MSU HRPP Manual Section 8-12

MSU as IRB of Record for Other Institutions

The Michigan State University (MSU) Principal Investigator (PI) is required to submit a request to the MSU Institutional Review Board (IRB) office through the MSU IRB online system when another institution requests reliance upon MSU as the IRB of record. This can be done as part of an initial study submission or as a modification submission to add the institution as an external site relying on MSU’s IRB review.  

When a request is made for MSU to serve as the reviewing IRB, before any research and/or clinical investigation involving human subjects may take place at the relying institution:

  • 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 MSU IRB must approve the IRB submission that includes the relying institution.

If the request for reliance is received during an initial study submission and the research could be conducted without involvement of the relying institution or the relying institution requires MSU IRB approval prior to entering into a reliance agreement, IRB review may proceed and the reliance may be processed via a modification submission. If the research could not be conducted without the involvement of the relying institution, IRB approval must wait until the IAA is executed or reliance is ceded under the SMART IRB.

If the request is for use of a Single IRB, the submission would follow MSU HRPP Manual 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health) or 2-2-G, Revised Common Rule Single IRB Requirement to agree to selection of the Single IRB.

The review of the IRB submission proceeds in accordance with the relevant MSU HRPP Manual sections. See Section 8, Types of IRB Review.

If it is determined during review of an initial study submission that a reliance on an external IRB would be more appropriate or is required, the MSU PI will be contacted by the MSU reliance coordinator to submit a request for review by an external IRB. See MSU HRPP Manual 8-11, External IRB Submissions.

MSU PI Responsibilities

In addition to the specific responsibilities identified in this document, if MSU serves as the reviewing IRB for another institution, the MSU PI is responsible for accurately describing the involvement of the relying institution in the MSU IRB submission and when appropriate, for coordinating with the PI at the relying institution to obtain any information requested by the MSU IRB in a timely manner.

If the institution does not routinely conduct human research, the MSU PI is responsible for providing any additional training or education that may be needed on IRB requirements such as human subject protection, following the IRB approved protocol, reportable events, and record retention.

Materials Required for Submission

To request that another institution rely upon MSU’s IRB review, the institution needs to be identified as relying upon MSU within the MSU IRB online system and any institution-specific study documents (e.g., recruitment materials, consent forms) provided.

Determination of Reliance

When another institution requests reliance upon MSU’s IRB review, the MSU reliance coordinator will be assigned as an ancillary reviewer when the SMART IRB agreement is used or where there is not an existing IAA in place. Another MSU IRB administrator may be assigned for reliance requests where there is an existing IAA or when the MSU reliance coordinator is unavailable.

If MSU has already been agreed upon as the Single IRB, that designation will be relied upon unless the proposed study is substantially different than what was originally proposed as part of the Single IRB designation process.

If there are concerns with MSU serving as the reviewing IRB based on the considerations below, the MSU HRPP director or MSU HRPP manager is assigned as an ancillary reviewer to review the request for reliance.

  • Complexity
  • Expertise
  • Number and types of sites (academic, hospital, other)
  • Location of research
  • Risk level
  • Resources

See MSU HRPP Manual 1-3, Use of Institutional Authorization Agreements for additional considerations when determining reliance.

When there is a question of whether MSU will serve as the reviewing IRB for another institution, the MSU HRPP director and/or MSU HRPP manager is assigned as an ancillary reviewer and a response is required. If the MSU HRPP director and/or MSU HRPP manager determines that it would not be appropriate for MSU to serve as the reviewing IRB for the institution, the MSU reliance coordinator will inform the MSU PI of the determination. If the MSU PI disagrees with the determination, they may request consideration by the MSU Institutional Official (IO). The MSU IO retains final authority to determine whether MSU may serve as the reviewing IRB for another institution.

Reliance Agreement

A fully executed IAA or reliance ceded under the SMART IRB must be in place and MSU IRB must approve the institution’s involvement in the research prior to the institution’s engagement in human research. When appropriate, the MSU reliance coordinator contacts the relying institution to inquire about possible reliance and the IAA or use of the SMART IRB Agreement, if not already in contact with the relying institution. The MSU reliance coordinator will obtain the contact information from the relying institution, when needed. See MSU HRPP Manual 1-3, Use of Institutional Authorization Agreements.

Federalwide Assurance (FWA)

For institutions where MSU has not acted as the reviewing IRB, the MSU reliance coordinator confirms that the relying institution has an active FWA. If the institution does not have an active FWA, the reliance can proceed as long as there is no federal funding and no potential for future federal funding. If the study is federally funded and the relying institution does not have an FWA, the institution will need to request / apply for an FWA through the U.S. Office for Human Research Protections (OHRP). If the institution will be designating an MSU IRB as their external IRB on their FWA, a reliance agreement must be in place prior to this designation. If the relying institution does not have an IRB, the IRB manager will be assigned as an ancillary reviewer to review a copy of their FWA and written policies and procedures for reporting.

