All aspects of clinical research studies are closely monitored by the federal and state governments, as well as the organizations that fund the studies. But when it comes to watching out for study volunteers, there's one more layer of protection: the Institutional Review Board, or IRB.
The IRB is a group of doctors, research experts, and community members whose only job is to protect the rights and well-being of study volunteers. Every institution or organization that conducts clinical research must first have the study approved by an independent IRB before they can begin.
IRBs ensure that studies are conducted ethically by, one, approving them before they start and, two, periodically checking in on the study while it is being done.
Every clinical research study done in the United States must get a seal of approval from an IRB before a single volunteer is enrolled. The IRB also serves as a resource for study volunteers, who can contact the IRB directly at any time if they have concerns about their rights as a research volunteer.