The FDA works to protect those who participate in clinical trials and ensure that reliable information is available so that they can make an informed decision about participating in a clinical trial. The federal government has issued regulations and guidelines for clinical research to protect participants from unreasonable risks.
Efforts are made by the trial sponsor to control risk, some risks are unavoidable because of the inherent uncertainty in medical research involving new medical treatments and pharmaceuticals.
The federal government requires researchers performing clinical trials to give potential participants complete and accurate information about what will happen during the trial. Participants must sign an informed consent form that they understand that the trial is research and that they can leave the trial at any time. The informed consent is part of what informs participants of the known risks associated with the study and that there may be potential, but as of yet unknown risks that may be associated with the study. This permits someone deciding if they want to participate in a clinical trial to make an informed decision about the level of risk they are willing to accept prior to entering the trial.