Guidelines for Ethical Review of Clinical Research or Research involving human subjects

Medical Review & Ethics Committee (MREC) Ministry of Health Malaysia


Guideline 1:     Waiver of MREC review and approval for research not involving human subject

1.         A human subject (in the context of research) is a living individual about whom an investigator obtains 
either
▪    Data  through  intervention  (e.g.  trial)  with  or  without  identifiable  private information or
▪    interaction (e.g. physical examination, questionnaires) with the individual with collection of identifiable 
private information

Source: US Code of Federal Regulation Title 45 Part 46

2.         All  research  NOT  involving  human  subject,  as  defined  in  (1)  above,  may  be exempted from MREC 
review and approval. Such research is also automatically exempted from obtaining informed consent from study subject 
since by definition no human subject is involved.

3.         The  authority  to  exempt  a  proposed  research  from  MREC  review  and  approval may  be  delegated  to  
an  individual  or  body  in  the  local  institution.  For  MOH healthcare   facilities,   this   would   typically   
be   the   local   Clinical   Research Committee.  Prior  to  authorizing  exemption  from  MREC  approval,  the  local 
authorizing  body  must  verify  that  the  proposed  research  is  registered  with  the National  Medical/Clinical  
Research  Register  to  allow  the  MREC  to  track  and review  the  appropriateness  of  exemption  from  MREC  
review.  An  investigator lacking access to a local body  to authorize the waiver may  apply instead to  the MREC for 
the purpose.

4.         The following types of research or data collection would be exempt from MREC review and approval:

a.   Study  or  data  collection  based  entirely  on  data  abstraction  from  existing medical  or  laboratory  
record;  with  no  interaction  with  the  human  subject concerned and with no collection of identifiable private 
information.

b.   Study based entirely on existing biological specimen; with no interaction with the  human  subject  concerned;  
with  no  collection  of  identifiable  private information and with no further processing of and/or testing on the 
specimen.

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c.   Research   involving   the   use   of   educational   tests   (cognitive,   diagnostic, aptitude,    achievement), 
   survey    procedures    (questionnaires),    interview procedures  or  observation  of  public  behaviour  and  with 
 no  collection  of identifiable private information.


















































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Guideline 2:     Waiver   of   informed   consent   for   research   involving human subject

1.         The  MREC  may  waive  the  requirement  to  obtain  individual  informed  consent from  the  human  subject 
 participating  in  the  research  provided  the  MREC  finds and documents that:

a.   Subjects would be exposed to no more than minimal risk and the requirement of  individual  informed  consent  
would  make  the  conduct  of  the  research impracticable

OR

b.   Subjects  would  be  exposed  to  no  more  than  minimal  risk  and  the  study involves only publicly available 
data,

OR

c.     The study involves private data but is carried out under legislative or public health authority.

Source:  CIOMS  International  Guideline  for  ethical  review  of  Epidemiological studies

2.         For this purpose, minimal risk means that the probability and magnitude of harm or  discomfort  anticipated  
in  the  research  are  not  greater  than  those  ordinarily encountered  in  daily  life  or  during  the  
performance  of  routine  physical  or psychological examinations or tests.

Source: US Code of Federal Regulation Title 45 Part 46

3.         The  following  types  of  research  or  data  collection  would  be  exempt  from obtaining informed 
consent:

a.   Research not involving human subject, as defined in Guideline 1

b.   Clinical  or  disease  registry  or  database,  or  large-scale  non-interventional observational study, would 
also qualify provided the data collection is based on existing medical or laboratory records, the risk is minimal, it 
is impractical otherwise to conduct such study and the MOH is a sponsor of the registry or database or study.

4.         Prior  to  waiving  the  requirement  to  obtain  individual  informed  consent,  the MREC must verify that 
the proposed research (all types of research) is registered with  the  National  Medical/Clinical  Research  Register  
to  allow  the  MREC  to document and track the occurrences of such waiver.

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