Every clinical trial follows a strict protocol designed to protect the safety of the study participants. Additionally, the federal government mandates that all clinical trials be overseen by an Institutional Review Board (IRB) made up of physicians, statisticians and members of the medical community. The IRB is appointed in order to ensure that the trial is ethical, that risks are minimal, and that potential benefits offset the risks.
The policy of “informed consent” dictates that each person involved in the study must be fully informed of the clinical trial’s methods, potential benefits and risks before agreeing to participate.