What protection does a study subject have in a clinical trial?
Clinical trials are governed by ethical and legal guidelines. In 1981, regulations of the Food and Drug Administration made it a requirement that federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee that includes experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goal is to help protect the rights and welfare of the research subjects. Study plans and the progress of clinical trials are reviewed periodically by the IRB as well as by the study sponsor and the investigator. The IRB must comply with regulations of the FDA, if applicable. An individual may call the IRB with questions about his or her rights as a research subject. The name and telephone number of the IRB overseeing the clinical trial is included in the informed consent form.
