ComplianceOnline

Institutional Review Boards


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.