Ethics Committee (EC) is a committee comprising medical, scientific, nonmedical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well‐being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions. Biomedical and health research means research including studies on basic, applied and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioural); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not include clinical trial as defined in New Drugs & Clinical Trials Rules- 2019. Clinical Trial in relation to a new drug or investigational new drug means any systematic study of a such new drug or investigational new drug in human subjects to generate data for discovering or verifying its,(i) clinical or; (ii) pharmacological including pharmacodynamics, pharmacokinetics or; (iii) adverse effects. Ethics Committee means for the purpose of (i) Clinical trial, Bioavailability and Bioequivalence study, should be registered with the Central Licencing Authority, Central Drug Standard Control Organisation (CDSCO); (ii) Biomedical and health research should be registered with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research ( DHR); Institutions desirous of conducting biomedical and health research as well as clinical trials or bioavailability or bioequivalence study shall require obtaining registration from both specified authorities ie DHR and CDSCO.

1. Roles and Responsibilities of
an Ethics committee
DR. PRAMOD KUMAR
MBBS; MD ( Pharmacology) NTTC ( JIPMER); BCBR ( ICMR-NIE)
Associate Professor & Head
Department of Pharmacology, AIIMS- Patna
Email: drpramodkumar@aiimspatna.org
Tuesday, 06 December 2022 IGIMS GCP Workshop 1

2. In next few minutes…..
Ethics Committee composition
Role of Individual member
Elements of review
Tuesday, 06 December 2022 IGIMS GCP Workshop 2

3. What is an Ethics Committee?
committee comprising medical, scientific, non‐ medical and nonscientific
members,
whose responsibility is to ensure the protection of the rights, safety and
well‐being of human subjects involved in a clinical trial
and it shall be responsible for reviewing and approving the protocol, the
suitability of the investigators, facilities, methods and adequacy of information
to be used for obtaining and documenting informed consent of the study
subjects and adequacy of confidentiality safeguards.
Tuesday, 06 December 2022 IGIMS GCP Workshop 3

4. Ethics Committee: Composition
Multi-disciplinary & multi-sectoral
Preferably 7-15 members, Quorum- atleast 5 members
Chairperson from outside the institute
Mix of medical/ non- medical, scientific, non- scientific, lay person
Adequate representation of age & gender, preferably 50 percent –non- affiliated, patient
groups may represent in EC
Set of alternate members, If required subject experts may be invited to offer their views
Supporting staff, Registration with DHR
Tuesday, 06 December 2022 IGIMS GCP Workshop 4

5. Composition, affiliations, and qualifications of an EC members
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Sl.
No.
Members of ECs Qualifications
1. Chairperson/ Vice
Chairperson (optional) Non-
affiliated
 A well-respected person from any background with prior experience of
having served/serving in an EC.
2. Member Secretary/
Alternate Member
Secretary (optional)
Affiliated
 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 the institution.
3. Basic Medical Scientist(s)
Affiliated/ non-affiliated
 Non-medical or medical person with qualifications in basic medical
sciences.
 In case of EC reviewing clinical trials with drugs, the basic medical
scientist should preferably be a pharmacologist.
4. Clinician(s) Affiliated/ non-
affiliated
 Should be individual/s with recognized medical qualification, expertise
and training.

6. Composition, affiliations, and qualifications of an EC members
Sl.
No.
Members of ECs Qualifications
5. Legal expert/s
Affiliated/ non-
affiliated
 Should have a basic degree in Law from a recognized university, with experience
 Desirable: Training in medical law.
6. Social scientist/
philosopher/
ethicist/theolog
ian Affiliated/
non-affiliated
 Should be an individual with social/behavioural science/ philosophy/ religious
qualification and training and/or expertise and be sensitive to local cultural and
moral values. Can be from an NGO involved in health-related activities.
7. Lay person(s)
Non-affiliated
 Literate person who has not pursued a medical science/ health related career in
the last 5 years.
 May be a representative of the community and aware of the local language,
cultural and moral values of the community.
 Desirable: involved in social and community welfare activities
Tuesday, 06 December 2022 IGIMS GCP Workshop 6