Local Context

A local context information sheet will be sent to the relying institution to complete unless the institution has a broad IAA with MSU. This document obtains local context information about the institution that may impact the IRB review, such as:

  • Community or cultural differences
  • Any local or institutional policies or requirements that would affect the conduct or approval of the research, including local ancillary reviews
  • Consent language
  • Involvement of HIPAA
  • Any applicable laws if the research is conducted outside the state of Michigan (e.g., legally authorized representative, age of majority)
  • Whether the FWA has been extended to non-federally funded research
  • If the institution is not AAHRPP accredited, designated contact individual(s) and explanations of how those individuals ensure the safe and appropriate performance of research at the relying institution, how potential unanticipated problems and/or serious or continuing noncompliance is identified and managed, and the relying institution’s process to receive and address concerns from subjects about the conduct of human subject research

The completed local context sheet is reviewed by the MSU reliance coordinator and/or MSU IRB administrator and is made available to IRB members reviewing the submission through the MSU IRB online system. The MSU IRB administrator may notify the MSU HRPP director and/or MSU HRPP manager if any answers to the questions may require additional review.

For institutions with a broad IAA, local context may be provided generally or at the time of a new IRB submission (e.g., institutional consultant).

If any changes are made to the local context that impacts the MSU IRB review, the MSU IRB must be notified. This may occur through the MSU PI or through the relying institution.

Conflict of Interest

The relying institution is responsible for performing its own conflict of interest review under its relevant policies and for providing MSU with any resulting conflict of interest determinations, prohibitions, and management plans, unless otherwise addressed in a reliance agreement or other document.

Consent

The relying institution is responsible for reviewing the congruence of any contract proposal with that institution for the study with the consent form and providing to the MSU IRB congruent language, such as compensation for injury, unless otherwise addressed in a reliance agreement or other document.

MSU HRPP Reliance Approval

The MSU HRPP office will notify the MSU PI that the study falls under reliance with the relying institution through the MSU IRB online system and through the standard MSU IRB approval letter. Research and/or clinical investigations involving human subjects that engage the relying institution (including enrollment of research subjects) cannot begin until the MSU PI receives the MSU IRB approval letter for the submission that includes reliance with the relying institution, and as applicable, all other applicable requirements and approvals for the study have been met.   

Pregnant Women, Fetuses, Neonates, and Children

The relevant MSU HRPP Manual sections regarding review of pregnant women, fetuses, neonates, and children will be followed. See MSU HRPP Manual Section 6, IRB Evaluation Criteria.

Prisoners

If the study 1) involves prisoners as research subjects, 2) is subject to the requirements of 45 CFR 46 Subpart C, and 3) the study is U.S. Health and Human Services (HHS)-conducted or -supported, the institution(s) engaged in the research must certify to the Secretary (through OHRP) that the IRB reviewed the research and made the seven findings as required by the regulations at 45 CFR 46.305(c) and 46.306(a)(1).

Each institution engaged in a 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 MSU is the reviewing IRB and prisoner certification is required, MSU will, on a study specific basis, obtain in writing from the relying institution whether the relying institution would like MSU to certify to OHRP on behalf of both institutions, or whether the relying institution would like to certify separately.

If the relying institution would like to certify separately, OHRP certification must be received for both institutions before any research involving prisoners may start. 

See MSU HRPP Manual 6-8-B, Prisoners, for requirements.

Data Safety Monitoring Reports

The MSU PI must assure that any data safety monitoring reports that are received from the PI at the relying institution are provided to the MSU IRB.

Consent

When a relying institution’s researchers are responsible for enrolling research subjects and consent will be obtained, the relying institution’s researchers must obtain, document, and maintain records of consent for each subject or each subject’s legally authorized representative in the manner required by the MSU IRB. See MSU HRPP Manual 4-7-A, Recordkeeping for Investigators.

Reportable Events

The relying institution is responsible for submitting reportable events to the MSU IRB or to the MSU PI in accordance with MSU’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 MSU IRB and the reliance agreement. See MSU HRPP Manual Section 9, Urgent Situations.

Continuing Review (When Required)

The relying institution is responsible for providing any information necessary for continuing review to the MSU PI in a timely manner, and the MSU PI is responsible for providing that information to the MSU IRB for continuing review.

Site Visits

The MSU HRPP Compliance office conducts post approval site visits for certain IRB approved studies. The site visits may be conducted in addition to, or in cooperation with, the relying IRB, when appropriate. See MSU HRPP Manual 8-10, Site Visits, for more information.

Closure

The relying institution is responsible for notifying the MSU PI in a timely manner when their institution’s engagement in non-exempt human subject research has ended. The MSU PI should notify the MSU HRPP when the study may be closed. Studies that involve relying institutions may be closed when all non-exempt human subject research and/or clinical investigations have ended at all institution(s) for which MSU serves as the reviewing IRB. See MSU HRPP Manual 8-9, Closure, for more information.

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 relying institutions. See MSU HRPP Manual Section 4-7-A, Recordkeeping for Investigators, for more information.

Approved By

Vice President for Research and Innovation on 12-8-2021.

This policy and procedure supersedes those previously drafted.

Related HRPP Manual Sections