Dartmouth College/CPHS/OSP Guidance on Budgeting for an External IRB for Multi-site Studies
Considerations and resources for proposed projects that involve multiple sites for non-exempt human subjects research.
● When a multi-site study is being proposed, the Principal Investigator or study
team should communicate with the IRB office (CPHS or Dartmouth Health) early in the
proposal preparation process to determine whether an independent IRB will be needed.
● Independent IRBs charge fees which can and should be incorporated into your budget. OSP and CPHS can help identify resources. See guidance below on budgeting and obtaining quotes from an Independent IRB.
● Multiple sites can involve additional effort in terms of coordination of data, IRB approvals and reliance agreements and associated documentation. There are likely to be staffing needs that should be incorporated into your budget.
● Consider requirements to report in clinical.trials.gov. Please see frequently asked questions.
● Contact OSP or CPHS with questions on responses and documentation for the grant application
Proposal considerations for an external or single IRB
For proposals involving multiple sites conducting human research studies, please review information on the CPHS website and the OSP guidance below concerning the need for a single IRB and budgeting for IRB costs, as applicable.
For CPHS studies:
When a multi-site study needing a single IRB is identified at the proposal stage for projects that do NOT involve Dartmouth Health, the PI should contact CPHS (CPHS@dartmouth.edu) at the proposal stage to initiate a preliminary discussion and determination of whether CPHS or an external or commercial IRB will serve as the IRB.
For Dartmouth Health studies:
When a multi-site study needing a single IRB is identified at the proposal stage for projects that involve Dartmouth Health, the PI should contact the DH Office of Research Oversight (email@example.com) at the proposal stage to initiate a preliminary discussion and determination of whether the DH IRB can be the IRB of record, or an external IRB will be needed.
Budgeting for an external IRB sIRB Fees
Independent/commercial and some academic IRBs may charge fees for the initial review and ongoing IRB oversight activities. Always verify any IRB fees with the external IRB for proposal /award budgeting purposes. It is recommended that you request quotes from several independent IRBs if you are contemplating or have been directed to use an independent IRB. Currently, CPHS has agreements with several independent IRBs including BRANY.
NIH allows IRB fees as a direct cost on the proposal/award budget. Other federal and non-federal sponsors may or may not allow these fees as a direct cost. Please consult with OSP and/or verify with your project’s sponsor how to budget/account for the IRB fee (if any).
A single IRB-of-Record (sIRB) may charge for their services on a cooperative or multi-site, non-exempt human research project. Estimated expenses are calculated on a case-by-case basis and, if allowed by project sponsor, listed as a direct cost in the budget for a funding proposal and award.
Sponsor Resources for Budgeting for an IRB:
Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research, Notice Number: NOT-OD-16-109.
A good general resource for proposals submitted to NIH that involve human subjects can be found at this link: NIH Human Subjects.