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. 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.

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

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. 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 requirements.

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

Process

The Principal Investigator (PI) is required to submit a request to the MSU IRB office before a study can be submitted to the independent IRB. To request review by an independent IRB, the HRP-513 - Template - External IRB Request is completed and submitted with the Click New Study submission. The study submission is assigned a Study number and tracked within the MSU IRB online system.

The MSU HRPP staff will evaluate the submission to determine if the independent IRB may be relied upon as IRB of record. A fee may be charged for each request to use an independent IRB to off-set administrative costs associated with the review process and interactions with the independent IRB. See the HRPP 5-8 “Institutional Review Board Fees” for requirements.

The MSU Institutional Official retains final authority to determine whether MSU may rely upon the independent IRB.

If the independent IRB may be relied upon as the IRB of record for the study, the IRB staff will notify the investigator and the independent IRB as defined by the agreement.  The PI is responsible for completing and submitting the independent IRB application to the independent IRB and providing a copy to the MSU IRB. The signed HRP-513 - Template - External IRB Request that indicates that MSU HRPP approval to use the independent IRB will be provided to the investigator to include with the independent IRB submission.

If the study involves a contract from an external sponsor, the MSU HRPP is also responsible for reviewing the executed contract and the MSU study consent form(s) to assure congruency (e.g. subject injury language). If the contract is not fully executed at the time of the initial request in Click to use an external independent IRB, the fully executed contract must be submitted so the contract and consent review may be conducted. If changes to the consent forms are required as a result of the contract review, revised consent forms will need to be submitted to the independent IRB for approval.

A fully executed Institutional Authorization Agreement must be in place and the reviewing independent IRB must approve MSU’s involvement in the research prior to MSU’s engagement in the research. The HRPP office will send the PI a reliance acknowledgment letter once the agreement has been signed by both institutions and approval for MSU’s involvement has been received. Research and/or clinical investigations involving human subjects that engage MSU cannot begin until the PI receives the MSU HRPP acknowledgement letter and as applicable, the executed contract and consent congruency review has been completed.   

Communication

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.”

Costs

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.

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