HRPP Manual Section 4-2

Authority of IRBs

Michigan State University (MSU) has established Institutional Review Boards (IRBs) under its Federal Wide Assurance #00004556.  The designated IRBs are:

  • Michigan State U IRB#1 – Biomedical: DHHS registration #00000297

  • Michigan State U IRB#3 – Social Science: DHHS registration #00005250

  1. These IRBs have the authority and responsibility to approve, require modifications in, or disapprove all non-exempt human subject research as defined in HRPP Manual 4-1 “Applicability” before it is initiated in order to comply with ethical principles, federal, state, and local laws and regulations, and university requirements.  For studies subject to the Revised Common Rule (2018 Requirements), this includes exempt research activities under  45 CFR 46.104 for which limited IRB review is a condition of exemption (under 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)).

  2. Except for activities that do not require renewed IRB approval, all non-exempt human subject research is subject to continuing oversight and review by the IRB at least annually with limited exceptions specified in HRPP Manual 4-11 “Applicability of the Revised Common Rule (2018 Requirements),” 8-8 “Flexibility Initiatives,” or specific HRPP Manual sections.

  3. Additional steps may be taken by the IRB to assure compliance with the requirements of other MSU HRPP components. See HRPP Manual 3-1 “MSU HRPP” for additional information.

  4. The IRBs have the authority to observe or have a third party observe the consent process and the research. 

  5. The IRBs have the authority to suspend or terminate IRB approval of research that is not being conducted in accordance with their requirements, or that has been associated with unexpected serious harm to subjects.

  6. The IRBs are responsible for prompt reporting to appropriate officials and entities (university, federal or state agencies, regulatory bodies, Office for Human Research Protections, U.S. Food and Drug Administration, sponsor agency, reliant IRB, etc.) of any unanticipated problems involving risks to subjects or others, of any serious or continuing noncompliance with federal regulations or IRB requirements, and of any suspension or termination of IRB approval.

  7. Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.

Details of the procedures for implementing these responsibilities are contained in the applicable sections of the MSU HRPP Manual. Also see HRPP Manual 4-6 “Responsibilities of IRBs.”

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 4-5-2006. Revision 2 approved by VP Research & Graduate Studies on 3-9-2008. Revision 3 approved by VP Research & Graduate Studies on 8-22-2011. Revision 4 approved by Assistant VP Regulatory Affairs on 11-23-2015. Revision 5 approved by Senior VP for Research and Innovation on 1-18-2019.

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