' opportunity to learn required
p.000063: educational content or the assessment of educators who provide instruction. This includes most research on
p.000063: regular and special education instructional strategies, and research on the effectiveness of or the comparison
p.000063: among instructional techniques, curricula, or classroom management methods.
p.000063:
p.000063: (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude,
...
p.000063: requirements to return individual research results.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
p.000063: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
p.000063:
p.000063: (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees;
...
p.000063: requirements are satisfied:
p.000063:
p.000063: (1) Risks to subjects are minimized:
p.000063:
p.000063: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose
p.000063: subjects to risk, and
p.000063:
p.000063: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
p.000063: treatment purposes.
p.000063:
p.000063: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance
p.000063: of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should
p.000063: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000063: benefits of therapies subjects would receive even if not participating in the research). The IRB should not
p.000063: consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of
p.000063: the research on public policy) as among those research risks that fall within the purview of its responsibility.
p.000063:
p.000063: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the
p.000063: purposes of the research and the setting in which the research will be conducted. The IRB should be particularly
p.000063: cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion
p.000063: or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or
p.000063: economically or educationally disadvantaged persons.
p.000063:
p.000063: (4) Informed consent will be sought from each prospective subject or the subject's legally authorized
p.000063: representative, in accordance with, and to the extent required by, §46.116.
p.000063:
p.000063: (5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
p.000063:
p.000063: (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to
p.000063: ensure the safety of subjects.
p.000063:
p.000063: (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
p.000063:
p.000063: confidentiality of data.
p.000063: (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office
p.000063: and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in
p.000063: assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of
p.000063: data.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (8) For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the
p.000063: determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
p.000063:
p.000063: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information
p.000063: or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
p.000063:
p.000063: (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance
p.000063: with §46.117; and
p.000063:
p.000063: (iii) If there is a change made for research purposes in the way the identifiable private information or
p.000063: identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of
p.000063: subjects and to maintain the confidentiality of data.
p.000063:
p.000063: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare
p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
p.000063: (a) Cooperative research projects are those projects covered by this policy that involve more than one
...
p.000063: neonates; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, ethics, law) and following opportunity for public review and comment, including a public meeting
p.000063: announced in the Federal Register, has determined either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.204, as applicable; or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;
p.000063:
p.000063: (ii) The research will be conducted in accord with sound ethical principles; and
p.000063:
p.000063: (iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other
p.000063: applicable subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral
p.000063: Research Involving Prisoners as Subjects
p.000063: Source: 43 FR 53655, Nov. 16, 1978, unless otherwise noted.
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
p.000063: ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it
p.000063: is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in
p.000063: activities to which this subpart is applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.303 Definitions.
p.000063:
p.000063: As used in this subpart:
p.000063:
p.000063: (a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (b) DHHS means the Department of Health and Human Services.
p.000063:
p.000063: (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is
p.000063: intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
p.000063: detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal
p.000063: prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or
p.000063: sentencing.
p.000063:
p.000063: (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally
p.000063: encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out
p.000063: responsibilities under this part with respect to research covered by this subpart, shall also meet the following
p.000063: specific requirements:
p.000063:
p.000063: (a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s)
p.000063: involved, apart from their membership on the Board.
p.000063:
p.000063: (b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate
p.000063: background and experience to serve in that capacity, except that where a particular research project is reviewed
p.000063: by more than one Board only one Board need satisfy this requirement.
p.000063:
p.000063: [43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: (a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the
p.000063: Board shall review research covered by this subpart and approve such research only if it finds that:
p.000063:
p.000063: (1) The research under review represents one of the categories of research permissible under §46.306(a)(2);
p.000063:
p.000063: (2) Any possible advantages accruing to the prisoner through his or her participation in the research, when
p.000063: compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings
p.000063: in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the
p.000063: value of such advantages in the limited choice environment of the prison is impaired;
p.000063:
p.000063: (3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner
p.000063:
p.000063: volunteers;
p.000063:
p.000063: (4) Procedures for the selection of subjects within the prison are fair to all prisoners and immune from
p.000063: arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board
p.000063: justification in writing for following some other procedures, control subjects must be selected randomly from the
p.000063: group of available prisoners who meet the characteristics needed for that particular research project;
p.000063:
p.000063: (5) The information is presented in language which is understandable to the subject population;
p.000063:
p.000063: (6) Adequate assurance exists that parole boards will not take into account a prisoner's participation in the
p.000063: research in making decisions regarding parole, and each prisoner is clearly informed in advance that
p.000063: participation in the research will have no effect on his or her parole; and
p.000063:
p.000063: (7) Where the Board finds there may be a need for follow-up examination or care of participants after the
p.000063: end of their participation, adequate provision has been made for such examination or care, taking into account
p.000063: the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
p.000063:
p.000063: (b) The Board shall carry out such other duties as may be assigned by the Secretary.
p.000063:
p.000063: (c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that
p.000063: the duties of the Board under this section have been fulfilled.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
p.000063: (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects
p.000063: only if:
p.000063:
p.000063: (1) The institution responsible for the conduct of the research has certified to the Secretary that the
p.000063: Institutional Review Board has approved the research under §46.305 of this subpart; and
p.000063:
p.000063: (2) In the judgment of the Secretary the proposed research involves solely the following:
p.000063:
p.000063: (i) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided
p.000063: that the study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the
p.000063: study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (iii) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other
p.000063: research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and
p.000063: psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may
p.000063: proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
p.000063: including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
p.000063: supported by DHHS shall not involve prisoners as subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000063: Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.401 To what do these regulations apply?
p.000063:
p.000063: (a) This subpart applies to all research involving children as subjects, conducted or supported by the
p.000063: Department of Health and Human Services.
p.000063:
p.000063: (1) This includes research conducted by Department employees, except that each head of an Operating
p.000063: Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate
p.000063: from an administrative standpoint.
p.000063:
p.000063: (2) It also includes research conducted or supported by the Department of Health and Human Services
p.000063: outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of §46.101
p.000063: of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
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Political / Indigenous
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p.000062: procedural modifications as may be appropriate from an administrative standpoint. It also includes research
p.000062: conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
p.000062: Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs)
p.000062: reviewing research that is subject to this policy must comply with this policy.
p.000062:
p.000062: (b) [Reserved]
p.000062:
p.000062: (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this
p.000062: policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.62
p.000062: 62
p.000062: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report.
p.000062: Washington, DC: U.S. Department of Health and Human Services. 1979.
p.000062:
p.000062: (d) Department or agency heads may require that specific research activities or classes of research activities
p.000062: conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise
p.000062: covered by this policy comply with some or all of the requirements of this policy.
p.000062:
p.000062: (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide
p.000062: additional protections for human subjects.
p.000062:
p.000062: (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official
p.000062: governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide
p.000062: additional protections for human subjects.
p.000062:
p.000062: (g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that
p.000062: provide additional protections to human subjects of research.
p.000062:
p.000062: (h) When research covered by this policy takes place in foreign countries, procedures normally followed in
p.000062: the foreign countries to protect human subjects may differ from those set forth in this policy. In these
p.000062: circumstances, if a department or agency head determines that the procedures prescribed by the institution
p.000062: afford protections that are at least equivalent to those provided in this policy, the department or agency head
p.000062: may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this
p.000062: policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices
p.000062: of these actions as they occur will be published in the Federal Register or will be otherwise published as provided
p.000062: in department or agency procedures.
p.000062:
p.000062: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000062: of the provisions of this policy to specific research activities or classes of research activities otherwise covered by
p.000062: this policy, provided the alternative procedures to be followed are consistent with the principles of the Belmont
p.000062: Report.63 Except when otherwise required by statute or Executive Order, the department or agency head shall
p.000062: forward advance notices of these actions to the Office for Human Research Protections, Department of Health
...
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
p.000063: (a) Cooperative research projects are those projects covered by this policy that involve more than one
p.000063: institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the
p.000063: rights and welfare of human subjects and for complying with this policy.
p.000063:
p.000063: (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon
p.000063: approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB
p.000063: will be identified by the Federal department or agency supporting or conducting the research or proposed by the
p.000063: lead institution subject to the acceptance of the Federal department or agency supporting the research.
p.000063:
p.000063: (2) The following research is not subject to this provision:
p.000063:
p.000063: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed
p.000063: by the official governing body of an American Indian or Alaska Native tribe); or
p.000063:
p.000063: (ii) Research for which any Federal department or agency supporting or conducting the research determines
p.000063: and documents that the use of a single IRB is not appropriate for the particular context.
p.000063:
p.000063: (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative
p.000063: project may enter into a joint review arrangement, rely on the review of another IRB, or make similar
p.000063: arrangements for avoiding duplication of effort.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.115 IRB records.
p.000063:
p.000063: (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB
p.000063: activities, including the following:
p.000063:
p.000063: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals,
p.000063: approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
p.000063: (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions
p.000063: taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining;
p.000063: the basis for requiring changes in or disapproving research; and a written summary of the discussion of
p.000063: controverted issues and their resolution.
p.000063:
p.000063: (3) Records of continuing review activities, including the rationale for conducting continuing review of
p.000063: research that otherwise would not require continuing review as described in §46.109(f)(1).
p.000063:
p.000063: (4) Copies of all correspondence between the IRB and the investigators.
p.000063:
...
p.000063: subject or legally authorized representative, or
p.000063:
p.000063: (2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing
p.000063: records or stored identifiable biospecimens.
p.000063:
p.000063: (h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal
p.000063: department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the
p.000063: awardee or the Federal department or agency component conducting the trial on a publicly available Federal
p.000063: Web site that will be established as a repository for such informed consent forms.
p.000063:
p.000063: (2) If the Federal department or agency supporting or conducting the clinical trial determines that certain
p.000063: information should not be made publicly available on a Federal Web site (e.g. confidential commercial
p.000063: information), such Federal department or agency may permit or require redactions to the information posted.
p.000063:
p.000063: (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to
p.000063: recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
p.000063:
p.000063: (i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable
p.000063: Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or
p.000063: Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be
p.000063: legally effective.
p.000063:
p.000063: (j) Emergency medical care. Nothing in this policy is intended to limit the authority of a physician to provide
p.000063: emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or
p.000063: local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.117 Documentation of informed consent.
p.000063:
p.000063: (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a
p.000063: written informed consent form approved by the IRB and signed (including in an electronic format) by the subject
p.000063: or the subject's legally authorized representative. A written copy shall be given to the person signing the
p.000063: informed consent form.
p.000063:
p.000063: (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the
p.000063: following:
p.000063:
p.000063: (1) A written informed consent form that meets the requirements of §46.116. The investigator shall give
p.000063: either the subject or the subject's legally authorized representative adequate opportunity to read the informed
p.000063: consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally
p.000063: authorized representative.
p.000063:
p.000063: (2) A short form written informed consent form stating that the elements of informed consent required by
p.000063: §46.116 have been presented orally to the subject or the subject's legally authorized representative, and that the
...
p.000063: necessary for the protection of human subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and
p.000063: Neonates Involved in Research
p.000063: Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
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p.000063: research for purposes of this policy, whether or not they are conducted or supported under a program that is
p.000063: considered research for other purposes. For example, some demonstration and service programs may include
p.000063: research activities. For purposes of this part, the following activities are deemed not to be research:
p.000063:
p.000063: (1) Scholarly and journalistic activities ( e.g., oral history, journalism, biography, literary criticism, legal
p.000063: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000063: specific individuals about whom the information is collected.
p.000063:
p.000063: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000063: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities
p.000063: are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate
p.000063: potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including
p.000063: trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such
p.000063: activities include those associated with providing timely situational awareness and priority setting during the
p.000063: course of an event or crisis that threatens public health (including natural or man-made disasters).
p.000063:
p.000063: (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for
p.000063: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000063:
p.000063: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000063: security, defense, or other national security missions.
p.000063:
p.000063: (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium ( e.g., paper) or in
p.000063: an electronic format.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.103 Assuring compliance with this policy—research conducted or supported by any Federal
p.000063: department or agency.
p.000063:
p.000063: (a) Each institution engaged in research that is covered by this policy, with the exception of research eligible
p.000063: for exemption under §46.104, and that is conducted or supported by a Federal department or agency, shall
p.000063: provide written assurance satisfactory to the department or agency head that it will comply with the
p.000063:
p.000063: requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency
p.000063: heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the
p.000063: Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that
p.000063: office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an
p.000063: assurance, reports (except certification) required by this policy to be made to department and agency heads
p.000063: shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal
p.000063: departments and agencies will conduct or support research covered by this policy only if the institution has
p.000063: provided an assurance that it will comply with the requirements of this policy, as provided in this section, and
...
p.000063:
p.000063: (c) [Reserved]
p.000063:
p.000063: (d) Except as described in paragraph (a) of this section, the following categories of human subjects research
p.000063: are exempt from this policy:
p.000063:
p.000063: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves
p.000063: normal educational practices that are not likely to adversely impact students' opportunity to learn required
p.000063: educational content or the assessment of educators who provide instruction. This includes most research on
p.000063: regular and special education instructional strategies, and research on the effectiveness of or the comparison
p.000063: among instructional techniques, curricula, or classroom management methods.
p.000063:
p.000063: (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude,
p.000063: achievement), survey procedures, interview procedures, or observation of public behavior (including visual or
p.000063: auditory recording) if at least one of the following criteria is met:
p.000063: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information
p.000063: from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the
p.000063: subject prospectively agrees to the intervention and information collection and at least one of the following
p.000063: criteria is met:
p.000063:
p.000063: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (C) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless,
p.000063: painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the
p.000063: investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided
p.000063: all such criteria are met, examples of such benign behavioral interventions would include having the subjects
p.000063: play an online game, having them solve puzzles under various noise conditions, or having them decide how to
p.000063: allocate a nominal amount of received cash between themselves and someone else.
p.000063:
p.000063: (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this
p.000063: exemption is not applicable unless the subject authorizes the deception through a prospective agreement to
p.000063: participate in research in circumstances in which the subject is informed that he or she will be unaware of or
p.000063: misled regarding the nature or purposes of the research.
p.000063:
p.000063: (4) Secondary research for which consent is not required: Secondary research uses of identifiable private
...
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
p.000063: ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it
p.000063: is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in
p.000063: activities to which this subpart is applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.303 Definitions.
p.000063:
p.000063: As used in this subpart:
p.000063:
p.000063: (a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (b) DHHS means the Department of Health and Human Services.
p.000063:
p.000063: (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is
p.000063: intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
p.000063: detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal
p.000063: prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or
p.000063: sentencing.
p.000063:
p.000063: (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally
p.000063: encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out
p.000063: responsibilities under this part with respect to research covered by this subpart, shall also meet the following
p.000063: specific requirements:
p.000063:
p.000063: (a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s)
p.000063: involved, apart from their membership on the Board.
p.000063:
p.000063: (b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate
p.000063: background and experience to serve in that capacity, except that where a particular research project is reviewed
p.000063: by more than one Board only one Board need satisfy this requirement.
p.000063:
p.000063: [43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981]
p.000063:
p.000063: Back to Top
p.000063:
...
p.000063:
p.000063: (6) Adequate assurance exists that parole boards will not take into account a prisoner's participation in the
p.000063: research in making decisions regarding parole, and each prisoner is clearly informed in advance that
p.000063: participation in the research will have no effect on his or her parole; and
p.000063:
p.000063: (7) Where the Board finds there may be a need for follow-up examination or care of participants after the
p.000063: end of their participation, adequate provision has been made for such examination or care, taking into account
p.000063: the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
p.000063:
p.000063: (b) The Board shall carry out such other duties as may be assigned by the Secretary.
p.000063:
p.000063: (c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that
p.000063: the duties of the Board under this section have been fulfilled.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
p.000063: (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects
p.000063: only if:
p.000063:
p.000063: (1) The institution responsible for the conduct of the research has certified to the Secretary that the
p.000063: Institutional Review Board has approved the research under §46.305 of this subpart; and
p.000063:
p.000063: (2) In the judgment of the Secretary the proposed research involves solely the following:
p.000063:
p.000063: (i) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided
p.000063: that the study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the
p.000063: study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (iii) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other
p.000063: research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and
p.000063: psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may
p.000063: proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
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p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
p.000063: ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it
p.000063: is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in
p.000063: activities to which this subpart is applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.303 Definitions.
p.000063:
p.000063: As used in this subpart:
p.000063:
p.000063: (a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (b) DHHS means the Department of Health and Human Services.
p.000063:
p.000063: (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is
p.000063: intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
p.000063: detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal
p.000063: prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or
p.000063: sentencing.
p.000063:
p.000063: (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally
p.000063: encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out
p.000063: responsibilities under this part with respect to research covered by this subpart, shall also meet the following
p.000063: specific requirements:
p.000063:
p.000063: (a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s)
p.000063: involved, apart from their membership on the Board.
p.000063:
p.000063: (b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate
p.000063: background and experience to serve in that capacity, except that where a particular research project is reviewed
p.000063: by more than one Board only one Board need satisfy this requirement.
p.000063:
p.000063: [43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000063:
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p.000063: §46.117.
p.000063:
p.000063: (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the
p.000063: proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB
p.000063: decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for
p.000063: its decision and give the investigator an opportunity to respond in person or in writing.
p.000063:
p.000063: (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals
p.000063: appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).
p.000063:
p.000063: (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following
p.000063: circumstances:
p.000063:
p.000063: (i) Research eligible for expedited review in accordance with §46.110;
p.000063:
p.000063: (ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)
p.000063: (3)(i)(C), or (d)(7) or (8);
p.000063:
p.000063: (iii) Research that has progressed to the point that it involves only one or both of the following, which are
p.000063: part of the IRB-approved study:
p.000063:
p.000063: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
p.000063:
p.000063: (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
p.000063:
p.000063: (2) [Reserved]
p.000063: (g) An IRB shall have authority to observe or have a third party observe the consent process and the
p.000063: research.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk,
p.000063: and for minor changes in approved research.
p.000063:
p.000063: (a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of
p.000063: categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary
p.000063: will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal
p.000063: departments and agencies and after publication in the Federal Register for public comment. A copy of the list is
p.000063: available from the Office for Human Research Protections, HHS, or any successor office.
p.000063:
p.000063: (b)(1) An IRB may use the expedited review procedure to review the following:
p.000063:
p.000063: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the
p.000063: reviewer determines that the study involves more than minimal risk;
p.000063:
p.000063: (ii) Minor changes in previously approved research during the period for which approval is authorized; or
p.000063:
p.000063: (iii) Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and
p.000063: (d)(7) and (8).
p.000063:
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000063: paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results
p.000063: to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal
p.000063: requirements to return individual research results.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
...
p.000063: institution's or IRB's use of the expedited review procedure.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.111 Criteria for IRB approval of research.
p.000063:
p.000063: (a) In order to approve research covered by this policy the IRB shall determine that all of the following
p.000063: requirements are satisfied:
p.000063:
p.000063: (1) Risks to subjects are minimized:
p.000063:
p.000063: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose
p.000063: subjects to risk, and
p.000063:
p.000063: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
p.000063: treatment purposes.
p.000063:
p.000063: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance
p.000063: of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should
p.000063: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000063: benefits of therapies subjects would receive even if not participating in the research). The IRB should not
p.000063: consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of
p.000063: the research on public policy) as among those research risks that fall within the purview of its responsibility.
p.000063:
p.000063: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the
p.000063: purposes of the research and the setting in which the research will be conducted. The IRB should be particularly
p.000063: cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion
p.000063: or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or
p.000063: economically or educationally disadvantaged persons.
p.000063:
p.000063: (4) Informed consent will be sought from each prospective subject or the subject's legally authorized
p.000063: representative, in accordance with, and to the extent required by, §46.116.
p.000063:
p.000063: (5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
p.000063:
p.000063: (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to
p.000063: ensure the safety of subjects.
p.000063:
p.000063: (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
p.000063:
p.000063: confidentiality of data.
p.000063: (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office
p.000063: and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in
p.000063: assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of
p.000063: data.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (8) For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the
p.000063: determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
p.000063:
p.000063: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information
p.000063: or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
p.000063:
p.000063: (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance
p.000063: with §46.117; and
p.000063:
p.000063: (iii) If there is a change made for research purposes in the way the identifiable private information or
p.000063: identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of
p.000063: subjects and to maintain the confidentiality of data.
p.000063:
p.000063: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare
p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000063:
p.000063: (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to
p.000063: research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this
p.000063: section only may apply to research subject to subpart D involving educational tests or the observation of public
p.000063: behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this
p.000063: section may not be applied to research subject to subpart D.
p.000063:
p.000063: (c) [Reserved]
p.000063:
p.000063: (d) Except as described in paragraph (a) of this section, the following categories of human subjects research
p.000063: are exempt from this policy:
p.000063:
p.000063: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves
p.000063: normal educational practices that are not likely to adversely impact students' opportunity to learn required
p.000063: educational content or the assessment of educators who provide instruction. This includes most research on
p.000063: regular and special education instructional strategies, and research on the effectiveness of or the comparison
p.000063: among instructional techniques, curricula, or classroom management methods.
p.000063:
p.000063: (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude,
p.000063: achievement), survey procedures, interview procedures, or observation of public behavior (including visual or
p.000063: auditory recording) if at least one of the following criteria is met:
p.000063: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information
p.000063: from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the
p.000063: subject prospectively agrees to the intervention and information collection and at least one of the following
p.000063: criteria is met:
p.000063:
p.000063: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
...
