Which CFR Part covers Institutional Review Boards (IRB)?

Which CFR Part covers Institutional Review Boards (IRB)?

• A. 21 CFR Part 50
• B. 21 CFR Part 58
• C. 21 CFR Part 56
• D. 21 CFR Part 210

Answer: (C)

Institutional Review Boards exist to protect people who participate in research by reviewing studies before they begin and during ongoing conduct. The CFR section that covers IRBs sets the rules for how an IRB is formed and how it operates: who can serve as members, how many members are needed, how conflicts of interest are handled, and the requirements for written procedures, meetings (including whether they’re convened or can use an expedited review), and recordkeeping. This framework ensures independent review, appropriate risk–benefit assessment, informed consent considerations, and ongoing oversight of research activities. Other CFR sections address related but broader topics—such as the protections for human subjects through informed consent, as well as unrelated areas like good laboratory practice and good manufacturing practice—but they do not establish the specific governance and procedures for Institutional Review Boards in the same way.

Institutional Review Boards exist to protect people who participate in research by reviewing studies before they begin and during ongoing conduct. The CFR section that covers IRBs sets the rules for how an IRB is formed and how it operates: who can serve as members, how many members are needed, how conflicts of interest are handled, and the requirements for written procedures, meetings (including whether they’re convened or can use an expedited review), and recordkeeping. This framework ensures independent review, appropriate risk–benefit assessment, informed consent considerations, and ongoing oversight of research activities. Other CFR sections address related but broader topics—such as the protections for human subjects through informed consent, as well as unrelated areas like good laboratory practice and good manufacturing practice—but they do not establish the specific governance and procedures for Institutional Review Boards in the same way.