7. IEC AIIMS Patna
Tuesday, 06 December 2022 IGIMS GCP Workshop 7

8. • Qualifications
• Experience
• interest
• Commitment, and
• willingness to volunteer time & effort.
 Selection of members : Roles Members selected in their personal capacities
& appointed for a particular role based on
their :
Tuesday, 06 December 2022 IGIMS GCP Workshop 8
Objective :To discuss the roles and responsibilities
of members of ethics committees.

9. EC: Primary Role
Tuesday, 06 December 2022 IGIMS GCP Workshop 9
Research Participants
Well -
Being
Rights
Safety

10. • Non-affiliated
• Qualifications: A well-respected person from any background with prior experience of having served/ serving in an EC
1.Chairperson
Conduct EC meetings.
Seek COI declaration
from members.
Ratify minutes of the
previous meetings.
Ensure quorum and fair
decision making.
Ensure independent
and efficient
functioning of the
committee.
Ensure active
participation of all
members (particularly
non-affiliated, non-
medical/ non-
technical).
Handle complaints
against researchers,
EC members, conflict
of interest issues and
requests for use of EC
data.
In case of anticipated
absence, a non-
affiliated committee
member nominated
as Acting Chairperson.
Roles and Responsibilities
Tuesday, 06 December 2022 IGIMS GCP Workshop 10

11. 2. Member Secretary
• Affiliated
• Qualifications: Should have knowledge and experience in clinical research and ethics. Be motivated. Have good
communication skills. Should be able to devote adequate time which should be protected by the institution.
Roles and Responsibilities
Prepare for and respond
to audits and inspections.
Ensure training of EC
secretariat and EC
members.
Schedule EC meetings,
prepare the agenda and
minutes.
Organize EC documentation,
communication and archiving.
Ensure quorum during the meeting
and record discussions and
decisions.
Assess the need for
expedited
review/exemption from
review or full review.
Ensure adherence of EC
functioning to the SOPs,
and SOPs are updated as
and when required.
Ensure completeness of
documentation at the
time of receipt and timely
inclusion in agenda for EC
review.
Assess the need to obtain prior
scientific review, invite
independent consultant, patient or
community representatives.
Organize an effective/efficient
procedure for receiving, preparing
circulating and maintaining each
proposal for review.
Tuesday, 06 December 2022 IGIMS GCP Workshop 11

12. Intervention
Benefit-risk
analysis
Research
design,
methodology &
statistics
Continuing
review process
(changes in
benefit risk)
SAE, protocol
deviation,
progress &
completion
reports
3. Basic Medical Scientist
• Affiliated/Non-affiliated
• Qualifications: Non-medical or medical person with qualifications in basic
medical sciences. If reviewing clinical trials with drugs preferably a
pharmacologist.
Roles and Responsibilities
Scientific & ethical review
Tuesday, 06 December 2022 IGIMS GCP Workshop 12

13. 4. Clinician
• Affiliated/Non-affiliated
• Qualifications: should be individual/s with recognized medical qualification,
expertise & training. For regulatory studies need PG qualifications.
Review of the
Intervention
Benefit-risk
analysis
Research design,
methodology,
statistics &
study site.
SAE (risk factor),
protocol deviation
or violation,
progress and
completion
reports.
Facility,
Appropriateness
of PI.
Provision of medical
care, management
and compensation.
Roles and Responsibilities
• Scientific initial review • Ongoing review
• Review medical care
Tuesday, 06 December 2022 IGIMS GCP Workshop 13

