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The Institutional Review Board is a key component of the University of Minnesota’s Human Research Protection Program. Other departments that contribute to ensuring the ethical conduct of human research include the Research Compliance Office, Sponsored Projects Administration, the Center for Bioethics and the Health Information and Privacy Office.
The United States developed regulations to protect the rights and welfare of human research participants in the 1970s which led to the establishment of the Institutional Review Board (IRB). IRB review is built on the foundation of three key principles defined in The Belmont Report.
Many IRBs in the United States (U.S.) also review clinical investigations regulated by the Food and Drug Administration (FDA) and clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products.
IRBs must include at least five members with varying backgrounds (scientific and non-scientific) and at least one member that has no affiliation with the institution (45 CFR 46, 21 CFR 56).
There are eight biomedical IRB panels and two social behavioral IRB panels at the University. The IRBs receive more than 10,000 initial applications, modification requests, reports of new information, or requests for changes to research teams each year (Learn more about IRB metrics). Each IRB biomedical panel meets every other week. Each social and behavioral panel meets at least once per month. The University IRBs are situated under the Human Research Protection Program (HRPP), a program that reports to the Office of the Vice President for Research in the University. The Vice President for Research also serves as the Institutional Official (IO).
Each committee consists of faculty, students and staff representing all University campuses, Fairview and Gillette Children’s Specialty Hospital. Membership expertise includes both scientist (biomedical and social behavioral), non-scientists and unaffiliated members.
The University’s IRB holds a Federalwide Assurance (FWA number 00000312) from the Office for Human Research Protection (OHRP) in the Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and the University of Minnesota and is updated and renegotiated at regular intervals.
Often sponsors or agencies request formal documentation regarding the IRB’s FWA and registration. Use this letter for these requests.
The University’s Human Research Protection Program is accredited by the Association for the Accreditation of Human Research Protection Programs. Learn more about AAHRPP accreditation.
IRBs review, before the research takes place, research that involves human participants to determine whether it meets the approval criteria defined by the federal regulations. Below is a high-level representation of what the IRB evaluates to determine whether the rights and welfare of human participants are protected. Based on the level of risk, the research will either be reviewed by a designated individual IRB member (minimal risk research) or the full committee (greater than minimal risk research).
Learn more about IRBs and research ethics by completing the Basic CITI Training Course.
The IRB’s foundation and primary charge are supported in the Code of Federal Regulations. These regulations include, but are not limited to, the following:
Office for Human Research Protections (OHRP)
45 CFR 46 - Protection of Human Subjects
U.S. Food and Drug Administration (FDA)
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 312 - Investigational New Drug Application
21 CFR 812 - Investigational Device Exemptions
Office for Civil Rights (OCR), within Health & Human Services (HHS) (HIPAA)
National Standards to Protect the Privacy of Personal Health Information