About Institutional Review Boards
December 12, 2004
Background: Institutional Review Boards
What is an IRB?
“Institutional review board (IRB). An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. Other names for such bodies include independent review board, independent ethics committee, committee for the protection of human subjects.” (Applied Clinical Trials, December 1, 2003)
“Regardless of the name chosen, the IRB is subject to the Agency’s IRB regulations when studies of FDA regulated products are reviewed and approved.” (FDA, www.fda.gov/oc/ohrt/irbs/faqs.html)
What federal laws and regulations govern IRBs?
- The Food and Drug Administration regulations 21 CFR parts 50 and 56 apply to IRBs that are studying products subject to FDA regulation.
For more information about FDA policy regarding IRBs, check the 1998 update to the FDA’s IRB Guidance at www.fda.gov/oc/ohrt/irbs/.
- The Department of Health and Human Services regulations Title 45 Part 46: Protection of Human Subjects apply to IRBs.
For more information about HHS policy regarding IRBs, check the Office for Human Research Protections at www.hhs.gov/ohrp/.
Federal regulations regarding IRBs and protection of human subjects apply “to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that has adopted the human subjects regulations.”
Are IRBs only subject to federal regulations?
No. The federal regulations are a “floor”. Local institutions often have their own additional requirements and standards.
Are all IRBs found at hospitals and universities?
No. There are private institutional review boards that can be hired as consultants and private companies can have their own IRBs as long as they follow applicable laws and regulations. The bulk of IRBs are run by academic institutions or hospitals.