Use of Single IRB

October 13, 2019

For researchers who plan to submit a grant proposal to the U.S. National Institutes of Health (NIH), it is important to be aware of the NIH requirement for use of a Single Institutional Review Board (IRB) for multi-site human subject research. When a study involves multiple domestic sites conducting the same non-exempt human research protocol, a Single IRB is required. This means that rather than each site obtaining separate IRB approvals from each of their institutions, the sites must rely upon a Single IRB that has been designated and agreed to by the sites.

Selection of the Single IRB occurs at the time of grant proposal submission, not at Just in Time. NIH requires a Single IRB plan with the grant proposal that includes information such as selection of the Single IRB, indication that all identified participating sites have agreed to rely on the proposed Single IRB, and communication plans. At Michigan State University (MSU), the MSU Human Research Protection Program (HRPP) must agree to selection of the Single IRB. The requirement to use a Single IRB will extend to other federally funded human research in January 2020.

To help identify sponsored human research projects that may require use of a Single IRB, a new question has been added Kuali Coeus Standard Proposal Questionnaire in Proposal Development that asks: “Does this research proposal include domestic external sites that will be engaged in conducting non-exempt human research?” This question was added to help determine if a project will require the use of a Single IRB. For NIH proposals, we highly recommend that researchers contact the MSU HRPP early and as soon as possible, as the decision of which IRB should serve as IRB of record may require discussions between the institutions’ IRBs.

More information: http://hrpp.msu.edu/help/reliance/nih-sirb.html