Institutional Review Board (IRB)/Independent Ethics Committee (IEC)

These bodies review and monitor clinical trial documents (protocol, informed consent documents, investigator brochures, and advertising material) in advance and by periodic review in accordance with written operating procedures. The IRB has the authority to approve, require modifications prior to giving a favorable opinion, disapprove, or terminate/suspend any prior approval of the research. Records must be kept for three years after the completion of the trial.

IRBs are composed of medical and nonmedical members that have no conflicting interest with the clinical trial. Regulations require IRBs to have a diverse membership, which can be in terms of race, gender, cultural background, and community members. The recommended composition of an IRB includes at least five members, with at least one whose primary area of interest is in a nonscientific area, and at least one member who is independent of the institution or trial site. Nonmembers with expertise in special areas may be invited. The investigator may attend an IRB meeting to provide information, but should not participate in the meeting discussion or vote.