MSU HRPP Manual Section 8-11-A

External IRB Submissions Involving Henry Ford Health Employed Principal Investigators

This Michigan State University (MSU) Human Research Protection Program (HRPP) Manual section can be used when there is a request for reliance on the Henry Ford Health (HFH) Institutional Review Board (IRB) or another external (non-MSU) reviewing IRB:

for a non-exempt human research study,
when there is a HFH employed lead Principal Investigator (PI),
on a proposal submitted through the Henry Ford Health + Michigan State University Health Sciences (HFH+MSU HS) doing / business / as MSU, and
there is no other MSU individual involvement.

See MSU HRPP Manual Section 1-7, Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements for more information.

For the purposes of this manual section:

the term PI is meant to encompass the PI in the circumstance described above.
the term reviewing IRB is meant to encompass the HFH IRB or another external reviewing IRB
another MSU HRPP staff member may perform the actions of the MSU reliance coordinator

For studies that also involve MSU employees or students, MSU HRPP Manual 8-11, External IRB Submissions, will generally be applied.

Components of the MSU HRPP Manual 8-11, External IRB Submissions, may also be applicable if the PI has initially submitted directly to the MSU HRPP IRB online system.

A fully executed Institutional Authorization Agreement (IAA) or reliance under the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB must be in place and the reviewing IRB must approve MSU’s involvement in the research prior to MSU’s engagement in the research. See MSU HRPP Manual 1-3, Use of Institutional Authorization Agreements, for more information.

The MSU HRPP office will make a reliance acknowledgment letter available to the PI through the MSU IRB online system once an agreement has been signed by both institutions or reliance is ceded under the SMART IRB and approval for MSU’s involvement has been received.

Research and/or clinical investigations involving human subjects that engage MSU cannot begin until the PI receives the MSU HRPP acknowledgement letter and as applicable, an executed contract and consent congruency review has been completed and all other applicable requirements and approvals for the study have been met.

See the MSU HRPP Manual 1-4, Reliance on Commercial IRB, for additional requirements when an independent (commercial) IRB serves as the reviewing external IRB. The requirements in this section will typically apply as appropriate.

See the MSU HRPP Manual 1-5, Use of the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) for additional requirements for reliance upon the NCI CIRB. The requirements in this section will typically apply as appropriate.

PI Responsibilities

In addition to the specific responsibilities identified in this document, the PI is responsible for assuring compliance with the determinations and requirements of the reviewing IRB. The PI must assure that they and their research team will cooperate as needed in the reviewing IRB’s initial and continuing review (when required), review of modifications/amendments, recordkeeping, and reporting. All information requested by the MSU HRPP and by the reviewing IRB will be provided in a timely manner.

Materials Required for Submission

To request IRB review by the reviewing IRB, the PI submits an initial, external, or amendment (modification) IRB application to the HFH IRB through the HFH IRB online system.

The following supporting documents must be included whenever applicable:

Full funding proposals and agreements, including submitted full funding proposal, executed contract, subcontract, subaward, or notice of award
Data management and sharing plan
Informed consent document(s)
Reliance screening form

Mechanism for Submission

The request must typically be completed and submitted using the HFH IRB online system. The request must be completed in full; all required questions must be completed. The HRP-513 – Template – External IRB Request will typically not be required as MSU specific questions are incorporated into the HFH IRB submission process.

An external IRB request will also be created in the MSU IRB online system. The following supporting documents will be included whenever applicable:

Full funding proposals and agreements, including submitted full funding proposal, executed contract, subcontract, subaward, or notice of award
HFH IRB initial, external or amendment application as applicable
HFH IRB or other reviewing IRB approval letter
Data management and sharing plan
Informed consent document(s)
Reliance screening form

MSU HRPP Review

The MSU reliance coordinator will be assigned as an administrative reviewer on the application in the HFH IRB online system. The MSU reliance coordinator will conduct a review of the IRB submission. The review includes but is not limited to, determining if MSU is engaged in non-exempt human subject research and whether the reviewing IRB may be relied upon as IRB of record.

Other ancillary reviewers will be assigned to studies that may require additional MSU reviews (e.g., biosafety or radiation review, or conflict of interest), that utilize MSU resources (e.g. MSU Health Care, Inc.) or that may be subject to additional federal or other requirements (e.g. Compliance office for U.S. Food and Drug Administration requirements, Clinical Research Billing Compliance, General Data Protection Regulations etc.). These reviews are separate from an IRB review and occur even with reliance upon another reviewing IRB. This may occur in the HFH IRB online system or the MSU IRB online system. If the review impacts the HFH IRB, the MSU HRPP will communicate with the HFH IRB. If the review impacts another reviewing IRB, the MSU HRPP may communicate with the HFH IRB, reviewing IRB, PI, or study team.

If the study involves genomic data, see HRPP Manual 1-7, Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements, for requirements.

