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 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).

Applicant/Offerors are expected to include a plan for use of an sIRB in the applications/proposals they submit to NIH. NIH’s acceptance of submitted plan will be incorporated as a term and condition in Notice of Award or in Contract Award.

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

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 F&A 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.

Related HRPP Manual Sections

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