Institutional Ethics Committee (IEC)
Composition, review categories & quorum under ICMR 2017 and the New Drugs & Clinical Trials Rules 2019 — RGUHS MD Pharmacology LAQ
Past RGUHS + DNB + MPMSU + VNSGU · 18
RGUHSMar '26
MPMSUMay '25
MPMSUOct '25
MPMSUJan '25
MPMSUJun '23
RGUHSMay '22
RGUHSMay '22
DNBDec '22
DNBJun '22
RGUHSNov '21
DNBJun '21
RGUHSNov '20
RGUHSJun '20
RGUHSMay '18
RGUHSMay '18
VNSGUApr '16
DNBDec '15
RGUHSApr '07
Definition, scope & terminology
- Ethics Committee (EC) — an appropriately constituted, competent and independent body that reviews and approves research on human participants before it begins, and has the continuing responsibility to monitor approved research for ethical compliance throughout (ICMR 2017 §4.0).
- Overriding mandate — to safeguard the dignity, rights, safety and well-being of all research participants — the single principle from which every composition, quorum and review rule is derived.
- Institutional Ethics Committee (IEC) — the EC constituted within and by an institution; the institution must establish it and provide infrastructure, staff, funds and protected time for the Member Secretary.
- Terminology (interchangeable) — IEC / EC (India), Institutional Review Board (IRB) (USA), Research Ethics Committee (REC) / Independent Ethics Committee (UK/EU) — all the same body.
- Scope (India) — all biomedical & health research — clinical, basic-science, epidemiological, behavioural, public-health — needs EC review first; the EC reviews both scientific and ethical aspects, independently confirming the methods are sound (ICMR 2017 §4.0.3–§4.0.4).
- IEC ≠ IAEC — the human-participant IEC is distinct from the Institutional Animal Ethics Committee (IAEC / CPCSEA), which clears animal experiments separately.
❦
Continue reading
Institutional Ethics Committee
PharmaNotes Pro · LAQ
Sign in with your Google account. If you're already subscribed, the chapter unlocks immediately — otherwise, pick Monthly or Annual on the next step.