Study Personnel

The PI is responsible for ensuring the initial and ongoing qualifications of investigators and research staff. This includes assuring that members of the research team have appropriate qualifications and expertise to conduct the research, are knowledgeable about laws, regulations, codes and guidance governing the research, and are knowledgeable about MSU’s policies and procedures that impact the study.

All individuals engaged in human subject research activities:

must receive and maintain current human subject training
must disclose conflict of interest in accordance with the MSU HRPP Manual 10-1, Conflict of Interest, and
are subject to MSU HRPP requirements, see MSU HRPP Manual 4-1, Applicability; this includes complying with any conflict of interest management plans that may result.

It is the responsibility of the PI to maintain oversight over all study personnel and to assure and to maintain appropriate tracking that these requirements are met (e.g., documentation of training completion, conflict of interest). Personnel changes should be reported to the HFH IRB or other reviewing IRB as required; personnel changes do not need to be reported to the MSU HRPP.

Determination of Reliance

The MSU reliance coordinator is assigned as an administrative reviewer in the HFH IRB online system to determine if MSU can rely upon the reviewing IRB. If the IRB reliance screening form for projects involving MSU and HFH has been completed, it is typically used in making the determination. See MSU HRPP Manual Section 1-7, Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements for more information. If the screening form has not been completed and a determination has not been made, the MSU reliance coordinator will make the determination using the considerations in HRPP Manual 1-3, Use of Institutional Authorization Agreements. The MSU HRPP director or MSU HRPP manager will be consulted as needed.

Reliance Agreement

A fully executed IAA or reliance under the SMART IRB must be in place and the reviewing IRB must approve MSU’s involvement in the research prior to MSU’s engagement in the research. The MSU reliance coordinator works with the HFH IRB or contacts the other reviewing IRB to inquire about possible reliance and execution of an IAA or use of the SMART IRB Agreement.

Consent Review

Even if MSU is relying upon another reviewing IRB, if informed consent will be obtained, the informed consent document typically must address MSU’s involvement in the study. This may be the HFH site specific consent form, if applicable. The MSU reliance coordinator reviews the consent form(s) for local context (if applicable) including the inclusion of individuals with oversight of research responsibilities in the confidentiality section (or other similar language that allows for access to research records by MSU individuals in the event of an audit) and whether the consent form is congruent with federal grant requirements in areas such as subject injury, whether the Certificate of Confidentiality or data sharing is applicable, and whether costs or compensation is congruent with the contract/subcontract (reviewed by the Compliance Office). The MSU HRPP director and/or MSU HRPP manager will be consulted on any questions about consent language. MSU legal counsel may be consulted when needed.

Submission to Reviewing IRB

The PI assures that the appropriate IRB documents are submitted to the reviewing IRB to add MSU’s involvement in the study (e.g., initial IRB application, external IRB application, modification/amendment).

The PI must provide any requested revisions to the consent form(s) to the reviewing IRB for review and approval. The PI also must provide the reviewing IRB with requested information about other local requirements or local research context issues relevant to the reviewing IRB’s determination, prior to or as part of IRB review. The MSU HRPP may also provide information about local context when requested by the reviewing IRB. If local policies that impact the local context and reviewing IRB review are updated, the MSU HRPP will notify the reviewing IRB as needed.

The HFH IRB initial, external or modification/amendment application, the reviewing IRB approval document(s), and the approved consent form(s) will be uploaded into the MSU IRB online system prior to release of the MSU HRPP reliance acknowledgement letter.

MSU HRPP Reliance Acknowledgement

The MSU HRPP office will send a notification and make available a reliance acknowledgment letter in the MSU IRB online system once:

A reliance agreement that encompasses MSU’s involvement has been finalized (e.g., a fully executed IAA, a SMART IRB Letter of Acknowledgment or via the SMART IRB online system), and
Approval from the reviewing IRB for MSU’s involvement has been received.

Research and/or clinical investigations involving human subjects that engage MSU (including enrollment of research subjects) cannot begin until the PI receives the MSU HRPP reliance acknowledgement letter and as applicable, the executed contract and completed consent congruency review and all other applicable requirements and approvals.

Data Safety Monitoring Reports

The PI must ensure that any data safety monitoring reports that they receive are provided to the reviewing IRB in accordance with the reviewing IRB’s requirements.

Consent

When consent will be obtained, the study team must obtain, document, and maintain records of consent for each subject or each subject’s legally authorized representative in the manner required by the reviewing IRB.

If any changes are made to the MSU local context in the informed consent document(s) the MSU HRPP must be notified. This may occur through the HFH IRB or by the PI or study team.

Prisoner Research

For HHS funded research, each institution engaged in a non-exempt multicenter research study involving prisoners must certify to OHRP in accordance with the requirements of HHS regulations at 45 CFR 46.305(c) and 46.306(a)(1), unless (a) an institution relied upon the review of an IRB operated by another institution engaged in the research; and (b) that IRB or the other institution certified to OHRP on behalf of both institutions.

