Background
As the university’s research portfolio continues to grow, fueled in part by close to 100 distinguished new faculty hired through the UF Preeminence initiative funded by the state legislature in 2013, the university is committed to continuously enhancing the research environment.
In August 2015, Dr. David Nelson, CTSI director and assistant vice president for research, was tapped to lead a UF Human Subject Research Taskforce convened by the UF Office of Research to examine all aspects of processes and corresponding regulations related to human subjects research with a focus on studies involving clinical services. Initially convening on August 31, the taskforce held eight subsequent working sessions along with stakeholder focus groups throughout the fall of 2015.
Goal
Identify opportunities to improve and streamline UF’s human subject research processes
Participants
Stakeholders and experts from the Office of Research, UF Health Research Billing Office, Epic IT staff, UF research teams, and College of Medicine Research Administration and Compliance Office
Issues Identified
The taskforce identified the following issues: information availability and operational efficiency, IRB operations efficiency, administrative burden and organization of resources, and collaborative interactions between research and clinical operations.
Recommendations and Actions
The taskforce made four recommendations to address the issues it identified, leading to the following actions and results as of January 2017:
1. Implement an enterprise-level clinical trial management system.
Actions taken:
- 2016: Informed by peer benchmarking and stakeholder input, CTSI partnered with key units and institutional leadership to develop a three-year plan for implementing OnCore as an enterprise-level clinical research management system and reorganizing UF’s clinical research resources and administration under a new Office of Clinical Research.
- 2017: With Office of Research and College of Medicine support, launched a phased OnCore implementation as part of a new Office of Clinical Research.
2. Improve efficiency and timelines of IRB reviews.
Actions taken:
- 2016:
- Through UF’s Discretionary Policy, extended approval periods from 1 year to 3 years for unfunded minimal risk studies (to date: approved 434 new protocols)
- Created full-time Vice Chair staff position (0.5 IRB-01, 0.5 IRB-02) dedicated to review of expedited submissions with target turn-around time of <3 days
- Finalized and implemented OneFlorida IRB processes as option for NIH single/ central IRB requirement (approved 22 studies as of January 2017)
- Developed IRB turn-around time metrics for transparent reporting to UF and NIH
- 2017:
- UF signed agreement to participate in SMART IRB as option for NIH single/ central IRB requirement
- Launched web-based Quality Improvement Project Registry and Approver to streamline and automate QI approval workflows through an algorithm that notifies users of project approval, incomplete requirements or IRB protocol requirements (informed by visit to Wisconsin CTSA, developed by CTS-IT)
- Under consideration:
- Expand IRB faculty membership
- Closure of under-enrolling studies
- Scientific review separate from IRB (protocol design, feasibility, budget, resources)
3. Implement an HSR “storefront” to operate as a single organizational unit facilitating all phases of human subjects research.
Actions taken:
- 2017: With Office of Research and College of Medicine support, created a new Office of Clinical Research as part of the CTSI, with joint oversight by the Cancer Center.
4. Enhance culture of research in the health system.
Actions taken:
- UF Health participation in OnCore/ Office of Clinical Research governance committees and implementation workgroups
- 4 new UF Health IT research FTEs allocated to help coordinate OnCore/ Office of Clinical Research implementation