SOUTH WEST REGIONAL HEALTH AUTHORITY


BIOETHICS COMMITTEE

Guidelines for Research  Protocols Submitted  for Review

"die  following  information  should  be  included  in  Research  Protocols  being  submitted  to  the Bioethics 
Committcc of the SWRI IA:

COVERING  NOTE: Briefly  introduce  your request  to conduct  research  at the SWRHA and specify any institutions to 
which  you are affiliated,  tor example whethcr  you are an employee
/  student  at  a  University,  employee  of  an  RHA,  etc.  List  the  documents  included  in  your application,  
for example  1. Research  Protocol,  2.  University’s  Ethics  Approval  / Employer’s Approval, 3. Informed  Consent 
Form, 4. Questionnaires, etc (100 words limit).

1.   TITLE OF THE PROPOSED RESEARCH
2.   DATF. (and Version - it’there has been a prcvious submission)
3.   NAME,    ADDRESS,    TELEPHONE     NUMBER     AND    EMAIL    1or    ALL    THE INVESTIGATORS,    COLI.ABORA4 ORS, 
 AND/OR   SUP ERVISORS   (starting  with  the Principal  Investigator).
4.   SITE/S (LOCATION)  OF RESEARCH
5.   NUMBER OF RESEARCH  PARTICIPANTS  TO BE ENROLLEI3
6.   PROPOSED  DURATION  OF THE STUDY
7.   A SUMMARY  OF THE  PROPOSED  STUDY  — not  more  than  250  words and should
include:
a.   The hypothesis and scientific basis or justification for the study
b.   The usefulness and significance of the study
c.   An outline of the study design
d.   An indication of steps taken to ensure and maintain confidentiality
e.   An assessment  of the bcnefits  to participants  (and/or  groups  in the communlty  or the entire community) and 
the risks

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8.   THE PROJECT PltOPOSAL
A.  An  introduction  and  background  information  on  the  research  topic.  This  should  also include  the  
justification  for  the  research  (review  of  the  current  knowledge  from  the literature on the  topic,  with an 
explanation  why this project  is necessary, and how it will contribute to the overall knowledge in this area)
B.   A clear statement of the objectives of the research proposal
C.  Design and Methodology:
i.      Study design
ii.      Data collection methods:
•     Details   of  procedures   to  be  performed   (e.  g.   volume   of   blood,  the frequency,   timing,   and   
possible   site   of   the   blood-taking;   any   drug administration, physiological measures, etc.).
•     Which   procedures   may   cause   pain   and/or   discomfort   for   research participants.
•     Details of the intervention (where appropriate)
•    Copy of the data collection tool in the Appendix
iii.      Study population and sampling methods
•     Choice of participants, inclusion exclusion criteria, any controls, etc.
•     A  statement  that  participants  were  selected  only  because  of the  specific pr‹›blem  under    
investigation, and  not  because  of  their  easy  availability, diminished autonomy, or any social bias.
•     Sampling methods
iv.      Statistical issues
•     Number of research participants and its justification
•     Planned data analysis
D.  A statement confirming that reasonable time will be given for the participant  to consider his/her involvement
E.  Procedures for obtaining informed consent, including statements that the researcher/s will read  the  informed  
consent  form  to  the  participant  or  his/her  legal  guardian  and  will provide  that  person  with  a  copy  of  
the  form,  that  questions  from  the  person  will  be invited, and that all efforts will be made to ensure that s/he 
understands  its content before the seeking of consent

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F.    A copy of the informed consent form and recruitment  posters (see details below)
G.  Data  privacy/confidentiality:  Mcthods  to  protect  the  confidentiality  of  participants,  and methods   to  
ensure  that  a  participant   who  opts  out  of  a  research  endeavour   is  well protected  as far as hcalth  care 
delivery  is concerned  and  not disadvantaged  in any way. Plans for the secure storage of the data.
H.  Assumptions  made
I.    Relevant references (i.c. literature citation)
J.    Conflicts of intcrest
K.  Dissemination  plan
L.  The  name,  address,  telephone  and  fax  numbers,  as  well  as  email  address  of  a  contact person

9.   THE INFonM«D CONSENT FORM should include the following:
a.   Statements  in  language  written  for  comprehension  by  the  lay  person  outlining  the purpose  of the  
research,  what  will  be done  in  the  research  study,  and  indicating  that this  has  been  explained  orally  
and  in  writing  to  the  participant  (or  the  participant’s parent   or   legal   guardian   —  if  a  child   or   
mcntally   challenged   individual)   who understands  what  will  be  done.  These  will  be  countersigned   by  the  
participant  or his/her legally authorized  representative;
b.   Explicit statements  about  risk  or discomfort  to the  participant,  with an assessment  of the degrec of risk, 
and viable alternatives;
c.   A  statement   that   the   participant’s   involvement   is  voluntary,   and   that  refusal   to participate  
or (if after  having agreed  to participate)  withdrawal  from  the study at any timc  will  not  affcct  the  
participant’s  access  to  or  thc  type  of  care  to  which  s/he  is entitled;
d.   The  name,  address,  telephone  numbcr,  as  well  as email  addrcss  of  a contact  person for any queries;
e.   A  statement  confirming  that  reasonable  time  will  be  given  for  the  participant  to consider her/his 
involvement;
f.    Statements  that the participant or her/his legal  guardian  has read the informed consent document,  or that  it 
 has  been  read  to  her/him,  and  that s/he  understands  its contents; that a copy will  be given to the 
participant; and that the signature of the participant or the legal guardian indicates that s/he has frccly agrccd to 
participate;


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g.   The  signature:  of  a  witness  to  the  consent  procedure  who  is  not  connected  to  the research 
undr'rtaking (i.e. a relative, caretaker, friend)

FORMATTING:
Font: Times New Roman Font Size: 12
Line spacing: 1.5
Limit: 4 to 6 pages (approximately 2000 words).


IN STRUCTI ONS:
Researchers  must submi  one (1) soft copy o1 their Rcscarch 1'rotoco1 and any other supporting documcnts to:

Mrs. Kathyann Thomas-Elbourne General Manager-Nursing /
Secretary, S WItflA 13io‹•thics Committee Levcl 8, San Fernando 4 caching 1lospital Chanccry Lane, San Fernando
Email:  i   u1It   iii iii c1 l›‹ ›i  n  n    ‹     «  i  ha .c‹›  i I

:      ii  c     I It i i c - la url‹c   rf  s  \›  i  1   ‹i.   c  t› . II  



CONFIlIMATION :
Upon receipt o1’ an application,  a confirmation email will  bc sent to the researcher. Should researchers  wish to 
also follow-up via telephone, thcy may contact 868-225-1763 ext 1763.















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