Searching for indicator impaired:
(return to top)
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
p.000063: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
p.000063:
p.000063: (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees;
...
p.000063: (1) Risks to subjects are minimized:
p.000063:
p.000063: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose
p.000063: subjects to risk, and
p.000063:
p.000063: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
p.000063: treatment purposes.
p.000063:
p.000063: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance
p.000063: of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should
p.000063: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000063: benefits of therapies subjects would receive even if not participating in the research). The IRB should not
p.000063: consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of
p.000063: the research on public policy) as among those research risks that fall within the purview of its responsibility.
p.000063:
p.000063: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the
p.000063: purposes of the research and the setting in which the research will be conducted. The IRB should be particularly
p.000063: cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion
p.000063: or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or
p.000063: economically or educationally disadvantaged persons.
p.000063:
p.000063: (4) Informed consent will be sought from each prospective subject or the subject's legally authorized
p.000063: representative, in accordance with, and to the extent required by, §46.116.
p.000063:
p.000063: (5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
p.000063:
p.000063: (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to
p.000063: ensure the safety of subjects.
p.000063:
p.000063: (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
p.000063:
p.000063: confidentiality of data.
p.000063: (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office
p.000063: and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in
p.000063: assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of
p.000063: data.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (8) For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the
p.000063: determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
p.000063:
p.000063: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information
p.000063: or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
p.000063:
p.000063: (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance
p.000063: with §46.117; and
p.000063:
p.000063: (iii) If there is a change made for research purposes in the way the identifiable private information or
p.000063: identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of
p.000063: subjects and to maintain the confidentiality of data.
p.000063:
p.000063: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare
p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
p.000063: (a) Cooperative research projects are those projects covered by this policy that involve more than one
p.000063: institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the
...
p.000063:
p.000063: (a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s)
p.000063: involved, apart from their membership on the Board.
p.000063:
p.000063: (b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate
p.000063: background and experience to serve in that capacity, except that where a particular research project is reviewed
p.000063: by more than one Board only one Board need satisfy this requirement.
p.000063:
p.000063: [43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: (a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the
p.000063: Board shall review research covered by this subpart and approve such research only if it finds that:
p.000063:
p.000063: (1) The research under review represents one of the categories of research permissible under §46.306(a)(2);
p.000063:
p.000063: (2) Any possible advantages accruing to the prisoner through his or her participation in the research, when
p.000063: compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings
p.000063: in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the
p.000063: value of such advantages in the limited choice environment of the prison is impaired;
p.000063:
p.000063: (3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner
p.000063:
p.000063: volunteers;
p.000063:
p.000063: (4) Procedures for the selection of subjects within the prison are fair to all prisoners and immune from
p.000063: arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board
p.000063: justification in writing for following some other procedures, control subjects must be selected randomly from the
p.000063: group of available prisoners who meet the characteristics needed for that particular research project;
p.000063:
p.000063: (5) The information is presented in language which is understandable to the subject population;
p.000063:
p.000063: (6) Adequate assurance exists that parole boards will not take into account a prisoner's participation in the
p.000063: research in making decisions regarding parole, and each prisoner is clearly informed in advance that
p.000063: participation in the research will have no effect on his or her parole; and
p.000063:
p.000063: (7) Where the Board finds there may be a need for follow-up examination or care of participants after the
p.000063: end of their participation, adequate provision has been made for such examination or care, taking into account
p.000063: the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
p.000063:
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000063: demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit
p.000063: or service programs, including procedures for obtaining benefits or services under those programs, possible
p.000063: changes in or alternatives to those programs or procedures, or possible changes in methods or levels of
p.000063: payment for benefits or services under those programs. Such projects include, but are not limited to, internal
p.000063: studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements,
p.000063: or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as
p.000063: sections 1115 and 1115A of the Social Security Act, as amended.
p.000063:
p.000063: (i) Each Federal department or agency conducting or supporting the research and demonstration projects
p.000063:
p.000063: must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency
p.000063: head may determine, a list of the research and demonstration projects that the Federal department or agency
p.000063: conducts or supports under this provision. The research or demonstration project must be published on this list
p.000063: prior to commencing the research involving human subjects.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (6) Taste and food quality evaluation and consumer acceptance studies:
p.000063:
p.000063: (i) If wholesome foods without additives are consumed, or
p.000063:
p.000063: (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe,
p.000063: or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and
p.000063: Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection
p.000063: Service of the U.S. Department of Agriculture.
p.000063:
p.000063: (7) Storage or maintenance for secondary research for which broad consent is required: Storage or
p.000063: maintenance of identifiable private information or identifiable biospecimens for potential secondary research
p.000063: use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
p.000063:
p.000063: (8) Secondary research for which broad consent is required: Research involving the use of identifiable
p.000063: private information or identifiable biospecimens for secondary research use, if the following criteria are met:
p.000063:
p.000063: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private
p.000063: information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and
p.000063: (d);
p.000063:
p.000063: (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance
p.000063: with §46.117;
p.000063:
p.000063: (iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes
p.000063: the determination that the research to be conducted is within the scope of the broad consent referenced in
p.000063: paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results
...
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
p.000063: (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects
p.000063: only if:
p.000063:
p.000063: (1) The institution responsible for the conduct of the research has certified to the Secretary that the
p.000063: Institutional Review Board has approved the research under §46.305 of this subpart; and
p.000063:
p.000063: (2) In the judgment of the Secretary the proposed research involves solely the following:
p.000063:
p.000063: (i) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided
p.000063: that the study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the
p.000063: study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (iii) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other
p.000063: research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and
p.000063: psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may
p.000063: proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
p.000063: including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
p.000063: supported by DHHS shall not involve prisoners as subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000063: Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.401 To what do these regulations apply?
p.000063:
p.000063: (a) This subpart applies to all research involving children as subjects, conducted or supported by the
p.000063: Department of Health and Human Services.
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
p.000063: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
p.000063:
p.000063: (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees;
p.000063: representative capacity; indications of experience such as board certifications or licenses sufficient to describe
p.000063: each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship
p.000063: between each member and the institution, for example, full-time employee, part-time employee, member of
p.000063: governing panel or board, stockholder, paid or unpaid consultant;
p.000063:
p.000063: (3) Establish and follow written procedures for:
p.000063:
p.000063: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the
p.000063: investigator and the institution;
p.000063:
p.000063: (ii) Determining which projects require review more often than annually and which projects need verification
...
Health / Physically Disabled
Searching for indicator physically:
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p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information
p.000063: from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the
p.000063: subject prospectively agrees to the intervention and information collection and at least one of the following
p.000063: criteria is met:
p.000063:
p.000063: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (C) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless,
p.000063: painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the
p.000063: investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided
p.000063: all such criteria are met, examples of such benign behavioral interventions would include having the subjects
p.000063: play an online game, having them solve puzzles under various noise conditions, or having them decide how to
p.000063: allocate a nominal amount of received cash between themselves and someone else.
p.000063:
p.000063: (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this
p.000063: exemption is not applicable unless the subject authorizes the deception through a prospective agreement to
p.000063: participate in research in circumstances in which the subject is informed that he or she will be unaware of or
p.000063: misled regarding the nature or purposes of the research.
p.000063:
p.000063: (4) Secondary research for which consent is not required: Secondary research uses of identifiable private
p.000063: information or identifiable biospecimens, if at least one of the following criteria is met:
p.000063:
p.000063: (i) The identifiable private information or identifiable biospecimens are publicly available;
p.000063:
p.000063: (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a
p.000063: manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers
p.000063: linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify
p.000063: subjects;
p.000063:
p.000063: (iii) The research involves only information collection and analysis involving the investigator's use of
...
Health / Pregnant
Searching for indicator pregnant:
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p.000062: Download the Code of Federal
p.000062: §46.111 Criteria for IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.112 Review by institution.
p.000062: Download the Electronic Code of Federal
p.000062: §46.113 Suspension or termination of IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.114 Cooperative research.
p.000062: Monthly Title and Part user viewing data §46.115 IRB records.
p.000062: for the e-CFR is available for download in
p.000062: §46.116 General requirements for informed consent.
p.000062: CSV format.
p.000062: §46.117 Documentation of informed consent.
p.000062: Parallel Table of Authorities and Rules §46.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000062: for the Code of Federal Regulations and
p.000062: §46.119 Research undertaken without the intention of involving human subjects.
p.000062: the United States Code
p.000062: Text | PDF §46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by
p.000062: a Federal department or agency.
p.000062: Find, review, and submit comments on
p.000062: Federal rules that are open for comment
p.000062: §46.121 [Reserved]
p.000062: and published in the Federal Register §46.122 Use of Federal funds.
p.000062: using Regulations.gov. §46.123 Early termination of research support: Evaluation of applications and proposals.
p.000062: Purchase individual CFR titles from the
p.000062: §46.124 Conditions.
p.000062: U.S. Government Online Bookstore.
p.000062: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in
p.000062: Find issues of the CFR (including issues Research
p.000062: prior to 1996) at a local Federal
p.000062: depository library.
p.000062: §46.201 To what do these regulations apply?
p.000062: [A2] §46.202 Definitions.
p.000062: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
...
p.000063:
p.000063: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits
p.000063: to which the subject is otherwise entitled, and the subject may discontinue participation at any time without
p.000063: penalty or loss of benefits to which the subject is otherwise entitled; and
p.000063:
p.000063: (9) One of the following statements about any research that involves the collection of identifiable private
p.000063: information or identifiable biospecimens:
p.000063:
p.000063: (i) A statement that identifiers might be removed from the identifiable private information or identifiable
p.000063: biospecimens and that, after such removal, the information or biospecimens could be used for future research
p.000063: studies or distributed to another investigator for future research studies without additional informed consent
p.000063: from the subject or the legally authorized representative, if this might be a possibility; or
p.000063:
p.000063: (ii) A statement that the subject's information or biospecimens collected as part of the research, even if
p.000063: identifiers are removed, will not be used or distributed for future research studies.
p.000063:
p.000063: (c) Additional elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section,
p.000063: one or more of the following elements of information, when appropriate, shall also be provided to each subject
p.000063: or the legally authorized representative:
p.000063:
p.000063: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo
p.000063: or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
p.000063:
p.000063: (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator
p.000063: without regard to the subject's or the legally authorized representative's consent;
p.000063:
p.000063: (3) Any additional costs to the subject that may result from participation in the research;
p.000063:
p.000063: (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly
p.000063: termination of participation by the subject;
p.000063:
p.000063: (5) A statement that significant new findings developed during the course of the research that may relate to
p.000063: the subject's willingness to continue participation will be provided to the subject;
p.000063:
p.000063: (6) The approximate number of subjects involved in the study;
p.000063:
p.000063: (7) A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial
p.000063: profit and whether the subject will or will not share in this commercial profit;
p.000063:
p.000063: (8) A statement regarding whether clinically relevant research results, including individual research results,
p.000063: will be disclosed to subjects, and if so, under what conditions; and
p.000063:
p.000063: (9) For research involving biospecimens, whether the research will (if known) or might include whole genome
p.000063: sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome
p.000063: or exome sequence of that specimen).
p.000063:
p.000063: (d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable
...
p.000063: be terminated or suspended in the manner prescribed in applicable program requirements, when the
p.000063: department or agency head finds an institution has materially failed to comply with the terms of this policy.
p.000063:
p.000063: (b) In making decisions about supporting or approving applications or proposals covered by this policy the
p.000063: department or agency head may take into account, in addition to all other eligibility requirements and program
p.000063: criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph
p.000063: (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the
p.000063: scientific and technical aspects of an activity has/have, in the judgment of the department or agency head,
p.000063: materially failed to discharge responsibility for the protection of the rights and welfare of human subjects
p.000063: (whether or not the research was subject to federal regulation).
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.124 Conditions.
p.000063:
p.000063: With respect to any research project or any class of research projects the department or agency head of
p.000063: either the conducting or the supporting Federal department or agency may impose additional conditions prior to
p.000063: or at the time of approval when in the judgment of the department or agency head additional conditions are
p.000063: necessary for the protection of human subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and
p.000063: Neonates Involved in Research
p.000063: Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
p.000063: Pregnant women or fetuses may be involved in research if all of the following conditions are met:
p.000063:
p.000063: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical
p.000063: studies, including studies on nonpregnant women, have been conducted and provide data for assessing
p.000063: potential risks to pregnant women and fetuses;
p.000063:
p.000063: (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct
p.000063: benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater
p.000063: than minimal and the purpose of the research is the development of important biomedical knowledge which
p.000063: cannot be obtained by any other means;
p.000063:
p.000063: (c) Any risk is the least possible for achieving the objectives of the research;
p.000063:
p.000063: (d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct
p.000063: benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
p.000063: biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
p.000063: informed consent provisions of subpart A of this part;
p.000063:
p.000063: (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the
p.000063: pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this
p.000063: part, except that the father's consent need not be obtained if he is unable to consent because of unavailability,
p.000063: incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
p.000063:
p.000063: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the
p.000063: reasonably foreseeable impact of the research on the fetus or neonate;
p.000063:
p.000063: (g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord
p.000063: with the provisions of subpart D of this part;
p.000063:
p.000063: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
p.000063:
p.000063: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or
p.000063: procedures used to terminate a pregnancy; and
p.000063:
p.000063: (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.205 Research involving neonates.
p.000063:
p.000063: (a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following
p.000063: conditions are met:
p.000063:
p.000063: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for
p.000063: assessing potential risks to neonates.
p.000063:
p.000063: (2) Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed
p.000063: regarding the reasonably foreseeable impact of the research on the neonate.
p.000063:
p.000063: (3) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: (4) The requirements of paragraph (b) or (c) of this section have been met as applicable.
p.000063:
...
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000063:
p.000063: The Secretary will conduct or fund research that the IRB does not believe meets the requirements of §46.204
p.000063: or §46.205 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or
p.000063: neonates; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, ethics, law) and following opportunity for public review and comment, including a public meeting
p.000063: announced in the Federal Register, has determined either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.204, as applicable; or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;
p.000063:
p.000063: (ii) The research will be conducted in accord with sound ethical principles; and
p.000063:
p.000063: (iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other
p.000063: applicable subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral
p.000063: Research Involving Prisoners as Subjects
p.000063: Source: 43 FR 53655, Nov. 16, 1978, unless otherwise noted.
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
...
Health / alcoholism
Searching for indicator alcoholism:
(return to top)
p.000063: the duties of the Board under this section have been fulfilled.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
p.000063: (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects
p.000063: only if:
p.000063:
p.000063: (1) The institution responsible for the conduct of the research has certified to the Secretary that the
p.000063: Institutional Review Board has approved the research under §46.305 of this subpart; and
p.000063:
p.000063: (2) In the judgment of the Secretary the proposed research involves solely the following:
p.000063:
p.000063: (i) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided
p.000063: that the study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the
p.000063: study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (iii) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other
p.000063: research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and
p.000063: psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may
p.000063: proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
p.000063: including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
p.000063: supported by DHHS shall not involve prisoners as subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000063: Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.401 To what do these regulations apply?
p.000063:
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p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
p.000063: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
p.000063:
p.000063: (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees;
p.000063: representative capacity; indications of experience such as board certifications or licenses sufficient to describe
p.000063: each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship
p.000063: between each member and the institution, for example, full-time employee, part-time employee, member of
p.000063: governing panel or board, stockholder, paid or unpaid consultant;
p.000063:
p.000063: (3) Establish and follow written procedures for:
p.000063:
p.000063: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the
p.000063: investigator and the institution;
p.000063:
p.000063: (ii) Determining which projects require review more often than annually and which projects need verification
p.000063: from sources other than the investigators that no material changes have occurred since previous IRB review; and
p.000063:
p.000063: (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that
p.000063: investigators will conduct the research activity in accordance with the terms of the IRB approval until any
p.000063: proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent
p.000063: immediate hazards to the subject.
p.000063:
p.000063: (4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate
p.000063: institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or
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p.000063: Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate
p.000063: from an administrative standpoint.
p.000063:
p.000063: (2) It also includes research conducted or supported by the Department of Health and Human Services
p.000063: outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of §46.101
p.000063: of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
p.000063:
p.000063: (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of
p.000063: §46.101 of Subpart A are applicable to this subpart.
p.000063:
p.000063: [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.402 Definitions.
p.000063:
p.000063: The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this
p.000063: subpart:
p.000063:
p.000063: (a) Children are persons who have not attained the legal age for consent to treatments or procedures
p.000063: involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
p.000063:
p.000063: (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should
p.000063: not, absent affirmative agreement, be construed as assent.
p.000063:
p.000063: (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in
p.000063: research.
p.000063:
p.000063: (d) Parent means a child's biological or adoptive parent.
p.000063:
p.000063: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000063: of a child to general medical care.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.403 IRB duties.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.404 Research not involving greater than minimal risk.
p.000063:
...
p.000063: under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained
p.000063: from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or
p.000063: not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
p.000063:
p.000063: (c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a
p.000063: research protocol is designed for conditions or for a subject population for which parental or guardian
p.000063: permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children),
p.000063: it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an
p.000063: appropriate mechanism for protecting the children who will participate as subjects in the research is substituted,
p.000063: and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an
p.000063: appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol,
p.000063: the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
p.000063:
p.000063: (d) Permission by parents or guardians shall be documented in accordance with and to the extent required
p.000063: by §46.117 of Subpart A.
p.000063:
p.000063: (e) When the IRB determines that assent is required, it shall also determine whether and how assent must
p.000063: be documented.
p.000063:
p.000063: Back to Top
p.000063: §46.409 Wards.
p.000063:
p.000063: (a) Children who are wards of the state or any other agency, institution, or entity can be included in research
p.000063: approved under §46.406 or §46.407 only if such research is:
p.000063: (1) Related to their status as wards; or
p.000063:
p.000063: (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.000063: involved as subjects are not wards.
p.000063:
p.000063: (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an
p.000063: advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as
p.000063: guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall
p.000063: be an individual who has the background and experience to act in, and agrees to act in, the best interests of the
p.000063: child for the duration of the child's participation in the research and who is not associated in any way (except in
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Searching for indicator child:
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p.000063: of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
p.000063:
p.000063: (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of
p.000063: §46.101 of Subpart A are applicable to this subpart.
p.000063:
p.000063: [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.402 Definitions.
p.000063:
p.000063: The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this
p.000063: subpart:
p.000063:
p.000063: (a) Children are persons who have not attained the legal age for consent to treatments or procedures
p.000063: involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
p.000063:
p.000063: (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should
p.000063: not, absent affirmative agreement, be construed as assent.
p.000063:
p.000063: (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in
p.000063: research.
p.000063:
p.000063: (d) Parent means a child's biological or adoptive parent.
p.000063:
p.000063: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000063: of a child to general medical care.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.403 IRB duties.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.404 Research not involving greater than minimal risk.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is
p.000063: presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and
p.000063: the permission of their parents or guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000063: the individual subjects.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
...
p.000063: (ii) The research will be conducted in accordance with sound ethical principles;
p.000063:
p.000063: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000063:
p.000063: (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of
p.000063: the IRB the children are capable of providing assent. In determining whether children are capable of assenting,
p.000063: the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment
p.000063: may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB
p.000063: deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.000063: cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a
p.000063: prospect of direct benefit that is important to the health or well-being of the children and is available only in the
p.000063: context of the research, the assent of the children is not a necessary condition for proceeding with the research.
p.000063: Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000063: requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.
p.000063:
p.000063: (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate
p.000063: provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission
p.000063: is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000063: under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained
p.000063: from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or
p.000063: not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
p.000063:
p.000063: (c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a
p.000063: research protocol is designed for conditions or for a subject population for which parental or guardian
p.000063: permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children),
p.000063: it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an
p.000063: appropriate mechanism for protecting the children who will participate as subjects in the research is substituted,
p.000063: and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an
p.000063: appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol,
p.000063: the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
p.000063:
p.000063: (d) Permission by parents or guardians shall be documented in accordance with and to the extent required
p.000063: by §46.117 of Subpart A.
