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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1 Introduction
1 Introduction
Pages 17-48
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From page 17... ...
Improvements that increase the number and improve the quality of organs that are available for transplantation have been slow to come, with most of them having been developed through innovations in local practice standards. Conducting research in deceased organ donors and on organs that have been recovered from deceased donors has emerged as one means to identify new methods to improve the quality and increase the quantity of organs that can be successfully transplanted and thus, hopefully, expand the number of people receiving an adequately functioning organ.
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Conducting organ donor intervention research presents new challenges to the organ donation and transplantation community by raising ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that the research does not threaten the equitable distribution of a scarce and valuable resource. Furthermore, when a research intervention is administered to a deceased donor prior to organ recovery and the intent is to have an effect on a specific organ such as a kidney (i.e., the target organ)
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Similarly, concerns about a donor's medical and 140,000 Waiting list 120,000 registrations 100,000 Organs transplanted 80,000 60,000 40,000 20,000 0 Year FIGURE 1-1 National transplant waiting list registrations for all organs (as of December 31 each year) and organs transplanted (living and deceased donors)
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* 40,000 Heart 20,000 Heart-Lung Lung 0 Year FIGURE 1-2 National transplant waiting list registrations, by organ, 1987–2016.
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As will be further discussed throughout this report, a number of deceased organ donor intervention studies have already been conducted in which the donor organs were transplanted into organ recipients. However, because of the complexities of the organ donation and transplantation process -- such as those that arise when one donor provides multiple organs that might be transplanted in different transplant centers across the United 1 The committee for this study was not tasked with evaluating research on interventions administered after the transplant candidate has received an organ.
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In response, a group of sponsors -- American Association for the Study of Liver Diseases, American Society of Transplant Surgeons, American Society of Transplantation, Association of Organ Procurement Organizations, Gift of Life Donor Program, Health Resources & Services Administration, Laura and John Arnold Foundation, National Institutes of Health (National Heart, Lung, and Blood Institute; National Instiute of Allergy and Infectious t Diseases; National Institute of Diabetes and Digestive and Kidney Dis eases) , National Kidney Foundation, OneLegacy Foundation, and The Transplantation Society -- funded a National Academies study on organ donor intervention research.
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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 information and input provided by the public and various agencies and organizations.
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. Goal 4: Promote informed consent for transplant recipients' participation in organ donor intervention research in a manner that is compatible with the logistical complexities of organ transplantation.
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b 71.2% 73.7% 72.1% Deceased donors -- neurologic determination of death 7,062 7,304 7,585 Deceased donors -- circulatory determination of death 1,206 1,292 1,494 Total deceased donors 8,268 8,596 9,079 aOPTN/UNOS defines an eligible death as a death that meets established inclusionary criteria (e.g., n eurologic determination of death, age 75 years or less) and without the presence of any exclusion criteria.
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Donor hospitals must abide by the regulations outlined in the Conditions of Participation for Hospitals Regarding Organ, Tissue and Eye Donation, which requires hospitals to promptly report all deaths to their OPO, establishes the OPO as the determiner of medical suitability for donation, and establishes the OPO or trained staff, rather than hospital staff, as the sole requesters of authorization for donation.a Organ Procurement and Transplantation Network (OPTN) : The OPTN is a p ublic– rivate partnership established by the National Organ Transplant Act in 1984 p to bring together the key stakeholders to develop policies and maintain the regula tory framework of the organ donation and transplantation system, with the goal of increasing the availability of organs and the accessibility of transplantations, improv ing health outcomes, and ensuring participant safety (OPTN, 2017a)
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: UNOS is a private, nonprofit organization that since 1986 has contracted with HRSA to operate the OPTN. UNOS is responsible for the day-to-day function of the donation and transplantation system, including the management of the waiting list and organ allocation process, maintenance of the transplantation database, verification that allocation practices are in line with policy guidelines, and encouragement of public education about the importance of organ donation (UNOS, 2015a)
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DSA = donation service area; OPO = organ procurement organization; OPTN = Organ Procurement and Transplantation Network.
