HRPP Manual Section 5-2-C

Human Research Protection Program:
Institutional Review Board

The descriptions provided below are intended to indicate the kinds of responsibilities of the Institutional Review Board (IRB) office staff. The descriptions shall not be construed as declaring what the specific duties and responsibilities of any particular person or position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his or her supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of similar kind or level of difficulty. The descriptions are not intended to limit or displace applicable Michigan State University Human Resources policies and procedures for employment.

The manager of the IRB office shall:

  1. Manage the daily operations of the IRB office.

  2. Supervise and direct IRB office staff.

  3. Conduct annual evaluations of IRB office staff.

  4. Coordinate and manage the IRB office process to assure that applications are processed consistently, in a timely manner, and in compliance with regulatory requirements, policies, and procedures for human subject research. 

  5. Generate internal reports and monitor IRB staff workload as needed.

  6. Assist in the MSU Human Research Protection Program (HRPP) reaccreditation efforts.

  7. Coordinate with the Compliance office as necessary, including post approval monitoring activities and noncompliance investigations.

  8. Assist with implementing the HRPP policies and procedures.

  9. Assist with implementing process changes and improvements to the IRB office as needed.

  10. Coordinate education provided by IRB staff to the research community.

  11. Promote a customer service oriented atmosphere.

  12. Prepare and present reports to the HRPP director regarding recent activities.

  13. Attend IRB meetings.

  14. Serve as a resource for researchers regarding regulatory requirements and university policies and procedures for conducting human research.

  15. Report changes in IRB membership as well as other relevant changes affecting the IRB to the U.S. Office for Human Research Protections or other appropriate federal agencies or departments.

  16. Assure IRB rosters are maintained and up to date.

  17. Perform ancillary reviews as needed.

  18. Assist in reporting as required by HRPP Manual 4-8 “Reporting Policy.”

  19. Perform some of the duties of the IRB Administrators when needed.

  20. Perform other projects or tasks as assigned.

IRB Administrators shall:

  1. Uphold and maintain knowledge of federal, state, and local regulations, as well as university policy and procedures and ethical standards with regard to the protection of human research subjects.

  2. Process incoming applications to the IRBs in a timely manner.

  3. Perform a pre-review of incoming applications. 

  4. Review requests for a determination of whether an activity involves human subject research in accordance with HRPP Manual 4-3 “Determination of Human Subject Research.”

  5. Review exempt applications in accordance with HRPP Manual 8-1 “Exemptions.”

  6. Coordinate the IRB review process using email and the MSU IRB online system.

  7. Maintain accurate, organized, and complete files and records (including electronic) for the IRB. This includes uploading study specific emails into the MSU IRB online system.

  8. Provide timely copies of all appropriate materials to researchers, IRB members, and engaged performance sites.

  9. Maintain IRB records for at least three years following study completion or as required by federal regulations (e.g., 45 CFR 46.115, 21 CFR 56.115).

  10. Support the IRB chair(s) and the Institutional Official for human subjects protections.

  11. Interact with the members of the IRBs and researchers to facilitate IRB review.

  12. Provide guidance regarding international, federal, and state regulations and university policies and procedures related to human research protection to researchers, IRB members, and others.

  13. Participate in site visits as appropriate.

  14. Maintain ongoing and current education in human research protections.

  15. Assist in education programming for IRB members and researchers as appropriate.

  16. Cross-train to be able to perform some of the duties of the IRB Administrator IIs when needed.

  17. Perform other projects or tasks as assigned.

In addition to the functions described above, the IRB Administrator IIs shall:

  1. Facilitate the expedited review process for U.S Food and Drug Administration (FDA) studies or studies funded by federal departments or agencies that have not signed onto the Revised Common Rule (2018 Requirements).

  2. Review requests for 45 CFR 46.118 designation or equivalent in accordance with HRPP Manual 8-4 “Request for 45 CFR 46.118 Designation.” 

  3. Review exempt studies funded by federal departments or agencies that have not signed onto the Revised Common Rule (2018 Requirements).

  4. Manage email correspondence between MSU Sponsored Programs and MSU Technologies.

  5. Review federally funded studies that have additional requirements when assigned.

  6. Assist the IRB Administrator IIIs at IRB meetings when needed. 

  7. Cross-train with the IRB reliance coordinator to assist with reliance studies when needed.

  8. Coordinate reviews with institutions with which MSU has institutional reliance agreements.

  9. Performs other projects or tasks as assigned.

In addition to the functions described above the IRB Administrator IIIs shall:

  1. Serve as the administrator of an IRB(s) to uphold federal regulations protecting human subjects of research.

  2. Coordinate IRB meetings, including preparation of the preliminary agenda and materials, meeting agenda and materials, and minutes.

  3. Assist the IRB chair in assuring that quorum is met and kept at convened IRB meetings.

  4. Draft and maintain accurate IRB meeting minutes.

  5. Maintain membership files.

  6. Maintain and update IRB rosters.

  7. Report changes in IRB membership as well as other relevant changes affecting the IRB to the IRB manager and others as appropriate.

  8. Assist in reporting as required by HRPP Manual 4-8 “Reporting Policy.”

  9. Assist in coordination of reviews for non-compliance allegations, potential unanticipated problems involving risks to subjects or others, suspension or termination of IRB approval, and/or subject complaints.

  10. Assist as requested in IRB membership evaluations.

In addition to the functions described above for IRB Administrator IIIs, the IRB Reliance Coordinator shall:

  1. Assist with implementing HRPP policies and procedures that relate to IRB reliance.

  2. Assist with issues that relate to IRB reliance.

  3. Communicate and coordinate with IRBs with which MSU has institutional agreements regarding IRB reliance processes.

  4. Communicate with external (non-MSU) IRBs to coordinate reliance arrangements. 

  5. Process and manage external IRB submissions.

  6.  Review non-exempt study submissions that identify new federal funding for applicability of single IRB requirements.

  7. Process single IRB designation requests.

  8. Make engagement determinations as needed. 

  9. Assist the HRPP Director with reliance processes and agreements.

Approved By

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 12-11-2015. Revision 4 approved by Assistant VP Regulatory Affairs on 11-7-2021.

This policy and procedure supersedes those previously drafted.

Related HRPP Manual Sections