Consent2Share Linking Cohort Discovery to Consent David R Nelson MD Assistant Vice President for Research Professor of Medicine Director, Clinical and.

Slides:



Advertisements
Similar presentations
CROMS NIDCR Clinical Monitoring
Advertisements

Ask Me Anything American Nurses Training Association.
+ HEALTH INSURANCE: UNDERSTANDING YOUR COVERAGE Navigator Name Blank County Extension UGA Health Navigators.
1 The HIPAA Privacy Rule and Research This presentation will probably involve audience discussion, which will create action items. Use PowerPoint to keep.
AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research Cindy Brach Agency for Healthcare Research and Quality Center for Delivery, Organization,
Centers for Medicare/Medicaid (CMS) Clinical Trials Policy (CTP) Training January 2009, Slide 1 Background: In 2000, Medicare issued a National Coverage.
Health Insurance Portability Accountability Act of 1996 HIPAA for Researchers: IRB Related Issues HSC USC IRB.
 IRB Webinar 11/13/2014.  To recognize how to conduct an adequate informed consent process in adults and children  To learn how to manage the process.
Efficient & Rapid Translation of Dementia Discovery IDND-PBRN Malaz Boustani, MD, MPH Chief Director of Research Indianapolis Discovery Network for Dementia.
Massachusetts: Transforming the Healthcare Economy John D. Halamka MD CIO, Harvard Medical School and Beth Israel Deaconess Medical Center.
Steven R. Cummings, MD Emeritus Professor of Medicine and Epidemiology, UCSF Director, SF Coordinating Center Mytrus, Founder & CEO.
Identification & Distinction of Clinical Trial Participant Charges Bethany Martell Office of Clinical Research Associate Director- Financial Operations.
A Primer on Healthcare Information Exchange John D. Halamka MD CIO, Harvard Medical School and Beth Israel Deaconess Medical Center.
EMRs, EHRs, PHRs, questions and answers
Health Insurance Portability and Accountability Act (HIPAA)
Welcome to the Performance Indicator Data Webinar Hosted by: The Family Institute for Education, Practice & Research The webinar will begin shortly. Thank.
Medicaid Hospital Utilization Review and DRG Audits: Frequently Asked Questions The Department of Medical Assistance Services Division of Program Integrity.
Opportunities for Big Data in Medical Records Mike Conlon, PhD
Clinical Registries Needs and Solutions Dr. Peter Greene, CMIO Diana Gumas, IT Director 1.
Memorial Hermann Healthcare System Clinical Integration & Disease Management Dan Wolterman April 15, 2010.
Human Research Protection Programs 1a: How to Navigate Human Subject Protection Regulations Sponsored by the American Society for Investigative Pathology.
Paula Peyrani, MD Medical/Project Director, HIV Program at the 550 Clinic Assistant Director, Research Design and Development Clinical and Translational.
Research and Development Protocol Submission and Continuing Review Processes Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas.
Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.
NAPHSIS Annual Meeting 2009 Electronic Health Records: Why are they important? Linette T Scott, MD, MPH Deputy Director Health Information and Strategic.
Joint Research & Enterprise Office Training The team, the procedures, the monitor and the Sponsor Lucy H H Parker Clinical Research Governance Manager.
Anticipated FY2016 Appropriations Agency$ Million NIH200 Cancer70 Cohort130 FDA10 Office of the Natl Coord. for Health IT (ONC) 5 TOTAL215 Mission: To.
Method How are data being collected? Data collection is done manually from paper IRB records. Every member of the CTSI Study Registry team is thoroughly.
HUMAN SUBJECTS PROTECTION PROGRAM Office Location: 1350 N. Vine Ave. (one block west of Cherry Ave. & three blocks north of Speedway) PO Box Phone:
Home More Information about I-SPY 2 Participating Cancer Centers Peer Support for I-SPY 2 Participants More Information About Breast Cancer I-SPY 2 Breast.
Using EPR2020 for Clinical Research Diana Gumas, Director of Clinical and Clinical Research IT 1.
An Introduction to the University of Florida Clinical and Translational Science Institute Mike Conlon, PhD COO, UF CTSI The UF CTSI is supported in part.
Consent for Research Study A study using 18 F-Fluoride for prostate cancer patients currently enrolled in Dr. Febbo’s “Genomic Guided Therapy” study A.
Consent for Research Study A study for patients newly diagnosed with advanced glioblastoma (brain cancer): Learning whether a PET scan with F-fluoromisonidazole.
Clinical Research Informatics at the University of Michigan Daniel Clauw M.D. Professor of Medicine, Division of Rheumatology Assistant Dean for Clinical.
Integrated Data Repository Mike Conlon, PhD Associate Director, UF CTSI The UF CTSI is supported in part by NIH awards UL1 TR000064, KL2 TR and TL1.
THE MURDOCK Study: A Rich Data Resource for Biomarker Discovery and Validation Brian D. Bennett 1, Jessica D. Tenenbaum 1, Victoria Christian 1, Melissa.
Health Insurance portability and Accountability Act (HIPAA)‏
Clinical Research and Outcomes Registry Workshop Creating an Informed Consent Form Daniel Ford, MD, MPH Joseph Carrese, MD.
Design of Patient-Centered Care Health IT Patient Advisor involvement in ePHR Design and Outcomes Research Patricia Sodomka, FACHE Senior Vice President,
JENNIFER WATSON, MA NATIONAL INSTITUTE ON AGING, NIH MAY 19, 2016 Healthy Aging & Participation in Research What Older Adults Should Know.
Communicare Presentation v March 2016 NOTE: All screen shots from Communicare indicate PCEHR. Any reference to the PCEHR or the My Health Record.
Responsibilities of Sponsor, Investigator and Monitor
Certificates of Confidentiality:
HIPAA 2017 JHSPH IRB Clarifications and Changes
The Role and Responsibilities of the Clinical Research Coordinator
Research Master ID (RMID)
Responsibilities of Sponsor, Investigator and Monitor
How to Navigate IRB Paperwork.
How to Navigate IRB Paperwork.
Hospice CTI Best Practice.
Amanda L. Do, MPH1,2, Ruby Y. Wan, MS1,2, Robert W
Advisors, Please Complete These Three Registration Steps in Order!
Bozeman Health Clinical Research
Advisors, Please Complete These Three Registration Steps in Order!
Research Master ID (RMID)
Office of Human Subjects Research
How to Navigate IRB Paperwork.
The HIPAA Privacy Rule and Research
EPIC Tools for Clinical Research
Medical Research Funding and Regulation Third Annual Medical Research Summit March 6, 2003 Mary S. McCabe National Institutes of Health.
2019 medical benefit plans University of Nebraska.
How to Navigate IRB Paperwork.
Recruitment Process.
Understanding the Process of Documenting Informed Consent
EPIC Tools for Clinical Research
Advisors, Please Complete These Three Registration Steps in Order!
Epic Tools for Clinical Research
Central IRB Components of ARCADIA
For Service Coordinators
Presentation transcript:

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