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Donor Management Research Consensus Conference

links image David P Nelson, MD
HFTXM Council Links Communications Liaison
Chief, Heart Transplant Medicine Division
INTEGRIS Nazih Zuhdi Transplant Institute
Oklahoma City, OK, USA

The Health Resources and Services Administration (HRSA) and the Organ Donation and Transplantation Alliance (ODTA) convened a national consensus conference on donor management research in Arlington, Virginia, September 16-17. I had the privilege of being one of the conference co-chairs, along with Peter Abt, an abdominal surgeon from the University of Pennsylvania, and Richard Hasz, Vice President, Clinical Services, Gift of Life donor program. Peter was lead author of a recent American Journal of Transplantation (AJT) article identifying the need for a national infrastructure to facilitate and oversee donor-related research. The article grew out of a white paper from the American Society of Transplant Surgeons (ASTS) exploring the themes that dominated the consensus conference. The White Paper received significant input from stakeholders who later were represented on the consensus conference planning committee. Planning committee membership included the Advisory Committee on Organ Transplantation (ACOT), the American Society of Transplantation (AST), ASTS, the Association of Organ Procurement Organizations (AOPO), the Organ Donor Research Consortium (ODRC), ODTA, and the Office for Human Research Protections (OHRP).

Three workgroups were formed dedicated to donor-focused issues, oversight, and transplant center issues. The donor-focused group addressed consent/authorization, donor IRB issues, and other OPO-related matters. Productivity of this group was greatly enhanced by its chair, Alexandra Glazier, J.D., M.P.H., who is vice president and general counsel of the New England Organ Bank. The oversight group was so named because it explored the concept of a national Institutional Review Board (IRB) and was chaired by Sandy Feng, abdominal surgeon from UCSF, who was one of Peter Abt's co-authors on the AJT article. The transplant center group focused on recipient consent and the financial impact on transplant centers. It was chaired by Jeff Punch, an abdominal surgeon who is the chief of transplantation at the University of Michigan.

Three key issues that were shared by the oversight and transplant center groups were:

  1. Effect of donor research on allocation;
  2. Communication of study details to transplant teams;
  3. Monitoring the outcome of recipients of target and non-target organs from an investigational donor.

The oversight group evolved the concept of a national IRB into consideration of 3 oversight bodies:

  1. A Scientific Review Board to assess the scientific merit of projects, ensure adequate protection of non-study recipients, and consider national research priorities;
  2. A national IRB that would function in a traditional IRB role and would consider effect on stakeholders, equity, and impact on non-studied organs;
  3. A Data and Safety Monitoring Board (DSMB) that would function in the usual role of patient protection from avoidable risk and also ensuring scientific and ethical merit of the research. It is anticipated the DSMB would be guided by the OHRP, FDA, and funding agencies.

The transplant center group determined that the national review process should grade risk, determine consent requirement based on risk, and have the power to reject protocols. Availability of research protocol information to transplant centers was considered paramount, and one communication paradigm discussed included the following:

  1. Communication of Board-approved studies to transplanters via UNOS' mailing list;
  2. Web-based "clearing house" of study information;
  3. Abstracted protocol version on DonorNet organ offers;
  4. 24/7 PI contact availability;
  5. Serious adverse event data transparency;
  6. Communication of study notices.

Two examples of unresolved topics at the conference were:

  1. How does a program with a recipient enrolled in the study reconcile that study with an organ offered from a donor who is also enrolled in a study?
  2. Can an OPO insist on initiating the research protocol if it has not already done so when the center has accepted an organ offer but declines research? It may sound straightforward that UNOS's allocation policy should trump a Board-approved investigation, but there was real concern at the conference that this would have a serious adverse effect on donor management research.

None of the concepts reported above represent final conclusions or recommendations of the conference. Proceedings of each workgroup were recorded by a transcriptionist, and ODTA staff and Planning Committee members are waiting to review the transcriptionists' records before discussing a report. The Planning Committee will also be meeting post conference to discuss the next step in developing the ideas generated at the Consensus Conference.

Opening speakers of the meeting included ASTS past president Kim Olthoff and AST past president Roz Mannon.

The guiding principles for the Consensus Conference and the national infrastructure that it seeks to promote were:

Disclosure Statement: The author has no conflicts of interest to report.

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