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Henry Ford Health + MSU Health Sciences (HFH + MSU HS)

Overview

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.

Human Research

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.

NIH Grant Proposals

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:

  • It will help facilitate the Just-In-Time (JIT) process as the Single IRB has already been determined. Determination of the Single IRB can take some time, especially if there are a number of collaborators. Having discussion early will help reduce delays at JIT.
  • The Single IRB determination could impact the study’s budget if the Single IRB charges for their review. While MSU and HFH do not charge for Single IRB review of NIH funded studies, other institutions or independent IRBs may charge. Use of an independent (commercial) IRB may be recommended for multi-State multi-site studies or Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) awards and should be considered early in the proposal development process in order to budget appropriately.
  • It will allow the HFH IRB and MSU HRPP offices to work with researchers early in the process to help provide guidance on next steps (which could include the need for external IRB review).

Overview of Single IRB Determination Process

Overview of Single IRB Determination Process
Process Step Details
1. Notification*
  • HFH IRB or MSU HRPP is notified of HFH+MSU HS grant proposal
  • This may be done by the Study Team, Sponsored Programs, or others
2. Reliance Screening Form
  • A simplified reliance screening form is completed by the Lead PI and submitted to the institutional IRB (HFH Lead PI submits to HFH, MSU Lead PI submits to MSU)
3. Review
  • HFH-MSU IRB Workgroup determines who will serve as the Single IRB
  • Clarification may be requested from the study team
4. Determination
  • HFH IRB or MSU HRPP staff provides Single IRB Determination to Lead PI by Email**
  • Instructions will be provided on next steps

* It is preferred that IRBs are notified prior to grant submission.

** If other institutions are engaged (other than MSU and HFH), 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.

Lead PI Considerations

HFH Employed Lead PI

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 for 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 awardee or subawardee on the NIH grant and the PI on the award to MSU has a dual role (HFH employee but receiving the award on behalf of MSU). If an institution is engaged in the research, IRB approval or reliance is required and Single IRB is required when applicable.

MSU Employed Lead PI

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 for 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 the What and How to Submit webpage: https://hrpp.msu.edu/help/submit/index.html

Multiple PI HFH and MSU Employed

When there are multiple PIs who are HFH employed and MSU employed, a Single IRB determination is required for both HFH and MSU.

The table below provides an overview of when a Single IRB determination is needed.

Single IRB Determination When Submitting Through the HFH+MSU HS
Lead PI HFH Single IRB Determination MSU Single IRB Determination Submit Through the MSU IRB Online System
HFH Employed Lead PI Required Required Not Required (see below***)
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

Next Steps After Single IRB Determination

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 request, acknowledgement of the reliance between the Single IRB and relying institution (usually under the SMART IRB agreement), and approval by the Single IRB for the addition of the relying institution as an external site.  The reason for the request for reliance / use of an external IRB requirement is that 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.

***When there is a HFH employed Lead PI and no MSU collaborator, the MSU HRPP review of the external IRB request (for MSU to rely on either HFH or another institution) will be incorporated into the HFH IRB Online System. A record will be created in the MSU IRB Online System that the HFH employed Lead PI has access to, but the HFH employed Lead PI is not required to submit through the MSU IRB Online System. Note that when HFH is the Single IRB, use of the HFH+MSU HS federally funded combined informed consent form template is required.

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.

NIH Award Transfers

The requirements for use of a Single IRB apply to transfers of NIH awards to the HFH+MSU HS. However, if the grant involves human research, there is typically already an IRB reviewing the study as the IRB of record or Single IRB. Because of this, each award transfer will be handled on a case-by-case basis.

A determination will need to be made on whether the IRB currently reviewing the study will agree to continue to serve as the Single IRB. For example, if the institution will no longer be engaged in conducting the research, the institution’s IRB would likely decline to continue to serve as the IRB of record.

  • If the IRB currently reviewing the study declines to be the Single IRB, a Single IRB determination will need to be made. This will follow the Overview of Single IRB Determination Process described above. There may also be additional considerations if there is a transfer of IRB oversight from the IRB currently reviewing the study to the new Single IRB.

  • If the IRB currently reviewing the study agrees to be the Single IRB, reliance requests and reliance agreements will be needed. HFH IRB and/or MSU HRPP staff will work directly with the PI on the IRB submissions. Please note that if the individual is an HFH employed Lead PI, reliance agreements will be needed for both HFH and MSU.

Because the human research activities are typically ongoing, providing notification to the Institutional Contacts (listed below) as early as possible about the award transfer will help to facilitate the process.

Other Federal Grant Proposals

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.

Other Collaborative Research Between HFH and MSU

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.

Exempt Research

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 research.

While HFH and MSU are exploring collaborative options for exempt research, currently, if a study involves both MSU and HFH, IRB submissions will be required at both MSU and HFH.

Other Research

There are human research activities conducted by MSU and HFH researchers that do not involve the HFH+MSU HS. For example, if a HFH employed PI is conducting research that does not involve employees or agents of MSU and the HFH+MSU HS is not the awardee or subawardee on an NIH grant, MSU may not be engaged in the research and an IRB submission to MSU may not needed.

We encourage researchers to contact us (information listed below) with any questions about the HFH+MSU HS and when IRB submissions are needed to MSU, HFH, or both.

Training

MSU researchers conducting human research activities at HFH must also comply with HFH's training requirements.

Institutional Contacts

If you have any questions about the HFH and MSU IRB processes, please contact us.

Institutional Contacts
Institution Email Project Specific Questions
HFH

IRBReliance@hfhs.org 

IRBReliance@hfhs.org
MSU

orrs.irbreliance@msu.edu

Kim Hess: orrs.irbreliance@msu.edu

Additional Resources

Please visit the following sites for more information:

HFH Institutional Review Board

MSU HRPP

MSU Sponsored Programs:  

MSU Health Colleges Research Services 

Help & Requirements