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Reprinted with permission from AOPO. SOURCE:3 scope of this report, but, in brief, waiting list criteria were developed with the goal of ensuring that donor organs are used optimally (i.e., in such a way as to minimize death among transplant candidates on the waiting list)
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. As a result, many transplant recipients across multiple transplant centers could become human subjects in a single organ donor intervention research study.
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For this study, the terms used in discussing deceased donation are particularly relevant. Organ donor intervention research occurs after the determination of the donor's death.
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The term "procure" is often used and has a transactional meaning, but more personal terms might be preferred. This report uses the terms "recover" and "procure." As noted throughout this report, one of the major challenges for organ donor intervention research is that an intervention conducted in the deceased donor's body to improve the viability of one organ for transplantation (the target organ)
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. Deceased donors who have characteristics that do not meet the OPTN/UNOS definition of an eligible death can be referred to as expanded-criteria donors.2 Current OPTN policy language defines a death as eligible for donation if the potential donor is age 75 years or less, declared dead by neurologic criteria, has at least one organ that meets organ-specific eligibility definitions, meets all other inclusionary criteria (weight, body mass index, etc.)
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-- all deceased donors are now tested for these diseases prior to organ recovery -- and established a process for obtaining informed consent, a requirement for the use of increased risk organs, from transplant candidates who choose to accept these organ offers (Seem et al., 2013)
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In both types of cases, some of the recovered organs may be useful for research purposes (see Table 1-5) , while others will not be useful for research or any other purpose (e.g., 40,000 All Recovered 35,000 All Transplanted 30,000 25,000 Organs 20,000 15,000 10,000 5,000 0 Year of Recovery and Transplant FIGURE 1-4 Number of deceased donor organs that were recovered compared with the number that were transplanted, 1988–2016.
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TABLE 1-4 Organs from Deceased Donors Discarded in 2016, by Type Organ Number Intestines 8 Hearts 31 Lungs 221 Pancreases 320 Livers 741 Kidneys 3,631 Total discarded 4,952 NOTE: This table does not include the number of organs from authorized donors that were never recovered for transplant. Please see Figures 1-6, 1-7, and 1-8 for more detail.
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Organ donor intervention research presents an opportunity to discover methods to improve organ quality and viability. Figures 1-6, 1-7, and 1-8 provide three examples (left kidney, heart, and liver, respectively)
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Geographic Disparities in Organ Allocation Because of past challenges in transporting organs and maintaining their viability, until recently the organ allocation system has focused primarily on local or regional allocation. However, there has been some discussion about the division of regions for particular organs because some regions have longer waiting lists than others do.
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South Carolina because the supply of organs in the latter states is greater relative to the number of transplant candidates on the waiting lists (Ladin et al., 2017)
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FIGURE 1-8 A summary of authorization, recovered, transplanted, and discard status of deceased donor livers in 2015. NOTE: OR = operating room.
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. QI and research are the two fundamental processes used to improve clinical practice, and organ donor management and transplantation efforts are already enmeshed with innovative procedures, formal research protocols, and the introduction of new interventions with deceased donor organs that fall somewhere on the spectrum between quality improvement and translational research.
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In Chapter 4 the committee discusses this issue further with regard to the oversight of organ donor intervention studies. CHALLENGES AND OPPORTUNITIES IN ORGAN DONOR INTERVENTION RESEARCH 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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2013. Challenges to research and innovation to optimize deceased donor organ quality and quantity.
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2015. etter to Division of Transplantation, Health Resources & Services Administration from L the Donor Intervention Research Expert Panel (DIREP)
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2017. OPTN/SRTR 2015 annual data report: Deceased organ donation.
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2017d. How organ donation works.
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2007. Organ donation after cardiac death.
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2011. Increasing organ donation and transplantation: The U.S.
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