What regulatory body is governed by 21 CFR 56?

The correct answer is Institutional Review Boards (IRBs), which are specifically governed by 21 CFR 56. This regulation outlines the requirements for the establishment, operation, and responsibilities of IRBs, which are essential in the ethical oversight of research involving human subjects. IRBs play a critical role in ensuring that participant rights and welfare are protected throughout clinical research processes.

The regulation mandates that IRBs must review and approve research protocols to ensure compliance with ethical standards and federal regulations. It also sets forth guidelines for how IRBs should function, including membership requirements, review procedures, and record-keeping practices.

Understanding the specifics of 21 CFR 56 is important for individuals involved in regulatory affairs, as it emphasizes the necessity of ethical oversight in clinical research and the protection of human participants.