Ethical Review Procedures

The composition, affiliations, qualifications, member specific roles and responsibilities

are given in Table 4.1.

Table 4.1 Composition, affiliations, qualifications, member specific roles and

responsibilities of an EC

S.
Members of EC Definition/description
No.
1. Chairperson/ • Conduct EC meetings and be accountable for independent
Vice Chairperson (optional) and efficient functioning of the committee
• Ensure active participation of all members (particularly
Non-affiliated non-affiliated, non-medical/ non- technical) in all
discussions and deliberations
Qualifications -
• Ratify minutes of the previous meetings
A well-respected person from
• In case of anticipated absence of both Chairperson and Vice
any background with prior
Chairperson at a planned meeting, the Chairperson should
experience of having served/
nominate a committee member as Acting Chairperson or
serving in an EC
the members present may elect an Acting Chairperson on
the day of the meeting. The Acting Chairperson should be
a non-affiliated person and will have all the powers of the
Chairperson for that meeting.
• Seek COI declaration from members and ensure quorum
and fair decision making.
• Handle complaints against researchers, EC members,
conflict of interest issues and requests for use of EC data,
etc.
2. Member Secretary/ Alternate • Organize an effective and efficient procedure for receiving,
Member Secretary (optional) preparing, circulating and maintaining each proposal for
review
Affiliated
• Schedule EC meetings, prepare the agenda and minutes
Qualifications - • Organize EC documentation, communication and
• Should be a staff member of archiving
the institution • Ensure training of EC secretariat and EC members
• Should have knowledge and • Ensure SOPs are updated as and when required
experience in clinical research • Ensure adherence of EC functioning to the SOPs
and ethics, be motivated and • Prepare for and respond to audits and inspections
have good communication • Ensure completeness of documentation at the time of
skills receipt and timely inclusion in agenda for EC review.
• Assess the need for expedited review/ exemption from
review or full review.

(Contd.)

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 Ethical Review Procedures

• Should be able to devote • Assess the need to obtain prior scientific review,
adequate time to this activity invite independent consultant, patient or community
which should be protected by representatives.
the institution • Ensure quorum during the meeting and record discussions
and decisions.
3. Basic Medical Scientist(s) • Scientific and ethical review with special emphasis on
the intervention, benefit-risk analysis, research design,
Affiliated/ non-affiliated
methodology and statistics, continuing review process,
Qualifications - SAE, protocol deviation, progress and completion report
• Non-medical or medical • For clinical trials, pharmacologist to review the drug
person with qualifications in safety and pharmacodynamics.
basic medical sciences
• In case of EC reviewing
clinical trials with drugs,
the basic medical scientist
V
should preferably be a
pharmacologist
4. Clinician(s) • Scientific review of protocols including review of the
intervention, benefit-risk analysis, research design,
Affiliated/ non-affiliated
methodology, sample size, site of study and statistics
Qualifications - • Ongoing review of the protocol (SAE, protocol deviation
or violation, progress and completion report)
• Should be individual/s • Review medical care, facility and appropriateness of
with recognized medical the principal investigator, provision for medical car,
qualification, expertise and management and compensation.
training
• Thorough review of protocol, investigators brochure (if
applicable) and all other protocol details and submitted
documents.
5. Legal expert/s • Ethical review of the proposal, ICD along with
translations, MoU, Clinical Trial Agreement (CTA),
Affiliated/ non-affiliated regulatory approval, insurance document, other site
Qualifications - approvals, researcher’s undertaking, protocol specific
other permissions, such as, stem cell committee for stem
• Should have a basic degree
cell research, HMSC for international collaboration,
in Law from a recognized
compliance with guidelines etc.
university, with experience
• Interpret and inform EC members about new regulations
• Desirable: Training in medical
if any
law.

(Contd.)

INDIAN COUNCIL OF MEDICAL RESEARCH 29

 Ethical Review Procedures

6. Social scientist/ philosopher/ • Ethical review of the proposal, ICD along

ethicist/theologian with the translations.
• Assess impact on community involvement,
Affiliated/ non-affiliated
socio–cultural context, religious or
Qualifications - philosophical context, if any

• Should be an individual with social/ • Serve as a patient/participant/ societal /

behavioural science/ philosophy/ religious community representative and bring in
qualification and training and/or expertise ethical and societal concerns.
and be sensitive to local cultural and moral
values. Can be from an NGO involved in
health-related activities
7. Lay person(s) • Ethical review of the proposal, ICD along
with translation(s).
Non-affiliated
• Evaluate benefits and risks from the
Qualifications - participant’s perspective and opine
• Literate person from the public or whether benefits justify the risks.
community • Serve as a patient/participant/ community
• Has not pursued a medical science/ health- representative and bring in ethical and
related career in the last 5 years societal concerns.

• May be a representative of the community • Assess on societal aspects if any.

from which the participants are to be drawn
• Is aware of the local language, cultural and
moral values of the community
• Desirable: involved in social and
community welfare activities

4.3.6 The quorum should be as specified in Box 4.2.

Box 4.2 Quorum requirements for EC meetings
1. A minimum of five members present in the meeting room.
2. The quorum should include both medical, non medical or technical or/and non-technical members.*
3. Minimum one non-affiliated member should be part of the quorum.
4. Preferably the lay person should be part of the quorum.
5. The quorum for reviewing regulatory clinical trials should be in accordance with current CDSCO
requirements.
6. No decision is valid without fulfilment of the quorum.

*Medical members are clinicians with appropriate medical qualifications. Technical members are persons
with qualifications related to a particular branch in which the study is conducted, for example social sciences.

30 INDIAN COUNCIL OF MEDICAL RESEARCH