Welcome! Donor Management Research Consensus Conference

1. Welcome!Donor Management Research Consensus Conference September 16-17, 2013 Arlington, VA Note: This document is not intended as final recommendation.

2. Conference 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

3. Planning Process • Early discussions: ACOT, OHRP, content experts • Planning Committee members represent: ACOT, AST, ASTS, AOPO, ODRC, Alliance, OHRP • ACOT represented by: Alexandra Glazier, JD, MPH David Gerber, MD

4. 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

5. 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, PhD University of California San Francisco

6. 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

7. Creating Consensus in the Community John C. Magee, MD Professor, Department of Surgery, Transplantation, University of Michigan, Organ Donation and Transplantation Alliance Board Member

8. Donor Management Research • Disclosures • Board Member, ODTA • Councilor-at-Large, ASTS • Advisory Board Member, Gift of Life Michigan • Funding from HRSA DoT and CMS • Not currently involved in any donor based research

9. Donor Management Research • Simplistic Starting Point

10. Donor Management Research • Research involves risks and benefits to all • Not doing research has more risk

11. SOCIETY IRB(s) DSMB(s) Researcher Institution Researcher Recipient Care Team Donor Care Team Recipient Donor Donor Institution Recipient Institution Recipient Family Donor Family OPO Transplant Center OPTN Professional Societies: AST, ASTS, AOPO, ODRC, ODTA, SCCM, … Transplant Oversight: HRSA, OPTN, CMS, … Research Oversight: HRSA, OSHRP, FDA, Funding Agencies, …

12. Donor Management Research • Clear Communication is critical • Information must be • Authoritative • Available • Appropriate level • Transparent • Communication key during planning, implementation, conduct, analysis, and sharing of research results

13. Donor Management Research • Need effective mechanism to engage members of the Donation and Transplantation Community of Practice • Diverse group of leaders

14. Intent of the Conference • 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

15. 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

16. 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

17. Conference Overview Intersections: Research vetting & policies Consistency in authorization practice Data, HIPAA, State UAGAs Submission of protocol for review Local & national IRB alignment 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

18. Donor Management Research • Multiple Stakeholders • All have responsibilities • Patients and society • Organizations • Financial • Regulatory and oversight mechanisms • Self contained single OPO research plan limiting • Broader organ sharing is only increasing

19. Donor Management Research • We are in transplantation because we want to help people • We are in transplantation because we enjoy multidisciplinary teams

20. Donor Management Research • Responsibility for communication • PI and Co-investigators • OPO • Recipient teams • OPTN • Responsible for transmission and comprehension

21. Donor Management Research • Terminology matters • Donor Authorization/Consent • Consent for “hi risk donor” • Informed Consent for procedure • Informed Consent for research • Context matters • Research process needs appropriate framing

22. Donor Management Research • The risks and benefits need to be responsibly conveyed and understood • Complex message and complex interaction • It is our responsibility to know the truth • One person can de-rail the work of hundreds

23. Donor Management Research • Will add costs that need to be acknowledged • Will add “inefficiency” • Research carries Risks and Benefits • Not doing research carries Risks and Benefits

24. Donor Management Research • Tremendous progress • DMRCC Planning Committee on June 10th • Need for follow-up from this conference

25. Donor Management Research • To make progress, we need … • Thoughtful and unified consensus of the community • Continued support and leadership of HRSA • Active engagement of other agencies central to research (e.g. FDA, OHRP, NIH, etc) • Rationale for ODTA

26. Donor Management Research • Donors are a national resource and effective management has required a national system • Donor Management Research will require national infrastructure as well • Guidance/facilitation from federal agencies • ?Central IRB / review board

27. Perspectives on Human Subjects Issues in Donor Management Research AOPO – Tim Taber, MD ASTS/AST – Kim Olthoff, MD and Roslyn Mannon, MD ODRC Dan Lebovitz, MD OHRP – Freda E. Yoder, MA

28. AOPO Tim Taber • Medical Director: Indiana University Kidney and Pancreas Transplant Programs • Chief Medical Officer: Indiana Organ Procurement Organization (IOPO) • Medical Advisor: Association of Organ Procurement Organizations (AOPO)

29. AOPO • AOPO - Non-profit organization representing 58 federally designated organ procurement organizations (OPOs) • OPOs • By federal law, they are the only organizations that can perform the life-saving mission of recovering organs from deceased donors for transplantation • Clinical services, donor family services, hospital development, public education