p.000063:
p.000063: (e) When the IRB determines that assent is required, it shall also determine whether and how assent must
p.000063: be documented.
p.000063:
p.000063: Back to Top
p.000063: §46.409 Wards.
p.000063:
p.000063: (a) Children who are wards of the state or any other agency, institution, or entity can be included in research
p.000063: approved under §46.406 or §46.407 only if such research is:
p.000063: (1) Related to their status as wards; or
p.000063:
p.000063: (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.000063: involved as subjects are not wards.
p.000063:
p.000063: (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an
p.000063: advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as
p.000063: guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall
p.000063: be an individual who has the background and experience to act in, and agrees to act in, the best interests of the
p.000063: child for the duration of the child's participation in the research and who is not associated in any way (except in
p.000063: the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart E—Registration of Institutional Review Boards
p.000063: Source: 74 FR 2405, Jan. 15, 2009, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.501 What IRBs must be registered?
p.000063:
p.000063: Each IRB that is designated by an institution under an assurance of compliance approved for federalwide
p.000063: use by the Office for Human Research Protections (OHRP) under §46.103(a) and that reviews research involving
p.000063: human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000063: registered with HHS. An individual authorized to act on behalf of the institution or organization operating the IRB
p.000063: must submit the registration information.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.502 What information must be provided when registering an IRB?
p.000063:
p.000063: The following information must be provided to HHS when registering an IRB:
p.000063:
p.000063: (a) The name, mailing address, and street address (if different from the mailing address) of the institution or
p.000063: organization operating the IRB(s); and the name, mailing address, phone number, facsimile number, and
p.000063: electronic mail address of the senior officer or head official of that institution or organization who is responsible
p.000063: for overseeing activities performed by the IRB.
p.000063:
p.000063: (b) The name, mailing address, phone number, facsimile number, and electronic mail address of the contact
p.000063: person providing the registration information.
p.000063:
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p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of children.
p.000062: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000062: §46.409 Wards.
p.000062:
p.000062: Subpart E—Registration of Institutional Review Boards
p.000062:
p.000062: §46.501 What IRBs must be registered?
p.000062: §46.502 What information must be provided when registering an IRB?
p.000062: §46.503 When must an IRB be registered?
p.000062: §46.504 How must an IRB be registered?
p.000062: §46.505 When must IRB registration information be renewed or updated?
p.000062:
p.000062:
p.000062: Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
p.000062:
p.000062: Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in
p.000062: part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the
p.000062: Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program.
p.000062: For further information see 47 FR 9208, Mar. 4, 1982.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062: Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062:
p.000062: (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted,
p.000062: supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate
p.000062: administrative action to make the policy applicable to such research. This includes research conducted by
...
p.000063: requirements to return individual research results.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
p.000063: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
p.000063:
...
p.000063: requirements are satisfied:
p.000063:
p.000063: (1) Risks to subjects are minimized:
p.000063:
p.000063: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose
p.000063: subjects to risk, and
p.000063:
p.000063: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
p.000063: treatment purposes.
p.000063:
p.000063: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance
p.000063: of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should
p.000063: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000063: benefits of therapies subjects would receive even if not participating in the research). The IRB should not
p.000063: consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of
p.000063: the research on public policy) as among those research risks that fall within the purview of its responsibility.
p.000063:
p.000063: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the
p.000063: purposes of the research and the setting in which the research will be conducted. The IRB should be particularly
p.000063: cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion
p.000063: or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or
p.000063: economically or educationally disadvantaged persons.
p.000063:
p.000063: (4) Informed consent will be sought from each prospective subject or the subject's legally authorized
p.000063: representative, in accordance with, and to the extent required by, §46.116.
p.000063:
p.000063: (5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
p.000063:
p.000063: (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to
p.000063: ensure the safety of subjects.
p.000063:
p.000063: (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
p.000063:
p.000063: confidentiality of data.
p.000063: (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office
p.000063: and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in
p.000063: assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of
p.000063: data.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (8) For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the
p.000063: determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
p.000063:
p.000063: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information
p.000063: or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
p.000063:
p.000063: (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance
p.000063: with §46.117; and
p.000063:
p.000063: (iii) If there is a change made for research purposes in the way the identifiable private information or
p.000063: identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of
p.000063: subjects and to maintain the confidentiality of data.
p.000063:
p.000063: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare
p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
...
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
p.000063: biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
p.000063: informed consent provisions of subpart A of this part;
p.000063:
p.000063: (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the
p.000063: pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this
p.000063: part, except that the father's consent need not be obtained if he is unable to consent because of unavailability,
p.000063: incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
p.000063:
p.000063: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the
p.000063: reasonably foreseeable impact of the research on the fetus or neonate;
p.000063:
p.000063: (g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord
p.000063: with the provisions of subpart D of this part;
p.000063:
p.000063: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
p.000063:
p.000063: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or
p.000063: procedures used to terminate a pregnancy; and
p.000063:
p.000063: (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.205 Research involving neonates.
p.000063:
p.000063: (a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following
p.000063: conditions are met:
p.000063:
p.000063: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for
p.000063: assessing potential risks to neonates.
p.000063:
p.000063: (2) Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed
p.000063: regarding the reasonably foreseeable impact of the research on the neonate.
p.000063:
p.000063: (3) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
...
p.000063: research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and
p.000063: psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may
p.000063: proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
p.000063: including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
p.000063: supported by DHHS shall not involve prisoners as subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000063: Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.401 To what do these regulations apply?
p.000063:
p.000063: (a) This subpart applies to all research involving children as subjects, conducted or supported by the
p.000063: Department of Health and Human Services.
p.000063:
p.000063: (1) This includes research conducted by Department employees, except that each head of an Operating
p.000063: Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate
p.000063: from an administrative standpoint.
p.000063:
p.000063: (2) It also includes research conducted or supported by the Department of Health and Human Services
p.000063: outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of §46.101
p.000063: of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
p.000063:
p.000063: (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of
p.000063: §46.101 of Subpart A are applicable to this subpart.
p.000063:
p.000063: [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.402 Definitions.
p.000063:
p.000063: The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this
p.000063: subpart:
p.000063:
p.000063: (a) Children are persons who have not attained the legal age for consent to treatments or procedures
p.000063: involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
p.000063:
p.000063: (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should
p.000063: not, absent affirmative agreement, be construed as assent.
p.000063:
p.000063: (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in
p.000063: research.
p.000063:
p.000063: (d) Parent means a child's biological or adoptive parent.
p.000063:
p.000063: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000063: of a child to general medical care.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.403 IRB duties.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.404 Research not involving greater than minimal risk.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is
p.000063: presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and
p.000063: the permission of their parents or guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000063: the individual subjects.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
p.000063: subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds
p.000063: that:
p.000063:
p.000063: (a) The risk is justified by the anticipated benefit to the subjects;
p.000063:
p.000063: (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented
p.000063: by available alternative approaches; and
p.000063:
p.000063: (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual
p.000063: subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the
p.000063: individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000063: only if the IRB finds that:
p.000063:
p.000063: (a) The risk represents a minor increase over minimal risk;
p.000063:
p.000063: (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with
p.000063: those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
p.000063:
p.000063: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or
p.000063: condition which is of vital importance for the understanding or amelioration of the subjects' disorder or
p.000063: condition; and
p.000063:
p.000063: (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of children.
p.000063:
p.000063: HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405,
p.000063: or §46.406 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of children; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, education, ethics, law) and following opportunity for public review and comment, has determined
p.000063: either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of children;
p.000063:
p.000063: (ii) The research will be conducted in accordance with sound ethical principles;
p.000063:
p.000063: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000063:
p.000063: (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of
p.000063: the IRB the children are capable of providing assent. In determining whether children are capable of assenting,
p.000063: the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment
p.000063: may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB
p.000063: deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.000063: cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a
p.000063: prospect of direct benefit that is important to the health or well-being of the children and is available only in the
p.000063: context of the research, the assent of the children is not a necessary condition for proceeding with the research.
p.000063: Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000063: requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.
p.000063:
p.000063: (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate
p.000063: provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission
p.000063: is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000063: under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained
p.000063: from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or
p.000063: not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
p.000063:
p.000063: (c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a
p.000063: research protocol is designed for conditions or for a subject population for which parental or guardian
p.000063: permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children),
p.000063: it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an
p.000063: appropriate mechanism for protecting the children who will participate as subjects in the research is substituted,
p.000063: and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an
p.000063: appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol,
p.000063: the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
p.000063:
p.000063: (d) Permission by parents or guardians shall be documented in accordance with and to the extent required
p.000063: by §46.117 of Subpart A.
p.000063:
p.000063: (e) When the IRB determines that assent is required, it shall also determine whether and how assent must
p.000063: be documented.
p.000063:
p.000063: Back to Top
p.000063: §46.409 Wards.
p.000063:
p.000063: (a) Children who are wards of the state or any other agency, institution, or entity can be included in research
p.000063: approved under §46.406 or §46.407 only if such research is:
p.000063: (1) Related to their status as wards; or
p.000063:
p.000063: (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.000063: involved as subjects are not wards.
p.000063:
p.000063: (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an
p.000063: advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as
p.000063: guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall
p.000063: be an individual who has the background and experience to act in, and agrees to act in, the best interests of the
p.000063: child for the duration of the child's participation in the research and who is not associated in any way (except in
p.000063: the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart E—Registration of Institutional Review Boards
p.000063: Source: 74 FR 2405, Jan. 15, 2009, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.501 What IRBs must be registered?
p.000063:
p.000063: Each IRB that is designated by an institution under an assurance of compliance approved for federalwide
p.000063: use by the Office for Human Research Protections (OHRP) under §46.103(a) and that reviews research involving
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.000062: Purchase individual CFR titles from the
p.000062: §46.124 Conditions.
p.000062: U.S. Government Online Bookstore.
p.000062: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in
p.000062: Find issues of the CFR (including issues Research
p.000062: prior to 1996) at a local Federal
p.000062: depository library.
p.000062: §46.201 To what do these regulations apply?
p.000062: [A2] §46.202 Definitions.
p.000062: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
...
p.000063: subjects' rights, and whom to contact in the event of a research-related injury to the subject;
p.000063:
p.000063: (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits
p.000063: to which the subject is otherwise entitled, and the subject may discontinue participation at any time without
p.000063: penalty or loss of benefits to which the subject is otherwise entitled; and
p.000063:
p.000063: (9) One of the following statements about any research that involves the collection of identifiable private
p.000063: information or identifiable biospecimens:
p.000063:
p.000063: (i) A statement that identifiers might be removed from the identifiable private information or identifiable
p.000063: biospecimens and that, after such removal, the information or biospecimens could be used for future research
p.000063: studies or distributed to another investigator for future research studies without additional informed consent
p.000063: from the subject or the legally authorized representative, if this might be a possibility; or
p.000063:
p.000063: (ii) A statement that the subject's information or biospecimens collected as part of the research, even if
p.000063: identifiers are removed, will not be used or distributed for future research studies.
p.000063:
p.000063: (c) Additional elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section,
p.000063: one or more of the following elements of information, when appropriate, shall also be provided to each subject
p.000063: or the legally authorized representative:
p.000063:
p.000063: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo
p.000063: or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
p.000063:
p.000063: (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator
p.000063: without regard to the subject's or the legally authorized representative's consent;
p.000063:
p.000063: (3) Any additional costs to the subject that may result from participation in the research;
p.000063:
p.000063: (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly
p.000063: termination of participation by the subject;
p.000063:
p.000063: (5) A statement that significant new findings developed during the course of the research that may relate to
p.000063: the subject's willingness to continue participation will be provided to the subject;
p.000063:
p.000063: (6) The approximate number of subjects involved in the study;
p.000063:
p.000063: (7) A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial
p.000063: profit and whether the subject will or will not share in this commercial profit;
p.000063:
p.000063: (8) A statement regarding whether clinically relevant research results, including individual research results,
p.000063: will be disclosed to subjects, and if so, under what conditions; and
p.000063:
p.000063: (9) For research involving biospecimens, whether the research will (if known) or might include whole genome
p.000063: sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome
p.000063: or exome sequence of that specimen).
p.000063:
p.000063: (d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable
...
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
...
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
p.000063: Pregnant women or fetuses may be involved in research if all of the following conditions are met:
p.000063:
p.000063: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical
p.000063: studies, including studies on nonpregnant women, have been conducted and provide data for assessing
p.000063: potential risks to pregnant women and fetuses;
p.000063:
p.000063: (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct
p.000063: benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater
p.000063: than minimal and the purpose of the research is the development of important biomedical knowledge which
p.000063: cannot be obtained by any other means;
p.000063:
p.000063: (c) Any risk is the least possible for achieving the objectives of the research;
p.000063:
p.000063: (d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct
p.000063: benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
p.000063: biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
p.000063: informed consent provisions of subpart A of this part;
p.000063:
p.000063: (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the
p.000063: pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this
p.000063: part, except that the father's consent need not be obtained if he is unable to consent because of unavailability,
p.000063: incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
p.000063:
p.000063: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the
p.000063: reasonably foreseeable impact of the research on the fetus or neonate;
p.000063:
p.000063: (g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord
p.000063: with the provisions of subpart D of this part;
p.000063:
p.000063: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
p.000063:
p.000063: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or
p.000063: procedures used to terminate a pregnancy; and
p.000063:
p.000063: (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.205 Research involving neonates.
p.000063:
p.000063: (a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following
p.000063: conditions are met:
p.000063:
p.000063: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for
p.000063: assessing potential risks to neonates.
p.000063:
...
p.000063: either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the
p.000063: informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph
p.000063: (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
p.000063: The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000063:
p.000063: The Secretary will conduct or fund research that the IRB does not believe meets the requirements of §46.204
p.000063: or §46.205 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or
...
Searching for indicator neonate:
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p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
p.000063: Pregnant women or fetuses may be involved in research if all of the following conditions are met:
p.000063:
p.000063: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical
...
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
p.000063: biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
p.000063: informed consent provisions of subpart A of this part;
p.000063:
p.000063: (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the
p.000063: pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this
p.000063: part, except that the father's consent need not be obtained if he is unable to consent because of unavailability,
p.000063: incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
p.000063:
p.000063: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the
p.000063: reasonably foreseeable impact of the research on the fetus or neonate;
p.000063:
p.000063: (g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord
p.000063: with the provisions of subpart D of this part;
p.000063:
p.000063: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
p.000063:
p.000063: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or
p.000063: procedures used to terminate a pregnancy; and
p.000063:
p.000063: (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.205 Research involving neonates.
p.000063:
p.000063: (a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following
p.000063: conditions are met:
p.000063:
p.000063: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for
p.000063: assessing potential risks to neonates.
p.000063:
p.000063: (2) Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed
p.000063: regarding the reasonably foreseeable impact of the research on the neonate.
p.000063:
p.000063: (3) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: (4) The requirements of paragraph (b) or (c) of this section have been met as applicable.
p.000063:
p.000063: (b) Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a
p.000063: neonate may not be involved in research covered by this subpart unless the following additional conditions are
p.000063: met:
p.000063:
p.000063: (1) The IRB determines that:
p.000063:
p.000063: (i) The research holds out the prospect of enhancing the probability of survival of the neonate to the point of
p.000063:
p.000063: viability, and any risk is the least possible for achieving that objective, or
p.000063:
p.000063: (ii) The purpose of the research is the development of important biomedical knowledge which cannot be
p.000063: obtained by other means and there will be no added risk to the neonate resulting from the research; and
p.000063: (2) The legally effective informed consent of either parent of the neonate or, if neither parent is able to
p.000063: consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent
p.000063: of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that
p.000063: the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted
p.000063: from rape or incest.
p.000063:
p.000063: (c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this
p.000063: subpart unless all of the following additional conditions are met:
p.000063:
p.000063: (1) Vital functions of the neonate will not be artificially maintained;
p.000063:
p.000063: (2) The research will not terminate the heartbeat or respiration of the neonate;
p.000063:
p.000063: (3) There will be no added risk to the neonate resulting from the research;
p.000063:
p.000063: (4) The purpose of the research is the development of important biomedical knowledge that cannot be
p.000063: obtained by other means; and
p.000063:
p.000063: (5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart
p.000063: A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) do not apply. However, if
p.000063: either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the
p.000063: informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph
p.000063: (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
p.000063: The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
...
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p.000062: Regulations in XML.
p.000062: §46.112 Review by institution.
p.000062: Download the Electronic Code of Federal
p.000062: §46.113 Suspension or termination of IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.114 Cooperative research.
p.000062: Monthly Title and Part user viewing data §46.115 IRB records.
p.000062: for the e-CFR is available for download in
p.000062: §46.116 General requirements for informed consent.
p.000062: CSV format.
p.000062: §46.117 Documentation of informed consent.
p.000062: Parallel Table of Authorities and Rules §46.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000062: for the Code of Federal Regulations and
p.000062: §46.119 Research undertaken without the intention of involving human subjects.
p.000062: the United States Code
p.000062: Text | PDF §46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by
p.000062: a Federal department or agency.
p.000062: Find, review, and submit comments on
p.000062: Federal rules that are open for comment
p.000062: §46.121 [Reserved]
p.000062: and published in the Federal Register §46.122 Use of Federal funds.
p.000062: using Regulations.gov. §46.123 Early termination of research support: Evaluation of applications and proposals.
p.000062: Purchase individual CFR titles from the
p.000062: §46.124 Conditions.
p.000062: U.S. Government Online Bookstore.
p.000062: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in
p.000062: Find issues of the CFR (including issues Research
p.000062: prior to 1996) at a local Federal
p.000062: depository library.
p.000062: §46.201 To what do these regulations apply?
p.000062: [A2] §46.202 Definitions.
p.000062: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
...
p.000063: department or agency head finds an institution has materially failed to comply with the terms of this policy.
p.000063:
p.000063: (b) In making decisions about supporting or approving applications or proposals covered by this policy the
p.000063: department or agency head may take into account, in addition to all other eligibility requirements and program
p.000063: criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph
p.000063: (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the
p.000063: scientific and technical aspects of an activity has/have, in the judgment of the department or agency head,
p.000063: materially failed to discharge responsibility for the protection of the rights and welfare of human subjects
p.000063: (whether or not the research was subject to federal regulation).
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.124 Conditions.
p.000063:
p.000063: With respect to any research project or any class of research projects the department or agency head of
p.000063: either the conducting or the supporting Federal department or agency may impose additional conditions prior to
p.000063: or at the time of approval when in the judgment of the department or agency head additional conditions are
p.000063: necessary for the protection of human subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and
p.000063: Neonates Involved in Research
p.000063: Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
...
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
p.000063: Pregnant women or fetuses may be involved in research if all of the following conditions are met:
p.000063:
p.000063: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical
p.000063: studies, including studies on nonpregnant women, have been conducted and provide data for assessing
p.000063: potential risks to pregnant women and fetuses;
p.000063:
p.000063: (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct
p.000063: benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater
p.000063: than minimal and the purpose of the research is the development of important biomedical knowledge which
p.000063: cannot be obtained by any other means;
p.000063:
p.000063: (c) Any risk is the least possible for achieving the objectives of the research;
p.000063:
p.000063: (d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct
p.000063: benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
...
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000063:
p.000063: The Secretary will conduct or fund research that the IRB does not believe meets the requirements of §46.204
p.000063: or §46.205 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or
p.000063: neonates; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, ethics, law) and following opportunity for public review and comment, including a public meeting
p.000063: announced in the Federal Register, has determined either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.204, as applicable; or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;
p.000063:
p.000063: (ii) The research will be conducted in accord with sound ethical principles; and
p.000063:
p.000063: (iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other
p.000063: applicable subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral
p.000063: Research Involving Prisoners as Subjects
p.000063: Source: 43 FR 53655, Nov. 16, 1978, unless otherwise noted.
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
...
