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The FDA regulations at 21 CFR 56 (Institutional Review Boards 2016) do not specifically list in one place what documents an IRB should review. FDA requires the IRB to review

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Final answer:

An Institutional Review Board (IRB) is a committee that reviews research proposals involving human participants.

The IRB ensures ethical conduct and compliance with federal regulations, focusing on minimizing risks, obtaining informed consent, and protecting participant privacy.

Step-by-step explanation:

An Institutional Review Board (IRB) is a committee that reviews proposals for research involving human participants. The IRB ensures that the research is ethically sound and in compliance with federal regulations.

The IRB considers factors such as minimizing risks to participants, obtaining informed consent, and protecting participant privacy and confidentiality.

It reviews research plans, questions to be asked, potential risk factors, means of protecting the identity of subjects, and the final plan for archiving the research data.

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