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Institutional Review Boards (IRBs), sometimes called Ethic Committees, are responsible for reviewing and approving research studies involving human subjects. The rules that govern IRBs are clearly laid out in 21 CFR 56 which contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA. The IRB has the authority to:
Topics: New FDA Guidance, IRB Oversight, 21 CFR 56, FDA
In clinical research, the purpose of an Institution Review Board (IRB) is to review and approve research studies involving human subjects. Its purpose first and foremost is to protect patients by ensuring the rights, safety, and well-being of potential research subjects. 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.
Topics: Medical Device CRO, IRB Oversight, 21 CFR Part 56