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p.000062: Download the Electronic Code of Federal
p.000062: §46.113 Suspension or termination of IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.114 Cooperative research.
p.000062: Monthly Title and Part user viewing data §46.115 IRB records.
p.000062: for the e-CFR is available for download in
p.000062: §46.116 General requirements for informed consent.
p.000062: CSV format.
p.000062: §46.117 Documentation of informed consent.
p.000062: Parallel Table of Authorities and Rules §46.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000062: for the Code of Federal Regulations and
p.000062: §46.119 Research undertaken without the intention of involving human subjects.
p.000062: the United States Code
p.000062: Text | PDF §46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by
p.000062: a Federal department or agency.
p.000062: Find, review, and submit comments on
p.000062: Federal rules that are open for comment
p.000062: §46.121 [Reserved]
p.000062: and published in the Federal Register §46.122 Use of Federal funds.
p.000062: using Regulations.gov. §46.123 Early termination of research support: Evaluation of applications and proposals.
p.000062: Purchase individual CFR titles from the
p.000062: §46.124 Conditions.
p.000062: U.S. Government Online Bookstore.
p.000062: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in
p.000062: Find issues of the CFR (including issues Research
p.000062: prior to 1996) at a local Federal
p.000062: depository library.
p.000062: §46.201 To what do these regulations apply?
p.000062: [A2] §46.202 Definitions.
p.000062: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of children.
...
p.000063:
p.000063: (b) In making decisions about supporting or approving applications or proposals covered by this policy the
p.000063: department or agency head may take into account, in addition to all other eligibility requirements and program
p.000063: criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph
p.000063: (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the
p.000063: scientific and technical aspects of an activity has/have, in the judgment of the department or agency head,
p.000063: materially failed to discharge responsibility for the protection of the rights and welfare of human subjects
p.000063: (whether or not the research was subject to federal regulation).
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.124 Conditions.
p.000063:
p.000063: With respect to any research project or any class of research projects the department or agency head of
p.000063: either the conducting or the supporting Federal department or agency may impose additional conditions prior to
p.000063: or at the time of approval when in the judgment of the department or agency head additional conditions are
p.000063: necessary for the protection of human subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and
p.000063: Neonates Involved in Research
p.000063: Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
...
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
p.000063: Pregnant women or fetuses may be involved in research if all of the following conditions are met:
p.000063:
p.000063: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical
p.000063: studies, including studies on nonpregnant women, have been conducted and provide data for assessing
p.000063: potential risks to pregnant women and fetuses;
p.000063:
p.000063: (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct
...
p.000063: part, except that the father's consent need not be obtained if he is unable to consent because of unavailability,
p.000063: incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
p.000063:
p.000063: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the
p.000063: reasonably foreseeable impact of the research on the fetus or neonate;
p.000063:
p.000063: (g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord
p.000063: with the provisions of subpart D of this part;
p.000063:
p.000063: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
p.000063:
p.000063: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or
p.000063: procedures used to terminate a pregnancy; and
p.000063:
p.000063: (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.205 Research involving neonates.
p.000063:
p.000063: (a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following
p.000063: conditions are met:
p.000063:
p.000063: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for
p.000063: assessing potential risks to neonates.
p.000063:
p.000063: (2) Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed
p.000063: regarding the reasonably foreseeable impact of the research on the neonate.
p.000063:
p.000063: (3) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: (4) The requirements of paragraph (b) or (c) of this section have been met as applicable.
p.000063:
p.000063: (b) Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a
p.000063: neonate may not be involved in research covered by this subpart unless the following additional conditions are
p.000063: met:
p.000063:
p.000063: (1) The IRB determines that:
p.000063:
p.000063: (i) The research holds out the prospect of enhancing the probability of survival of the neonate to the point of
p.000063:
p.000063: viability, and any risk is the least possible for achieving that objective, or
p.000063:
p.000063: (ii) The purpose of the research is the development of important biomedical knowledge which cannot be
p.000063: obtained by other means and there will be no added risk to the neonate resulting from the research; and
p.000063: (2) The legally effective informed consent of either parent of the neonate or, if neither parent is able to
p.000063: consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent
p.000063: of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that
p.000063: the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted
p.000063: from rape or incest.
p.000063:
p.000063: (c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this
p.000063: subpart unless all of the following additional conditions are met:
p.000063:
p.000063: (1) Vital functions of the neonate will not be artificially maintained;
p.000063:
p.000063: (2) The research will not terminate the heartbeat or respiration of the neonate;
p.000063:
p.000063: (3) There will be no added risk to the neonate resulting from the research;
p.000063:
p.000063: (4) The purpose of the research is the development of important biomedical knowledge that cannot be
p.000063: obtained by other means; and
p.000063:
p.000063: (5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart
p.000063: A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) do not apply. However, if
p.000063: either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the
p.000063: informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph
p.000063: (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
p.000063: The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000063:
p.000063: The Secretary will conduct or fund research that the IRB does not believe meets the requirements of §46.204
p.000063: or §46.205 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or
p.000063: neonates; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, ethics, law) and following opportunity for public review and comment, including a public meeting
p.000063: announced in the Federal Register, has determined either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.204, as applicable; or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;
p.000063:
p.000063: (ii) The research will be conducted in accord with sound ethical principles; and
p.000063:
p.000063: (iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other
p.000063: applicable subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral
p.000063: Research Involving Prisoners as Subjects
p.000063: Source: 43 FR 53655, Nov. 16, 1978, unless otherwise noted.
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
p.000063: ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it
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Social / Incarcerated
Searching for indicator incarcerated:
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p.000063: end of their participation, adequate provision has been made for such examination or care, taking into account
p.000063: the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
p.000063:
p.000063: (b) The Board shall carry out such other duties as may be assigned by the Secretary.
p.000063:
p.000063: (c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that
p.000063: the duties of the Board under this section have been fulfilled.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
p.000063: (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects
p.000063: only if:
p.000063:
p.000063: (1) The institution responsible for the conduct of the research has certified to the Secretary that the
p.000063: Institutional Review Board has approved the research under §46.305 of this subpart; and
p.000063:
p.000063: (2) In the judgment of the Secretary the proposed research involves solely the following:
p.000063:
p.000063: (i) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided
p.000063: that the study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the
p.000063: study presents no more than minimal risk and no more than inconvenience to the subjects;
p.000063:
p.000063: (iii) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other
p.000063: research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and
p.000063: psychological problems such as alcoholism, drug addiction and sexual assaults) provided that the study may
p.000063: proceed only after the Secretary has consulted with appropriate experts including experts in penology medicine
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
p.000063: including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
...
Searching for indicator prison:
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p.000063:
p.000063: (b) DHHS means the Department of Health and Human Services.
p.000063:
p.000063: (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is
p.000063: intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
p.000063: detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal
p.000063: prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or
p.000063: sentencing.
p.000063:
p.000063: (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally
p.000063: encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out
p.000063: responsibilities under this part with respect to research covered by this subpart, shall also meet the following
p.000063: specific requirements:
p.000063:
p.000063: (a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s)
p.000063: involved, apart from their membership on the Board.
p.000063:
p.000063: (b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate
p.000063: background and experience to serve in that capacity, except that where a particular research project is reviewed
p.000063: by more than one Board only one Board need satisfy this requirement.
p.000063:
p.000063: [43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: (a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the
p.000063: Board shall review research covered by this subpart and approve such research only if it finds that:
p.000063:
p.000063: (1) The research under review represents one of the categories of research permissible under §46.306(a)(2);
p.000063:
p.000063: (2) Any possible advantages accruing to the prisoner through his or her participation in the research, when
p.000063: compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings
p.000063: in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the
p.000063: value of such advantages in the limited choice environment of the prison is impaired;
p.000063:
p.000063: (3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner
p.000063:
p.000063: volunteers;
p.000063:
p.000063: (4) Procedures for the selection of subjects within the prison are fair to all prisoners and immune from
p.000063: arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board
p.000063: justification in writing for following some other procedures, control subjects must be selected randomly from the
p.000063: group of available prisoners who meet the characteristics needed for that particular research project;
p.000063:
p.000063: (5) The information is presented in language which is understandable to the subject population;
p.000063:
p.000063: (6) Adequate assurance exists that parole boards will not take into account a prisoner's participation in the
p.000063: research in making decisions regarding parole, and each prisoner is clearly informed in advance that
p.000063: participation in the research will have no effect on his or her parole; and
p.000063:
p.000063: (7) Where the Board finds there may be a need for follow-up examination or care of participants after the
p.000063: end of their participation, adequate provision has been made for such examination or care, taking into account
p.000063: the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
p.000063:
p.000063: (b) The Board shall carry out such other duties as may be assigned by the Secretary.
p.000063:
p.000063: (c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that
p.000063: the duties of the Board under this section have been fulfilled.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
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Social / Linguistic Proficiency
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p.000063: through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance
p.000063: with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research
p.000063: uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in
p.000063: research involving public benefit and service programs conducted by or subject to the approval of state or local
p.000063: officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is
p.000063: described in paragraph (f) of this section. Except as provided elsewhere in this policy:
p.000063:
p.000063: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally
p.000063: effective informed consent of the subject or the subject's legally authorized representative.
p.000063:
p.000063: (2) An investigator shall seek informed consent only under circumstances that provide the prospective
p.000063: subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to
p.000063: participate and that minimize the possibility of coercion or undue influence.
p.000063:
p.000063: (3) The information that is given to the subject or the legally authorized representative shall be in language
p.000063: understandable to the subject or the legally authorized representative.
p.000063:
p.000063: (4) The prospective subject or the legally authorized representative must be provided with the information
p.000063: that a reasonable person would want to have in order to make an informed decision about whether to
p.000063: participate, and an opportunity to discuss that information.
p.000063:
p.000063: (5) Except for broad consent obtained in accordance with paragraph (d) of this section:
p.000063:
p.000063: (i) Informed consent must begin with a concise and focused presentation of the key information that is most
p.000063: likely to assist a prospective subject or legally authorized representative in understanding the reasons why one
p.000063: might or might not want to participate in the research. This part of the informed consent must be organized and
p.000063: presented in a way that facilitates comprehension.
p.000063:
p.000063: (ii) Informed consent as a whole must present information in sufficient detail relating to the research, and
p.000063: must be organized and presented in a way that does not merely provide lists of isolated facts, but rather
p.000063: facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one
p.000063: might or might not want to participate.
p.000063:
p.000063: (6) No informed consent may include any exculpatory language through which the subject or the legally
p.000063: authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or
p.000063: appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
p.000063:
p.000063:
p.000063: (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in
p.000063: seeking informed consent the following information shall be provided to each subject or the legally authorized
p.000063: representative:
p.000063:
p.000063: (1) A statement that the study involves research, an explanation of the purposes of the research and the
p.000063: expected duration of the subject's participation, a description of the procedures to be followed, and
p.000063: identification of any procedures that are experimental;
p.000063:
p.000063: (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.000063:
p.000063: (3) A description of any benefits to the subject or to others that may reasonably be expected from the
p.000063: research;
p.000063:
p.000063: (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
p.000063: advantageous to the subject;
p.000063:
p.000063: (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
p.000063: maintained;
p.000063:
p.000063: (6) For research involving more than minimal risk, an explanation as to whether any compensation and an
p.000063: explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or
p.000063: where further information may be obtained;
p.000063:
...
p.000063: Board shall review research covered by this subpart and approve such research only if it finds that:
p.000063:
p.000063: (1) The research under review represents one of the categories of research permissible under §46.306(a)(2);
p.000063:
p.000063: (2) Any possible advantages accruing to the prisoner through his or her participation in the research, when
p.000063: compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings
p.000063: in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the
p.000063: value of such advantages in the limited choice environment of the prison is impaired;
p.000063:
p.000063: (3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner
p.000063:
p.000063: volunteers;
p.000063:
p.000063: (4) Procedures for the selection of subjects within the prison are fair to all prisoners and immune from
p.000063: arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board
p.000063: justification in writing for following some other procedures, control subjects must be selected randomly from the
p.000063: group of available prisoners who meet the characteristics needed for that particular research project;
p.000063:
p.000063: (5) The information is presented in language which is understandable to the subject population;
p.000063:
p.000063: (6) Adequate assurance exists that parole boards will not take into account a prisoner's participation in the
p.000063: research in making decisions regarding parole, and each prisoner is clearly informed in advance that
p.000063: participation in the research will have no effect on his or her parole; and
p.000063:
p.000063: (7) Where the Board finds there may be a need for follow-up examination or care of participants after the
p.000063: end of their participation, adequate provision has been made for such examination or care, taking into account
p.000063: the varying lengths of individual prisoners' sentences, and for informing participants of this fact.
p.000063:
p.000063: (b) The Board shall carry out such other duties as may be assigned by the Secretary.
p.000063:
p.000063: (c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that
p.000063: the duties of the Board under this section have been fulfilled.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.306 Permitted research involving prisoners.
p.000063:
p.000063: (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects
p.000063: only if:
p.000063:
p.000063: (1) The institution responsible for the conduct of the research has certified to the Secretary that the
p.000063: Institutional Review Board has approved the research under §46.305 of this subpart; and
p.000063:
p.000063: (2) In the judgment of the Secretary the proposed research involves solely the following:
p.000063:
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Social / Marital Status
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p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
p.000063: (a) Cooperative research projects are those projects covered by this policy that involve more than one
p.000063: institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the
p.000063: rights and welfare of human subjects and for complying with this policy.
p.000063:
p.000063: (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon
p.000063: approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB
p.000063: will be identified by the Federal department or agency supporting or conducting the research or proposed by the
p.000063: lead institution subject to the acceptance of the Federal department or agency supporting the research.
p.000063:
p.000063: (2) The following research is not subject to this provision:
p.000063:
p.000063: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed
p.000063: by the official governing body of an American Indian or Alaska Native tribe); or
p.000063:
p.000063: (ii) Research for which any Federal department or agency supporting or conducting the research determines
p.000063: and documents that the use of a single IRB is not appropriate for the particular context.
p.000063:
p.000063: (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative
p.000063: project may enter into a joint review arrangement, rely on the review of another IRB, or make similar
p.000063: arrangements for avoiding duplication of effort.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.115 IRB records.
p.000063:
p.000063: (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB
p.000063: activities, including the following:
p.000063:
p.000063: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals,
p.000063: approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
p.000063: (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions
p.000063: taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining;
p.000063: the basis for requiring changes in or disapproving research; and a written summary of the discussion of
p.000063: controverted issues and their resolution.
p.000063:
p.000063: (3) Records of continuing review activities, including the rationale for conducting continuing review of
p.000063: research that otherwise would not require continuing review as described in §46.109(f)(1).
p.000063:
p.000063: (4) Copies of all correspondence between the IRB and the investigators.
p.000063:
p.000063: (5) A list of IRB members in the same detail as described in §46.108(a)(2).
p.000063:
p.000063: (6) Written procedures for the IRB in the same detail as described in §46.108(a)(3) and (4).
p.000063:
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Searching for indicator officer:
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p.000063: 2019; and
p.000063:
p.000063: (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
p.000063:
p.000063: (m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to
p.000063: any person or circumstance, shall be construed so as to continue to give maximum effect to the provision
p.000063: permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the
p.000063: provision shall be severable from this part and shall not affect the remainder thereof or the application of the
p.000063: provision to other persons not similarly situated or to other dissimilar circumstances.
p.000063:
p.000063: [82 FR 7259, 7273, Jan. 19, 2017, as amended at 83 FR 28518, June 19, 2018]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.102 Definitions for purposes of this policy.
p.000063:
p.000063: (a) Certification means the official notification by the institution to the supporting Federal department or
p.000063: agency component, in accordance with the requirements of this policy, that a research project or activity
p.000063: involving human subjects has been reviewed and approved by an IRB in accordance with an approved
p.000063: assurance.
p.000063:
p.000063: (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to
p.000063: one or more interventions (which may include placebo or other control) to evaluate the effects of the
p.000063: interventions on biomedical or behavioral health-related outcomes.
p.000063:
p.000063: (c) Department or agency head means the head of any Federal department or agency, for example, the
p.000063: Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority
p.000063: provided by these regulations to the department or agency head has been delegated.
p.000063:
p.000063: (d) Federal department or agency refers to a federal department or agency (the department or agency itself
p.000063: rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy
p.000063: applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S.
p.000063: Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).
p.000063:
p.000063: (e)(1) Human subject means a living individual about whom an investigator (whether professional or student)
p.000063: conducting research:
p.000063:
p.000063: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000063: studies, or analyzes the information or biospecimens; or
p.000063:
p.000063: (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
p.000063: biospecimens.
p.000063:
p.000063: (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g.,
p.000063: venipuncture) and manipulations of the subject or the subject's environment that are performed for research
p.000063: purposes.
p.000063:
p.000063: (3) Interaction includes communication or interpersonal contact between investigator and subject.
p.000063:
p.000063: (4) Private information includes information about behavior that occurs in a context in which an individual
p.000063: can reasonably expect that no observation or recording is taking place, and information that has been provided
...
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
...
p.000063: Source: 43 FR 53655, Nov. 16, 1978, unless otherwise noted.
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
p.000063: ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it
p.000063: is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in
p.000063: activities to which this subpart is applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.303 Definitions.
p.000063:
p.000063: As used in this subpart:
p.000063:
p.000063: (a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (b) DHHS means the Department of Health and Human Services.
p.000063:
p.000063: (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is
p.000063: intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
p.000063: detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal
p.000063: prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or
p.000063: sentencing.
p.000063:
p.000063: (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally
p.000063: encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out
p.000063: responsibilities under this part with respect to research covered by this subpart, shall also meet the following
p.000063: specific requirements:
p.000063:
...
p.000063: be an individual who has the background and experience to act in, and agrees to act in, the best interests of the
p.000063: child for the duration of the child's participation in the research and who is not associated in any way (except in
p.000063: the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart E—Registration of Institutional Review Boards
p.000063: Source: 74 FR 2405, Jan. 15, 2009, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.501 What IRBs must be registered?
p.000063:
p.000063: Each IRB that is designated by an institution under an assurance of compliance approved for federalwide
p.000063: use by the Office for Human Research Protections (OHRP) under §46.103(a) and that reviews research involving
p.000063: human subjects conducted or supported by the Department of Health and Human Services (HHS) must be
p.000063: registered with HHS. An individual authorized to act on behalf of the institution or organization operating the IRB
p.000063: must submit the registration information.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.502 What information must be provided when registering an IRB?
p.000063:
p.000063: The following information must be provided to HHS when registering an IRB:
p.000063:
p.000063: (a) The name, mailing address, and street address (if different from the mailing address) of the institution or
p.000063: organization operating the IRB(s); and the name, mailing address, phone number, facsimile number, and
p.000063: electronic mail address of the senior officer or head official of that institution or organization who is responsible
p.000063: for overseeing activities performed by the IRB.
p.000063:
p.000063: (b) The name, mailing address, phone number, facsimile number, and electronic mail address of the contact
p.000063: person providing the registration information.
p.000063:
p.000063: (c) The name, if any, assigned to the IRB by the institution or organization, and the IRB's mailing address,
p.000063: street address (if different from the mailing address), phone number, facsimile number, and electronic mail
p.000063: address.
p.000063:
p.000063: (d) The name, phone number, and electronic mail address of the IRB chairperson.
p.000063:
p.000063: (e)(1) The approximate numbers of:
p.000063:
p.000063: (i) All active protocols; and
p.000063:
p.000063: (ii) Active protocols conducted or supported by HHS.
p.000063:
p.000063: (2) For purpose of this regulation, an “active protocol” is any protocol for which the IRB conducted an initial
p.000063: review or a continuing review at a convened meeting or under an expedited review procedure during the
p.000063: preceding twelve months.
p.000063:
p.000063: (f) The approximate number of full-time equivalent positions devoted to the IRB's administrative activities.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.503 When must an IRB be registered?
p.000063:
p.000063: An IRB must be registered before it can be designated under an assurance approved for federalwide use by
p.000063: OHRP under §46.103(a). IRB registration becomes effective when reviewed and accepted by OHRP. The
p.000063: registration will be effective for 3 years.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.504 How must an IRB be registered?
p.000063:
p.000063: Each IRB must be registered electronically through http://ohrp.cit.nih.gov/efile unless an institution or
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p.000062: Home Electronic Code of Federal Regulations
p.000062: gpo.gov
p.000062: govinfo.gov You are now viewing previous e - CFR data
p.000062:
p.000062: Browse / Search Current Select date:
p.000062: July 19 2018 GO
p.000062: e-CFR Navigation Aids
p.000062: Browse Now viewing e - CFR data in effect on July 19, 2018
p.000062: Simple Search
p.000062:
p.000062: Advanced Search
p.000062: Title 45 → Subtitle A → Subchapter A → Part 46
p.000062: — Boolean
p.000062: — Proximity
p.000062: Browse Previous | Browse Next
p.000062: Search History
p.000062: Search Tips Title 45: Public Welfare
p.000062: Corrections
p.000062: Latest Updates
p.000062: User Info PART 46—PROTECTION OF HUMAN SUBJECTS
p.000062: FAQs
p.000062: Agency List Contents
p.000062: Incorporation By Reference
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062: §46.102 Definitions for purposes of this policy.
p.000062: §46.103 Assuring compliance with this policy—research conducted or supported by any Federal department or
p.000062: Related Resources
p.000062: agency.
p.000062: The Code of Federal Regulations (CFR)
p.000062: §46.104 Exempt research.
p.000062: annual edition is the codification of the
p.000062: general and permanent rules published §46.105-46.106 [Reserved]
p.000062: in the Federal Register by the §46.107 IRB membership.
