Who protects my safety in a clinical trial?

Your safety in a clinical trial is protected through several layers working together. The informed consent process makes sure you understand the trial's purpose, procedures, and risks before you agree to join. An Institutional Review Board (IRB) reviews and approves the trial's protocol before it can enroll anyone, and continues reviewing it at least once a year afterward. Ongoing monitoring throughout the trial, sometimes by an independent Data and Safety Monitoring Board (DSMB), especially in phase 3 trials, watches for safety concerns as the study runs.

The FDA is also involved, particularly for trials that could lead to a new drug approval, overseeing drug approval and protecting the integrity of trial data.

Together, these layers mean a trial isn't just reviewed once at the start — it's checked repeatedly, and it can be changed or stopped if safety concerns come up.