Identifying patient study participants
Recruitment Support
Identifying potential research subjects is a key part of a successful research enterprise. We are the link to help our clients reach as many eligible participants as possible. The IDR team uses our Consent2Share program and our patient lists to support recruitment for clinical studies, connecting research teams to patients meeting unique study criteria.
In several UF Health Physicians outpatient clinical practices, patients are asked to participate in the Consent2Share patient recruitment program.
Consent2Share asks patients at the point of care whether they would be willing to be re-contacted in the future about participating in research studies. To date, over 65,000 UF Health patients have agreed to participate. Because of this, the IDR team can provide researchers with contact info for patients who meet their unique study criteria, and researchers can independently recruit patients via mail, phone, and email. In addition, the IDR team can provide regular patient lists to researchers looking to recruit patients in outpatient practices in coordination with the patients’ care teams. The IDR team has processes for securely sharing lists of eligible patients, such as those scheduled for an upcoming physician visit or those recently discharged. In some cases, these lists are deliverable on a daily basis. New sites for recruitment continue to be added to the program.
When patients agree to participate in the program, they are consenting to:
- A periodic review of their medical information to determine if they might qualify for a future research study. If they do, then,
- They agree to be contacted sometime in the future to be asked if they are interested in participating in a UF Health research study. However, when they are contacted at a future date, the patient can decide whether they wish to participate.
Resources
UF Consent2Share Information Sheet and FAQs
Background
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 Health Integrated Data Repository (IDR). A related opportunity exists to develop processes by which patients under our care can consent to be contacted about opportunities to participate in research. The UF Consent2Share initiative was launched to develop, pilot and expand such a consent process at UF Health.
Goals and Objectives
- Develop and put in common practice appropriate consent processes by which patients can provide and remove informed consent for research contact as they wish.
- Develop and implement information systems by which consent status can be tracked and associated with research contact.
- Provide patients with an easy way to agree to be notified about future research studies for which they may be qualified.
Team
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, iafrate@ufl.edu. Project sponsors include Dr. David Nelson, Dr. Michael Conlon, and Dr. Michael Clare-Salzler.
Impact
This project creates a fundamental new capability in the clinical and translational research environment at the University of Florida. Informed consent is at the center of research participation. The UF Consent2Share project is developing a large group of potential research participants who have consented to be re-contacted for future research studies. Having this consent data available in combination with the other data in the IDR will make it much faster and more feasible to identify potentially willing research participants who meet the study criteria. Creating a consent process with tracking will create new opportunities for our ability to study and improve human health.
Timeline
This process is ongoing in the Internal Medicine and Medical Specialties practices at UF Health Medical Plaza, Gainesville, Fla. Expansion of the project is expected when an electronic consent and signature process can be put in place.