They need to understand what is involved, including details about the prevention approach, tests, and the possible risks and benefits before agreeing to take part in the trial. After they have discussed all aspects of the study, they receive an informed consent form to read. The form explains the study in detail. If a person agrees to take part in the trial, they sign the form. If new benefits, risks, or side effects are discovered during the trial, the researcher informs participants.
Participants are always free to leave the study if they choose.
Clinical trials are carefully reviewed to be sure the study is reasonably safe and ethical before anyone participates. Those who take part are monitored very closely during and after the trial. Each study site has an Institutional Review Board that reviews the trial for patient safety. Before deciding to enter a clinical trial, people should get the facts.