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Searching for indicator race:
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p.000063:
p.000063: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private
p.000063: information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and
p.000063: (d);
p.000063:
p.000063: (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance
p.000063: with §46.117;
p.000063:
p.000063: (iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes
p.000063: the determination that the research to be conducted is within the scope of the broad consent referenced in
p.000063: paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results
p.000063: to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal
p.000063: requirements to return individual research results.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
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Social / Soldier
Searching for indicator military:
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p.000062:
p.000062: §46.501 What IRBs must be registered?
p.000062: §46.502 What information must be provided when registering an IRB?
p.000062: §46.503 When must an IRB be registered?
p.000062: §46.504 How must an IRB be registered?
p.000062: §46.505 When must IRB registration information be renewed or updated?
p.000062:
p.000062:
p.000062: Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
p.000062:
p.000062: Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in
p.000062: part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the
p.000062: Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program.
p.000062: For further information see 47 FR 9208, Mar. 4, 1982.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062: Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062:
p.000062: (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted,
p.000062: supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate
p.000062: administrative action to make the policy applicable to such research. This includes research conducted by
p.000062: Federal civilian employees or military personnel, except that each department or agency head may adopt such
p.000062: procedural modifications as may be appropriate from an administrative standpoint. It also includes research
p.000062: conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
p.000062: Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs)
p.000062: reviewing research that is subject to this policy must comply with this policy.
p.000062:
p.000062: (b) [Reserved]
p.000062:
p.000062: (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this
p.000062: policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.62
p.000062: 62
p.000062: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report.
p.000062: Washington, DC: U.S. Department of Health and Human Services. 1979.
p.000062:
p.000062: (d) Department or agency heads may require that specific research activities or classes of research activities
p.000062: conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise
p.000062: covered by this policy comply with some or all of the requirements of this policy.
p.000062:
p.000062: (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide
p.000062: additional protections for human subjects.
p.000062:
p.000062: (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official
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Social / Student
Searching for indicator student:
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p.000063:
p.000063: §46.102 Definitions for purposes of this policy.
p.000063:
p.000063: (a) Certification means the official notification by the institution to the supporting Federal department or
p.000063: agency component, in accordance with the requirements of this policy, that a research project or activity
p.000063: involving human subjects has been reviewed and approved by an IRB in accordance with an approved
p.000063: assurance.
p.000063:
p.000063: (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to
p.000063: one or more interventions (which may include placebo or other control) to evaluate the effects of the
p.000063: interventions on biomedical or behavioral health-related outcomes.
p.000063:
p.000063: (c) Department or agency head means the head of any Federal department or agency, for example, the
p.000063: Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority
p.000063: provided by these regulations to the department or agency head has been delegated.
p.000063:
p.000063: (d) Federal department or agency refers to a federal department or agency (the department or agency itself
p.000063: rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy
p.000063: applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S.
p.000063: Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).
p.000063:
p.000063: (e)(1) Human subject means a living individual about whom an investigator (whether professional or student)
p.000063: conducting research:
p.000063:
p.000063: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000063: studies, or analyzes the information or biospecimens; or
p.000063:
p.000063: (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
p.000063: biospecimens.
p.000063:
p.000063: (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g.,
p.000063: venipuncture) and manipulations of the subject or the subject's environment that are performed for research
p.000063: purposes.
p.000063:
p.000063: (3) Interaction includes communication or interpersonal contact between investigator and subject.
p.000063:
p.000063: (4) Private information includes information about behavior that occurs in a context in which an individual
p.000063: can reasonably expect that no observation or recording is taking place, and information that has been provided
p.000063: for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,
p.000063: a medical record).
p.000063:
p.000063: (5) Identifiable private information is private information for which the identity of the subject is or may
p.000063: readily be ascertained by the investigator or associated with the information.
p.000063:
p.000063: (6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be
p.000063: ascertained by the investigator or associated with the biospecimen.
p.000063:
p.000063: (7) Federal departments or agencies implementing this policy shall:
p.000063:
p.000063: (i) Upon consultation with appropriate experts (including experts in data matching and re-identification),
p.000063: reexamine the meaning of “identifiable private information,” as defined in paragraph (e)(5) of this section, and
...
Social / Women
Searching for indicator women:
(return to top)
p.000062: Download the Code of Federal
p.000062: §46.111 Criteria for IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.112 Review by institution.
p.000062: Download the Electronic Code of Federal
p.000062: §46.113 Suspension or termination of IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.114 Cooperative research.
p.000062: Monthly Title and Part user viewing data §46.115 IRB records.
p.000062: for the e-CFR is available for download in
p.000062: §46.116 General requirements for informed consent.
p.000062: CSV format.
p.000062: §46.117 Documentation of informed consent.
p.000062: Parallel Table of Authorities and Rules §46.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000062: for the Code of Federal Regulations and
p.000062: §46.119 Research undertaken without the intention of involving human subjects.
p.000062: the United States Code
p.000062: Text | PDF §46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by
p.000062: a Federal department or agency.
p.000062: Find, review, and submit comments on
p.000062: Federal rules that are open for comment
p.000062: §46.121 [Reserved]
p.000062: and published in the Federal Register §46.122 Use of Federal funds.
p.000062: using Regulations.gov. §46.123 Early termination of research support: Evaluation of applications and proposals.
p.000062: Purchase individual CFR titles from the
p.000062: §46.124 Conditions.
p.000062: U.S. Government Online Bookstore.
p.000062: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in
p.000062: Find issues of the CFR (including issues Research
p.000062: prior to 1996) at a local Federal
p.000062: depository library.
p.000062: §46.201 To what do these regulations apply?
p.000062: [A2] §46.202 Definitions.
p.000062: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000062: §46.204 Research involving pregnant women or fetuses.
p.000062: §46.205 Research involving neonates.
p.000062: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000062: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000062: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners
p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
...
p.000063: be terminated or suspended in the manner prescribed in applicable program requirements, when the
p.000063: department or agency head finds an institution has materially failed to comply with the terms of this policy.
p.000063:
p.000063: (b) In making decisions about supporting or approving applications or proposals covered by this policy the
p.000063: department or agency head may take into account, in addition to all other eligibility requirements and program
p.000063: criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph
p.000063: (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the
p.000063: scientific and technical aspects of an activity has/have, in the judgment of the department or agency head,
p.000063: materially failed to discharge responsibility for the protection of the rights and welfare of human subjects
p.000063: (whether or not the research was subject to federal regulation).
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.124 Conditions.
p.000063:
p.000063: With respect to any research project or any class of research projects the department or agency head of
p.000063: either the conducting or the supporting Federal department or agency may impose additional conditions prior to
p.000063: or at the time of approval when in the judgment of the department or agency head additional conditions are
p.000063: necessary for the protection of human subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and
p.000063: Neonates Involved in Research
p.000063: Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
...
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
p.000063: Pregnant women or fetuses may be involved in research if all of the following conditions are met:
p.000063:
p.000063: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical
p.000063: studies, including studies on nonpregnant women, have been conducted and provide data for assessing
p.000063: potential risks to pregnant women and fetuses;
p.000063:
p.000063: (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct
p.000063: benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater
p.000063: than minimal and the purpose of the research is the development of important biomedical knowledge which
p.000063: cannot be obtained by any other means;
p.000063:
p.000063: (c) Any risk is the least possible for achieving the objectives of the research;
p.000063:
p.000063: (d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct
p.000063: benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
p.000063: biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
p.000063: informed consent provisions of subpart A of this part;
p.000063:
...
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
p.000063:
p.000063: The Secretary will conduct or fund research that the IRB does not believe meets the requirements of §46.204
p.000063: or §46.205 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or
p.000063: neonates; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, ethics, law) and following opportunity for public review and comment, including a public meeting
p.000063: announced in the Federal Register, has determined either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.204, as applicable; or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;
p.000063:
p.000063: (ii) The research will be conducted in accord with sound ethical principles; and
p.000063:
p.000063: (iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other
p.000063: applicable subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart C—Additional Protections Pertaining to Biomedical and Behavioral
p.000063: Research Involving Prisoners as Subjects
p.000063: Source: 43 FR 53655, Nov. 16, 1978, unless otherwise noted.
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
...
Social / Youth/Minors
Searching for indicator minor:
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p.000062: Simple Search
p.000062:
p.000062: Advanced Search
p.000062: Title 45 → Subtitle A → Subchapter A → Part 46
p.000062: — Boolean
p.000062: — Proximity
p.000062: Browse Previous | Browse Next
p.000062: Search History
p.000062: Search Tips Title 45: Public Welfare
p.000062: Corrections
p.000062: Latest Updates
p.000062: User Info PART 46—PROTECTION OF HUMAN SUBJECTS
p.000062: FAQs
p.000062: Agency List Contents
p.000062: Incorporation By Reference
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062: §46.102 Definitions for purposes of this policy.
p.000062: §46.103 Assuring compliance with this policy—research conducted or supported by any Federal department or
p.000062: Related Resources
p.000062: agency.
p.000062: The Code of Federal Regulations (CFR)
p.000062: §46.104 Exempt research.
p.000062: annual edition is the codification of the
p.000062: general and permanent rules published §46.105-46.106 [Reserved]
p.000062: in the Federal Register by the §46.107 IRB membership.
p.000062: departments and agencies of the Federal §46.108 IRB functions and operations.
p.000062: Government produced by the Office of
p.000062: §46.109 IRB review of research.
p.000062: the Federal Register (OFR) and the
p.000062: Government Publishing Office. §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for
p.000062: minor changes in approved research.
p.000062: Download the Code of Federal
p.000062: §46.111 Criteria for IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.112 Review by institution.
p.000062: Download the Electronic Code of Federal
p.000062: §46.113 Suspension or termination of IRB approval of research.
p.000062: Regulations in XML.
p.000062: §46.114 Cooperative research.
p.000062: Monthly Title and Part user viewing data §46.115 IRB records.
p.000062: for the e-CFR is available for download in
p.000062: §46.116 General requirements for informed consent.
p.000062: CSV format.
p.000062: §46.117 Documentation of informed consent.
p.000062: Parallel Table of Authorities and Rules §46.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000062: for the Code of Federal Regulations and
p.000062: §46.119 Research undertaken without the intention of involving human subjects.
p.000062: the United States Code
p.000062: Text | PDF §46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by
p.000062: a Federal department or agency.
p.000062: Find, review, and submit comments on
p.000062: Federal rules that are open for comment
p.000062: §46.121 [Reserved]
p.000062: and published in the Federal Register §46.122 Use of Federal funds.
p.000062: using Regulations.gov. §46.123 Early termination of research support: Evaluation of applications and proposals.
p.000062: Purchase individual CFR titles from the
p.000062: §46.124 Conditions.
p.000062: U.S. Government Online Bookstore.
...
p.000063:
p.000063: (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals
p.000063: appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).
p.000063:
p.000063: (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following
p.000063: circumstances:
p.000063:
p.000063: (i) Research eligible for expedited review in accordance with §46.110;
p.000063:
p.000063: (ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)
p.000063: (3)(i)(C), or (d)(7) or (8);
p.000063:
p.000063: (iii) Research that has progressed to the point that it involves only one or both of the following, which are
p.000063: part of the IRB-approved study:
p.000063:
p.000063: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
p.000063:
p.000063: (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
p.000063:
p.000063: (2) [Reserved]
p.000063: (g) An IRB shall have authority to observe or have a third party observe the consent process and the
p.000063: research.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk,
p.000063: and for minor changes in approved research.
p.000063:
p.000063: (a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of
p.000063: categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary
p.000063: will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal
p.000063: departments and agencies and after publication in the Federal Register for public comment. A copy of the list is
p.000063: available from the Office for Human Research Protections, HHS, or any successor office.
p.000063:
p.000063: (b)(1) An IRB may use the expedited review procedure to review the following:
p.000063:
p.000063: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the
p.000063: reviewer determines that the study involves more than minimal risk;
p.000063:
p.000063: (ii) Minor changes in previously approved research during the period for which approval is authorized; or
p.000063:
p.000063: (iii) Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and
p.000063: (d)(7) and (8).
p.000063:
p.000063: (2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or
p.000063: more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the
p.000063: research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not
p.000063: disapprove the research. A research activity may be disapproved only after review in accordance with the
p.000063: nonexpedited procedure set forth in §46.108(b).
p.000063:
p.000063: (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised
p.000063: of research proposals that have been approved under the procedure.
p.000063:
p.000063: (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an
p.000063: institution's or IRB's use of the expedited review procedure.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.111 Criteria for IRB approval of research.
p.000063:
p.000063: (a) In order to approve research covered by this policy the IRB shall determine that all of the following
p.000063: requirements are satisfied:
p.000063:
p.000063: (1) Risks to subjects are minimized:
p.000063:
p.000063: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose
p.000063: subjects to risk, and
p.000063:
p.000063: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
p.000063: treatment purposes.
p.000063:
...
p.000063: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
p.000063: subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds
p.000063: that:
p.000063:
p.000063: (a) The risk is justified by the anticipated benefit to the subjects;
p.000063:
p.000063: (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented
p.000063: by available alternative approaches; and
p.000063:
p.000063: (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual
p.000063: subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the
p.000063: individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000063: only if the IRB finds that:
p.000063:
p.000063: (a) The risk represents a minor increase over minimal risk;
p.000063:
p.000063: (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with
p.000063: those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
p.000063:
p.000063: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or
p.000063: condition which is of vital importance for the understanding or amelioration of the subjects' disorder or
p.000063: condition; and
p.000063:
p.000063: (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of children.
p.000063:
p.000063: HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405,
p.000063: or §46.406 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of children; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
...
Social / education
Searching for indicator education:
(return to top)
p.000063: (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for
p.000063: research aimed at involving a broader subject population that only incidentally includes prisoners.
p.000063:
p.000063: (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to
p.000063: research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this
p.000063: section only may apply to research subject to subpart D involving educational tests or the observation of public
p.000063: behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this
p.000063: section may not be applied to research subject to subpart D.
p.000063:
p.000063: (c) [Reserved]
p.000063:
p.000063: (d) Except as described in paragraph (a) of this section, the following categories of human subjects research
p.000063: are exempt from this policy:
p.000063:
p.000063: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves
p.000063: normal educational practices that are not likely to adversely impact students' opportunity to learn required
p.000063: educational content or the assessment of educators who provide instruction. This includes most research on
p.000063: regular and special education instructional strategies, and research on the effectiveness of or the comparison
p.000063: among instructional techniques, curricula, or classroom management methods.
p.000063:
p.000063: (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude,
p.000063: achievement), survey procedures, interview procedures, or observation of public behavior (including visual or
p.000063: auditory recording) if at least one of the following criteria is met:
p.000063: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information
...
p.000063: those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
p.000063:
p.000063: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or
p.000063: condition which is of vital importance for the understanding or amelioration of the subjects' disorder or
p.000063: condition; and
p.000063:
p.000063: (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of children.
p.000063:
p.000063: HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405,
p.000063: or §46.406 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of children; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, education, ethics, law) and following opportunity for public review and comment, has determined
p.000063: either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of children;
p.000063:
p.000063: (ii) The research will be conducted in accordance with sound ethical principles;
p.000063:
p.000063: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000063:
p.000063: (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of
p.000063: the IRB the children are capable of providing assent. In determining whether children are capable of assenting,
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Searching for indicator educational:
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p.000063: affiliated with the institution, or as set forth in a research protocol).
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.104 Exempt research.
p.000063:
p.000063: (a) Unless otherwise required by law or by department or agency heads, research activities in which the only
p.000063: involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are
p.000063: exempt from the requirements of this policy, except that such activities must comply with the requirements of
p.000063: this section and as specified in each category.
p.000063:
p.000063: (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D:
p.000063: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C,
p.000063: and D, is as follows:
p.000063:
p.000063: (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the
p.000063: conditions of the exemption are met.
p.000063:
p.000063: (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for
p.000063: research aimed at involving a broader subject population that only incidentally includes prisoners.
p.000063:
p.000063: (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to
p.000063: research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this
p.000063: section only may apply to research subject to subpart D involving educational tests or the observation of public
p.000063: behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this
p.000063: section may not be applied to research subject to subpart D.
p.000063:
p.000063: (c) [Reserved]
p.000063:
p.000063: (d) Except as described in paragraph (a) of this section, the following categories of human subjects research
p.000063: are exempt from this policy:
p.000063:
p.000063: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves
p.000063: normal educational practices that are not likely to adversely impact students' opportunity to learn required
p.000063: educational content or the assessment of educators who provide instruction. This includes most research on
p.000063: regular and special education instructional strategies, and research on the effectiveness of or the comparison
p.000063: among instructional techniques, curricula, or classroom management methods.
p.000063:
p.000063: (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude,
p.000063: achievement), survey procedures, interview procedures, or observation of public behavior (including visual or
p.000063: auditory recording) if at least one of the following criteria is met:
p.000063: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information
p.000063: from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the
p.000063: subject prospectively agrees to the intervention and information collection and at least one of the following
p.000063: criteria is met:
p.000063:
p.000063: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
p.000063:
p.000063: (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the
p.000063: subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability,
p.000063: educational advancement, or reputation; or
p.000063:
p.000063: (C) The information obtained is recorded by the investigator in such a manner that the identity of the human
p.000063: subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a
p.000063: limited IRB review to make the determination required by §46.111(a)(7).
p.000063:
p.000063: (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless,
p.000063: painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the
p.000063: investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided
p.000063: all such criteria are met, examples of such benign behavioral interventions would include having the subjects
p.000063: play an online game, having them solve puzzles under various noise conditions, or having them decide how to
p.000063: allocate a nominal amount of received cash between themselves and someone else.
p.000063:
p.000063: (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this
p.000063: exemption is not applicable unless the subject authorizes the deception through a prospective agreement to
p.000063: participate in research in circumstances in which the subject is informed that he or she will be unaware of or
p.000063: misled regarding the nature or purposes of the research.
p.000063:
p.000063: (4) Secondary research for which consent is not required: Secondary research uses of identifiable private
p.000063: information or identifiable biospecimens, if at least one of the following criteria is met:
p.000063:
...