30. AOPO • OPO’s • Non-profit • Federally funded / federally regulated • Regulation • OTPD • Patient mix • SCD, ECD, DCD . . . • Organs provided for research • Observed/expected donation rate • OPTN and CMS oversight & audited • AOPO Accreditation (93% Accredited)

31. AOPO • Allocation • Initiated by local OPO – multiple mechanisms & processes by which the offer is made and accepted (e.g. directly by OPO coordinator, through UNOS, TX surgeon, TX coordinator, third party) • Research potentially complicates • Delays / refusal of organ • OTPD • Direct loss of organ • Secondary loss of organ for transplantation due to delay of procurement • Financial and regulatory incentive to maximize the gift of donation

32. AOPO • Hospital Development • Liaison / facilitator between the donor and transplantation • Work with local physicians/staff p-procurement • Education (e.g. declaration of death, donor management, management for preservation of donation option) • Engagement - Keep these physicians as advocates for donation • Explain outcomes

33. AOPO • Clinical Staff • Very difficult / emotional occupation • Time intensive • Research – “unfunded mandate” • Patient X 8 • Maximize the gift • Medical Director • Oversight of donor issues • Important figure in research oversight within their OPO • Medical Directors’ Council - AOPO • ODRC

34. AOPO • Donor Family Services If the family is well cared for before, during and after donation, they will more likely continue to support the mission of saving lives through donation. • Healing begins with donation • Number of lives saved/healed is important to the donor family • Care and support of the family • F/U to donor family • Hospitals will also recognize the quality of care given to the donor and family

35. AOPO • OPO • Unique position • Facilitator between the donor family and transplant professionals • Regulatory / economic incentives (non-profit world) • OTPD • Economic and time disincentives to participate in research (short term) • Humanistic • Maximize the gift • Creating a time-intensive burden

36. AOPO • OPO’s • We all know the OPO mandate • Committed to optimizing organ donation • Understand and embrace the need for continuous quality improvement • Donation is a fragile process • Donor families, hospitals, transplant physicians • Avoid loss of donor / organ / support through being too conservative / overzealous • Change must come through the OPO structure • Communication!

37. ASTS PerspectiveKim M. Olthoff, MDASTS Immediate Past President September 16, 2013 Arlington, VA

38. ASTS Mission Science Professional Development Training and Education Organ Donation Advocacy

39. ASTS efforts in donor research SEP 2013 DMRC conference Discussions with Key Stakeholders

40. ASTS Approach

41. ASTS Approach • These issues extend well beyond the reasonable reach of individual investigators and require a larger body to first define and then tackle. • The transplant community must demand leadership and vision from professional organizations and governmental agencies to set the research agenda, to give it the highest priority, and, most importantly, to dedicate the necessary resources to ensure a vigorous engagement of the community. • Research to improve donor and organ quality is an absolute imperative as it offers the greatest promise to relieve suffering and prolong the lives of our patients. S. Feng, AJT 2010; 10: 1155-1162

42. ASTS Approach

43. Donor Management Research Intervention • Complex area with numerous consent, ethical, regulatory issues • Involves numerous stakeholders • Persistent significant barriers exist • Requires major resources and infrastructure

44. Our Vision for Change • Need a catalyst, a springboard • Partner with transplant community • Stakeholder engagement • Mechanistic framework • Regulatory change • Process re-engineering • Paradigm shift

45. Your Challenge • Bring all the stakeholders and regulatory government agencies to the table • Commit personnel time, effort, thought to create a mechanistic framework

46. Your Challenge • Define goals going forward • Determining oversight and communication • Need to provide specifics • Use the momentum of this conference to keep moving forward

47. Donor Management Research Consensus Conference:The American Society of Transplantation Perspective Roslyn B. Mannon, M.D. Immediate Past-President, AST

48. Background • The current limited supply of donor organs is a continued pressure on the field. Thousands of lives continue to be lost due to this inequity. • Innovative investigation into donor management and organ preservation could increase the number and quality of organs in this supply. The AST recognizes the need for this innovation and creativity, which has long been part of the field of transplantation.

49. AST Supports ASTS Position • ASTS invitation January 4, 2012 to review the Research and Innovation in Organ Donation document. • March 5, 2012: AST strongly supported and endorsed this document

50. Specific Comments • A common goal: a national framework to produce evidence-based donor management that results in more and better transplantable organs. • “We are concerned about the potential for contention, especially about consent, to stall deliberations and untrack participants..” • “We recommend that the forum’s primary mission is to facilitate, not build barriers to, donor research, and that this will necessitate compromise on some issues.”