MSU HRPP Newsletter

October 14, 2019

Use of Single IRB

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.

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Graduate Student Research Requirements

Are you planning on advising graduate students with their research? There are additional requirements for graduate student research at MSU. Graduate student research refers to research conducted to fulfill graduate degree requirements, i.e., preparation of master’s theses and doctoral dissertations. MSU masters’ theses and Ph.D. dissertations are considered to present generalizable knowledge and require submission to the IRB. Graduate students who conduct human subject research for their thesis/dissertation must provide a copy of their IRB approval letter to the Graduate school with their form for final submission of their thesis/dissertation.

In the case of graduate student research for theses or dissertations, the graduate student’s major advisor or another faculty member should be designated on the IRB application as the principal investigator (PI) and the graduate student should be designated as a co-investigator. Only faculty members and fixed-term faculty employees with the rank of assistant professor or higher may be designated as the PI on the IRB application.

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Transferring Projects to MSU

New to MSU? If you are still engaged in human research (e.g., interacting and/or intervening with subjects, obtaining and/or analyzing private identifiable data about living individuals), this activity needs to be reviewed by an MSU IRB or a reliance agreement must be executed before you can continue your human research activities. This includes continued collaborations with a previous institution, transfer of the activities to MSU, bringing private identifiable data to MSU to analyze, etc. If you have any questions about this process, please contact the IRB office.

Update to Click SmartForm

An enhancement has been added to the Click™ Research Compliance System to help streamline the IRB review process. Several questions on the “HRP-503 – Template – Protocol” form that are frequently updated by researchers have been incorporated into the online Click SmartForm. This change was made because we anticipate that it will be faster for researchers to update the questions on the Click SmartForm rather than having to make the change in the HRP-503 and upload the revised document when submitting a modification that impacts these questions. Incorporating the questions in the Click SmartForm will also allow individuals to use the “View Differences” function in Click to see updates made to these questions.

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