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
p.000063: supported by DHHS shall not involve prisoners as subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000063: Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.401 To what do these regulations apply?
p.000063:
p.000063: (a) This subpart applies to all research involving children as subjects, conducted or supported by the
p.000063: Department of Health and Human Services.
p.000063:
p.000063: (1) This includes research conducted by Department employees, except that each head of an Operating
p.000063: Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate
p.000063: from an administrative standpoint.
p.000063:
p.000063: (2) It also includes research conducted or supported by the Department of Health and Human Services
p.000063: outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of §46.101
p.000063: of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
p.000063:
p.000063: (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of
p.000063: §46.101 of Subpart A are applicable to this subpart.
p.000063:
p.000063: [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.402 Definitions.
p.000063:
p.000063: The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this
p.000063: subpart:
p.000063:
p.000063: (a) Children are persons who have not attained the legal age for consent to treatments or procedures
p.000063: involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
p.000063:
p.000063: (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should
p.000063: not, absent affirmative agreement, be construed as assent.
p.000063:
p.000063: (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in
p.000063: research.
p.000063:
...
p.000063:
p.000063: (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented
p.000063: by available alternative approaches; and
p.000063:
p.000063: (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual
p.000063: subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the
p.000063: individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000063: only if the IRB finds that:
p.000063:
p.000063: (a) The risk represents a minor increase over minimal risk;
p.000063:
p.000063: (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with
p.000063: those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
p.000063:
p.000063: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or
p.000063: condition which is of vital importance for the understanding or amelioration of the subjects' disorder or
p.000063: condition; and
p.000063:
p.000063: (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of children.
p.000063:
p.000063: HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405,
p.000063: or §46.406 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of children; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, education, ethics, law) and following opportunity for public review and comment, has determined
p.000063: either:
p.000063:
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p.000062: §46.409 Wards.
p.000062:
p.000062: Subpart E—Registration of Institutional Review Boards
p.000062:
p.000062: §46.501 What IRBs must be registered?
p.000062: §46.502 What information must be provided when registering an IRB?
p.000062: §46.503 When must an IRB be registered?
p.000062: §46.504 How must an IRB be registered?
p.000062: §46.505 When must IRB registration information be renewed or updated?
p.000062:
p.000062:
p.000062: Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
p.000062:
p.000062: Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in
p.000062: part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the
p.000062: Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program.
p.000062: For further information see 47 FR 9208, Mar. 4, 1982.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062: Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062:
p.000062: (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted,
p.000062: supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate
p.000062: administrative action to make the policy applicable to such research. This includes research conducted by
p.000062: Federal civilian employees or military personnel, except that each department or agency head may adopt such
p.000062: procedural modifications as may be appropriate from an administrative standpoint. It also includes research
p.000062: conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
p.000062: Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs)
p.000062: reviewing research that is subject to this policy must comply with this policy.
p.000062:
p.000062: (b) [Reserved]
p.000062:
p.000062: (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this
p.000062: policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.62
p.000062: 62
p.000062: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report.
p.000062: Washington, DC: U.S. Department of Health and Human Services. 1979.
p.000062:
p.000062: (d) Department or agency heads may require that specific research activities or classes of research activities
p.000062: conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise
p.000062: covered by this policy comply with some or all of the requirements of this policy.
p.000062:
p.000062: (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide
p.000062: additional protections for human subjects.
p.000062:
p.000062: (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official
...
p.000063: conducted at an institution within the constraints set forth by the IRB and by other institutional and federal
p.000063: requirements.
p.000063:
p.000063: (i) Legally authorized representative means an individual or judicial or other body authorized under
p.000063: applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s)
p.000063: involved in the research. If there is no applicable law addressing this issue, legally authorized representative
p.000063: means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch
p.000063: context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the
p.000063: research.
p.000063:
p.000063: (j) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research
p.000063: are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of
p.000063: routine physical or psychological examinations or tests.
p.000063:
p.000063: (k) Public health authority means an agency or authority of the United States, a state, a territory, a political
p.000063: subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a
p.000063: grant of authority from or contract with such public agency, including the employees or agents of such public
p.000063: agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public
p.000063: health matters as part of its official mandate.
p.000063:
p.000063: (l) Research means a systematic investigation, including research development, testing, and evaluation,
p.000063: designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute
p.000063: research for purposes of this policy, whether or not they are conducted or supported under a program that is
p.000063: considered research for other purposes. For example, some demonstration and service programs may include
p.000063: research activities. For purposes of this part, the following activities are deemed not to be research:
p.000063:
p.000063: (1) Scholarly and journalistic activities ( e.g., oral history, journalism, biography, literary criticism, legal
p.000063: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000063: specific individuals about whom the information is collected.
p.000063:
p.000063: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000063: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities
p.000063: are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate
p.000063: potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including
...
p.000063: “public health activities and purposes” as described under 45 CFR 164.512(b); or
p.000063:
p.000063: (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-
p.000063: generated or government-collected information obtained for nonresearch activities, if the research generates
p.000063: identifiable private information that is or will be maintained on information technology that is subject to and in
p.000063: compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable
p.000063: private information collected, used, or generated as part of the activity will be maintained in systems of records
p.000063: subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was
p.000063: collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
p.000063:
p.000063: (5) Research and demonstration projects that are conducted or supported by a Federal department or
p.000063: agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of
p.000063: bureaus or other subordinate agencies that have been delegated authority to conduct the research and
p.000063: demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit
p.000063: or service programs, including procedures for obtaining benefits or services under those programs, possible
p.000063: changes in or alternatives to those programs or procedures, or possible changes in methods or levels of
p.000063: payment for benefits or services under those programs. Such projects include, but are not limited to, internal
p.000063: studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements,
p.000063: or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as
p.000063: sections 1115 and 1115A of the Social Security Act, as amended.
p.000063:
p.000063: (i) Each Federal department or agency conducting or supporting the research and demonstration projects
p.000063:
p.000063: must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency
p.000063: head may determine, a list of the research and demonstration projects that the Federal department or agency
p.000063: conducts or supports under this provision. The research or demonstration project must be published on this list
p.000063: prior to commencing the research involving human subjects.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (6) Taste and food quality evaluation and consumer acceptance studies:
p.000063:
p.000063: (i) If wholesome foods without additives are consumed, or
p.000063:
p.000063: (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe,
p.000063: or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and
p.000063: Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection
p.000063: Service of the U.S. Department of Agriculture.
p.000063:
p.000063: (7) Storage or maintenance for secondary research for which broad consent is required: Storage or
p.000063: maintenance of identifiable private information or identifiable biospecimens for potential secondary research
...
p.000063: grants in which the activities involving subjects remain to be selected; and projects in which human subjects'
p.000063: involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.
p.000063: Except for research waived under §46.101(i) or exempted under §46.104, no human subjects may be involved in
p.000063: any project supported by these awards until the project has been reviewed and approved by the IRB, as provided
p.000063: in this policy, and certification submitted, by the institution, to the Federal department or agency component
p.000063: supporting the research.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.119 Research undertaken without the intention of involving human subjects.
p.000063:
p.000063: Except for research waived under §46.101(i) or exempted under §46.104, in the event research is undertaken
p.000063: without the intention of involving human subjects, but it is later proposed to involve human subjects in the
p.000063: research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification
p.000063: submitted by the institution to the Federal department or agency component supporting the research, and final
p.000063: approval given to the proposed change by the Federal department or agency component.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.120 Evaluation and disposition of applications and proposals for research to be conducted or
p.000063: supported by a Federal department or agency.
p.000063:
p.000063: (a) The department or agency head will evaluate all applications and proposals involving human subjects
p.000063: submitted to the Federal department or agency through such officers and employees of the Federal department
p.000063: or agency and such experts and consultants as the department or agency head determines to be appropriate.
p.000063: This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these
p.000063: risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge
p.000063: gained or to be gained.
p.000063:
p.000063: (b) On the basis of this evaluation, the department or agency head may approve or disapprove the
p.000063: application or proposal, or enter into negotiations to develop an approvable one.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.121 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.122 Use of Federal funds.
p.000063:
p.000063: Federal funds administered by a Federal department or agency may not be expended for research involving
p.000063: human subjects unless the requirements of this policy have been satisfied.
p.000063:
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.123 Early termination of research support: Evaluation of applications and proposals.
p.000063: (a) The department or agency head may require that Federal department or agency support for any project
p.000063: be terminated or suspended in the manner prescribed in applicable program requirements, when the
p.000063: department or agency head finds an institution has materially failed to comply with the terms of this policy.
p.000063:
p.000063: (b) In making decisions about supporting or approving applications or proposals covered by this policy the
p.000063: department or agency head may take into account, in addition to all other eligibility requirements and program
p.000063: criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph
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p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.124 Conditions.
p.000063:
p.000063: With respect to any research project or any class of research projects the department or agency head of
p.000063: either the conducting or the supporting Federal department or agency may impose additional conditions prior to
p.000063: or at the time of approval when in the judgment of the department or agency head additional conditions are
p.000063: necessary for the protection of human subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart B—Additional Protections for Pregnant Women, Human Fetuses and
p.000063: Neonates Involved in Research
p.000063: Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.201 To what do these regulations apply?
p.000063:
p.000063: (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant
p.000063: women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the
p.000063: Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any
p.000063: person and all research conducted in any facility by DHHS employees.
p.000063:
p.000063: (b) The exemptions at §46.101(b)(1) through (6) are applicable to this subpart.
p.000063:
p.000063: (c) The provisions of §46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in
p.000063: this subpart and in §46.101(f) is intended to include the laws of federally recognized American Indian and Alaska
p.000063: Native Tribal Governments.
p.000063:
p.000063: (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
...
p.000063: and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
p.000063:
p.000063: (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability
p.000063: of improving the health or well-being of the subject. In cases in which those studies require the assignment of
p.000063: prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit
p.000063: from the research, the study may proceed only after the Secretary has consulted with appropriate experts,
p.000063: including experts in penology medicine and ethics, and published notice, in the Federal Register, of his intent to
p.000063: approve such research.
p.000063:
p.000063: (b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or
p.000063: supported by DHHS shall not involve prisoners as subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000063: Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.401 To what do these regulations apply?
p.000063:
p.000063: (a) This subpart applies to all research involving children as subjects, conducted or supported by the
p.000063: Department of Health and Human Services.
p.000063:
p.000063: (1) This includes research conducted by Department employees, except that each head of an Operating
p.000063: Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate
p.000063: from an administrative standpoint.
p.000063:
p.000063: (2) It also includes research conducted or supported by the Department of Health and Human Services
p.000063: outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of §46.101
p.000063: of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
p.000063:
p.000063: (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of
p.000063: §46.101 of Subpart A are applicable to this subpart.
p.000063:
p.000063: [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.402 Definitions.
p.000063:
p.000063: The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this
p.000063: subpart:
p.000063:
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p.000063: information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and
p.000063: (d);
p.000063:
p.000063: (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance
p.000063: with §46.117;
p.000063:
p.000063: (iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes
p.000063: the determination that the research to be conducted is within the scope of the broad consent referenced in
p.000063: paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results
p.000063: to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal
p.000063: requirements to return individual research results.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
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Searching for indicator parent:
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p.000063: regarding the reasonably foreseeable impact of the research on the neonate.
p.000063:
p.000063: (3) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: (4) The requirements of paragraph (b) or (c) of this section have been met as applicable.
p.000063:
p.000063: (b) Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a
p.000063: neonate may not be involved in research covered by this subpart unless the following additional conditions are
p.000063: met:
p.000063:
p.000063: (1) The IRB determines that:
p.000063:
p.000063: (i) The research holds out the prospect of enhancing the probability of survival of the neonate to the point of
p.000063:
p.000063: viability, and any risk is the least possible for achieving that objective, or
p.000063:
p.000063: (ii) The purpose of the research is the development of important biomedical knowledge which cannot be
p.000063: obtained by other means and there will be no added risk to the neonate resulting from the research; and
p.000063: (2) The legally effective informed consent of either parent of the neonate or, if neither parent is able to
p.000063: consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent
p.000063: of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that
p.000063: the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted
p.000063: from rape or incest.
p.000063:
p.000063: (c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this
p.000063: subpart unless all of the following additional conditions are met:
p.000063:
p.000063: (1) Vital functions of the neonate will not be artificially maintained;
p.000063:
p.000063: (2) The research will not terminate the heartbeat or respiration of the neonate;
p.000063:
p.000063: (3) There will be no added risk to the neonate resulting from the research;
p.000063:
p.000063: (4) The purpose of the research is the development of important biomedical knowledge that cannot be
p.000063: obtained by other means; and
p.000063:
p.000063: (5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart
p.000063: A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) do not apply. However, if
p.000063: either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the
p.000063: informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph
p.000063: (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
p.000063: The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
...
p.000063: type.
p.000063: (b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at
p.000063: §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)
p.000063: (2) for research involving survey or interview procedures or observations of public behavior does not apply to
p.000063: research covered by this subpart, except for research involving observation of public behavior when the
p.000063: investigator(s) do not participate in the activities being observed.
p.000063:
p.000063: (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of
p.000063: §46.101 of Subpart A are applicable to this subpart.
p.000063:
p.000063: [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.402 Definitions.
p.000063:
p.000063: The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this
p.000063: subpart:
p.000063:
p.000063: (a) Children are persons who have not attained the legal age for consent to treatments or procedures
p.000063: involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
p.000063:
p.000063: (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should
p.000063: not, absent affirmative agreement, be construed as assent.
p.000063:
p.000063: (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in
p.000063: research.
p.000063:
p.000063: (d) Parent means a child's biological or adoptive parent.
p.000063:
p.000063: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000063: of a child to general medical care.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.403 IRB duties.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.404 Research not involving greater than minimal risk.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is
p.000063: presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and
p.000063: the permission of their parents or guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000063: the individual subjects.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
...
p.000063: may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB
p.000063: deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.000063: cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a
p.000063: prospect of direct benefit that is important to the health or well-being of the children and is available only in the
p.000063: context of the research, the assent of the children is not a necessary condition for proceeding with the research.
p.000063: Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000063: requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.
p.000063:
p.000063: (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate
p.000063: provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission
p.000063: is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000063: under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained
p.000063: from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or
p.000063: not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
p.000063:
p.000063: (c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a
p.000063: research protocol is designed for conditions or for a subject population for which parental or guardian
p.000063: permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children),
p.000063: it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an
p.000063: appropriate mechanism for protecting the children who will participate as subjects in the research is substituted,
p.000063: and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an
p.000063: appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol,
p.000063: the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
p.000063:
p.000063: (d) Permission by parents or guardians shall be documented in accordance with and to the extent required
p.000063: by §46.117 of Subpart A.
p.000063:
p.000063: (e) When the IRB determines that assent is required, it shall also determine whether and how assent must
p.000063: be documented.
p.000063:
p.000063: Back to Top
p.000063: §46.409 Wards.
p.000063:
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p.000062: as Subjects
p.000062:
p.000062: §46.301 Applicability.
p.000062: §46.302 Purpose.
p.000062: §46.303 Definitions.
p.000062: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000062: §46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
p.000062: §46.306 Permitted research involving prisoners.
p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of children.
p.000062: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000062: §46.409 Wards.
p.000062:
p.000062: Subpart E—Registration of Institutional Review Boards
p.000062:
p.000062: §46.501 What IRBs must be registered?
p.000062: §46.502 What information must be provided when registering an IRB?
p.000062: §46.503 When must an IRB be registered?
p.000062: §46.504 How must an IRB be registered?
p.000062: §46.505 When must IRB registration information be renewed or updated?
p.000062:
p.000062:
p.000062: Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
p.000062:
p.000062: Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in
p.000062: part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the
p.000062: Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program.
p.000062: For further information see 47 FR 9208, Mar. 4, 1982.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062: Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062:
p.000062: (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted,
p.000062: supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate
p.000062: administrative action to make the policy applicable to such research. This includes research conducted by
...
p.000063: consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent
p.000063: of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that
p.000063: the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted
p.000063: from rape or incest.
p.000063:
p.000063: (c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this
p.000063: subpart unless all of the following additional conditions are met:
p.000063:
p.000063: (1) Vital functions of the neonate will not be artificially maintained;
p.000063:
p.000063: (2) The research will not terminate the heartbeat or respiration of the neonate;
p.000063:
p.000063: (3) There will be no added risk to the neonate resulting from the research;
p.000063:
p.000063: (4) The purpose of the research is the development of important biomedical knowledge that cannot be
p.000063: obtained by other means; and
p.000063:
p.000063: (5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart
p.000063: A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) do not apply. However, if
p.000063: either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the
p.000063: informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph
p.000063: (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
p.000063: The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
p.000063: (b) If information associated with material described in paragraph (a) of this section is recorded for research
p.000063: purposes in a manner that living individuals can be identified, directly or through identifiers linked to those
p.000063: individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or
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p.000063: research.
p.000063:
p.000063: (d) Parent means a child's biological or adoptive parent.
p.000063:
p.000063: (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf
p.000063: of a child to general medical care.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.403 IRB duties.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.404 Research not involving greater than minimal risk.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is
p.000063: presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and
p.000063: the permission of their parents or guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to
p.000063: the individual subjects.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that holds out the prospect of direct benefit for the individual
p.000063: subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds
p.000063: that:
p.000063:
p.000063: (a) The risk is justified by the anticipated benefit to the subjects;
p.000063:
p.000063: (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented
p.000063: by available alternative approaches; and
p.000063:
p.000063: (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual
p.000063: subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000063:
p.000063: HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is
p.000063: presented by an intervention or procedure that does not hold out the prospect of direct benefit for the
p.000063: individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject,
p.000063: only if the IRB finds that:
p.000063:
p.000063: (a) The risk represents a minor increase over minimal risk;
p.000063:
p.000063: (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with
p.000063: those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
p.000063:
p.000063: (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or
p.000063: condition which is of vital importance for the understanding or amelioration of the subjects' disorder or
p.000063: condition; and
p.000063:
p.000063: (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or
p.000063: alleviate a serious problem affecting the health or welfare of children.
p.000063:
p.000063: HHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405,
p.000063: or §46.406 only if:
p.000063:
p.000063: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding,
p.000063: prevention, or alleviation of a serious problem affecting the health or welfare of children; and
p.000063:
p.000063: (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science,
p.000063: medicine, education, ethics, law) and following opportunity for public review and comment, has determined
p.000063: either:
p.000063:
p.000063: (1) That the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or
p.000063:
p.000063: (2) The following:
p.000063:
p.000063: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of
p.000063: a serious problem affecting the health or welfare of children;
p.000063:
p.000063: (ii) The research will be conducted in accordance with sound ethical principles;
p.000063:
p.000063: (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.000063: guardians, as set forth in §46.408.
p.000063:
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p.000063:
p.000063: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000063:
p.000063: (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of
p.000063: the IRB the children are capable of providing assent. In determining whether children are capable of assenting,
p.000063: the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment
p.000063: may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB
p.000063: deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.000063: cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a
p.000063: prospect of direct benefit that is important to the health or well-being of the children and is available only in the
p.000063: context of the research, the assent of the children is not a necessary condition for proceeding with the research.
p.000063: Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.000063: requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.
p.000063:
p.000063: (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall
p.000063: determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate
p.000063: provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission
p.000063: is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted
p.000063: under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained
p.000063: from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or
p.000063: not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
p.000063:
p.000063: (c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a
p.000063: research protocol is designed for conditions or for a subject population for which parental or guardian
p.000063: permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children),
p.000063: it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an
p.000063: appropriate mechanism for protecting the children who will participate as subjects in the research is substituted,
p.000063: and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an
p.000063: appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol,
p.000063: the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
p.000063:
p.000063: (d) Permission by parents or guardians shall be documented in accordance with and to the extent required
p.000063: by §46.117 of Subpart A.
p.000063:
p.000063: (e) When the IRB determines that assent is required, it shall also determine whether and how assent must
p.000063: be documented.
p.000063:
p.000063: Back to Top
p.000063: §46.409 Wards.
p.000063:
p.000063: (a) Children who are wards of the state or any other agency, institution, or entity can be included in research
p.000063: approved under §46.406 or §46.407 only if such research is:
p.000063: (1) Related to their status as wards; or
p.000063:
p.000063: (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.000063: involved as subjects are not wards.
p.000063:
p.000063: (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an
p.000063: advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as
p.000063: guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall
p.000063: be an individual who has the background and experience to act in, and agrees to act in, the best interests of the
p.000063: child for the duration of the child's participation in the research and who is not associated in any way (except in
p.000063: the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
p.000063:
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p.000063:
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General/Other / Incapacitated
Searching for indicator incapacity:
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p.000063: (c) Any risk is the least possible for achieving the objectives of the research;
p.000063:
p.000063: (d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct
p.000063: benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when
p.000063: risk to the fetus is not greater than minimal and the purpose of the research is the development of important
p.000063: biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the
p.000063: informed consent provisions of subpart A of this part;
p.000063:
p.000063: (e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the
p.000063: pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this
p.000063: part, except that the father's consent need not be obtained if he is unable to consent because of unavailability,
p.000063: incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
p.000063:
p.000063: (f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the
p.000063: reasonably foreseeable impact of the research on the fetus or neonate;
p.000063:
p.000063: (g) For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord
p.000063: with the provisions of subpart D of this part;
p.000063:
p.000063: (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
p.000063:
p.000063: (i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or
p.000063: procedures used to terminate a pregnancy; and
p.000063:
p.000063: (j) Individuals engaged in the research will have no part in determining the viability of a neonate.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.205 Research involving neonates.
p.000063:
p.000063: (a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following
p.000063: conditions are met:
p.000063:
p.000063: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for
p.000063: assessing potential risks to neonates.
p.000063:
...
p.000063:
p.000063: (4) The requirements of paragraph (b) or (c) of this section have been met as applicable.
p.000063:
p.000063: (b) Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a
p.000063: neonate may not be involved in research covered by this subpart unless the following additional conditions are
p.000063: met:
p.000063:
p.000063: (1) The IRB determines that:
p.000063:
p.000063: (i) The research holds out the prospect of enhancing the probability of survival of the neonate to the point of
p.000063:
p.000063: viability, and any risk is the least possible for achieving that objective, or
p.000063:
p.000063: (ii) The purpose of the research is the development of important biomedical knowledge which cannot be
p.000063: obtained by other means and there will be no added risk to the neonate resulting from the research; and
p.000063: (2) The legally effective informed consent of either parent of the neonate or, if neither parent is able to
p.000063: consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent
p.000063: of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that
p.000063: the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted
p.000063: from rape or incest.
