Plan Ahead for NIH Grant Submissions Involving Multiple Research Sites

Effective September 25, all grant submissions to the National Institutes of Health (NIH) that propose multi-site human subject research must include a plan for using a single Institutional Review Board (sIRB) to review and approve the research conducted at all sites. Plan ahead to ensure your study meets the new requirements, which are part of the NIH Single Institutional Review Board policy for multi-site research, and be aware of the added nuances this policy introduces, such as:

• allowing adequate time, effort and resources to implement Reliance and/or lRB Authorization Agreements with each site
• including IRB review costs in the budget
• budget justification (see below for link to scenarios documents)
• oversight of non-UR research sites (e.g., site training, communications, and monitoring)

To ensure adequate selection of a single IRB, budgeting, and planning, all study teams are required to meet with Tiffany Gommel, RSRB director, and Kelley O’Donoghue, associate VP for human subject research, prior to submission of any NIH grants involving multi-site human subject research. To aid study teams in planning, the Office for Human Subject Protection presented a seminar on preparing these, which you can watch online.

Additional resources include:

• Scenarios illustrating the use of direct and indirect costs for single IRB review under this policy, available here.
• Copies of the slides presented during the OHSP seminar on the policy (presented 10/4/2016) and a video recording of the presentation, available on the OHSP website.

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This article first appeared in the University of Rochester’s Research Connections newsletter as part of a monthly series to help principal investigators understand their role in ensuring that human subject protection requirements are met in their studies.

Michael Hazard | 4/25/2017