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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4 Research Approval, Implementation, and Oversight: Ensuring Quality and Trust
4 Research Approval, Implementation, and Oversight: Ensuring Quality and Trust
Pages 115-142
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From page 115... ...
Moreover, oversight and monitoring are needed to ensure adherence to the relevant ethical, l egal, and regulatory policies and thus to promote public trust. This chapter outlines a framework for centrally administered oversight of deceased organ donor intervention research, concentrating on its essential functions.
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This chapter provides the committee's recommendations for extensive, independent, transparent, and ethics-based oversight and management of organ donor intervention research. The entire edifice of organ donation and transplantation is held together by bonds of trust among the public, prospective donors, family members of deceased donors, transplant candidates, transplant recipients, transplant centers, donor hospitals, and organ procurement organizations (OPOs)
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In 2014–2015 organ donation and transplantation professionals serving on the Donor Intervention Research Expert Panel (DIREP, see Chapter 1 for more information) concluded that an area of research as complex as
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Organ donor intervention research involves three different parties as participants in the research -- donors, target organ recipients, and nontarget 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. For deceased organ donors, their families, and their surrogate decision makers, the focus is on fulfilling these people's decisions regarding organ donation and honoring their gift of life for other individuals.
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DONOR RESEARCH OVERSIGHT COMMITTEE The committee envisions D-ROC as a centrally administered standing committee. As part of its charter, D-ROC should be empowered to work with stakeholders to prioritize, review, implement, and track research p rotocols as well as to develop and disseminate information about organ donor intervention research.
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. The committee adapted these goals for a system for D-ROC's support of donor intervention research as follows: • Ensure coordination and cooperation among the functionally diverse components: All members of the organ donation and transplanta tion community should be represented, including community mem bers, donor families, transplant recipients, OPOs, transplant centers, d onor hospitals, federal regulatory agencies, and industry.
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"Improve standardization of tools and procedures for trial design, data cap ture, data sharing, and administrative functions to minimize duplication of effort, and to facilitate development of a shared infrastructure to support an integrated national cancer clinical trials network." 4. "Improve operational efficiency by increasing the rate of patient accrual and reducing operational barriers so that trials can be initiated and executed in a timely, cost-effective manner" (NCI, 2005, p.
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Review and Prioritize Donor Intervention Proposals One of the major responsibilities of D-ROC would be to perform the initial review of all proposals for organ donor intervention research for C ORE RESPONSIBILITIES OF THE Box 4-2 DONOR RESEARCH OVERSIGHT COMMITTEE • Review and prioritize donor intervention proposals • Assess and monitor the impact of organ donor intervention research on organ allocation and distribution • Coordinate and facilitate clinical and research informatics and promote communications • Promote effective trial design • Maintain liaisons with key external groups
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The criteria developed by D-ROC to differentiate QI and research in organ donor inter vention studies and the mechanisms that D-ROC uses to implement and enforce those criteria will need to place utmost emphasis on ensuring the safety of transplant recipients (target organ recipients and non-target organ recipients) and upholding the public's trust and confidence throughout the organ donation and transplantation process.
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are also helpful. A concern of the committee is that investigators may use QI as a mechanism for avoiding the more time- and resource-intensive efforts required to adhere to human research protections.
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An early priority of D-ROC could be to develop the criteria by which it will assess and prioritize new protocols for donor intervention research. Criteria will be needed in order to limit the negative effects of competition on the ability of researchers to recruit and successfully enroll donor organs and transplant candidates in studies.
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, it will also be important to consider a study's potential impact on the allocation of organs within the national system and on the morbidity and mortality of waitlist transplant candidates as well as its possible effects on transplant outcomes for all organs, including non-target organs, that are exposed to the research intervention. Donor intervention research protocols could threaten fairness and e quity in organ distribution in a variety of ways, as suggested by the following examples.
