50 - Single IRB Consultation: A Solution to Researcher Support at Grant Time

Background: : Our University’s Single IRB Consultation process was developed in response to the single IRB regulatory agency mandates, after the research community expressed a need for documentation that the IRB would be amenable to single IRB oversight prior to submission of the study for IRB review.

Program

Description: : Single IRB mandates presented a logistical challenge to provide documentation of IRB support of a proposal prior to submission of the corresponding study for IRB review. In response to the University research community requests for such documentation, the IRB Office developed a Single IRB Consultation process in 2018.

Study teams submit a consultation request utilizing an intake survey that gathers high level information. IRB analysts evaluate and communicate with study staff if further information is needed. If the proposal meets regulatory and institutional criteria, a Single IRB Letter of Support (sIRB LOS) and fee breakdown for the project is issued. The study team uses this documentation for their grant proposal and, if funded, provides the sIRB LOS in the IRB submission.

The University IRB Reliance Team has tracked consultation requests since FY2018. These data to evaluate research community adoption of the program and insight into University's multi-site portfolio.

Program

Assessment: : The Single IRB Consultation process allows staff assessment of the IRB support of proposed multi-site research and documentation. Further, Single IRB Consultation provides a valuable opportunity for IRB Office staff to review single IRB policies and potential issues concerning reliance and institutional policies with study teams during grant proposal time, rather than discovering problems at the time of IRB review of the study.

The sIRB LOS generated after consultation provides helpful documentation and delivers a single IRB fee schedule when applicable.

Data gathered since implementation of the program shows research community acceptance and growth of the program. FY18-FY24 saw a 400% increase in Single IRB Consultation requests since inception. Fee data has also been gathered.

As to be expected, the implementation of the Single IRB Planning program did give rise to new issues, including;
• Additional administrative burden
• How and whether fees are assessed
• Adding relying sites in later years of the project
• Logistical issues obtaining information in the Single IRB Consultation form
• Study teams unfamiliar with institutional Single IRB policies

Limitations:: Single IRB Consultation was initially implemented in 2018 and has since evolved to better meet research community needs. Process changes have naturally led to instances of inconsistent data gathering, particularly from early days. Further, the University Single IRB Planning process occurs outside of the institution’s electronic IRB review and grant tracking management system, limiting the ability to connect data between the proposal, funding, and IRB review stages of a study.

Discussion: : Single IRB Consultation provides a unique opportunity for study teams to connect with the IRB Office during grant proposal for projects subject to single IRB requirements and solve potential issues prior to IRB review. This opportunity ultimately saves time and energy for the study team and IRB Office and will continue to be relevant as institutions increasingly engage in multi-site and collaborative human subjects research. The University’s Single IRB Consultation program may serve as a helpful template for other institutions facing similar documentation requests from study teams submitting grant proposals for multi-site human subjects research.