The benefit of using the OneFlorida Clinical Research Consortium infrastructure involves the availability of a wide array of research resources, including but not limited to:
- Support to identify eligible patient populations and/or clinical practices
- OneFlorida Data Trust with extensive health care information for cohort discovery, study feasibility, study data collection, and observational studies
- Information technology resources, including a collaborative portal and ResearchACTS software for study management, data collection and point-of-care interventions
- Data analytics warehouse
- A statewide biorepository capability
The OneFlorida partners have all signed agreements to be part of the OneFlorida Institutional Review Board (IRB) to facilitate the review and approval of multisite protocols. Peter Iafrate, PharmD is the Director for the OneFlorida IRB. The OneFlorida IRB was designed to streamline the submission process and facilitate the conduct of pragmatic clinical trials and implementation science studies in multiple sites. Signed agreements are in place with all OneFlorida Partners. The OneFlorida IRB’s expertise and experience with streamlining the approval processes is an asset within our project and nationally and will be used to facilitate study approvals and position OneFlorida very well to participate in any national agreements.
The University of Florida Health Science Center Institutional Review Board (UF-HSC IRB) has substantial experience to provide leadership for the One Florida IRB. In total, the Institutional Review Boards (IRBs) at UF oversee 3,500 research protocols. There are three on-campus IRBs and one contracted IRB. IRB-01, the largest IRB in the UF system, reviews and oversees biomedical research conducted on the Gainesville, Florida campus, for the North Florida/South Georgia Veteran’s Health System (NF/SG VHS), and for all of the hospitals and facilities owned by UF Health. IRB-03 reviews and oversees biomedical research on the Jacksonville, Florida campus. IRB-02 reviews and oversees social and behavioral research on the Gainesville, Florida campus. Several years ago, UF contracted with the Western IRB (WIRB) to offset some of the workload for IRB-01. UF faculty conducting multicenter drug or device protocols sponsored by industry are able to submit their protocols for review by the WIRB. Annually, WIRB reviews an average of 110 protocols a year, allowing the investigators who conduct industry-sponsored protocols to compete nationally due to faster review times.
Seventeen staff members at the three on-campus IRB offices provide investigator education, protocol design consultation as it relates to regulatory considerations, and compliance monitoring. No human subject protections issues have been identified during recent FDA audits, CTSI competitive grant renewal reviews, or AHCA VA licensure accreditation surveys. IRB-01 has had experience serving as the central IRB for the United States’ portion of a 150-site, multinational, 23K-subject research protocol. All IRB-01 new study submissions are made through the electronic myIRB program. The electronic submission program will be implemented in the IRB-02 and -03 offices in the near future. IRB-01 meets twice a month and investigators are encouraged to attend so that changes can be made by the investigator during the meetings to facilitate rapid turnaround time. A robust IRB-01 website is available for investigators, which provides them with all current forms, educational bulletins, required standard language, IRB position papers on common topics, and links to frequently used web sites. IRB-01 also serves as the Privacy Board for UF Gainesville Campus and the NF/SG VHS in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and implementing its regulations.
- For information on how to obtain a myIRB account, click here
- Participant recruitment services, including the Consent2Share process
- Availability of clinical champions to facilitate practice recruitment
- Community practice research facilitators to support study implementation
- Community engagement programs
- Research training and education programs for clinicians, patients and caregivers