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MSU HRPP Manual Section 1-7

Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements

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.

This section provides MSU Human Research Protection Program (HRPP) requirements and specifics for projects that involve HFH and MSU.

HFH+MSU HS d/b/a MSU

The “Henry Ford Health + Michigan State University Health Sciences” (HFH+MSU HS) was established as a “doing business as” (d/b/a) of MSU for the purposes of grant submissions. Beginning November 1, 2022, grants and cooperative agreement applications (excluding contract proposals) submitted directly to the US National Institutes of Health (NIH) were submitted through the HFH+MSU HS if the lead Principal Investigator (PI) is 1) from HFH (with MSU appointment) or 2) from MSU and has a base appointment in the College of Human Medicine, College of Osteopathic Medicine, or College of Nursing. It is expected that submissions through the HFH+MSU HS will expand to other federal agencies.

  1. HFH Employed Lead PI

When there is an HFH employed lead PI on a proposal submitted through the HFH+MSU HS, both HFH and MSU are considered engaged in human research encompassed within the proposal. This includes subawards that involve the HFH+MSU HS.

  • HFH is considered engaged because the lead PI is employed by HFH and the research may involve HFH data, patients, employees, staff, resources, equipment, or space.
  • MSU is considered engaged in the research because MSU would be the awardee or subawardee on the federal award and the HFH lead PI is submitting the proposal on behalf of MSU with their MSU appointment.

If there is no other MSU individual involvement, modified MSU HRPP processes have been developed for these HFH lead PI studies.

For studies that also involve MSU employees or students, the standard MSU HRPP / IRB processes would be followed.

  1. MSU Employed Lead PI

When there is an MSU employed Lead PI, the standard MSU HRPP / IRB processes would be followed. 

HFH MSU HS

There is also a separate legal entity named “Henry Ford Health Michigan State University Health Sciences.” This entity provides funding opportunities to advance research collaborations between HFH and MSU. When funding is awarded by Henry Ford Health Michigan State University Health Sciences, HFH and MSU are awarded funds directly. MSU would not be engaged in the HFH activities based solely on the award from the separate legal entity and each institution would be responsible for determining engagement. For MSU requirements, see MSU HRPP Manual 4-12, Engagement.

Reliance Screening Form

For studies that involve HFH, an HRP-584 – Template - Screening form for projects involving MSU and Henry Ford Health is typically completed by the lead PI and submitted to the institutional IRB (i.e. if the lead PI is a HFH employee the screening form is submitted to the HFH IRB, if the lead PI is an MSU employee the screening form is submitted to the MSU HRPP). The MSU HRPP and HFH IRB determine the institution (e.g., HFH, MSU, other reviewing IRB) that may serve as the reviewing IRB and provide notification and next steps to the study team. Whan making the determination, MSU HRPP uses the considerations in MSU HRPP Manual 1-3, Use of Institutional Authorization Agreements.

Health Insurance Portability and Accountability Act (HIPAA)

If protected health information (PHI) will be obtained as part of a collaborative research study with MSU and HFH, MSU HRPP Manual Section 7-6, Health Insurance Portability and Accountability Act Compliance in Human Research and its subsections will apply with the following exceptions:

  • If the covered entity is HFH, the MSU HRPP Compliance office will defer to HFH’s HIPAA determinations unless:
    • MSU is the IRB of record, and
    • a compound form will be used
  • The MSU HRPP Compliance office would not be expected to provide notice to the PI for the HFH requirements.

NIH Good Clinical Practice Training Requirements

When an NIH clinical trial involves HFH employees, the MSU HRPP Compliance office will defer to HFH to ensure that all HFH employees who require Good Clinical Practice (GCP) training have completed the training.

United States Food and Drug Administration (FDA) Statement of Investigator (Form FDA 1572)

The Statement of Investigator, Form FDA 1572 (1572), is an agreement signed by the investigator to provide certain information to the sponsor and assure that they will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic. HFH will be responsible for obtaining completed Form FDA 1572s from HFH investigators when required.

Institutional Genomic Data Sharing Certification

When an award is made to the HFH+MSU HS and that award requires the NIH Institutional Genomic Data Sharing Certification, the following process would typically be followed:

  • MSU Office of Sponsored Programs (OSP) would sign for MSU
  • The institutional name should be HFH+MSU HS
  • If the study involves HFH, HFH should be listed as a collaborating site (not HFH+MSU HS as this is a d/b/a of MSU)

If HFH is acting as the reviewing IRB, it is reasonable to rely upon HFH to perform the separate GDS Institutional Certification IRB review if they are willing. When that review is complete, HFH should inform MSU that the assurance certifications are satisfied so the GDS Institutional Certification may be signed by MSU.

See MSU HRPP Manual 2-2-F-iv, US National Institutes of Health Data Management and Sharing for more information about GDS requirements and processes.

Approved By: Vice President for Research and Innovation on 1-27-2025. Revision 1 approved by Associate VP Research Regulatory Support on 11-28-2025.

This policy and procedure supersedes those previously drafted.

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