ABA Family Legal Guide

Health-Care Law

Regulating Health-Care Professionals

Research on Humans

What is an Institutional Review Board?

The National Research Act required that institutional review boards (IRBs) be established at every program conducting research funded by the U.S. Department of Health and Human Services or carried out on products regulated by the Food and Drug Administration. Since the federal government is a major source of research funds, IRBs have been set up at virtually all medical schools, universities, and hospitals where research on humans is conducted.

The IRB reviews the research plans or experiments that are requested and either approves or denies the request. It reviews the plans to make certain that they provide subjects with adequate opportunity to provide informed consent and do not expose them to unreasonable risks. After the research is approved, the IRB provides continuing oversight to ensure that protections remain in force.