Which federal agency oversees IRB regulations?

The Office for Human Research Protections (OHRP) is the federal agency specifically established to oversee the regulations governing Institutional Review Boards (IRBs) and the protection of human subjects involved in research. OHRP operates under the Department of Health and Human Services (HHS) and has the primary responsibility for ensuring that research complies with federal regulations that protect participants' rights and welfare.

OHRP provides guidance and oversight that is essential to maintaining ethical standards in research practices, ensuring that IRBs function effectively by evaluating research proposals and monitoring ongoing studies for compliance with ethical standards. This includes oversight of the Common Rule, which outlines the requirements for IRB membership, functions, and review processes.

While other agencies, such as the NIH and FDA, do have roles in research involving human subjects, they focus primarily on specific areas: NIH emphasizes funding and medical research, and FDA is centered on the safety and efficacy of drugs and medical devices. The CDC is mainly concerned with public health and disease prevention rather than the direct oversight of IRB regulations. Hence, OHRP is the correct choice as it specializes in IRB oversight.