MSU HRPP Manual Section 4-5

4-5, Responsibilities of the Institutional Review Boards

The Michigan State University Institutional Review Boards shall:

  1. Review, approve, require modifications to, or disapprove non-exempt research studies involving human subjects.
  2. Monitor approved research studies on a regular basis for compliance with federal, state, and local regulations and university policies, including the consent process.
  3. Monitor, and may act in response to, unanticipated problems that may involve risks to subjects or others.
  4. Review the submission of renewal applications from investigators on at least an annual basis or more frequently depending on the degree of risk with limited exceptions provided in the Human Research Protection Program (HRPP) Manual 8-8, “Flexibility Initiatives.”
  5. Comply fully with the requirements of 45 CFR 46, 21 CFR 50 and 56, the Federal Wide Assurance (FWA) and the terms of the assurance, all appropriate federal, state and local laws, and university requirements.
  6. Arrange for prompt reporting, in conjunction with the university, pursuant to HRPP Manual 4-8 “Reporting” of any:

    a.     Unanticipated problems involving risks to subjects or others;
    b.     Serious or continuing noncompliance; and
    c.     Suspension or termination of IRB approval.

  7. Follow relevant written procedures within the HRPP Manual (e.g. for conducting its initial and continuing review of research and reporting findings and actions to the investigator and the institution).
  8. Implement written policies and procedures for addressing potential unanticipated problems involving risks to subjects or others.
  9. Implement written policies and procedures for addressing allegations and findings of non-compliance with IRB requirements.
  10. Implement written policies and procedures for suspension or termination of IRB approval.

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 7-21-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 12-11-2015.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 4-5, Responsibilities of the IRBs.