14. Ethical review of the
proposal and ICD
Interpret and inform EC
members about new
regulations if any.
MoU, Clinical Trial Agreement (CTA), regulatory
approval, insurance document, researchers
undertaking, protocol specific other permissions, such
as stem cell committee for stem cell research, HMSC
for international collaboration, compliance with
guidelines etc.
5. Legal Expert
• Affiliated/Non-affiliated
• Qualifications: Should have a basic degree in Law from a recognized university. With experience.
Training in medical law.
Roles and Responsibilities
Tuesday, 06 December 2022 IGIMS GCP Workshop 14

15. 6. Social Scientist/ philosopher / ethicist / theologian
• Affiliated/Non-affiliated
• Qualifications: Should be an individual with appropriate qualification, training and/or expertise. Be sensitive
to local culture & moral values. Can be from a NGO involved in health-related activities.
Roles and Responsibilities
Ethical review of the
proposal, ICD along
with the
translations.
Bring in ethical and
societal concerns.
Serve as a
patient/participant/
societal /community
representative
Assess impact on
community involvement,
socio-cultural context,
religious or philosophical
context, if any
Tuesday, 06 December 2022 IGIMS GCP Workshop 15

16. 7. Lay Person
• Non-affiliated
• Qualifications: Literate person from the public or community. Has not pursued a medical science/health
related career in the last 5 years. May be a representative of the community from which the participants
are to be drawn. Is aware of the local language, cultural and moral values of the community. Involved in
social and community welfare activities.
Roles and Responsibilities
Assess societal
aspects if any.
Ethical review of the
proposal, ICD along
with translation(s).
Evaluate benefits and
risks from the
participant's
perspective and opine
whether benefits justify
the risks
Serve as a
patient/participant
/ community
representative and
bring in ethical and
societal concerns
Tuesday, 06 December 2022 IGIMS GCP Workshop 16

17. Quorum
Minimum of
five members
Include both
technical and
non-technical
members.
Minimum one
non-affiliated
member.
Preferably the
lay person
should be part
of the quorum.
Regulatory
clinical trials: as
per current
CDSCO rules.
No decision is
valid without
fulfilment of
the quorum.
Tuesday, 06 December 2022 IGIMS GCP Workshop 17

18. What we do? IEC meeting
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From Protocol to publication
• Title, Novelty, Rationale, Aims & Objective
Research question & research hypothesis
• RCT, Randomisation, Blinding
Methodology
• Study design, Sample size, Data collection & statistical analysis plan
Informed consent process
SAE management , ADR reporting form
Medical care, Compensation, Insurance, Payment for participation
Budget

19. Types of decisions by EC
• With or without suggestions or comments
Approved
• with minor modifications/ ammendments
• With major modifications for resubmission
Revision
• or termination with clearly defined
reasons
Not approved
Tuesday, 06 December 2022 IGIMS GCP Workshop 19

20. Tuesday, 06 December 2022 IGIMS GCP Workshop 20

21. Responsibilities of EC members
Provide competent
and comprehensive
review of proposal
Review objectively;
free from bias and
external influences
Maintain total
confidentiality of EC
documents &
proceedings
Advice researchers
on all aspects of
welfare & safety of
research
participants
Declare conflict of
interest before
participating in the
review process
Tuesday, 06 December 2022 IGIMS GCP Workshop 21

22. Summary:
Independent, competent, robust, time bound
To safeguard rights, welfare, safety of research participants
Scientific and ethical review
continuing review, monitoring, decisions regarding ongoing studies
Educate, hand hold, Support (researchers, clinicians, students),Facilitatory & friendly
Abreast with ethical, International, local community values
EC registration (DHR, CDSCO)
Tuesday, 06 December 2022 IGIMS GCP Workshop 22

23. ICMR: National Ethical Guidelines for Biomedical &
Health Research involving Human Participants
06-12-2022 23
• https://ethics.ncdirindia.org/asset/pd
f/ICMR_National_Ethical_Guidelines.
pdf

24. Questions ?
Tuesday, 06 December 2022 IGIMS GCP Workshop 24