FDA has authority over clinical trials for drug, biologic, and medical device products regulated by the agency. This authority includes studies that are funded by the U.S. Department of Health and Human Services (with joint oversight by FDA and the Office for Human Research Protections), as well as studies that are solely funded by industry or by private parties.
Clinical trial procedures are reviewed by institutional review boards (IRBs). These boards are composed of at least five members that include scientists, doctors, and lay people. They review and approve clinical trials taking place within their jurisdiction before the trials can begin.
The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research. If the risks to participants are found to be too great, the IRB will not approve the research, or it will specify changes that must be made before the research can be done.
As part of their review, IRBs consider participant inclusion and exclusion requirements to be sure that appropriate people have been identified as eligible for the trial. They often look at how and where recruitment for clinical trials will occur.
IRBs review the adequacy of the informed consent document to ensure that it includes all the elements required by law, and that it is at an appropriate reading level and understandable to study participants.
To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, FDA performs inspections of clinical trial study sites and anyone involved in the research.
Many groups play important roles in looking out for the safety of research subjects. These groups include FDA, other government agencies, and institutional review boards. There is also monitoring of studies by industry or private sponsors, as well as oversight and reporting by investigators and their staff.