Institutional Review Board Policy

Custodian of Policy: Institutional Review Board Committee

Relevant Federal Policies: Code of Federal Regulations (CFR) 45, Part 46, Protection of Human Subjects.

Relevant Procedures: IRB Guidelines & Resources

Effective Date: Fall 2026

Last Review: Spring 2026

Next Review: Spring 2033

Policy

The Institutional Review Board (IRB) is a mandated compliance committee that holds a Federal-wide Assurance from the Office for Human Research Protection (OHRP) in the U.S. Department of Health and Human Services (DHHS). This FWA is a binding agreement between DHHS and Minnesota State University Moorhead. The IRB at Minnesota State University Moorhead (MSUM) is delegated to protect the welfare of human subjects recruited to participate in research.

When the University, employees, and students are involved in research conducted with human subjects, the research activity must be reviewed by the IRB. The IRB has the authority to approve, require modification in, or disapprove of all such research activities. The IRB has the authority to suspend or terminate approval of research that is not in compliance with the IRB's determinations and is, or has been, associated with unexpected risk to subjects. For IRB purposes, these decisions are based on the criteria set forth in the federal regulations.

Human subjects are involved if: 1) there is an intervention or an interaction with a living person that would not be occurring or would be occurring in some other fashion, but for this research, or 2) identifiable private data, information, or biological samples will be obtained for this research in a form associable with the individual. Certain categories of research may qualify for exemption or may not require IRB review, as defined in federal regulations.

IRB review procedures are established by the University in accordance with federal regulations per CFR 45, Part 46, Protection of Human Subjects.

Rationale

CFR 45, Part 46, dictates IRB Policy and Procedures. Procedure details have been removed from the University policy to make it easier to implement federal changes as they are issued and remain in compliance.