Fundamental new opportunities for understanding and improving human health are being developed as a result of new information management capabilities. Data previously collected during clinical inpatient and outpatient care has tremendous retrospective and prospective value for planning studies, studying usage patterns, understanding comparative effectiveness, matching phenotypic and genotypic results, matching phenotypic and therapeutic approaches and much more. Our data systems are improving rapidly. Our ability to store and track medical, encounter, genome, pharmaceutic and other information and associate this information to outcomes is being created through the UF Academic Health Center Integrated Data Repository.
A related opportunity exists to develop processes by which patients under our care can consent to be contacted about opportunities to participate in research or to have tissue collected on their behalf used for research purposes. The UF Consent2Share initiative was launched to develop, pilot and expand such consent processes at UF Health.
Goals and Objectives
- Develop appropriate consent language by which a clinical patient can consent to have a portion of the tissue collected as part of their clinical care placed in a biorepository for subsequent use in research studies, and/or consent to allow researchers to contact patients if they meet entrance criteria for future studies.
- Develop and put in common practice appropriate consent processes by which patients can provide and remove informed consent for research contact and use of tissue as they wish.
- Develop and implement information systems by which consent status can be tracked and associated with research contact and use of tissue.
This effort is led by Peter Iafrate, Chairman of the UF Institutional Review Board, and Gigi Lipori, Senior Director, Planning and Analysis, Shands HealthCare. Project participation includes CTSI Biorepository, CTSI Regulatory Knowledge and Research Support, Internal Medicine & Medical Specialties, UF Health Compliance and Legal, UF Health Information Technology, UF Privacy Office and others. For additional information, please contact Peter Iafrate at firstname.lastname@example.org.
Project sponsors include Dr. David Nelson, Dr. Michael Conlon, and Dr. Michael Clare-Salzler.
Informed consent is at the center of research participation. Tissue resulting from clinical care at UF Health hospitals and clinics can be made more easily available to researchers when there is clear, appropriate, informed consent, with status tracked for any future use or change in consent status.
This project creates a fundamental new capability in the clinical and translational research environment at the University of Florida. Previously, tissue collected during clinical care was inaccessible to research. Creating a consent process with tracking will create new opportunities for our ability to study and improve human health.
This process is being piloted in the Internal Medicine & Medical Specialties clinic at Shands Medical Plaza in Gainesville, Fla., during the fall of 2012. It will expand to more patients in 2013.
- On the Same Page, Dec. 12, 2012: Our Continuously Learning Health System