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How are participants protected?

Every clinical study in the United States 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 an independent committee of physicians, statisticians, community advocates, and others that helps ensure that a clinical study is ethical and the rights of study participants are protected. All institutions that conduct or support clinical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.