An institutional review board (IRB) is an independent committee
made up of medical and nonmedical members, such as physicians, statisticians,
and community advocates. It ensures that a clinical trial is ethical and that
the rights of study participants are protected.
All institutions that conduct or support biomedical research
involving people, by U.S. government regulation, must have an IRB that
initially approves and periodically reviews the research.
An IRB reviews and approves protocols, informed-consent forms,
physician credentials and eligibility, and other patient materials. The role of
an IRB is to work closely with the U.S. Food and Drug Administration (FDA) to
make sure that patient safety is the main priority of a clinical trial.