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 (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).

This section does not apply to MSU’s reliance on external independent (commercial) IRBs or use of the National Cancer Institute (NCI) Central Institutional Review Board (CIRB). 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.” For policies and procedures for use of the NCI CIRB, see the Human Research Protection Program (HRPP) Manual 1-5 “Use of the National Cancer Institute Central Institutional Review Board.”

Single IRB

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.

Projects seeking funding from a federal department or agency that has adopted the Revised Common Rule for the protection of human subjects in research are now required to identify and use a Single IRB when certain criteria are met. Any institution located in the United States that is engaged in cooperative non-exempt research must rely upon approval by a Single IRB for that portion of the research that is conducted in the United States, with limited exceptions. See HRPP Manual 2-2-G “Revised Common Rule Single IRB Requirement” for additional requirements when use of a single IRB is required.

The Revised Common Rule Single IRB requirement is in addition to the U.S. NIH grant policy requirement for Single IRB review. If a study is conducted or supported by NIH, both the NIH Single IRB Policy for Multi-site Research and the Revised Common Rule Single IRB requirement for cooperative research would apply. A Single IRB must be used if it was required under either the NIH Single IRB Policy for Multi-site Research or the Revised Common Rule Single IRB requirement.

SMART IRB

MSU is a participating institution with the SMART IRB, the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance platform, and has signed onto the SMART Master Common Reciprocal Institutional Review Board Authorization Agreement. The SMART IRB agreement may be used when appropriate. When the SMART IRB agreement is used, a Letter of Acknowledgement (LOA) must be in place between the institutions, or the reliance must be documented via the SMART IRB online reliance system.

Considerations

MSU may enter into reliance through an IAA or the SMART IRB 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 reliance through an IAA or the SMART IRB. Each IAA or reliance under the SMART IRB is situation and context dependent.

Considerations of whether to enter into reliance through an IAA or the SMART IRB may include:

  • Engagement of the institutions
  • 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.
  • Complexity
  • Expertise
  • Number and types of sites (academic, hospital, other)
  • Location of research
  • Risk level
  • Resources
  • Requirement for use of a single IRB

These considerations apply both when MSU is asked to serve as the reviewing IRB or when MSU is asked to rely upon an External (non-MSU) IRB.

MSU does not typically enter into IAAs or reliance under the SMART IRB:

  • For research that is determined to be exempt. See HRPP Manual 8-1 “Exemptions” for more information about the requirements for exempt research.
  • To serve as the Reviewing IRB when MSU is a subcontractee for a Small Business Innovation Research (SBIR) / Small Business Technology Transfer (STTR) award.
  • Unless there is MSU involvement in the study that would also require MSU IRB review (i.e., MSU engagement).

When determining whether to enter into reliance through an IAA or the SMART IRB 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, MSU may rely upon non-accredited IRBs for a portion of the research, but must take reasonable steps, based on the risks posed by the research, to ensure participants in the research are adequately protected. For minimal risk research, this may involve obtaining an assurance that the reviewing IRB will comply with applicable ethical standards and regulations (e.g., obtain assurance, ask for confirmation that the institution has completed its own internal quality review process). For greater than minimal risk research, or if the relying organization is required to rely on an organization with significant regulatory issues, the relying organization may consider more extensive oversight (e.g., review of IRB minutes or IRB records related to the study, review of relevant policies and procedures, serve as a consultant for the study, conduct routine site visits, observe a portion of the meeting where the study is discussed) . When more extensive review is considered, it should be reasonable and flexible, and the organizations should work together to develop innovative approaches to work collaboratively to ensure human participants are protected. Use of the SMART IRB agreement may be used to demonstrate the institution’s commitment to the protection of human subjects.

Scope

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 study, sub-set of studies, certain types of research) or may be institution-wide (e.g., not limited to named studies 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 studies between the institutions, etc.

Unless otherwise agreed upon between the reviewing and relying institutions, the Reviewing IRB is responsible for initial and continuing review (when required) of the non-exempt human research study, including review of sound research design, potential noncompliance (e.g. complaints, protocol deviations, results of audits that may involve IRB noncompliance) including determining whether each allegation of noncompliance has a basis in fact and if so, whether each incident of noncompliance is serious or continuing, and review of unanticipated problems involving risks to subjects or others.

Unless otherwise agreed upon between the reviewing and relying institutions, the Reviewing IRB is responsible for reporting serious or continuing non-compliance, unanticipated problems involving risks to participants or others, and suspensions or terminations of IRB approval.

Alternate arrangements may be agreed upon between the institutions in the IAA or SMART LOA, but also may be made through other means such as local context forms.

Review

When MSU is relying upon an External IRB, the HRPP Director reviews any new IAAs that do not use the SMART IRB agreement.

When the HRPP Director is reviewing the IAA, they may consult with MSU legal counsel and/or MSU risk management when needed. Any requested changes will be provided to the other institution, and meetings may be scheduled to discuss changes. Once both institutions come to agreement on the language, the agreement is provided to the MSU IO’s office by the HRPP office.

When MSU is serving as the reviewing IRB, any new IAAs will use the MSU study specific template IAA, unless the SMART IRB agreement is used. If the relying institution requests significant changes to the IAA or SMART LOA, the HRPP Director will review and determine if the changes are appropriate. Once both institutions come to agreement on the language, the agreement is provided to the MSU IO’s office by the HRPP office.

Termination

Should termination of the IAA or reliance under the SMART IRB occur and non-exempt human research is still ongoing, the institutions will work together to assure concurrent transfer by the Reviewing IRB of the study to an appropriate IRB to assure continued oversight of the study until closure.

Study Specific Reliance

The IRB staff will evaluate research studies to determine if IRB reliance is applicable, needed, or should be entered into. The MSU Principal Investigator (PI) is encouraged to contact the IRB reliance coordinator if they are unsure if reliance is applicable. The MSU PI is also encouraged to have their external (non-MSU) collaborators contact their IRBs for their institution’s reliance requirements.

A request to use an External IRB must be submitted to the MSU Human Research Protection Program (HRPP) office and a reliance acknowledgement letter issued before any research and/or clinical investigation with human subjects is conducted by MSU individuals. 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. See HRPP Manual 8-11 “External IRB Submissions.”

To request that another institution rely upon MSU for IRB review, a request must be submitted through a new study or modification submission in the MSU IRB online system. See HRPP Manual 8-12 “MSU as IRB of Record for Other Institutions.”

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. Revision 3 approved by Assistant VP Regulatory Affairs on 12-11-2021.

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