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Coordinate and Facilitate Clinical and Research Informatics and Promote Communications A primary role for D-ROC will be ensuring that the necessary infor matics and communications infrastructure is in place and actively implemented to facilitate and promote organ donor intervention research. The goals of data sharing include facilitating discovery science while avoiding duplication and ensuring reproducibility; increasing the understanding of human disease; improving the design, efficiency, and quality of clinical t rials; and managing the cost and administrative burden of clinical research (IOM, 2015)
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Ideally, the registry would be a useful tool for the prioritization of new proposals -- for example, as an aid to identify studies that might compete or place stress on overlapping resources. Data management tools and data sharing Coordinated data management tools will also be critical to the success of organ donor intervention research in several ways.
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The combined data of all OPOs would be a powerful source with which to guide innovation and support the development of novel strategies for organ donor intervention research. Thus, another focus for D-ROC's informatics could be to develop a pan-OPO donor management database that connects with existing relevant data sources.
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are constructed to encourage and not penalize organizations that participate in organ donor intervention research. Conditions of participation are policies and regulations designated by CMS to identify and maintain high-quality effective donation and transplantation programs (see Box 4-3)
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Local IRB oversight -- with the challenges of inconsistent amendment requirements and the near-certain guarantee of these studies being conducted across many transplant centers -- would likely severely limit the feasibility of donor intervention research. Taking these two things together, the committee concluded that a single IRB for all of organ donor intervention research is necessary to ensure adequate human subjects protections under the conditions in which this research will be performed.
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. A single IRB would offer the advantages of developing and maintaining core expertise in organ donor intervention research.
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for multi-site research to establish the expecta tion that a single IRB (sIRB) of record will be used in the ethical review of non exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.
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The Common Rule sets some minimum requirements for IRB composition and delineates the IRB's responsibility in the review of research.4 IRBs are required to include at least five members with "varying backgrounds to promote complete and adequate review of research activities." IRBs shall also be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender and cultural backgrounds and sensitivity to such issues as community atti tudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.5 For the single IRB on organ donor intervention research, expertise would be needed in organ donation and transplantation, relevant medical and scientific disciplines, ethics, and law, and it would require members who bring both donor and recipient perspectives to the board. DSMBs DSMBs are independent committees that oversee the conduct of clinical trials.
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STRUCTURE AND OPERATIONS FOR CENTRALIZED MANAGEMENT OF ORGAN DONOR INTERVENTION RESEARCH The centralized management of organ donor intervention research will require the involvement and commitment of the organ donation and transplantation community. The committee explored several options for the management structure that could best get this endeavor off the ground and running.
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The committee believes that it is critical to the success of organ donor intervention research that all donor intervention research studies should be reviewed by a single IRB that has the appropriate scientific, ethical and regulatory expertise. As previously discussed, the committee recognizes that the IRB function could be done by (1)
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the analysis and dissemination of results and archiving in a retrievable catalog. D-ROC, the single IRB, and the DSMB for the specific study would work together to oversee the implementation and dissemination of donor intervention research, which is critically needed to improve the lives of individuals through improving the quality and quantity of donated organs.
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SUMMARY AND RECOMMENDATIONS In order to effectively enhance the quality and increase the quantity of donated organs for transplantation, research oversight will be needed to approve well-designed organ donor intervention protocols. To promote feasibility while maintaining the same protections that would hold in other research realms, the committee recommends an organizational structure to oversee deceased organ donor intervention research planning, approval, implementation, and reporting.
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GOAL 6: Promote transparency regarding organ donor intervention r esearch and enable the implementation, tracking, and analysis of organ donor intervention research to improve transplantation outcomes. 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.
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2015. Letter to Division of Transplantation, Health Resources & Services Administration from the Donor Intervention Research Expert Panel (DIREP)
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2005. Report of the Clinical Trials Working Group of the National Cancer Advisory Board: Restructuring the National Cancer Clinical Trials Enterprise.
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