IRBs, designed to protect patients, are made up of scientists, doctors, clergy and other people from the local community. An IRB reviews a study to see that it is well designed with safeguards for patients and that the risks are reasonable in relation to the potential benefits. Federally supported or regulated studies also go through reviews by a government agency, such as the National Cancer Institute, which sponsors and monitors many trials around the country. Any well run clinical trial, whether federally supported or not, is carefully reviewed for medical ethics, patient safety, and scientific merit by the research institution. Every study should provide for monitoring the data and the safety of patients on an ongoing basis.
Informed consent is also an important process that helps to protect patients.
After patients join a clinical trial and it progresses, the doctors report the results of the trial to scientific meetings, to medical journals and whose articles are approved by experts, and to various government agencies.