The document discusses the roles and responsibilities of ethics committees (ECs) or institutional review boards (IRBs). It states that ECs are independent bodies composed of medical, scientific, and non-scientific members who ensure the protection of human subjects in clinical trials. Their key responsibilities include reviewing and approving study protocols and informed consent documents. The document outlines that ECs should have a diverse membership including specialists in different areas like science, medicine, ethics, law, and lay persons. It explains the perspectives and expertise that different member types, such as basic scientists, legal experts, and social workers, provide to the EC. Finally, it states that the primary purpose of EC/IRB review is to assure the protection of subjects' rights
2. 1. What constitutes an EC?
2. What is its authority?
3. Who all are members?
4. What are their roles?
5. What does EC review?
Understanding EC!
3. Institutional Review Board (IRB)
An independent body constituted of medical, scientific, and non scientific members, whose responsibility it is to
ensure the protection of the rights, safety, and wellbeing of human subjects involved in a trial by, among other
things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material
to be used in obtaining and documenting informed consent of the trial subjects.
4. Research Ethics Committee (REC) in the United Kingdom
Medical Research Ethics Committee (MREC) in the Netherlands
Comités de Protection des Personnes (CPP) in France
Institutional Review Board in United States
Research Ethics Board (REB) in Canada
Human Research ethics committee (HREC) in Australia
Some EC/IRB around
world
5. What is an EC/IRB!
An independent body
Made of medical professionals and non-
medical members
Protect the participant & provide public
assurance
6. What authority does EC/IRB
have!
It is required by law
It is mandated (give someone authority) by national & International
guidelines
Established by the Institutions highest body
Mandated to act independently
7. Who all should be members!
Reasonable number of members
Collectively have qualifications and experience to review and
evaluate the proposed research
Science
Medical aspects
Ethics
9. EC- Basic Medical
Scientist
Who can be a Basic Medical Scientist?
Scientific
Specialized or professional knowledge of subject matter
(Pharmacology)*
Qualification of an expert (MD- Pharmacology)*
10. EC- Lay
Person
Who can be a lay person?
• Non Scientific
• No Specialized or professional knowledge of subject matter (in this
case bio medical research, health/medicine)*
• No qualification of an expert
• Should be from the community/society served by the hospital
11. Why a lay person!
What is a Lay person’s perspective?
Safeguard the public interest
To contribute a user perspective or
‘patient voice’ to professional
discussions
Review the ICF for language &
understanding
12. EC- Legal
Person
Who can be a legal person?
Non Scientific
Professional Qualification to practice law as per the requirements of the country
An expert in given field of knowledge (Legal)
Specialized or professional knowledge of subject matter (in this case knowledge of
medico-legal cases)
13. Why have a legal person!
What is a Legal person’s perspective?
Ensure EC decisions do not contravene the law
Ensure the legal rights of patient are protected
Review ICF
Review Insurance
Review CTA (Clinical trail approval)
14. EC- Social
Worker
Who can be a Social Worker?
Non scientific
Social worker engaged with a NGO
An expert in given field of knowledge (Bioethics)
Specialized or professional knowledge of subject matter (in this case
knowledge of public health policy and societal risk/impact)
15. Why a Social worker!
What does a SW person do?
• Is any project likely to cause any social harm? (eg-discrimination)
• Review ICF from to protect rights of participants
• Language understandable and will help in decision making
• No harm due to Socio- economic vulnerability
• Culturally acceptable
• No risk due to Social hierarchy
• No language to undue influence participation
• In cases of vulnerable participants, help EC determine measures to
enhance protection
16. What is the purpose of EC/IRB
review!
The primary purpose of such review is –
“ Assure the protection”
Rights
Safety
Welfare
of the human subjects
17. What does an EC/IRB do?
Reviewing and providing opinion on-
• Trial protocol
• Suitability of the investigator(s)
• Suitability of facilities
• Methods and material used in obtaining and
documenting informed consent of trial subjects
18. • First patient in
• Number of subjects recruited/ withdrawn
• Investigator to promptly report-
o Deviations from protocol
o New safety information
o Any increased risk to participants/ unanticipated problems
o Serious & unexpected AE
o Complaints from subjects
What does the EC/IRB do?