Your Rights and Safety

  • Joining a clinical trial is not required. If you’re uncomfortable joining a trial, tell your doctor. Your doctor and health care team will take good care of you whether or not you join a trial.
  • After you’ve joined a clinical trial, you may quit at any time. You do not have to do anything that makes you uncomfortable or unhappy.

Clinical trials must follow strict rules to keep patients safe. In the U.S., clinical trials are checked by the Office of Human Research Protections (OHRP). Sometimes, they’re also checked by the Food and Drug Administration (FDA). An Institutional Review Board (IRB) watches each clinical trial closely. The IRB reviews the trial to make sure that it is ethical (the expected benefit of the study outweighs the potential risks) and that the rights of people who join are protected.

Throughout the trial, researchers report to the OHRP, FDA and IRB. The trial can be shut down at any time to protect the people in it. They will stop the trial if any unexpected risks are found, such as dangerous side effects. The FDA and the OHRP also make sure patients give informed consent before joining a clinical trial.