What does 21 CFR 56 relate to?

21 CFR 56 pertains specifically to Institutional Review Boards (IRBs). This section of the Code of Federal Regulations outlines the regulations governing the formation, function, and operation of IRBs, which are key components in the protection of human subjects involved in research. It establishes definitions, requirements for composition, and responsibilities of IRBs, including their role in reviewing research protocols and ensuring that informed consent is appropriately obtained.

The regulations also specify the criteria IRBs must consider when evaluating research proposals, ensuring that risks to participants are minimized and reasonable in relation to anticipated benefits. This regulation plays a crucial role in maintaining ethical standards in clinical research, emphasizing the importance of independent review in protecting participant rights and welfare.

Understanding the role of 21 CFR 56 is essential for anyone involved in clinical research, as it helps ensure compliance with federal regulations designed to protect human subjects and uphold the integrity of clinical trials.