Ethics committee is a committee formally designated to review and approve the initiation of clinical research study involving human participants and to provide continuous review of the research study.

Constituted of medical, non-medical, scientific and non-scientific members for ensuring the protection of the rights, safety and well-being of human subjects involved in the clinical study.

Might have different names in different institutions- Independent Ethics Committee, Institutional Review Board (IRB)- it’s an American preferred nomenclature.

Composition

• Member secretary
• Chairperson (outside the Institution)
• Basic Medical Scientist
• Clinician
• Legal Expert
• Lay person
• Social worker
• Minimum 50% of the members should be from outside the institution.
• At least one female member should be present.
• There should be adequate representation of age and gender.
• EC should preferably between 7 and 15 members and a minimum of five members should be present to meet the quorum requirements.