Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).
Various Federal agencies, including the Office of Human Subjects Research Protection and the FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.