p.000063:
p.000063: (c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this
p.000063: subpart unless all of the following additional conditions are met:
p.000063:
p.000063: (1) Vital functions of the neonate will not be artificially maintained;
p.000063:
p.000063: (2) The research will not terminate the heartbeat or respiration of the neonate;
p.000063:
p.000063: (3) There will be no added risk to the neonate resulting from the research;
p.000063:
p.000063: (4) The purpose of the research is the development of important biomedical knowledge that cannot be
p.000063: obtained by other means; and
p.000063:
p.000063: (5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart
p.000063: A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) do not apply. However, if
p.000063: either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the
p.000063: informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph
p.000063: (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
p.000063: The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will
p.000063: not suffice to meet the requirements of this paragraph (c)(5).
p.000063:
p.000063: (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in
p.000063: research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
p.000063:
p.000063: (a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue,
p.000063: or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local
p.000063: laws and regulations regarding such activities.
p.000063:
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General/Other / Public Emergency
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p.000063:
p.000063: (h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal
p.000063: department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the
p.000063: awardee or the Federal department or agency component conducting the trial on a publicly available Federal
p.000063: Web site that will be established as a repository for such informed consent forms.
p.000063:
p.000063: (2) If the Federal department or agency supporting or conducting the clinical trial determines that certain
p.000063: information should not be made publicly available on a Federal Web site (e.g. confidential commercial
p.000063: information), such Federal department or agency may permit or require redactions to the information posted.
p.000063:
p.000063: (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to
p.000063: recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
p.000063:
p.000063: (i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable
p.000063: Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or
p.000063: Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be
p.000063: legally effective.
p.000063:
p.000063: (j) Emergency medical care. Nothing in this policy is intended to limit the authority of a physician to provide
p.000063: emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or
p.000063: local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.117 Documentation of informed consent.
p.000063:
p.000063: (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a
p.000063: written informed consent form approved by the IRB and signed (including in an electronic format) by the subject
p.000063: or the subject's legally authorized representative. A written copy shall be given to the person signing the
p.000063: informed consent form.
p.000063:
p.000063: (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the
p.000063: following:
p.000063:
p.000063: (1) A written informed consent form that meets the requirements of §46.116. The investigator shall give
p.000063: either the subject or the subject's legally authorized representative adequate opportunity to read the informed
p.000063: consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally
p.000063: authorized representative.
p.000063:
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General/Other / Relationship to Authority
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p.000062:
p.000062: Subpart D—Additional Protections for Children Involved as Subjects in Research
p.000062:
p.000062: §46.401 To what do these regulations apply?
p.000062: §46.402 Definitions.
p.000062: §46.403 IRB duties.
p.000062: §46.404 Research not involving greater than minimal risk.
p.000062: §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the
p.000062: individual subjects.
p.000062: §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects,
p.000062: but likely to yield generalizable knowledge about the subject's disorder or condition.
p.000062: §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate
p.000062: a serious problem affecting the health or welfare of children.
p.000062: §46.408 Requirements for permission by parents or guardians and for assent by children.
p.000062: §46.409 Wards.
p.000062:
p.000062: Subpart E—Registration of Institutional Review Boards
p.000062:
p.000062: §46.501 What IRBs must be registered?
p.000062: §46.502 What information must be provided when registering an IRB?
p.000062: §46.503 When must an IRB be registered?
p.000062: §46.504 How must an IRB be registered?
p.000062: §46.505 When must IRB registration information be renewed or updated?
p.000062:
p.000062:
p.000062: Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
p.000062:
p.000062: Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in
p.000062: part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the
p.000062: Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program.
p.000062: For further information see 47 FR 9208, Mar. 4, 1982.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062: Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062:
p.000062: (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted,
p.000062: supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate
p.000062: administrative action to make the policy applicable to such research. This includes research conducted by
p.000062: Federal civilian employees or military personnel, except that each department or agency head may adopt such
p.000062: procedural modifications as may be appropriate from an administrative standpoint. It also includes research
p.000062: conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
p.000062: Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs)
...
p.000063:
p.000063: (m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to
p.000063: any person or circumstance, shall be construed so as to continue to give maximum effect to the provision
p.000063: permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the
p.000063: provision shall be severable from this part and shall not affect the remainder thereof or the application of the
p.000063: provision to other persons not similarly situated or to other dissimilar circumstances.
p.000063:
p.000063: [82 FR 7259, 7273, Jan. 19, 2017, as amended at 83 FR 28518, June 19, 2018]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.102 Definitions for purposes of this policy.
p.000063:
p.000063: (a) Certification means the official notification by the institution to the supporting Federal department or
p.000063: agency component, in accordance with the requirements of this policy, that a research project or activity
p.000063: involving human subjects has been reviewed and approved by an IRB in accordance with an approved
p.000063: assurance.
p.000063:
p.000063: (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to
p.000063: one or more interventions (which may include placebo or other control) to evaluate the effects of the
p.000063: interventions on biomedical or behavioral health-related outcomes.
p.000063:
p.000063: (c) Department or agency head means the head of any Federal department or agency, for example, the
p.000063: Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority
p.000063: provided by these regulations to the department or agency head has been delegated.
p.000063:
p.000063: (d) Federal department or agency refers to a federal department or agency (the department or agency itself
p.000063: rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy
p.000063: applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S.
p.000063: Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).
p.000063:
p.000063: (e)(1) Human subject means a living individual about whom an investigator (whether professional or student)
p.000063: conducting research:
p.000063:
p.000063: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000063: studies, or analyzes the information or biospecimens; or
p.000063:
p.000063: (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
p.000063: biospecimens.
p.000063:
p.000063: (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g.,
p.000063: venipuncture) and manipulations of the subject or the subject's environment that are performed for research
p.000063: purposes.
p.000063:
p.000063: (3) Interaction includes communication or interpersonal contact between investigator and subject.
p.000063:
p.000063: (4) Private information includes information about behavior that occurs in a context in which an individual
p.000063: can reasonably expect that no observation or recording is taking place, and information that has been provided
p.000063: for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,
p.000063: a medical record).
...
p.000063: site.
p.000063:
p.000063: (f) Institution means any public or private entity, or department or agency (including federal, state, and other
p.000063: agencies).
p.000063:
p.000063: (g) IRB means an institutional review board established in accord with and for the purposes expressed in
p.000063: this policy.
p.000063:
p.000063: (h) IRB approval means the determination of the IRB that the research has been reviewed and may be
p.000063: conducted at an institution within the constraints set forth by the IRB and by other institutional and federal
p.000063: requirements.
p.000063:
p.000063: (i) Legally authorized representative means an individual or judicial or other body authorized under
p.000063: applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s)
p.000063: involved in the research. If there is no applicable law addressing this issue, legally authorized representative
p.000063: means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch
p.000063: context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the
p.000063: research.
p.000063:
p.000063: (j) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research
p.000063: are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of
p.000063: routine physical or psychological examinations or tests.
p.000063:
p.000063: (k) Public health authority means an agency or authority of the United States, a state, a territory, a political
p.000063: subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a
p.000063: grant of authority from or contract with such public agency, including the employees or agents of such public
p.000063: agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public
p.000063: health matters as part of its official mandate.
p.000063:
p.000063: (l) Research means a systematic investigation, including research development, testing, and evaluation,
p.000063: designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute
p.000063: research for purposes of this policy, whether or not they are conducted or supported under a program that is
p.000063: considered research for other purposes. For example, some demonstration and service programs may include
p.000063: research activities. For purposes of this part, the following activities are deemed not to be research:
p.000063:
p.000063: (1) Scholarly and journalistic activities ( e.g., oral history, journalism, biography, literary criticism, legal
p.000063: research, and historical scholarship), including the collection and use of information, that focus directly on the
p.000063: specific individuals about whom the information is collected.
p.000063:
p.000063: (2) Public health surveillance activities, including the collection and testing of information or biospecimens,
p.000063: conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities
p.000063: are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate
p.000063: potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including
p.000063: trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such
p.000063: activities include those associated with providing timely situational awareness and priority setting during the
p.000063: course of an event or crisis that threatens public health (including natural or man-made disasters).
p.000063:
p.000063: (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for
p.000063: activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
p.000063:
p.000063: (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland
p.000063: security, defense, or other national security missions.
p.000063:
p.000063: (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium ( e.g., paper) or in
p.000063: an electronic format.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.103 Assuring compliance with this policy—research conducted or supported by any Federal
p.000063: department or agency.
p.000063:
p.000063: (a) Each institution engaged in research that is covered by this policy, with the exception of research eligible
p.000063: for exemption under §46.104, and that is conducted or supported by a Federal department or agency, shall
...
p.000063: manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers
p.000063: linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify
p.000063: subjects;
p.000063:
p.000063: (iii) The research involves only information collection and analysis involving the investigator's use of
p.000063: identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for
p.000063: the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for
p.000063: “public health activities and purposes” as described under 45 CFR 164.512(b); or
p.000063:
p.000063: (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-
p.000063: generated or government-collected information obtained for nonresearch activities, if the research generates
p.000063: identifiable private information that is or will be maintained on information technology that is subject to and in
p.000063: compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable
p.000063: private information collected, used, or generated as part of the activity will be maintained in systems of records
p.000063: subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was
p.000063: collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
p.000063:
p.000063: (5) Research and demonstration projects that are conducted or supported by a Federal department or
p.000063: agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of
p.000063: bureaus or other subordinate agencies that have been delegated authority to conduct the research and
p.000063: demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit
p.000063: or service programs, including procedures for obtaining benefits or services under those programs, possible
p.000063: changes in or alternatives to those programs or procedures, or possible changes in methods or levels of
p.000063: payment for benefits or services under those programs. Such projects include, but are not limited to, internal
p.000063: studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements,
p.000063: or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as
p.000063: sections 1115 and 1115A of the Social Security Act, as amended.
p.000063:
p.000063: (i) Each Federal department or agency conducting or supporting the research and demonstration projects
p.000063:
p.000063: must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency
p.000063: head may determine, a list of the research and demonstration projects that the Federal department or agency
p.000063: conducts or supports under this provision. The research or demonstration project must be published on this list
p.000063: prior to commencing the research involving human subjects.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (6) Taste and food quality evaluation and consumer acceptance studies:
p.000063:
p.000063: (i) If wholesome foods without additives are consumed, or
p.000063:
p.000063: (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe,
p.000063: or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and
...
p.000063: from sources other than the investigators that no material changes have occurred since previous IRB review; and
p.000063:
p.000063: (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that
p.000063: investigators will conduct the research activity in accordance with the terms of the IRB approval until any
p.000063: proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent
p.000063: immediate hazards to the subject.
p.000063:
p.000063: (4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate
p.000063: institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or
p.000063: any successor office, or the equivalent office within the appropriate Federal department or agency of
p.000063:
p.000063: (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing
p.000063: noncompliance with this policy or the requirements or determinations of the IRB; and
p.000063:
p.000063: (ii) Any suspension or termination of IRB approval.
p.000063:
p.000063: (b) Except when an expedited review procedure is used (as described in §46.110), an IRB must review
p.000063: proposed research at convened meetings at which a majority of the members of the IRB are present, including at
p.000063: least one member whose primary concerns are in nonscientific areas. In order for the research to be approved,
p.000063: it shall receive the approval of a majority of those members present at the meeting.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.109 IRB review of research.
p.000063:
p.000063: (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or
p.000063: disapprove all research activities covered by this policy, including exempt research activities under §46.104 for
p.000063: which limited IRB review is a condition of exemption (under §46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)).
p.000063:
p.000063: (b) An IRB shall require that information given to subjects (or legally authorized representatives, when
p.000063: appropriate) as part of informed consent is in accordance with §46.116. The IRB may require that information, in
p.000063: addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the
p.000063: information would meaningfully add to the protection of the rights and welfare of subjects.
p.000063:
p.000063: (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with
p.000063: §46.117.
p.000063:
p.000063: (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the
p.000063: proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB
p.000063: decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for
p.000063: its decision and give the investigator an opportunity to respond in person or in writing.
p.000063:
p.000063: (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals
p.000063: appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).
p.000063:
p.000063: (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following
p.000063: circumstances:
p.000063:
p.000063: (i) Research eligible for expedited review in accordance with §46.110;
p.000063:
p.000063: (ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)
p.000063: (3)(i)(C), or (d)(7) or (8);
p.000063:
p.000063: (iii) Research that has progressed to the point that it involves only one or both of the following, which are
p.000063: part of the IRB-approved study:
p.000063:
p.000063: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
p.000063:
p.000063: (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
p.000063:
p.000063: (2) [Reserved]
p.000063: (g) An IRB shall have authority to observe or have a third party observe the consent process and the
p.000063: research.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk,
p.000063: and for minor changes in approved research.
p.000063:
p.000063: (a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of
p.000063: categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary
p.000063: will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal
p.000063: departments and agencies and after publication in the Federal Register for public comment. A copy of the list is
p.000063: available from the Office for Human Research Protections, HHS, or any successor office.
p.000063:
p.000063: (b)(1) An IRB may use the expedited review procedure to review the following:
p.000063:
p.000063: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the
p.000063: reviewer determines that the study involves more than minimal risk;
p.000063:
p.000063: (ii) Minor changes in previously approved research during the period for which approval is authorized; or
p.000063:
p.000063: (iii) Research for which limited IRB review is a condition of exemption under §46.104(d)(2)(iii), (d)(3)(i)(C), and
p.000063: (d)(7) and (8).
p.000063:
...
p.000063: with §46.117; and
p.000063:
p.000063: (iii) If there is a change made for research purposes in the way the identifiable private information or
p.000063: identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of
p.000063: subjects and to maintain the confidentiality of data.
p.000063:
p.000063: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare
p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
p.000063: (a) Cooperative research projects are those projects covered by this policy that involve more than one
p.000063: institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the
p.000063: rights and welfare of human subjects and for complying with this policy.
p.000063:
p.000063: (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon
p.000063: approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB
p.000063: will be identified by the Federal department or agency supporting or conducting the research or proposed by the
p.000063: lead institution subject to the acceptance of the Federal department or agency supporting the research.
p.000063:
p.000063: (2) The following research is not subject to this provision:
p.000063:
p.000063: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed
...
p.000063: department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the
p.000063: awardee or the Federal department or agency component conducting the trial on a publicly available Federal
p.000063: Web site that will be established as a repository for such informed consent forms.
p.000063:
p.000063: (2) If the Federal department or agency supporting or conducting the clinical trial determines that certain
p.000063: information should not be made publicly available on a Federal Web site (e.g. confidential commercial
p.000063: information), such Federal department or agency may permit or require redactions to the information posted.
p.000063:
p.000063: (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to
p.000063: recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
p.000063:
p.000063: (i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable
p.000063: Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or
p.000063: Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be
p.000063: legally effective.
p.000063:
p.000063: (j) Emergency medical care. Nothing in this policy is intended to limit the authority of a physician to provide
p.000063: emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or
p.000063: local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.117 Documentation of informed consent.
p.000063:
p.000063: (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a
p.000063: written informed consent form approved by the IRB and signed (including in an electronic format) by the subject
p.000063: or the subject's legally authorized representative. A written copy shall be given to the person signing the
p.000063: informed consent form.
p.000063:
p.000063: (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the
p.000063: following:
p.000063:
p.000063: (1) A written informed consent form that meets the requirements of §46.116. The investigator shall give
p.000063: either the subject or the subject's legally authorized representative adequate opportunity to read the informed
p.000063: consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally
p.000063: authorized representative.
p.000063:
...
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.202 Definitions.
p.000063:
p.000063: The definitions in §46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:
p.000063:
p.000063: (a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous
p.000063: movement of voluntary muscles, nor pulsation of the umbilical cord.
p.000063:
p.000063: (b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other
p.000063: means.
p.000063:
p.000063: (c) Fetus means the product of conception from implantation until delivery.
p.000063:
p.000063: (d) Neonate means a newborn.
p.000063:
p.000063: (e) Nonviable neonate means a neonate after delivery that, although living, is not viable.
p.000063:
p.000063: (f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed
p.000063: to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until
p.000063: the results of a pregnancy test are negative or until delivery.
p.000063:
p.000063: (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of
p.000063: available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary
p.000063: may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist
p.000063: in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be
p.000063: included in research only to the extent permitted and in accordance with the requirements of subparts A and D
p.000063: of this part.
p.000063: Back to Top
p.000063:
p.000063: §46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
p.000063:
p.000063: In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered
p.000063: by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart
p.000063: and the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.204 Research involving pregnant women or fetuses.
p.000063:
...
p.000063: Back to Top
p.000063:
p.000063: §46.301 Applicability.
p.000063:
p.000063: (a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or
p.000063: supported by the Department of Health and Human Services involving prisoners as subjects.
p.000063:
p.000063: (b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth
p.000063: herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by
p.000063: applicable State or local law.
p.000063:
p.000063: (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.302 Purpose.
p.000063:
p.000063: Inasmuch as prisoners may be under constraints because of their incarceration which could affect their
p.000063: ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it
p.000063: is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in
p.000063: activities to which this subpart is applicable.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.303 Definitions.
p.000063:
p.000063: As used in this subpart:
p.000063:
p.000063: (a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the
p.000063: Department of Health and Human Services to whom authority has been delegated.
p.000063:
p.000063: (b) DHHS means the Department of Health and Human Services.
p.000063:
p.000063: (c) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is
p.000063: intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals
p.000063: detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal
p.000063: prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or
p.000063: sentencing.
p.000063:
p.000063: (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally
p.000063: encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.304 Composition of Institutional Review Boards where prisoners are involved.
p.000063:
p.000063: In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out
p.000063: responsibilities under this part with respect to research covered by this subpart, shall also meet the following
p.000063: specific requirements:
p.000063:
p.000063: (a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s)
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000063: to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal
p.000063: requirements to return individual research results.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.105-46.106 [Reserved]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.107 IRB membership.
p.000063:
p.000063: (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate
p.000063: review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified
p.000063: through the experience and expertise of its members (professional competence), and the diversity of its
p.000063: members, including race, gender, and cultural backgrounds and sensitivity to such issues as community
p.000063: attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human
p.000063: subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional
p.000063: commitments (including policies and resources) and regulations, applicable law, and standards of professional
p.000063: conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly
p.000063: reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are
p.000063: knowledgeable about and experienced in working with these categories of subjects.
p.000063:
p.000063: (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least
p.000063: one member whose primary concerns are in nonscientific areas.
p.000063:
p.000063: (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is
p.000063: not part of the immediate family of a person who is affiliated with the institution.
p.000063:
p.000063: (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the
p.000063: member has a conflicting interest, except to provide information requested by the IRB.
p.000063:
p.000063: (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of
p.000063: issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote
p.000063: with the IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.108 IRB functions and operations.
p.000063:
p.000063:
p.000063: (a) In order to fulfill the requirements of this policy each IRB shall:
p.000063: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
p.000063:
...
p.000063: §46.111 Criteria for IRB approval of research.
p.000063:
p.000063: (a) In order to approve research covered by this policy the IRB shall determine that all of the following
p.000063: requirements are satisfied:
p.000063:
p.000063: (1) Risks to subjects are minimized:
p.000063:
p.000063: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose
p.000063: subjects to risk, and
p.000063:
p.000063: (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
p.000063: treatment purposes.
p.000063:
p.000063: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance
p.000063: of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should
p.000063: consider only those risks and benefits that may result from the research (as distinguished from risks and
p.000063: benefits of therapies subjects would receive even if not participating in the research). The IRB should not
p.000063: consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of
p.000063: the research on public policy) as among those research risks that fall within the purview of its responsibility.
p.000063:
p.000063: (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the
p.000063: purposes of the research and the setting in which the research will be conducted. The IRB should be particularly
p.000063: cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion
p.000063: or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or
p.000063: economically or educationally disadvantaged persons.
p.000063:
p.000063: (4) Informed consent will be sought from each prospective subject or the subject's legally authorized
p.000063: representative, in accordance with, and to the extent required by, §46.116.
p.000063:
p.000063: (5) Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
p.000063:
p.000063: (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to
p.000063: ensure the safety of subjects.
p.000063:
p.000063: (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
p.000063:
p.000063: confidentiality of data.
p.000063: (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office
p.000063: and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in
p.000063: assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of
p.000063: data.
p.000063:
p.000063: (ii) [Reserved]
p.000063:
p.000063: (8) For purposes of conducting the limited IRB review required by §46.104(d)(7)), the IRB need not make the
p.000063: determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
p.000063:
p.000063: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information
p.000063: or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
p.000063:
p.000063: (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance
p.000063: with §46.117; and
p.000063:
p.000063: (iii) If there is a change made for research purposes in the way the identifiable private information or
p.000063: identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of
p.000063: subjects and to maintain the confidentiality of data.
p.000063:
p.000063: (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as
p.000063: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally
p.000063: disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare
p.000063: of these subjects.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.112 Review by institution.
p.000063:
p.000063: Research covered by this policy that has been approved by an IRB may be subject to further appropriate
p.000063: review and approval or disapproval by officials of the institution. However, those officials may not approve the
p.000063: research if it has not been approved by an IRB.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.113 Suspension or termination of IRB approval of research.
p.000063:
p.000063: An IRB shall have authority to suspend or terminate approval of research that is not being conducted in
p.000063: accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
p.000063: Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall
p.000063: be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.114 Cooperative research.
p.000063:
...
p.000063: paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b)
p.000063: through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance
p.000063: with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research
p.000063: uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in
p.000063: research involving public benefit and service programs conducted by or subject to the approval of state or local
p.000063: officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is
p.000063: described in paragraph (f) of this section. Except as provided elsewhere in this policy:
p.000063:
p.000063: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally
p.000063: effective informed consent of the subject or the subject's legally authorized representative.
p.000063:
p.000063: (2) An investigator shall seek informed consent only under circumstances that provide the prospective
p.000063: subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to
p.000063: participate and that minimize the possibility of coercion or undue influence.
p.000063:
p.000063: (3) The information that is given to the subject or the legally authorized representative shall be in language
p.000063: understandable to the subject or the legally authorized representative.
p.000063:
p.000063: (4) The prospective subject or the legally authorized representative must be provided with the information
p.000063: that a reasonable person would want to have in order to make an informed decision about whether to
p.000063: participate, and an opportunity to discuss that information.
p.000063:
p.000063: (5) Except for broad consent obtained in accordance with paragraph (d) of this section:
p.000063:
p.000063: (i) Informed consent must begin with a concise and focused presentation of the key information that is most
p.000063: likely to assist a prospective subject or legally authorized representative in understanding the reasons why one
p.000063: might or might not want to participate in the research. This part of the informed consent must be organized and
p.000063: presented in a way that facilitates comprehension.
p.000063:
p.000063: (ii) Informed consent as a whole must present information in sufficient detail relating to the research, and
p.000063: must be organized and presented in a way that does not merely provide lists of isolated facts, but rather
p.000063: facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one
p.000063: might or might not want to participate.
p.000063:
...
