MSU HRPP Manual Section 1-3

1-3, Use of Institutional Authorization Agreements

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

When entering into an IAA where MSU will rely on another institution’s IRB, MSU will evaluate whether the non-MSU IRB has equivalent human subject protections in place. Such evaluation will include consideration of whether the non-MSU 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). 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 and when appropriate, additions to the U.S. Office of Human Research Protection Program Federal Wide Assurance, are required before MSU may rely on the non-MSU IRB for review or before an institution may rely on a MSU IRB.

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 MSU IRB office 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. A “Reliance Application to Request Review by a Non-MSU IRB” may be submitted to request reliance in lieu of an MSU IRB initial application.

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.

Related HRPP Manual Sections

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