The institutional review board (IRB) is a committee that protects the rights and privacy of the individuals that participate in studies. Typically IRBs are composed of health professionals and researchers that are not involved in the proposed research that can serve as an objective judge of the potential benefits and harms of a proposed research project. They review all documentation involved in research studies involving humans, including the research protocol, informed consent documents, any materials developed for recruiting research participants, and security measures taken to protect sensitive participant data. Any research that involves human subjects must obtain IRB approval or an exemption. To learn more about the IRB approval process and why it is important for drug development, click on the links below.
- FDA: Clinical Trials and Institutional Review Boards
What is ‘IRB approval’ and why is it important in drug development?
