Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is a committee of physicians, statisticians, patient advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support medical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
