Donor Management Research
Consensus Conference
September 16-17, 2013
Sheraton Pentagon City
Donor Management Research Consensus Conference
AGENDA
Meeting Intent:
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To align separate efforts in the Donation and Transplantation Community of Practice (DTCP) addressing issues
in donor management research
To leverage these efforts in a unified process to optimize donor management within agreed upon parameters
respecting donors, families, and recipients
To encourage a defined and agreed upon network within the DTCP to share information and improvement
regarding the donor management research continuum from the donor setting to the recipient’s post-transplant
care
Meeting Objectives:
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Identify challenges that the community feels need to be addressed related to donor management research.
Reach consensus on donor and family authorization/consent processes.
Identify issues related to informed consent in the recipient and reach consensus as to appropriate procedure.
Recognize and address informed 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.
Guiding Principles:
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Respect for the donor, recipient, and all families will be paramount.
No processes in the donor management research continuum will be a threat to public trust in the system.
No donor management study will be supported if it has 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.
1
Monday, September 16, 2013
1:00 – 1:15 PM
Welcome & Overview
Peter L. Abt, MD
Co-Chair, 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
Co-Chair, Vice President, Clinical Services, Gift of Life Donor Program
David Nelson, MD
Co-Chair, Chief, Heart Transplant Medicine Division, Nazih Zuhdi Transplant Institute
INTEGRIS Baptist Medical Center
1:15 – 1:30 PM
Framing, Need for Consensus in Community
John C. Magee, MD
Professor, Department of Surgery, Transplantation, University of Michigan, Organ
Donation and Transplantation Alliance Board Member
1:30 – 2:15 PM
Perspectives on Human Subjects Issues in Donor Management Research
Procurement – AOPO
Transplant – ASTS/AST
Research Design – ODRC
Federal Human Subjects Oversight – OHRP
2:15 – 2:45 PM
Learning from Other Experiences
NIH
FDA
2:45 – 3:00 PM
Break
3:00 – 4:00 PM
Overview of Domains and Framing Questions – Panel of Domain Leads
1. Donation Setting Issues
- Authorization in the donor setting
- Donor hospital review and approval of research protocol
- Communication about research and sequelae
2. Oversight
- IRB/Data Safety Monitoring Board
- Defining risk
- Allocation and distribution implications
- Communication
- National oversight
2
3. Transplant Center Issues
- Communication about protocol relative to candidates/recipients
- Recipient consent, two-tiered (listing and acceptance)
- Standardized recipient follow-up metrics
- Minimizing negative outcome and financial impact on transplant centers
4:00 – 4:30 PM
Table Discussion
Assure that the full and most relevant scope of each issue is identified. Attendees will
provide input for content in Donation Setting, Oversight, and Transplant Center Issues
domains.
4:30 – 5:15 PM
Full Group Report Out of Table Discussion
Speaker for each table will summarize discussion, which will inform discussion in Day 2
breakout sessions.
5:15 – 5:30 PM
Wrap-Up & Adjourn
Co-Chairs
Tuesday, September 17, 2013
8:00 – 8:15 AM
Recap of Day 1 – Facilitator
8:15 – 11:00 AM
Breakout Groups – Domain Leads
Participants will discuss questions in their assigned domains.
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Donation Setting Issues– Domain Lead
Oversight – Domain Lead
Transplant Center Issues – Domain Lead
Donation Setting Issues group will 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.
Oversight group will 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.
Transplant Center Issues group will 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.
3
11:00 – Noon
National Research Oversight
What are the pros and cons of a national oversight body?
What processes would facilitate research in the complex arena of donor management and
organ allocation while protecting human subjects across the spectrum?
12:00 – 1:00 PM
Lunch (on your own)
1:00 – 2:30 PM
Group Report Out
Each group will present consensus/solutions found for the framing questions and identify
necessary action steps.
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Donation Setting Issues – Domain Lead
Oversight – Domain Lead
Transplant Center Issues – Domain Lead
2:30 – 3:00 PM
Reflections from OHRP
Elyse Summers, JD
Director, Division of Education and Development, Office for Human Research Protections
3:00 – 3:30 PM
Next Steps – Meeting Chairs
3:30 PM
Adjourn
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