Institutional Review Board [IRB]
An Institutional Review Board (IRB) is an independent review body comprised of medical, scientific and non-scientific members established and designated by an entity (often a hospital, research center, or university) to ensure the protection of the rights, safety, and well-being of human subjects recruited to participate in biomedical or behavioral research according to the requirements outlined in Title 38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U.S. Code of Federal Regulations.
IRB responsibilities include but not limited to the reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material(s) to be used in obtaining and documenting informed consent of the trial. Other equivalent committees with the same or similar functions, such as an Independent Ethics Committee (IEC) are also considered to be IRBs. Although IRBs are often established by research institutes, research hospitals, and universities, independent IRBs do exist. Additionally, IRBs may agree to review research from affiliated or unaffiliated investigators.
Informed Consent for Registries from “Registries for Evaluating Patient Outcomes: A User’s Guide” [Internet, 4th Edition]
NCATS Toolkit for Patient-Focused Therapy Development: Institutional Review Board
Rare Diseases Registry Program (RaDaR): Protect Human Research Participants