Independent Ethics Committee (IEC)

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subject(s) involved in a study and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the protocol, the suitability of the investigator, facilities, and the methods and material to be used in obtaining and documenting informed consent (IC) of participants. The legal status, composition, function, operations, and regulatory requirements pertaining to Independent Ethics Committees may differ among countries but should allow the Independent Ethics Committee to act in agreement with Good Clinical Practice (GCP) guidelines. ICH GCP, 1.27