MSU HRPP Manual Section 2-2-F-iii
Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health)
The Final 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) (NOT-OD-16-094). The NIH sIRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards. The NIH sIRB policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow the NIH sIRB policy.
An authorization agreement must be in place between the sIRB and the participating site(s). The Authorization Agreement, which is also called a reliance agreement, is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating site relying on the sIRB. See HRPP Manual Sections 1-3, Use of Institutional Authorization Agreements and 1-4, Reliance on External Independent (Commercial) Institutional Review Boards.
Selection of the sIRB
When a NIH proposal may involve a sIRB, the MSU Principal Investigator contacts the MSU Human Research Protection Program (HRPP) to identify the sIRB. When an MSU Institutional Review Board (IRB) will be identified as the sIRB, the MSU HRPP must agree upon the selection of MSU as the sIRB. When MSU will be involved as a participating site, the MSU HRPP must still be contacted regarding the reliance upon another institution as the sIRB.
When MSU is the primary awardee, selection of the sIRB will be dependent upon factors such as:
- Complexity of the proposed study
- Expertise
- Number and types of sites (academic, hospital, other)
- Location of research
- Risk level
- Resources
Awardees
Awardees are responsible for ensuring that authorization agreements are in place; copies of authorization agreements and other necessary documentation should be maintained to document compliance with the NIH sIRB policy, as needed. As appropriate, awardees are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established. Awardees may delegate the tasks associated with these responsibilities.
Participating Sites
All sites participating in a multi-site study are expected to rely on an sIRB to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46. Participating sites are responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB. Participating sites must communicate relevant information necessary for the sIRB to consider local context issues and state/local regulatory requirements during its deliberations. Participating sites are expected to rely on the sIRB to satisfy the regulatory requirements relevant to the ethical review. Although IRB ethical review at a participating site would be counter to the intent and goal of the NIH sIRB policy, the policy does not prohibit any participating site from duplicating the sIRB. However, if this approach is taken, NIH funds may not be used to pay for the cost of the duplicate review.
sIRB
The sIRB is responsible for conducting the ethical review of NIH-funded multi-site studies for participating sites. The sIRB will be expected to carry out the regulatory requirements as specified under the HHS regulations at 45 CFR Part 46. In reviewing multi-site research protocols, the sIRB may serve as a Privacy Board, as applicable, to fulfill the requirements of the HIPAA Privacy Rule for use or disclosure of protected health information for research purposes. The sIRB will collaborate with the awardee to establish a mechanism for communication between the sIRB and the participating sites.
Genomic Data Sharing (GDS)
The NIH sIRB policy does not apply to IRB review of the investigator’s proposal for data submission under the NIH GDS policy, as required for the Institutional Certification, because this type of IRB review does not fall under the IRB review requirements of 45 CFR 46. Even though the NIH sIRB policy does not apply, the institution submitting the data may wish to consult with the relevant NIH Institute and Center Genomic Program Administrator to determine the most appropriate way to submit the Institutional Certification (i.e., single-site vs. multi-site Institutional Certification), which includes the IRB review of the proposal for data submission.
The relying and reviewing institutions will work together on a project specific basis to regarding Institutional Certification under the GDS policy.
Costs
When MSU serves as the sIRB, researchers cannot include direct costs to support the administrative tasks of supporting a sIRB in the budget.
When an independent (commercial) IRB serves as the sIRB, the fees charged by independent IRBs may be charged as a direct cost when they are serving as the single IRB. Independent IRBs, which are not affiliated with a research institution, are neither included under another institution’s Facilities and Administrative (F&A) cost rate agreement nor do they have Federally-negotiated indirect cost rate agreements of their own.
When another institution’s IRB serves as the sIRB, that institution’s requirements related to direct costs to support administrative tasks must be followed.
This policy and procedure supersedes those previously drafted.
Approved By: Vice President of Research and Graduate Studies, 3-21-2018. Revision 1 approved by Assistant VP Regulatory Affairs on 11-27-2021.