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What does FDA consider an “adequately constituted” IEC?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

FDA regulations at 21 CFR 312.3(b) define an IEC as a “review panel that is responsible for ensuring the protections of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection.” FDA believes an “adequately constituted” IEC is one that consists of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial. As provided in ICH E6, section 3.2, an IEC includes at least five members, including at least one member whose primary area is in a nonscientific area and at least one member who is independent of the institution where the research will be conducted (i.e., not otherwise affiliated with the institution and not part of the immediate family of a person who is affiliated with the institution). FDA recommends that every nondiscriminatory effort be made to ensure that the IEC composition is not limited to only one gender and that it reflects the social and cultural diversity of the community(ies) from which research participants are most likely to be drawn. It is further advised that only those members who are independent of the investigator and the sponsor of the trial vote on trial-related matters.

FDA recognizes that the organization and membership of IECs may differ among countries because of local needs of the host country. Such variation is acceptable as long as the IEC can assure the protection of the rights, safety, and well-being of human subjects involved in the clinical investigation.

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