In 2021, a long-term partnership agreement was signed between Henry Ford Health (HFH) and Michigan State University (MSU). Key features of the agreement include fostering innovative, groundbreaking research, providing best-in-class cancer care, interprofessional training, increasing diversity among the next generation of health care professionals, and addressing the needs of traditionally underserved communities. For more information about the partnership, please visit: https://www.henryfordmsu.org/
In this arrangement, the “Henry Ford Health + Michigan State University Health Sciences” (HFH+MSU HS) is a part of MSU: NIH grants are submitted through MSU and MSU must report research activities for the HFH (MSU appointed) and MSU faculty in the College of Human Medicine (CHM), College of Osteopathic Medicine (COM), and College of Nursing (CON). Submission of grant proposals through the HFH+MSU HS started with NIH submissions after November 1, 2022.
The HFH Institutional Review Board (IRB) and MSU Human Research Protection Program (HRPP) are collaborating in an HFH-MSU IRB Workgroup to provide optimal guidance and information about human research protection requirements for studies that involve both HFH and MSU. This group meets weekly to continue to align and streamline institutional processes and address project specific reliance questions. We expect that this information will evolve as collaborations progress.
Beginning November 1, 2022, grants and cooperative agreement applications (excluding contract proposals) submitted directly to NIH will be submitted through the HFH+MSU HS IF the lead PI is from HFH or MSU and has a base appointment in the CHM, COM, or CON.
If the grant proposal involves human participants, federal requirements related to human research protection including Single IRB will apply. With limited exceptions, reliance on a Single IRB is required for studies that have at least one non-exempt component and engage more than one domestic institution. For more information on Single IRB requirements, please visit: https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm
The HFH IRB and MSU HRPP will work together to determine whether Single IRB applies and if so, what institution will serve as the Single IRB. For example, the Single IRB could be HFH, MSU, or another institution.
It is preferred that determination of the Single IRB occur at the time of NIH grant submission. This timing is important and benefits researchers in several ways:
Process Step | Details |
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1. Notification* |
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2. Reliance Screening Form |
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3. Review |
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4. Determination |
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* It is preferred that IRBs are notified prior to grant submission.
** If other institutions are engaged, Lead PI confirms with collaborators that the collaborators’ IRBs also agree to the Single IRB determination; if there is disagreement, the Lead PI contacts the institutional IRB
HFH+MSU HS NIH grant proposals are being submitted through MSU. When there is a HFH employed Lead PI, a Single IRB determination is required from both HFH and MSU. HFH is considered engaged in the research because the Lead PI is employed by HFH. MSU is considered engaged in the research because MSU, through the HFH+MSU HS, would be the primary awardee on the NIH grant. If an institution is engaged in the research, IRB approval is required or Single IRB is required when applicable.
When there is an MSU employed Lead PI and there is a HFH collaborator or HFH otherwise requires IRB approval (e.g., recruiting HFH patients or employees, use of HFH medical records, use of HFH facilities) a Single IRB determination is required from both HFH and MSU. If there are any questions about whether HFH requires IRB approval, please contact the HFH institutional contacts listed below.
When there is an MSU employed Lead PI and there is no collaboration or involvement with HFH, the standard MSU HRPP / IRB processes would be followed. For more information on MSU HRPP / IRB processes, please visit What and How to Submit webpage: https://hrpp.msu.edu/help/submit/index.html
When there are multiple PIs who are HFH employed and MSU employed, a Single IRB determination is required from both HFH and MSU.
The table below provides an overview of when a Single IRB determination is needed.
Lead PI | HFH Single IRB Determination | MSU Single IRB Determination | Submit Through the MSU IRB Online System |
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HFH Employed Lead PI | Required | Required | Required |
MSU Employed Lead PI | Required only if HFH Collaborator or HFH Requires IRB Approval | Required | Required |
Multiple PI with HFH Employed and MSU Employed | Required | Required | Required |
While the IRBs aim to streamline processes, when a Single IRB is used, a request for reliance / use of an external IRB is still required at the relying institution. Typically, the request for reliance / use of an external IRB involves a shortened form to document the reliance. The reason for this is because even when an institution relies, the institution must document the reliance and remains responsible for safeguarding the rights and welfare of human participants and for complying with the protection of human research requirements.
Instructions will be provided to the Lead PI after the Single IRB determination. If there are any questions, please contact the HFH or MSU institutional contacts listed below. HFH IRB and MSU HRPP staff are available to assist researchers through these processes.
Reliance on a Single IRB is required for many federally funded human research studies that engage more than one domestic institution and that are not exempt. If both MSU and HFH will be engaged in a federally funded study requiring Single IRB, the Overview of Single IRB Determination Process described above will also be followed.
Studies that are not federally funded do not require reliance on a Single IRB. However, IRB reliance may still be requested and is encouraged for studies that are not exempt. If both MSU and HFH will be engaged in a study that does not require Single IRB, the Overview of Single IRB Determination Process described should be used. However, it is possible that institutions may require their own IRB review.
Reliance on an IRB only applies to human research studies that do not qualify for an exemption. The MSU HRPP does not enter into reliance for exempt submissions.
While HFH and MSU are exploring collaborative options for exempt studies, currently, if a study involves both MSU and HFH, IRB submissions will be required at both MSU and HFH.
If you have any questions about the HFH and MSU IRB processes, please contact us.
Institution | Project Specific Questions | |
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HFH | IRBReliance@hfhs.org |
Hazera Begum: |
MSU | ora.irbreliance@msu.edu | Kim Hess: ora.irbreliance@msu.edu |
Please visit the following sites for more information:
HFH Institutional Review Board
MSU HRPP
MSU Sponsored Programs:
MSU Health Colleges Research Services