MSU HRPP Manual Section 1-4

Reliance on External Independent (Commercial) Institutional Review Boards

Michigan State University (MSU) may rely on an external independent (commercial) Institutional Review Board (IRB) to oversee the management and review of certain studies. When entering into such a relationship, MSU will evaluate whether the independent IRB has equivalent human subject protections in place. Such evaluation will include consideration of whether the independent IRB is accredited. To assure accreditation standards are fulfilled, MSU will typically only rely on independent IRBs that have accreditation from the Association for the Accreditation of Human Research Protection Programs. 

An Institutional Authorization Agreement (IAA) is used to document MSU's reliance on the external independent 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). 

A fully executed IAA or reliance agreement between MSU and the independent IRB is required before MSU may rely on an independent IRB for review. Please visit the MSU Human Research Protection Program (HRPP) website for a current list of independent IRBs with which MSU has an executed agreement for IRB services. Agreements may also be executed on a project specific basis. 

Use of an Independent IRB

A research study may be considered for review by an independent IRB based on factors such as:

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

Typically only new research studies will be eligible for independent IRB review. No transfer of research studies already submitted to a MSU IRB will typically be allowed. 

If the study involves, including but not limited to, the following types of research, additional consideration will be given to whether reliance upon an independent IRB is appropriate.

  • Xenotransplantation
  • Embryonic stem cells
  • Phase I clinical trials
  • Review and approval by other committees – e.g., studies that involve recombinant DNA, radioisotopes, biorepositories

MSU may also require review by an independent IRB when the expertise needed to review the study is not available on the MSU IRBs and use of additional expertise from on or off campus, as described in HRPP Manual 5-4 “Additional Expertise,” is not feasible. In addition, MSU may require review by an independent IRB when a study requires use of a single IRB under the Final NIH Policy on Use of a Single IRB for Multi-Site Research or the Revised Common Rule Single IRB requirement. See HRPP Manual 2-2-F-iii “Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health)” and HRPP Manual 2-2-G “Revised Common Rule Single IRB Requirement” for requirements.

 MSU retains final authority to determine whether a research study can be submitted to an independent IRB for IRB review. 


See HRPP Manual 8-11 “External IRB Submission,” for the process. 


A finalized contract is required before submitting to an independent (commercial) IRB. 


Communication between the independent IRB and the MSU IRB staff and reporting notifications will occur as defined by the agreement and in compliance with HRPP Manual 4-8 “Reporting Policy.” 


The PI is responsible for assuring that the independent IRB fees are paid for by the sponsor. If the sponsor fails to pay the IRB fees within the required time frame, the PI’s department will be responsible for the fees.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 7-19-2011. Revision 1 approved by the VP Research & Graduate Studies on 4-13-2016. 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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