The Institutional Review Board (IRB) is a federally mandated committee whose purpose is to ensure that 1) the rights, well-being, and safety of human subjects in research are protected; and 2) that Iowa State University research is compliant with applicable federal and state regulations as well as Iowa State policies and guidelines. Toward that end, the IRB has the authority to:
- approve, require modifications to secure approval, or disapprove human subjects research.
- oversee the conduct of the study and monitor ongoing progress.
- suspend or terminate approval of research that is not conducted in accordance with the IRB’s requirements or that has been associated with harm to participants.
Authority for IRB oversight of all federally-regulated human subjects research is provided in the regulations of the U.S. Department of Health and Human Services (DHHS) at 45 CFR 46, similar regulations issued by other federal agencies, and the Food and Drug Administration (FDA) at 21 CFR 50 and 56. In addition, Iowa State University Policy mandates that all human subjects research conducted by agents or employees of Iowa State or under Iowa State’s auspices must receive IRB approval or certification of exemption prior to initiation.