Opportunities for Organ Donor Intervention Research Saving Lives by Improving the Quality and Quantity of Organs for Transplantation (2017) / Chapter Skim
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Yet, almost all transplantation research to date has focused on transplant recipients and on ways to improve transplantation processes and post- transplant health outcomes rather than on how to enhance the quality and increase the quantity of organs that can be recovered from deceased donors and then successfully transplanted. Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols)
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The supply of organs available for transplantation is affected by several factors including the number of potential organ donors and the public's willingness to donate organs. Additionally, every year a number of of donor organs are not transplanted (see Figure S-2)
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For these reasons, a group of organizations came forward to sponsor a study by the National Academies of Sciences, Engineering, and Medicine (the National Academies) on deceased organ donor intervention research: American Association for the Study of Liver Diseases, American Society of Transplant Surgeons, American Society of Transplantation, Asso ciation of Organ Procurement Organizations, Gift of Life Donor Program, Health Resources & Services Administration, Laura and John Arnold Foun dation, National Institutes of Health (National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Diseases; National Institute of Diabetes and Digestive and Kidney Diseases)
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Specifically, the report will delineate the issues pertinent to organ donor inter vention research and make recommendations that take into account public and professional trust in the organ donation process and ethical conduct of organ donor intervention research with attention to • Ethical principles relevant to the conduct of interventional research on deceased donors and deceased donor grafts • Responsibilities to donors and donor families • Roles and responsibilities of donor hospitals • Responsibilities to patients awaiting organs • Responsibilities to transplant recipients of organs from donor intervention studies • Delineation of ethical and regulatory oversight considerations specific to the safety of patients impacted by the study interventions (recipients of organs that were the target of the research intervention, and recipients of organs that were exposed to a research intervention but were not the targeted organs under study) • Oversight and monitoring of organ donor intervention research, including addressing issues relevant to the type of review and oversight needed for o Evaluation of the scientific validity and potential efficacy of interven tions in deceased donors to mitigate organ injury o Ethical framework for reviewing and evaluating conduct of clinical trials involving donor interventions o Evaluation of the impact on organ distribution with respect to waitlist morbidity and mortality o Review of the impact on transplant outcomes for all organs exposed to the intervention • Impact on the distribution of research organs within the national system, and the implications for patients, health systems, investigators, donation professionals, organ procurement organizations, transplant professionals, and transplant centers After examining the complexities and challenges surrounding organ donor intervention research, the committee identified six goals to guide its work (see Box S-2)
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. • Promote informed consent for transplant recipients' participation in organ donor intervention research in a manner that is compatible with the logisti cal complexities of organ transplantation.
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Organ donor intervention research therefore involves three different parties as potential participants in the research -- organ donors, target organ recipients, and non-target organ recipients -- with each deserving specific considerations, all of which are needed to ensure that a respectful, fair, and trustworthy donation and transplantation system is in place in the United States. Deceased organ donor intervention research offers an opportunity to gain the knowledge needed to maximize the benefits of the gifts of donated organs.
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donation and transplantation system, including confidence and reliance that the organizations and health professionals involved will fully and fairly communicate the facts and the nuances of the complex donation and transplantation processes, is essential. However, questions remain as to what the transplantation community and society as a whole should do to maintain that trust, as opposed to what merely must be done to be in legal and regulatory compliance.
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Additionally, there are no requirements for what information about organ donation options, including research, should be provided to individuals who are contemplating registering to be an organ donor. Messaging and communication strategies regarding organ donor intervention research need to be developed and thoroughly tested to meet the health literacy needs across the general public.
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for organ donor intervention research. The committee considered other options that would require revisions to the Common Rule, but concluded that the proposed two-stage process should stay within current human research subjects protection regulations and that this process offers the best opportunities to • fully inform transplant candidates about organ donor intervention research at a time when they can consider the risks, benefits, and alternatives in depth; • provide a thorough informed consent process for participation in research; and • allow the process to be conducted as expeditiously as possible by only doing the more in-depth informed consent processes with those candidates who have expressed an interest in receiving a research organ.
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10 OPPORTUNITIES FOR ORGAN DONOR INTERVENTION RESEARCH FIGURE S-3 Research authorization and consent decision points. NOTE: IRB = institutional review board.
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Model state legislation should be developed to facilitate this merger. GOAL 3: Clarify legal guidance on organ donation for the purpose of research followed by transplantation (organ donor intervention research)
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Therefore, the com mittee recommends that the Organ Procurement and Transplantation Network and transplant community should engage in public consulta tion and determine whether to amend the UAGA and state laws to Specify that when the decedent has authorized transplantation this • denotes that the gift is authorized for research followed by trans plantation, or Specify research followed by transplantation as an additional pur • pose of donation that would be added to the list of choices for the donor. GOAL 4: Promote informed consent for transplant recipients' par ticipation in organ donor intervention research in a manner that is compatible with the logistical complexities of organ transplantation.
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Moreover, oversight and monitoring are needed to ensure adherence to the relevant ethical, legal, and regulatory policies and thus to promote public trust. Several of the unique challenges to conducting organ donor intervention research illustrate the rationale for a more centralized research system: • Brevity of the timeframe: Time is extremely limited due to con cerns about the viability of the organs.
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As part of its charter, D-ROC should be empowered to work with stakeholders to prioritize, review, implement, and track research protocols as well as to develop and disseminate information about organ donor intervention research. Core responsibilities of D-ROC should include • Reviewing and prioritizing donor intervention proposals • Assessing and monitoring the impact of organ donor intervention research on organ allocation and distribution • Coordinating and facilitating clinical and research informatics and promoting communications • Promoting effective trial design • Maintaining liaisons with key external groups The standard model of local IRB oversight for multi-site studies, in which each research institution must review and approve the research
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A single IRB for organ donor intervention research could oversee h uman research protections and ensure that processes are carried out in accord with relevant regulatory and policy requirements and guidance, particularly the Common Rule. Also, a single IRB would offer the advantages of developing and maintaining core expertise in organ donor intervention research.
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RECOMMENDATION 6: The Donor-Research Oversight Commit tee, in collaboration with the Organ Procurement and Transplantation Network, the National Institutes of Health, the Health Resources & Services Administration, professional associations, organ procurement organizations, patient advocacy organizations, and transplant centers and programs should create organ donor intervention research elec tronic tools to ensure that organ donor intervention studies are listed on a publicly available website, that clinicians have the information to provide to potential recipients, that researchers can conduct studies effectively, that research outcomes are tracked and monitored appro priately, and that research outcomes are widely available in aggregate. These tools could use or link to new or current relevant databases but should, at the minimum, provide the following functions: Access to real-time study information used to maintain study con • tinuity and monitor key elements of active studies necessary for project management; Additional data fields in UNet and other relevant databases to • allow for the designation of the organ as a research organ and to note other relevant information about the research protocol for clinical use and in the tracking of research outcomes; • online registry of pending, approved, active, closed, and discon An tinued organ donor intervention research studies; and • to research outcome data, abstracts, and scientific publications.
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