U m a r F a r o o q u e S h a i k h
1 s t Y e a r M . S c C l i n i c a l R e s e a r c h
Institutional Ethics Committee

Learning Objective
▪ Introduction of Institutional Ethics committee (IEC)
▪ Composition of IEC
▪ Responsibilities of IEC
▪ Functions of IEC
▪ Maintenance of records IEC
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▪ After the World War II, trial was conducted by 23 Nazi doctors and scientists
at Nuremberg for the murder of concentration camp inmates who were used
as research subjects.
▪ The code highlighted on the need for informed consent, prior animal work,
qualified scientists, risk justification by anticipated benefits, avoidance of
physical and mental suffering, death, or disabling injury.
▪ In Willowbrook Hepatitis Study (1956), children were deliberately infected
with mild form of hepatitis, and consent was obtained from parents without
informing about the risk invlove and giving the opportunity of school
admission on participation in the study
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Introduction : Evolution of Ethics Guidelines

▪ In 1963, Jewish Chronic Disease Study was conducted where cancer cells
were inoculated in senile subject without proper explanation on risk.
▪ in view of the emerging situation, World Medical Association (WMA)
General Assembly (Helsinki, Finland, 1964) developed a set of guidelines
to safeguard the rights and well-being of subjects participating in clinical
research.
▪ This is referred to as the Declaration of Helsinki and is revised from time
to time, the last amendment in 64 WMA general assembly in Brazil, 2013.
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Introduction : Evolution of Ethics Guidelines

▪ The declaration of WMA binds the physician with the words, “The
health of my patient will be my first consideration,” and the
International Code of Medical Ethics declares that, “A physician
shall act in the patient's best interest when providing medical care.”
▪ The declaration specifically defines that the duty of the physician
who are involved in medical research is to promote and safeguard
the health, well-being, and rights of patients
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Introduction : Evolution of Ethics Guidelines

▪ In a very shocking turn of events, unethical research conducted by the United
States Public Health Service (Tuskegee Syphilis Study) surfaced in 1972.
▪ The sheer misconduct led the US government to set up ‘International Ethical
Guidelines for Biomedical Research Involving Human Subjects’ that submitted
the report (Belmont report) in 1979, which stressed on three basic ethical
principles: autonomy, beneficence, and justice, and recently, two more pillars
are added which includes confidentiality and honesty.
▪ In India Indian Council of Medical Research (ICMR) introduced “Ethical
Guidelines for Biomedical Research on Human Subjects” last amendment on
2017.
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Introduction : Evolution of Ethics Guidelines

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Introduction : ICMR guidelines on IEC
▪ “It is mandatory that all proposals on biomedical research involving human participants to
safeguard the welfare and the rights of the participants….” should be cleared by an
appropriately constituted Institutional Ethics Committee (IEC) in India.
▪ The ethics committees are based at clinical or academic institutions and hospitals.
▪ Ethics committee ensures a competent review of all the ethical aspects of the project
proposal submitted and does it free from any bias or external influence.
In other country EC also knowns as
▪ Institutional Review Board (IRB) United States,
▪ Research Ethics Board (REB) Canada.
▪ Human Research Ethics Committee (HREC) in Australia

▪ Ethics Committees (EC) are multidisciplinary, independent groups of individuals
appointed to review biomedical research protocols involving human beings to help
ensuring the dignity, fundamental rights, safety, and well-being of research participants
are protected.
▪ Number of persons: 7 -15 (Maximum of 15 members recommended)
▪ Quorum –minimum of 7
▪ Chairperson. Out Side the Institution
▪ Member secretary. Associate of Institution
▪ One to two basic medical scientists (preferably one pharmacologist)
▪ One to two clinicians from various institutions
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Composition of IEC

▪ One legal expert or retired judge
▪ One social scientist/representative of nongovernmental voluntary agency
▪ One philosopher/ethicist/theologian
▪ One lay person from the community .
▪ at least one member whose primary area of interest / specialization is
nonscientific
▪ at least one member who is independent of the institution / trial site
 Besides, there should be appropriate gender representation on the IEC.
 If required, Subject experts may be invited to offer their views.
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Composition of IEC

