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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2 Ethical Framework
2 Ethical Framework
Pages 49-66
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From page 49... ...
. To identify and elucidate the relevant ethical principles for assessing and guiding the policies for and practices of organ donor intervention r esearch -- research that is at the intersection of organ donation and research involving human subjects -- it is useful to examine "current practices, policies, laws, opinion surveys, and cultural and religious traditions as inter reted by the spokespeople for relevant organizations and other p experts (e.g., philosophers, theologians, anthropologists, and sociologists)
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, which is the core federal policy that governs federally funded and much privately funded research involving human subjects in the United States.4 Each of these incorporates and seeks to balance several principles. 1 This white paper does not represent Organ Procurement and Transplantation Network (OPTN)
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With this understanding, determining whether organ donor intervention research can be ethically acceptable under certain circumstances requires close attention to the relevant ethical principles as well as to the applicable legal, regulatory, and policy frameworks that represent, even if imperfectly, attempts to embody those principles. This chapter explicates several relevant ethical principles; the next chapter will delve more deeply into these frameworks.
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Respect for Persons Respect for persons is a central and complex principle both in organ donation and transplantation and in research involving human participants. It includes, but is not reducible to, respect for personal autonomy, which is shorthand for respect for persons' autonomous choices.
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National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979)
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, costs, etc., in evaluating research involving human subjects. This version of beneficence is often identified as the principle of utility, for instance, in setting criteria for the allocation of donated organs, as in the OPTN Ethics Committee's report Ethical Principles in the Allocation of Human Organs (OPTN, 2015)
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but also to evaluate risks in relation to the potential benefits for future o rgan transplant recipients. The evaluative process is even more complicated for the recipients of non-target organs, since organ donor intervention research, by design, does not directly seek to benefit such recipients, and yet they may face some risks.
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Although the phrase "transplant community" has sometimes been limited to including just transplant professionals, transplant recipients, and donor families, it is possible to adopt a broader interpretation that includes the public at large because all members of society are potential organ donors and potential
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Other questions of fairness surface in considering the impact of organ donor intervention research on non-target organs -- that is, organs that may be affected by the research intervention even though they were not the intervention's intended target. For example, even if a particular research intervention targeting a deceased donor's kidneys will probably not have a negative impact on the efficacy or safety of a heart transplanted from the same donor, it may not be possible to completely rule this out.
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Thus, the requirement of validity dictates that for any research involving human subjects to be ethical, it must produce evidence that is sufficiently reliable to guide decision making in research and clinical care. In many bioethical discussions, the concept of validity is implied by beneficence or utility because only valid research can produce benefits.
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In addition, various social factors -- such as unconscious bias, financial interest, or professional incentives that reward only "positive" findings -- can impede proper scientific conduct. In the context of organ donor intervention research, the principle of validity stipulates that, when conducting donor intervention studies, researchers and oversight structures should minimize any factors that introduce validity threats, while encouraging those practices -- including transparency, reporting, and rigorous study design -- that facilitate an accurate understanding of the treatment effect for a donor intervention.
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Clearly a lack of trust or frank distrust can hamper organ donation and transplantation. In public opinion surveys, respondents give several reasons for not registering as organ donors, such as not having thought about organ donation or not wanting to contemplate death (IOM, 2006; HRSA, 2013)
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This suggests that any direct or indirect impact on organ allocation from organ donor intervention research must be carefully evaluated in light of both the standards and the perceptions of fairness in organ distribution. Otherwise public trust may suffer.
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In Chapter 4 the committee proposes a three-part structure for the robust oversight of organ donor intervention research. Finally, not only is trustworthiness a necessary precondition for organ donor intervention research to thrive -- through authorization for organ dona tion and consent to participate in research -- but the research itself must not compromise the trustworthiness of the system of organ donation and transplantation or damage public trust.
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2013. Deceased organ donation consent rates among racial and ethnic minorities and older potential donors.
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2016. Ethics of deceased organ donor recovery.
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1987. Organ transplantation: Issues and recom mendations: Report of the Task Force on Organ Transplantation.
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