This document outlines the roles and responsibilities of ethics committee (EC) members in reviewing clinical trial protocols. It describes the composition of ECs, which includes chairs, clinicians, scientists, legal experts, social scientists, philosophers, theologians, and lay people. The roles of EC members include scientifically and ethically reviewing protocols, informed consent documents, risks and benefits, qualifications, and providing ongoing trial oversight. The chair oversees meetings while the member secretary organizes documentation and communication. Together the multidisciplinary EC works to protect research participants.

1. ROLE AND
RESPONSIBILITIES OF EC
MEMBERS
Mr. Vinendrasinh Parmar
Ph. D Research Scholar
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2. OUTLINE
 Introduction
 Compositions
 Quorum
 Steps in EC
 Role and responsibilities
 References
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3. INTODUCTION:
 IRB:
 ICH GCP 1.31: an independent body constituted of
medical, scientific and non-scientific members
whose responsibility to ensure the protections of
right, safety, and well being of human subject
involved in a clinical trial, or among other things,
reviewing, approving, and providing continuing
review of clinical trail protocols and its
amendments, methods and material to be used in
obtaining and documenting informed consent of the
trial subjects.
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4. COMPOSITION
8-12 members
 Chairperson
 One-two persons from basic medical science area
 One-two clinicians from various institutes
 One legal expert
 One social scientist/ representative NGO
 One philosopher/ ethicist/ theologian
 One lay person from community
 Member secretary
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5. QUORAM AS PER SCHEDULE Y
 Basic medical scientist
 Clinician
 Legal expert
 social scientist/ philosopher/ ethicist/ theologian
 Lay person
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6. STEPS IN EC REVIEW:
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7. Chairperson:
Qualifications:
 A well respected person from any background with prior
experience of having served/ serving an EC
Role:
 Conduct an EC meeting and be accountable for
independent and efficient functioning of the committee.
 Enumerate active participation of all members(particularly
non-affiliated, non-medical, non-technical) in all
discussion and deliberations
 Ratify minutes of the previous meetings
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8.  In case of anticipated absence of both chairperson and
vice-chairperson at a planned meeting, a chairperson
should nominated a committee member as acting
chairperson or members present may elect an acting
chairperson on the day of meeting.
 The acting chairperson should be non affiliated person
and will have all power of chairperson for that meeting.
 Seek COI declaration from members and ensure quorum
and fair decision making
 Handle complaints against researches, EC members,
conflict of interest issues and requests for use of EC data
etc.
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9. Member secretary:
Qualifications:
 Should be a staff member of the institution.
 Should have knowledge and experience in clinical
research and ethics, be motivated and have good
communication skills.
 Should be able to devote adequate time to this
activity which should be protected by institution.
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10. Role:
 Organize an effective and efficient procedure for
receiving, preparing, circulating and maintaining each
proposal for review.
 Schedule EC meeting, prepare the agenda and minutes.
 Organize the EC documentation, communication and
archiving.
 Ensure training of EC secretarial and EC members.
 Ensure SOPs are update as and when required.
 Ensure adherence of EC functioning to the SOPs.
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11.  Prepare report and response to audits and inspections.
 Ensure completeness of documentation at the time of
receipt and timely inclusion in agenda for EC review.
 Assess the need for expedited review / exemption from
review or full review.
 Assess the need to obtain prior scientific review, invite
independent consultant, patient or community
representative.
 Ensure quorum during the meeting and record
discussions and decision.
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12. Basic medical scientist:
Qualifications:
 Non-medical or medical person with qualification in basic
medical science.
 In case of EC reviewing clinical trial with drugs, the basic
medical scientist should preferably be a Pharmacologist.
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13. Role:
 Scientific and ethical review with special emphasis
on the intervention, benefit-risk, analysis, research
design, methodology and statistic, continuing
review process, SAE, protocol deviation, progress,
and completion report.
 For clinical trials, pharmacologist to review the drug
safety and pharmacodynamics
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14. Clinician (s):
Qualifications:
 Should be individual/s with recognized medical
qualification, experience, expertise and training.
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15. Role:
 Scientific review of protocol including review of the
intervention, benefit-risk analysis, research design,
methodology, sample size, site of study and
statistics.
 On going review of protocol (SAE, protocol
deviations, or violations, progression and
completion of report)
 Review of medical care and facility,
appropriateness of principal investigator, provision
for medical care, management and compensation.
 Thorough review of protocol, investigator brouchure
(if applicable), and all other protocol details and
submitted documents.
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16. Legal expert:
Qualifications:
 Should have basic degree in Law from a
recognized university, with experience.
 Training in medical Law.
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17.  Ethical review of proposal, ICD, along with
transitions, MoU, clinical trial agreement (CTA),
regulatory approval, insurance document, other site
approvals, researchers understanding, protocol
specific other permissions, such as , stem cell
committee from stem cell research, HMSC for
international collaboration, compliance with
guideline etc.
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18. Social scientist/ Philosopher/ethicist/theologian:
Qualifications:
 Should be an individual with social/ behavioral science/
philosophy/ religious qualification and training and / or
expertise and and be sensitive to local cultural and
moral values.
 Can be NGO involved in health-related activities.
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19. Role:
 Ethical review of the proposal, ICD along with the
translations.
 Assess impact on community involvment, socio-
cultural context, religious, or philosophical context,
if any
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20. Lay person(s)
Qualifications:
 Literate person from the public or community.
 Has not pursued a medical science/ health-related
career in the last 5 years
 May be representative of the community from which the
participants are to be drawn
 Is aware of local language, cultural and moral values of
community.
 Desirable involved in social and community welfare
acivities 20

21.  Role:
 Ethical review of the proposal, ICD along with
translation.
 Evaluate benefits and risk from the participants
perspective and opine whether benefit justify the
risk
 Serve as a patient/ participant/ community
representative and bring in ethical and societal
concerns.
 Assess on societal aspects if any.
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22. REFERENCES:
 Schedule Y
 Ethical Guidelines for Biomedical Research on
Human ICMR
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23. ANY QUESTIONS?
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24. THANK YOU…!
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