Fall NIH funding deadlines are here! Proposals for human subjects research which will conduct the same protocol at multiple institutions must include a plan for compliance with the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
The policy requires a single IRB (sIRB) to provide review for all sites. If you are working on a grant application which is subject to the policy, please contact Ryan Ballard at the Human Subjects Office (HSO) at 317-278-7812 or email@example.com immediately to discuss the application requirements.
Identifying the single IRB
Identifying the sIRB (the IRB that will provide review for all sites) is an important part of the sIRB process. The NIH policy does not define which IRB should serve as the sIRB, and the decision should be made on a study-by-study basis after discussion with HSO and the participating sites, depending on the specific needs of the study. HSO staff will work with you to identify the most appropriate sIRB and assure that the identified sIRB is qualified to review the research.
Budgeting for single IRB
The sIRB process raises additional budgeting concerns:
- IRB fees - Serving as the single IRB requires additional resources for IRB offices. As such, the policy allows the single IRB to charge direct costs for their review. Once you’ve identified the single IRB for your proposal, be sure to ask about IRB review fees.
- When IU is serving as the reviewing IRB, the budget should include $2,500 for review of each non-IU participating site.
- View the IU IRB Fee Schedule.
- Regulatory - The single IRB process can be extremely complicated for study teams and requires additional resources for regulatory support which should be included in the budget. HSO will talk with you about appropriate levels of regulatory support given the nature and complexity of the proposal. Resources may be available through the Indiana CTSI.
View the IU HRPP Quick Guide on Submitting an Applicable NIH Grant Requiring sIRB for more information.