Guidance on Single IRB (sIRB) Consultation for Multi-Institutional Studies
This resource provides detailed guidance on the requirements and processes for consulting with the Human Subjects Division (HSD) for single Institutional Review Board (IRB) studies involving multiple institutions, federally-funded research, and new NIH funding. It includes information on when a sIRB is applicable, who can serve as the sIRB, funding agencies' policies, considerations for UW IRB involvement, costs, and consulting procedures with HSD. Researchers are urged to consult early in the proposal preparation process and follow specific steps outlined for a smooth and compliant approval process.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
Required Consultation with HSD for Single IRB (sIRB) Studies Adrienne Meyer, Assistant Director of Reliances Human Subjects Division MRAM 5/9/2024
When is it applicable? The human subjects research is: non-exempt, and federally-funded or supported, and engages multiple domestic institutions, and newly approved by an IRB after January 2020, ornew NIH funding for an existing project (includes competing renewals). Federal Single IRB (sIRB) Requireme nt What is the requirement? All engaged sites must rely on a sIRB instead of conducting their own IRB review.
Who should be the sIRB? Unless specified in the FOA or the study is within an existing network with a designated IRB (e.g. NCI cIRB), there is no default IRB that must or should serve as the sIRB. The IRB of the primary awardee is not required to serve as the sIRB. Any registered domestic IRB may serve as the sIRB, including commercial IRBs. Funding Agency Policies What information do funders need? NIH: Only requires that the name of the selected sIRB be provided at JIT. AHRQ: Requires a single IRB plan with several elements as part of proposal. Other funders: Officially silent. In practice, may request confirmation at JIT that sIRB review will take place. Budget considerations, e.g. IRB review fees.
When will UW IRB agree to serve as sIRB? In general: UW IRB can often, but not always, agree to serve as the sIRB when UW is the direct awardee or has a significant leadership role. UW IRB typically does not serve as sIRB when sub-awardee, but can make exceptions. UW HSD Policy Are there costs? Possibly. UW IRB does charge for some studies, e.g. large number of engaged institutions. If UW IRB cannot be sIRB, may need to seek review from an IRB that might charge. PIs may need to budget for additional resources (e.g. FTE) to support sIRB review. UW PIs must therefore consult with HSD before submitting proposals to funders if they wish to use UW IRB as the sIRB. HSD cannot guarantee UW IRB review for any multi-institutional research for which it has not been consulted.
Consulting with HSD Consult early in the proposal preparation process! At least a few weeks before internal deadlines. PI or team provide basic study information via email at hsdrely@uw.edu. Draft materials ok. HSD Reliance Team reviews materials. May request a meeting with PI for complicated research. HSD will confirm willingness and provide a letter of support, costs estimates (for larger studies) to be included in budget, and advice on additional FTE PIs may need to support sIRB review.
More information When UW IRB can serve as sIRB: https://www.washington.edu/research/hsd/single-irb/uw-irb-as-a- single-irb/ How to request a consultation/letter of support: https://www.washington.edu/research/hsd/single-irb/uw-lead- coordinating-site/letters-support-single-irb/ Other considerations for single IRB review: https://www.washington.edu/research/hsd/single-irb/uw-lead- coordinating-site/
