How are clinical trial participants protected?
An Institutional Review Board (IRB) must approve all clinical trials. An IRB consists of physicians, scientists, and lay people from the community who review the study to make sure that subjects’ rights are protected and that there are no unnecessary risks. Top Any subject who participates in a clinical trial must first read and sign an Informed Consent form that describes the study. Informed consent means that you understand the nature of the study, that your questions have been answered to your satisfaction, and that you voluntarily agree to participate. The Informed Consent form will answer such questions as: • Why is the research being done? • What do the researchers wish to accomplish? • What procedures or evaluations will be performed during the study? • How long will my participation in the study last? • What potential risks are involved? • What are the potential benefits? • What other treatment options are available? Participation in a clinical trial is completely voluntary. Yo