When prisoner certification to OHRP is required, the certification to OHRP should typically include MSU. The MSU reliance coordinator will work with the reviewing IRB to ensure that the OHRP certification includes MSU.

Reportable Events

Researchers are responsible for submitting reportable events to the reviewing IRB in accordance with the reviewing IRB’s requirements and timelines. This includes reporting any unanticipated problems involving risks to subjects or others, non-compliance, subject complaints, protocols deviations, or other events as required by the reviewing IRB and the reliance agreement.

The HFH IRB (or other reviewing IRB as applicable) will notify the MSU HRPP of the following:

Any project specific audit (e.g., NIH or FDA)
Unanticipated problem involving risks to subjects or others (UPIRSO)
Serious or continuing noncompliance with the federal regulations or the requirements or determinations of the HFH IRB or other reviewing IRB
Suspension or termination of IRB approval

When reportable information is received for a study involving HFH, the MSU reliance coordinator will consult with the MSU HRPP director, MSU HRPP manager, and/or MSU IRB chair when needed. The IAA or SMART IRB Agreement will be reviewed as needed to determine if additional actions are needed.

Continuing Review

The MSU reliance coordinator will track the expiration of IRB approval (if applicable).

When continuing review is required, the MSU reliance coordinator will create an Update in the MSU IRB online system to update the expiration of IRB approval and upload the current continuing review approval letter, if available.

When continuing review is not required, the MSU reliance coordinator will typically check the HFH IRB online system annually to confirm the status of the study (i.e., still open with the reviewing IRB).

Research Sites

Any research site(s) that will be engaged in research and/or clinical investigation with human subjects in addition to those initially approved with the reviewing IRB will be communicated to the MSU HRPP if there could be an impact on MSU or the reliance with HFH or other reviewing IRB.

Updates

The PI is responsible for reporting promptly to the reviewing IRB any proposed changes to the research. The PI cannot implement changes to the research (including changes in the consent document) without prior reviewing IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.

The MSU reliance coordinator may create an Update in the MSU IRB online system for a study involving HFH to enter information or at the request of the PI.

The HFH IRB will typically notify the MSU HRPP of the following:

Change in HFH employed lead PI
Enrollment of prisoners, if the study has not been certified to OHRP on behalf of MSU
New potential conflicts of interest for HFH staff supported by the HFH+MSU HS grant
Changes in funding (e.g., new or additional funding)
New informed consent documents that do not include MSU local context

The MSU reliance coordinator will consult with the MSU HRPP director and/or MSU HRPP manager when needed.

Review by Other MSU Officials

For a study involving HFH that is subject to a reliance agreement, MSU officials may not approve the research subject to the reliance agreement if it has not been approved by the reviewing IRB.

Site Visits

The MSU HRPP Compliance office conducts post approval site visits for certain IRB approved studies. This includes studies reviewed by the reviewing IRB. The site visits may be conducted in addition to, or in cooperation with, the reviewing IRB, when appropriate. Full cooperation by the department, PI and other members of the research team (if necessary) is expected. See MSU HRPP Manual 8-10, Site Visits, for more information.

TEACH Visits

Teaching Education and Compliance Help (TEACH) is a collaborative, educational initiative designed to assist the PIs and their research team with regulatory compliance that are performed for certain IRB approved studies. This includes studies reviewed by the reviewing IRB. For these studies, TEACH is typically done by providing the TEACH form to the PI, study team member(s), and HFH IRB staff member(s). See HRPP Manual 3-3, Evaluation and Quality Improvement, for more information.

Closure

Studies reviewed by a reviewing IRB may be closed when either the study is closed with the reviewing IRB or a modification/amendment is approved by the reviewing IRB that indicates MSU is no longer engaged in research with human subjects.

The MSU HRPP will be notified when the study may be closed and the MSU reliance coordinator will upload the closure letter or modification/amendment approval letter, if available, into the external IRB study in the MSU IRB online system.

The MSU reliance coordinator will review the information to confirm that the study may be closed. If the study may be closed, the study record will be closed in the MSU IRB online system.

Record Retention

All records relating to the research must be appropriately managed and retained, including for external IRB studies. See MSU HRPP Manual 4-7-A, Recordkeeping for Investigators, for more information.

Questions

Researchers and research staff who want to obtain answers to questions, express concerns, and convey suggestions regarding the use of the reviewing IRB should contact the MSU reliance coordinator. The MSU HRPP director or MSU HRPP managers may also be contacted with programmatic inquiries. Contact information is available on the MSU HRPP website.

Approved By

Vice President for Research and Innovation on 1-27-2025.

This policy and procedure supersedes those previously drafted.

Human Research Protection Program Office of Research Regulatory Support