Responsibilities of IEC
 Safeguard the rights, safety, and well-being of all trial subjects
 Reviews a proposed clinical trial within a reasonable time and document its views in
writing
 conducts continuing review of each ongoing trial at least once per year
 Provide advice to the researchers on all aspects of welfare and safety of research
participants
 Ensures that information regarding payment to subjects(including the methods,
amounts, schedule of payment) is set forth in the written informed consent form and
any other written information is provided to the subjects
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Responsibility of IEC Members : Chairman
▪ A well-respected person from any background with prior experience of having served/serving in an EC.
▪ Conduct IEC meetings and accountable for functioning of the committee.
▪ Ensure active participation of all members (particularly non-affiliated, nonmedical) in all discussions
and review.
▪ Handling of complaints against Investigators, IEC members, conflict of interest.
▪ Ratify minutes of mitting of the previous meetings.
▪ Review SAE reports with causality assessment and report accordingly.
▪ In case of anticipated absence of Chairperson and Vice Chairperson (optional) at a planned meeting, the
Chairperson should nominate a committee member as acting Chairperson, or the members present may
elect an acting Chairperson on the day of the meeting.
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▪ Should be a staff member of the institution, 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.
▪ Organize an effective and efficient procedure for receiving, preparing circulating,
and maintaining each proposal for review.
▪ Schedule IEC meetings .
▪ Organize IEC documentation, communication and archival.
▪ Arrange for training/refresher training of IEC members.
▪ Ensure SOPs are updated as and when required.
▪ Prepare for and respond to audits and inspections
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Responsibility of IEC Members : Member Secretory

▪ 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.
▪ Scientific and ethical review on the intervention, benefit-risk analysis,
research design, methodology and statistics, 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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Responsibility of IEC Members : Basic Medical Scientist

▪ Should have a basic degree in Law from a recognized university, with
experience. Desirable: Training in medical law.
▪ Ethical review of the proposal, ICD along with translations, MoU, Clinical
Trial Agreement (CTA), regulatory approval, insurance document, other
site approvals, researcher’s undertaking, protocol specific other
permissions.
▪ Interpret and inform EC members about new regulations if any.
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Responsibility of IEC Members : Legal Expert

Responsibility of IEC Members : Social scientist/ /social worker/
Philosopher/ethicist/theologian
▪ Ethical review of the proposal, ICD along with the translations.
▪ Assess impact on community involvement, socio–cultural context,
religious or philosophical context, if any Serve as a
patient/participant/ societal / community representative and bring
in ethical and societal concerns.
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Responsibility of IEC Members : Lay person
▪ 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.
▪ Assess on societal aspects if any
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Functions
 Only members who participate in the IEC review and discussion should
vote/provide their opinion or advise.
 The IEC should perform its functions according to written standard operating
procedures, should maintain written records of its activities and minutes of its
meetings, and should comply with GCP and with the applicable regulatory
requirement Maintaining current knowledge of application regulation, laws and
institutional policies
▪ Conducting initial and continuing review of trials
▪ Determining the frequency of continuing review, as appropriate
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Functions
▪ Specifying that no deviations from, or changes of, the protocol should be initiated
without prior written IEC
▪ Specifying that no subject should be admitted to a trial before the IEC issues its
written approval / favorable opinion of the trial.
▪ Specifying that the investigator should promptly report to the IEC. Deviations
from, or changes of, the protocol to eliminate immediate hazards to the trial
subjects.
▪ Changes increasing the risk to subjects and/or affecting significantly the conduct of
the trial.
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Maintenance and recorded of IEC
▪ IEC retains all relevant records (e.g., written procedures, lists of
occupations/affiliations of members, submitted documents, minutes
of meetings, IEC Communication etc.) for a period of at least 5
years after completion of the trial and makes them available upon
request from the regulatory authority
▪ IEC may be asked by investigators, sponsors, or regulatory
authorities to provide copies of its written procedures and
membership lists
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Mandatory Documents EC Should Review
▪ Protocol (for scientific rationale)
▪ Informed consent document (for the safety and welfare of research
participants)
▪ Informed consent document’s vernacular translation
▪ Investigator brochure for information regarding clinical and nonclinical
data of the investigational product
▪ Study advertisement for participant recruitment or any other written
information to the patient
▪ Grants, payments, insurance documents.
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IEC changes as per new CT rules 2019
▪ EC Application - Form CT-01, approval granted in Form CT-02
▪ Constitution of EC :
1. One woman out of seven members
2. Preferably 50% external members - adequate age and gender
3. Any change - informed to CLA within 30 days
4. Any member not successfully completed training disqualified as
member
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IEC changes as per new CT rules 2019
5. EC registration validity increased from 3 to 5 years.
6. EC approval - informed to CLA within 15 working days.
7. Site does not have its own Ethics Committee : obtain
approval from independent EC or another site EC, locked
with in same city or within radius of 50kms
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Thank You