HRPP Manual Section 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. For studies subject to the Revised Common Rule (2018 Requirements), this also 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. Require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with 45 CFR 46.116. The IRB may require that information, in addition to that specifically mentioned in 45 CFR 46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

  3. Require documentation of informed consent or may waive documentation in accordance with 45 CFR 46.117.

  4. Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

  5. Monitor approved research studies on a regular basis for compliance with federal, state, and local regulations and university policies, including the consent process, and shall have authority to observe or have a third party observe the consent process and the research.

  6. Monitor, and may act in response to, unanticipated problems that may involve risks to subjects or others.

  7. When continuing review is required, review the submission of renewal applications from investigators on at least an annual basis or more frequently depending on the degree of risk.

  8. 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.

  9. 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).

  10. Implement written policies and procedures to arrange for prompt reporting, in conjunction with the university, pursuant to HRPP Manual 4-8 “Reporting” of any:
    1. Unanticipated problems involving risks to subjects or others;
    2. Serious or continuing noncompliance; and
    3. Suspension or termination of IRB approval.

  11. Implement written policies and procedures for addressing potential unanticipated problems involving risks to subjects or others. See HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others.”

  12. Implement written policies and procedures for addressing allegations and findings of non-compliance with IRB requirements. See HRPP Manual 9-2 “Noncompliance.”

  13. Implement written policies and procedures for suspension or termination of IRB approval. See HRPP Manual 9-3 “Suspension or Termination of IRB Approval.”

  14. Implement written policies and procedures to determine which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review. See HRPP Manual 8-1 “Initial Review,8-6 “Modifications to An Approved Research Study,” and 8-7 “Renewed Approval.”

  15. Implement written policies and procedures to ensure prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. See HRPP Manual Section 8-6 “Modifications to an Approved Research Study” and 9-5 “Unapproved Change in Protocol.”

  16. Implement written policies and procedures to assure that except when an expedited review procedure is used, review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. See HRPP Manual 8-3 “Full Board Review Procedure” and 5-5 “Meetings.”

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. Revision 3 approved by Senior VP for Research and Innovation on 1-18-2019.

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