Advancing Donor Management Research Processes September 16-17, 2013

1. Advancing Donor ManagementResearch ProcessesSeptember 16-17, 2013 Teresa M. Beigay, DrPH Director, Special Donation Initiatives Division of Transplantation Health Resources and Services Administration U.S. Department of Health and Human Services

2. Why Conduct Donor Intervention Research? • Produce knowledge • Increase safety • Improve decision making • Inform and test new approaches • Solve problems • MOVE FORWARD!

3. Current State of Donor Management Research

4. Current State of Donor Management Research

5. Donor Management Research Issues Human subjects concerns in donor management research: • Consent/Authorization • IRB processes • Recipient follow-up

6. ACOT Why address these challenges? Need for examination of issue and consensus National Societies Donor Management Task Force “Real World” Experience Discussion in Community

7. Public perception is critical

8. Public perception is critical

9. Consensus Conference • HRSA Cooperative Agreement (form of grant) • Recipient: Organ Donation and Transplantation Alliance The project described was supported by Grant Number UD2HS22186 from the Division of Transplantation, Health Resources and Services Administration, U.S. Department of Health and Human Services.

10. Intent • Align separate efforts in the community addressing issues in donor management research • Leverage these efforts in a unified process to foster examination of donor management methods that can optimize organ yield and function • Encourage a defined and agreed upon network to share information and improvement regarding the donor management research continuum from the donor setting to the recipient’s post-transplant care

11. Objectives • Identify challenges r/t donor management research • Understand requirements for donor and family authorization/consent • Identify issues related to consent in the recipient and reach consensus as to appropriate procedure • Recognize and address consent issues regarding the effect of research on organs that are not receiving the direct impact of the research protocol • Promote donor management research and consent processes that are satisfactory to donor hospitals, donation community, transplant community, and the public

12. Guiding Principles • Respect for the donor, recipient, and all families will be paramount • Processes in the donor management research continuum will not threaten public trust in the system • Donor management studies must not have a high risk of causing a transplantable organ to become unsuitable for transplantation • The donor management research process should not alter the allocation required by policy

13. Planning Process • Early discussions: ACOT, OHRP, content experts • Planning Committee members represent DTCP partner organizations conducting foundational work: ACOT, AST, ASTS, AOPO, ODRC, Alliance, OHRP

14. Co-Chairs Peter L. Abt, MD Associate Professor of Surgery at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia Richard D. Hasz, BS, MFS, CPTC Vice President, Clinical Services, Gift of Life Donor Program David Nelson, MD Chief, Heart Transplant Medicine Division, Nazih Zuhdi Transplant Institute INTEGRIS Baptist Medical Center

15. Intersections: Research vetting & policies Consistency in authorization practice Data, HIPAA, State UAGAs Submission of protocol for review Local & national IRB alignment Consensus Topics Overview Oversight Workgroup: National oversight Access to protocol Uniform study approval process Adequacy of monitoring Donor-Focused Issues Workgroup: Donor authorization for clinical research Registry donors Donor family practices COMMUNICATION & TRANSPARENCY • Intersections: • Process of posting protocol for access • Collateral effects on other organs • Recipient & concurrent research projects • Maximizing organs available for transplant Intersections: Clarification of levels of risk for review Recipient/Physician informing process Follow-up data burden Transplant Center Workgroup: Recipient consent Levels of risk Knowledge about research protocol Implications for acceptance & allocation

16. Workgroups Donor-Focused Issues Address issues related to conducting research in the donor management setting including consent, family discussion, challenges related to IRB submission/approval, and communication with relevant entities about research protocol effect on organs  Workgroup Lead: Alexandra K. Glazier, JD, MPH New England Organ Bank

17. Key Topics: Donor-Focused Issues • Donor authorization • Research authorization • Duties to family • Privacy issues

18. Workgroups Oversight Address IRB and Data Safety Monitoring Board issues, definition of risk for recipients, allocation and distribution implications for organs affected by research interventions, communication about risk, and possibilities related to a national oversight body Workgroup Lead: Sandy Feng, MD University of California San Francisco

19. Key Topics: Oversight • National review body • Scientific merit and human subjects • Data and safety monitoring • Uniform protocol and approval processes • Access to protocol • Clarification of risk

20. Workgroups Transplant Center Issues Address communication about research interventions and possible impact on transplanted organs and outcomes, recipient consent at listing and acceptance, standardized recipient follow-up metrics, and minimizing negative outcome and financial impact on transplant centers Workgroup Lead: Jeffrey Punch, MD University of Michigan

21. Key Topics: Transplant Center Issues • Access to protocol • Collateral effects on other organs • Recipient consent – listing and acceptance • Involvement in other research protocols • Follow-up data burden • Implications for other organs

22. Contact Information Teresa Beigay, DrPH Director, Special Donation Initiatives 301-443-5464 tbeigay@hrsa.gov