MSU HRPP Manual Section 1-3

Use of Institutional Authorization Agreements

Revised Common Rule (2018 Requirements)

“For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to §46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol).” 45 CFR 46.103(e)(2018 Requirements)

Institutional authorization agreements (IAA) are written agreements entered into between institutions to “rely” on Institutional Review Board (IRB) review for non-exempt human subject research. Such agreements are entered into to reduce duplicate IRB review when appropriate. Michigan State University (MSU) may enter into an IAA to rely on another institution’s IRB review or to allow another institution to rely on MSU’s IRB review.

The IAA is used to document the institution's reliance on the IRB for oversight of the research. For research subject to the Revised Common Rule (2018 Requirements), the IAA is also typically used to document the responsibilities that each entity will undertake to ensure compliance with the requirements of the Revised Common Rule. If the responsibilities that each entity will undertake to ensure compliance with the requirements of the Revised Common Rule are not included in the IAA, they must be documented through another agreed upon process.

MSU may enter into an IAA after a determination is made that it is appropriate under the particular circumstances. The MSU Institutional Official retains final authority to determine whether MSU may enter into an IAA. Each IAA is situation and context-dependent. Considerations of whether to enter into an IAA may include engagement of the institutions, the location of the research interaction or intervention or subject recruitment, whether there is a prime award for a contract, grant, or cooperative agreement, whether there is a subcontract, involvement of certain types of research such as xenotransplantation, embryonic stem cell, phase I clinical trials, review and approval of other university committees such as recombinant DNA, radioisotopes, etc

MSU does not enter into IAAs for research that is determined to be exempt. See HRPP Manual 8-1, Exemptions, for more information about the requirements for exempt research.

This policy does not apply to MSU’s reliance on external independent (commercial) IRBs. For policies and procedures for reliance on an external independent (commercial) IRB, see the Human Research Protection Program (HRPP) Manual 1-4 “Reliance on External Independent (Commercial) Institutional Review Boards.”

The Final U.S. National Institutes of Health (NIH) Policy on Use of a Single IRB for Multi-Site Research establishes the expectation that all domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB). See HRPP Manual 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health) for additional requirements when use of a single IRB is required.

When entering into an IAA where MSU will rely on another institution’s IRB, MSU will evaluate whether the External (non-MSU) IRB has equivalent human subject protections in place. Such evaluation will include consideration of whether the External IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). If the institution is not accredited, evaluation of the Human Research Protection Program (HRPP) will occur to assure equivalent human subject protections are in place, considering AAHRPP accreditation standards. Evaluation may include review of written materials such as policies, procedures, application forms, and other relevant documents and meetings or interactions with the HRPP staff. Supplemental appendixes or additional review considerations specific to the MSU research project may be requested to be incorporated into the IRB review of the research study. If the institution is found to have equivalent protections, an agreement may be entered into between MSU and the institution.

MSU may also agree to enter into an IAA to oversee the management and review of certain research studies. Except for special circumstances, the MSU IRB does not enter into an IAA unless there is MSU involvement in the study that would also require MSU IRB review (i.e., MSU engagement).

MSU and the institution can define the scope of the IAA. Scope of the agreements will vary by agreement and may be limited (e.g., single project, sub-set of projects, certain types of research) or may be institution-wide (e.g., not limited to named projects or conditions). See the HRPP website for a current list of institutions with which MSU has institution-wide agreements. The scope of the IAA will be situation specific and will be determined based on discussions between the institutions. Such discussions may include consideration of the amount of research conducted between the two institutions, the likelihood of future research projects between the institutions, etc.

A fully executed agreement is required before MSU may rely on the External IRB for review or before an institution may rely on a MSU IRB. MSU has become a participating institution with the SMART IRB, the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance platform, by signing onto the SMART Master Common Reciprocal Institutional Review Board Authorization Agreement. The SMART IRB agreement may be used when appropriate.

The IRB staff will evaluate research studies to determine if an IAA is applicable, needed, or should be entered into. The PI is encouraged to contact the IRB Reliance Coordinator if they are unsure if an IAA is applicable. The PI is also encouraged to contact the other institution’s IRB for their reliance requirements. To request review by a External IRB, the HRP-513 - Template - External IRB Request is completed and submitted with the Click New Study submission. This request must be submitted for all instances where MSU may rely upon an External IRB, including when there is an institution-wide agreement already in place. Such requests must be reviewed and an Acknowledgement letter issued before any human subject research begins.

This policy and procedure supersedes those previously drafted.

Approved By:  Vice President of Research and Graduate Studies, 7-20-2011. Revision 1 approved by Assistant VP Regulatory Affairs on 12-11-2015. Revision 2 approved by Senior VP for Research and Innovation on 1-18-2019.

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