Institutional Ethics Committee (IEC)

Institutional Ethics Committee (IEC)

1. Definition, purpose & terminology

• An Ethics Committee (EC) is an appropriately constituted, competent and independent body entrusted with reviewing and approving research proposals involving human participants before initiation, and with the continuing responsibility to monitor approved research for ethical compliance throughout its conduct (ICMR 2017 §4.0).
• The basic responsibility of an EC is to safeguard the dignity, rights, safety and well-being of all research participants — this is the single overriding mandate from which every composition, quorum and review rule is derived (ICMR 2017 §4.0, §4.7.1).
• The committee constituted within and by an institution to discharge this function is the Institutional Ethics Committee (IEC) — the institution is responsible for establishing the EC and for providing logistical support (infrastructure, staff, space, funds, protected time for the Member Secretary) to sustain quality ethical review (ICMR 2017 §4.0.1, §4.0.2).
• Terminology is interchangeable across jurisdictions — the same body is called:
  • IEC / EC in India (ICMR / CDSCO usage) (ICMR 2017 §4.0).
  • Institutional Review Board (IRB) in the United States (Browner 5e Ch.7).
  • Research Ethics Committee (REC) / Independent Ethics Committee / Research Ethics Board in the UK/EU (B&B Ch.4).
  • US federal regulations also list "independent ethics committee, ethical review board, or research ethics board" as synonyms for IRB (Browner 5e Ch.7).
• Scope of EC review (India): all types of biomedical and health research — clinical, basic science, policy, implementation, epidemiological, behavioural and public-health research — must be reviewed by an EC before it is conducted (ICMR 2017 §4.0.4). The EC reviews both scientific and ethical aspects; even where a prior scientific review exists, the EC must independently determine that research methods are scientifically sound (ICMR 2017 §4.0.3, §4.8.12).
• EC vs IAEC (institutional caveat): the human-participant committee (IEC) is distinct from the Institutional Animal Ethics Committee (IAEC / CPCSEA) which clears animal experiments; a PG protocol may need IAEC clearance separately via the animal ethics form (Medhi Ch.8). This note covers the human-research IEC.