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: Spring 2019
    Last Review: Spring 2019
    Next Review: Spring 2026

    Policy

    The Institutional Review Board (IRB) is a mandated compliance committee that holds a Federalwide Assurance from the Office for Human Research Projection (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 will be obtained for this research in a form associable with the individual. For example, secondary analysis of aggregate data does not require IRB approval.

    The procedures related to the review of proposals submitted to the IRB are governed by the federal government 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.