Budgeting

The costs for IRB review at a single institution by that institution’s IRB have typically been considered an indirect cost covered under an institution’s Facilities and Administration (F&A) rate (except for industry-initiated-and-sponsored studies). NIH, however, expects that many sIRBs will charge fees to serve as a single IRB and review other sites.

Fees charged by independent IRBs may be charged as a direct cost when they are serving as the sIRB. For more information, see the Cost section of the NIH FAQ and guidance document.  The grant budget must include appropriate provisions for IRB review fees to avoid gaps in coverage.

Review the HRPP Guidance for detailed information regarding Human Subjects Research Budgeting and Billing When Yale Uses External (Commercial) IRB as its IRB of Record for sIRB (multi-site studies).

The Yale Center for Clinical Investigation (YCCI) offers a Research Budget Development service and can help investigators with budgeting. Please contact clinicalresearchresources@yale.edu if you have questions. 

The Yale HRPP is also available to help with obtaining estimates for sIRB review fees. You can request is by filling out the Request for a Letter of Support form.

Multi-site studies will require additional resources to manage across-site communications associated with the use of an sIRB. It is typically a staff member on the research team at the lead site e.g. IRB Liaison. Ensure that you have budgeted appropriately for this additional resource. Yale Center of Clinical Investigation offers Multicenter Trial Management Services. You can direct questions about costs associated with the service to Rhoda Arzoomanian, Associate Director of YCCI and Yale Cancer Center, at 203.785.4816, rhoda.arzoomanian@yale.edu.