General/Other / belmont
Searching for indicator belmont:
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p.000062: Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program.
p.000062: For further information see 47 FR 9208, Mar. 4, 1982.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: Subpart A—Basic HHS Policy for Protection of Human Research Subjects
p.000062: Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted.
p.000062:
p.000062: Back to Top
p.000062:
p.000062: §46.101 To what does this policy apply?
p.000062:
p.000062: (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted,
p.000062: supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate
p.000062: administrative action to make the policy applicable to such research. This includes research conducted by
p.000062: Federal civilian employees or military personnel, except that each department or agency head may adopt such
p.000062: procedural modifications as may be appropriate from an administrative standpoint. It also includes research
p.000062: conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
p.000062: Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs)
p.000062: reviewing research that is subject to this policy must comply with this policy.
p.000062:
p.000062: (b) [Reserved]
p.000062:
p.000062: (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this
p.000062: policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.62
p.000062: 62
p.000062: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report.
p.000062: Washington, DC: U.S. Department of Health and Human Services. 1979.
p.000062:
p.000062: (d) Department or agency heads may require that specific research activities or classes of research activities
p.000062: conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise
p.000062: covered by this policy comply with some or all of the requirements of this policy.
p.000062:
p.000062: (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide
p.000062: additional protections for human subjects.
p.000062:
p.000062: (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official
p.000062: governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide
p.000062: additional protections for human subjects.
p.000062:
p.000062: (g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that
p.000062: provide additional protections to human subjects of research.
p.000062:
p.000062: (h) When research covered by this policy takes place in foreign countries, procedures normally followed in
p.000062: the foreign countries to protect human subjects may differ from those set forth in this policy. In these
p.000062: circumstances, if a department or agency head determines that the procedures prescribed by the institution
p.000062: afford protections that are at least equivalent to those provided in this policy, the department or agency head
p.000062: may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this
p.000062: policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices
p.000062: of these actions as they occur will be published in the Federal Register or will be otherwise published as provided
p.000062: in department or agency procedures.
p.000062:
p.000062: (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all
p.000062: of the provisions of this policy to specific research activities or classes of research activities otherwise covered by
p.000062: this policy, provided the alternative procedures to be followed are consistent with the principles of the Belmont
p.000062: Report.63 Except when otherwise required by statute or Executive Order, the department or agency head shall
p.000062: forward advance notices of these actions to the Office for Human Research Protections, Department of Health
p.000062: and Human Services (HHS), or any successor office, or to the equivalent office within the appropriate Federal
p.000062: department or agency, and shall also publish them in the Federal Register or in such other manner as provided
p.000062: in department or agency procedures. The waiver notice must include a statement that identifies the conditions
p.000062: under which the waiver will be applied and a justification as to why the waiver is appropriate for the research,
p.000062: including how the decision is consistent with the principles of the Belmont Report.
p.000063: 63
p.000063: Id.
p.000063:
p.000063: (j) Federal guidance on the requirements of this policy shall be issued only after consultation, for the
p.000063: purpose of harmonization (to the extent appropriate), with other Federal departments and agencies that have
p.000063: adopted this policy, unless such consultation is not feasible.
p.000063:
p.000063: (k) [Reserved]
p.000063:
p.000063: (l) Compliance dates and transition provisions:
p.000063:
p.000063: (1) Pre-2018 Requirements. For purposes of this section, the pre-2018 Requirements means this subpart as
p.000063: published in the 2016 edition of the Code of Federal Regulations.
p.000063:
p.000063: (2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for
p.000063: the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the
p.000063: 2018 Requirements is January 21, 2019. The compliance date for §46.114(b) (cooperative research) of the 2018
p.000063: Requirements is January 20, 2020.
p.000063:
p.000063: (3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following
p.000063: research, unless the research is transitioning to comply with the 2018 Requirements in accordance with
p.000063: paragraph (l)(4) of this section:
p.000063:
p.000063: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
p.000063:
p.000063: (ii) Research for which IRB review was waived pursuant to §46.101(i) of the pre-2018 Requirements before
p.000063: January 21, 2019; and
p.000063:
p.000063: (iii) Research for which a determination was made that the research was exempt under §46.101(b) of the
p.000063: pre-2018 Requirements before January 21, 2019.
p.000063:
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000063:
p.000063: (5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research:
p.000063:
p.000063: (i) Research initially approved by an IRB on or after January 21, 2019;
p.000063:
p.000063: (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21,
p.000063: 2019; and
p.000063:
p.000063: (iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.
p.000063:
p.000063: (m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to
p.000063: any person or circumstance, shall be construed so as to continue to give maximum effect to the provision
p.000063: permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the
p.000063: provision shall be severable from this part and shall not affect the remainder thereof or the application of the
p.000063: provision to other persons not similarly situated or to other dissimilar circumstances.
p.000063:
p.000063: [82 FR 7259, 7273, Jan. 19, 2017, as amended at 83 FR 28518, June 19, 2018]
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.102 Definitions for purposes of this policy.
p.000063:
p.000063: (a) Certification means the official notification by the institution to the supporting Federal department or
p.000063: agency component, in accordance with the requirements of this policy, that a research project or activity
p.000063: involving human subjects has been reviewed and approved by an IRB in accordance with an approved
p.000063: assurance.
p.000063:
p.000063: (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to
p.000063: one or more interventions (which may include placebo or other control) to evaluate the effects of the
p.000063: interventions on biomedical or behavioral health-related outcomes.
p.000063:
p.000063: (c) Department or agency head means the head of any Federal department or agency, for example, the
p.000063: Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority
p.000063: provided by these regulations to the department or agency head has been delegated.
p.000063:
p.000063: (d) Federal department or agency refers to a federal department or agency (the department or agency itself
p.000063: rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy
p.000063: applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S.
p.000063: Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).
p.000063:
p.000063: (e)(1) Human subject means a living individual about whom an investigator (whether professional or student)
p.000063: conducting research:
p.000063:
p.000063: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses,
p.000063: studies, or analyzes the information or biospecimens; or
p.000063:
p.000063: (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
p.000063: biospecimens.
p.000063:
p.000063: (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g.,
p.000063: venipuncture) and manipulations of the subject or the subject's environment that are performed for research
p.000063: purposes.
p.000063:
...
Orphaned Trigger Words
p.000063: arrangements for avoiding duplication of effort.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.115 IRB records.
p.000063:
p.000063: (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB
p.000063: activities, including the following:
p.000063:
p.000063: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals,
p.000063: approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
p.000063: (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions
p.000063: taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining;
p.000063: the basis for requiring changes in or disapproving research; and a written summary of the discussion of
p.000063: controverted issues and their resolution.
p.000063:
p.000063: (3) Records of continuing review activities, including the rationale for conducting continuing review of
p.000063: research that otherwise would not require continuing review as described in §46.109(f)(1).
p.000063:
p.000063: (4) Copies of all correspondence between the IRB and the investigators.
p.000063:
p.000063: (5) A list of IRB members in the same detail as described in §46.108(a)(2).
p.000063:
p.000063: (6) Written procedures for the IRB in the same detail as described in §46.108(a)(3) and (4).
p.000063:
p.000063: (7) Statements of significant new findings provided to subjects, as required by §46.116(c)(5).
p.000063:
p.000063: (8) The rationale for an expedited reviewer's determination under §46.110(b)(1)(i) that research appearing
p.000063: on the expedited review list described in §46.110(a) is more than minimal risk.
p.000063:
p.000063: (9) Documentation specifying the responsibilities that an institution and an organization operating an IRB
p.000063: each will undertake to ensure compliance with the requirements of this policy, as described in §46.103(e).
p.000063:
p.000063: (b) The records required by this policy shall be retained for at least 3 years, and records relating to research
p.000063: that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB
p.000063: may maintain the records in printed form, or electronically. All records shall be accessible for inspection and
p.000063: copying by authorized representatives of the Federal department or agency at reasonable times and in a
p.000063: reasonable manner.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.116 General requirements for informed consent.
p.000063:
p.000063: (a) General. General requirements for informed consent, whether written or oral, are set forth in this
p.000063: paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b)
p.000063: through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance
p.000063: with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research
p.000063: uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in
p.000063: research involving public benefit and service programs conducted by or subject to the approval of state or local
p.000063: officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is
p.000063: described in paragraph (f) of this section. Except as provided elsewhere in this policy:
p.000063:
p.000063: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally
p.000063: effective informed consent of the subject or the subject's legally authorized representative.
p.000063:
p.000063: (2) An investigator shall seek informed consent only under circumstances that provide the prospective
p.000063: subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to
...
p.000063:
p.000063: (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator
p.000063: without regard to the subject's or the legally authorized representative's consent;
p.000063:
p.000063: (3) Any additional costs to the subject that may result from participation in the research;
p.000063:
p.000063: (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly
p.000063: termination of participation by the subject;
p.000063:
p.000063: (5) A statement that significant new findings developed during the course of the research that may relate to
p.000063: the subject's willingness to continue participation will be provided to the subject;
p.000063:
p.000063: (6) The approximate number of subjects involved in the study;
p.000063:
p.000063: (7) A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial
p.000063: profit and whether the subject will or will not share in this commercial profit;
p.000063:
p.000063: (8) A statement regarding whether clinically relevant research results, including individual research results,
p.000063: will be disclosed to subjects, and if so, under what conditions; and
p.000063:
p.000063: (9) For research involving biospecimens, whether the research will (if known) or might include whole genome
p.000063: sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome
p.000063: or exome sequence of that specimen).
p.000063:
p.000063: (d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable
p.000063: private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary
p.000063: research use of identifiable private information or identifiable biospecimens (collected for either research
p.000063: studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the
p.000063: informed consent requirements in paragraphs (b) and (c) of this section. If the subject or the legally authorized
p.000063:
p.000063: representative is asked to provide broad consent, the following shall be provided to each subject or the subject's
p.000063: legally authorized representative:
p.000063: (1) The information required in paragraphs (b)(2), (b)(3), (b)(5), and (b)(8) and, when appropriate, (c)(7) and (9)
p.000063: of this section;
p.000063:
p.000063: (2) A general description of the types of research that may be conducted with the identifiable private
p.000063: information or identifiable biospecimens. This description must include sufficient information such that a
p.000063: reasonable person would expect that the broad consent would permit the types of research conducted;
p.000063:
p.000063: (3) A description of the identifiable private information or identifiable biospecimens that might be used in
p.000063: research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the
p.000063: types of institutions or researchers that might conduct research with the identifiable private information or
p.000063: identifiable biospecimens;
p.000063:
p.000063: (4) A description of the period of time that the identifiable private information or identifiable biospecimens
p.000063: may be stored and maintained (which period of time could be indefinite), and a description of the period of time
p.000063: that the identifiable private information or identifiable biospecimens may be used for research purposes (which
p.000063: period of time could be indefinite);
p.000063:
p.000063: (5) Unless the subject or legally authorized representative will be provided details about specific research
p.000063: studies, a statement that they will not be informed of the details of any specific research studies that might be
p.000063: conducted using the subject's identifiable private information or identifiable biospecimens, including the
p.000063: purposes of the research, and that they might have chosen not to consent to some of those specific research
p.000063: studies;
p.000063:
p.000063: (6) Unless it is known that clinically relevant research results, including individual research results, will be
p.000063: disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject;
p.000063: and
p.000063:
p.000063: (7) An explanation of whom to contact for answers to questions about the subject's rights and about storage
p.000063: and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in
p.000063: the event of a research-related harm.
p.000063:
p.000063: (e) Waiver or alteration of consent in research involving public benefit and service programs conducted by or
p.000063: subject to the approval of state or local officials—(1) Waiver. An IRB may waive the requirement to obtain
p.000063: informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the
p.000063: requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the
p.000063: storage, maintenance, and secondary research use of identifiable private information or identifiable
p.000063: biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an
p.000063: IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private
p.000063: information or identifiable biospecimens.
p.000063:
p.000063: (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the
p.000063: elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the
p.000063: requirements of paragraph (e)(3) of this section. An IRB may not omit or alter any of the requirements described
p.000063: in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the
p.000063: elements required under paragraph (d) of this section.
p.000063:
p.000063: (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this
p.000063: subsection, the IRB must find and document that:
p.000063:
p.000063: (i) The research or demonstration project is to be conducted by or subject to the approval of state or local
p.000063: government officials and is designed to study, evaluate, or otherwise examine:
p.000063:
p.000063: (A) Public benefit or service programs;
p.000063:
p.000063: (B) Procedures for obtaining benefits or services under those programs;
p.000063:
p.000063: (C) Possible changes in or alternatives to those programs or procedures; or
p.000063:
p.000063: (D) Possible changes in methods or levels of payment for benefits or services under those programs; and
p.000063:
p.000063: (ii) The research could not practicably be carried out without the waiver or alteration.
p.000063:
p.000063: (f) General waiver or alteration of consent —(1) Waiver. An IRB may waive the requirement to obtain
p.000063: informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the
p.000063: requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the
p.000063: storage, maintenance, and secondary research use of identifiable private information or identifiable
p.000063: biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an
p.000063: IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private
p.000063: information or identifiable biospecimens.
p.000063:
p.000063: (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the
p.000063: elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the
p.000063:
p.000063: requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described
p.000063: in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the
p.000063: elements required under paragraph (d) of this section.
p.000063: (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this
p.000063: subsection, the IRB must find and document that:
p.000063:
p.000063: (i) The research involves no more than minimal risk to the subjects;
p.000063:
p.000063: (ii) The research could not practicably be carried out without the requested waiver or alteration;
p.000063:
p.000063: (iii) If the research involves using identifiable private information or identifiable biospecimens, the research
p.000063: could not practicably be carried out without using such information or biospecimens in an identifiable format;
p.000063:
p.000063: (iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
p.000063:
p.000063: (v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional
p.000063: pertinent information after participation.
p.000063:
p.000063: (g) Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an
p.000063: investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the
p.000063: eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally
p.000063: authorized representative, if either of the following conditions are met:
p.000063:
p.000063: (1) The investigator will obtain information through oral or written communication with the prospective
p.000063: subject or legally authorized representative, or
p.000063:
p.000063: (2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing
p.000063: records or stored identifiable biospecimens.
p.000063:
p.000063: (h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal
p.000063: department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the
p.000063: awardee or the Federal department or agency component conducting the trial on a publicly available Federal
p.000063: Web site that will be established as a repository for such informed consent forms.
p.000063:
p.000063: (2) If the Federal department or agency supporting or conducting the clinical trial determines that certain
p.000063: information should not be made publicly available on a Federal Web site (e.g. confidential commercial
p.000063: information), such Federal department or agency may permit or require redactions to the information posted.
p.000063:
p.000063: (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to
p.000063: recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
p.000063:
...
p.000063: or the subject's legally authorized representative. A written copy shall be given to the person signing the
p.000063: informed consent form.
p.000063:
p.000063: (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the
p.000063: following:
p.000063:
p.000063: (1) A written informed consent form that meets the requirements of §46.116. The investigator shall give
p.000063: either the subject or the subject's legally authorized representative adequate opportunity to read the informed
p.000063: consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally
p.000063: authorized representative.
p.000063:
p.000063: (2) A short form written informed consent form stating that the elements of informed consent required by
p.000063: §46.116 have been presented orally to the subject or the subject's legally authorized representative, and that the
p.000063: key information required by §46.116(a)(5)(i) was presented first to the subject, before other information, if any,
p.000063: was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally
p.000063: authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the
p.000063: short form itself is to be signed by the subject or the subject's legally authorized representative. However, the
p.000063:
p.000063: witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent
p.000063: shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally
p.000063: authorized representative, in addition to a copy of the short form.
p.000063: (c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for
p.000063: some or all subjects if it finds any of the following:
p.000063:
p.000063: (i) That the only record linking the subject and the research would be the informed consent form and the
p.000063: principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally
p.000063: authorized representative) will be asked whether the subject wants documentation linking the subject with the
p.000063: research, and the subject's wishes will govern;
p.000063:
p.000063: (ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures
p.000063: for which written consent is normally required outside of the research context; or
p.000063:
p.000063: (iii) If the subjects or legally authorized representatives are members of a distinct cultural group or
p.000063: community in which signing forms is not the norm, that the research presents no more than minimal risk of
p.000063: harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed
p.000063: consent was obtained.
p.000063:
p.000063: (2) In cases in which the documentation requirement is waived, the IRB may require the investigator to
p.000063: provide subjects or legally authorized representatives with a written statement regarding the research.
p.000063:
p.000063: (Approved by the Office of Management and Budget under Control Number 0990-0260)
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.118 Applications and proposals lacking definite plans for involvement of human subjects.
p.000063:
p.000063: Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal
p.000063: departments or agencies with the knowledge that subjects may be involved within the period of support, but
p.000063: definite plans would not normally be set forth in the application or proposal. These include activities such as
p.000063: institutional type grants when selection of specific projects is the institution's responsibility; research training
p.000063: grants in which the activities involving subjects remain to be selected; and projects in which human subjects'
p.000063: involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.
p.000063: Except for research waived under §46.101(i) or exempted under §46.104, no human subjects may be involved in
p.000063: any project supported by these awards until the project has been reviewed and approved by the IRB, as provided
p.000063: in this policy, and certification submitted, by the institution, to the Federal department or agency component
p.000063: supporting the research.
p.000063:
p.000063: Back to Top
p.000063:
p.000063: §46.119 Research undertaken without the intention of involving human subjects.
p.000063:
p.000063: Except for research waived under §46.101(i) or exempted under §46.104, in the event research is undertaken
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| alcoholism | alcoholism |
| authority | Relationship to Authority |
| belmont | belmont |
| child | Child |
| children | Child |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| detained | person in detention center |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| gender | gender |
| home | Property Ownership |
| impaired | Cognitive Impairment |
| incapacity | Incapacitated |
| incarcerated | Incarcerated |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| native | Indigenous |
| neonate | Fetus/Neonate |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| parent | parents |
| parents | parents |
| party | political affiliation |
| physically | Physically Disabled |
| placebo | participants in a control group |
| pregnant | Pregnant |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| race | Racial Minority |
| single | Marital Status |
| student | Student |
| undue influence | Undue Influence |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impaired'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['neonate', 'fetuses', 'neonates'] |
| fetuses | ['fetus', 'neonate', 'neonates'] |
| impaired | ['cognitive'] |
| incarcerated | ['prison'] |
| neonate | ['fetus', 'fetuses', 'neonates'] |
| neonates | ['fetus', 'neonate', 'fetuses'] |
| parent | ['parents'] |
| parents | ['parent'] |
| prison | ['incarcerated'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
harm
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input