In the United States, federal regulations formally designate institutional review boards (IRBs) as the entities responsible for reviewing and monitoring human subjects research with the goal of protecting the rights and welfare of human subjects. Human subjects research in most other countries is overseen by similar bodies, known by a variety of names such as research ethics committees or research ethics boards.

The focus of this chapter is the Federal Policy for the Protection of Human Subjects (45 CFR §46), or the “Common Rule,” which is the federal regulation that governs the scope, composition, and procedures of IRBs. Section 5 of this chapter discusses the differences between the Common Rule and Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR §50 and §56).

While the Common Rule addresses only human subjects research conducted or supported by relevant federal agencies, and the FDA regulations apply only to human subjects research involving FDA-regulated therapies (drugs, biologics, devices, and diagnostics), most institutions extend IRB oversight to all human subjects research regardless of whether the research is federally supported or subject to FDA regulations.

It is also important to consider the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR §160 and §164), which requires a “privacy board” to review any research that uses protected health information. This review is similar to a routine IRB review, with the main difference being a different agreement for participation—the HIPAA authorization—which can be a freestanding form or can be combined with the research consent document. In most institutions, the IRB acts as the privacy board for research-related activities.

See the Consent, Disclosure, and Non-Disclosure chapter for a discussion of HIPAA authorization.