Consent2Share Linking Cohort Discovery to Consent David R Nelson MD Assistant Vice President for Research Professor of Medicine Director, Clinical and Translational Science Institute University of Florida Gainesville, USA

Americans are Interested in Clinical Trials I am interested in finding out more about taking part in clinical trials o 62% agree I would take part in a clinical trial if I was asked by someone I trust o 63% agree Taking part in a clinical trial is as valuable to our health care system as giving blood o 67% agree 72% likely to participate in clinical trial if their doctor recommended it to them o 70% of doctors do not talk to patient about medical research opportunities Research!America poll conducted in partnership with Zogby Analytics from May 2013

UF Learning Health System Create, strengthen and integrate the infrastructure required to accelerate discoveries toward better health Link patients with samples and medical/research data o EMR (EPIC) + Integrated Data Repository Biorepository: institutional and centralized, CAP certified Genomics and metabolomics Link researchers to patients and data o Consent2Share (universal consent) o i2b2 cohort discovery Link participants to researchers o StudyConnect (web-based trials portal) o HealthStreet (community engagement) Link populations and community clinicians to researchers o One Florida Clinical Research Consortium UF + UMiami + FSU state-wide network (13.5M lives)

StudyConnect StudyConnect: Web site with > 400 active studies for potential research participants to find opportunities

Consent2Share An effort by UF Health to offer patients the opportunity to consent to be contacted sometime in the future about being part of new research studies at UF Health for which they might qualify

Consent2Share - Process 1.Consent form printed from EPIC, includes patient specific bar code 2.Admission folks hand 2 copies of the consent form to the patient, briefly describe what it entails, provides flier describing program 3.Any straight forward questions are addressed, if someone has more questions, they are referred to either their doctor or the Consent2Share Hotline 4.Patients are given time to review 5.If they return the documents and have checked boxes, initialed and signed; Admission staff then record the patient’s answers in EPIC 6.The signed consent forms are scanned into OnBase, linked to EPIC 7.All newly enrolled subjects information is checked to confirm o That the consent form is “valid” o That the consent form is attached to the correct patient o That the choices made were recorded correctly. 8.Each verified record will be so marked by the individual conducting the QA before that information can be sent to the IDR.

This is the main section, describes what we are asking to collect. Re-contact Hotline The IRB has to review and approve any research being done with their data

Can stop at any time Risks Reminds them what they are agreeing to. Check for signature

Recruitment Language Consent2Share Contacts Dear, My name is and I from. I am contacting you to see if you are interested in participating in a research study. During a past clinic visit, you signed a consent form telling us you were interested in being contacted for future research that you might qualify for. Would you like to hear more about this study?

Consent2Share To Date: ~20,000 subjects have been approached 84% “yes’ rate Research support to date: 4,157 patient names have been released to clinical research projects Tracking outcomes of these contacts and ongoing IRB QA process

UF Integrated Data Repository (IDR) i2b2 DataMart (Limited Data Set) Research Extract (PHI removed) Research Extract (PHI removed) Cohort Discovery Privacy Wall Outpatient EMR Inpatient EMR Billing Claims Labs Integrated Data repository Healthcare Data Extract-Transform-Load Pharmacy

UF Consent2Share – Next Steps Implement electronic form with electronic signature Expand to all clinics Expand to patients under 18 who will require a parent or guardian signature Expand to OneFlorida network o UF, UMiami, and FSU statewide network Cover 13.5M lives

Consent2Share: Conclusion An effort by UF Health to offer patients the opportunity to consent to be contacted sometime in the future about being part of new research studies at UF Health for which they might qualify Identifying potential research participants is a key part to a successful research enterprise and patient engagement More than 20,000 patients enrolled to date: 84% of patients approached agreed to be re- contacted 4,157 patient names linked (with IRB approval) to researchers Enterprise-wide implementation at UF Health underway with electronic consent