2

Ethical Framework

The ethical principles presented in this chapter support the committee’s working assumptions that organ transplantation is a good that is worth pursuing and expanding and that it is thus important to increase the number and improve the quality of organs for transplantation in order to save lives and improve recipients’ quality of life. A close analysis of these principles—and the legal, regulatory, and policy frameworks that to some extent embody them—indicates several conditions under which organ donor intervention research as a way to improve and increase organs available for transplantation can be both ethically justified and ethically conducted. In discharging its task to examine “ethical principles relevant to the conduct of interventional research on deceased donors and deceased donor grafts” (see Chapter 1), the committee sought to illuminate the responsibilities of various agents—to the donors and donor families/surrogates, to candidates for organ transplantation, and to the recipients of organs from such research (both recipients of research-targeted organs and of non-target organs).

To identify and elucidate the relevant ethical principles for assessing and guiding the policies for and practices of organ donor intervention research—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 interpreted by the spokespeople for relevant organizations and other experts (e.g., philosophers, theologians, anthropologists, and sociologists)” (IOM, 2006, p. 77). While there are diverse views, there is a rough consensus concerning several ethical principles.

This rough consensus is evident in the work of several interdisciplinary groups that have, with public input, attempted to formulate principles for the spheres of activity that are central to the current committee’s work. For instance, in 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Moreover, in 2015 the Ethics Committee of the United Network for Organ Sharing (UNOS) updated an earlier white paper entitled Ethical Principles in the Allocation of Human Organs (OPTN, 2015).¹ While focused on the allocation of donated organs, this white paper presents principles that are also applicable to recovering deceased donor organs: “The principles involved are essentially the same as those that apply to other areas of human conduct, . . . reflect the conclusions of American public bodies which have examined general principles of ethics . . ., [and in] slightly different language . . . are essentially the same as those that appeared in the Belmont Report”^2,3 (OPTN, 2015).

Ethical principles are often embodied and embedded in laws, regulations, and policies. A good example is the Uniform Anatomical Gift Act (UAGA), some version of which guides the transfer of organs from deceased persons in each state, the District of Columbia, and Puerto Rico (Organ Donation & Transplantation Alliance, 2017). Another good example is the Federal Policy for the Protection of Human Subjects (also termed the Common Rule), 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.

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¹ This white paper does not represent Organ Procurement and Transplantation Network (OPTN) policy but is rather intended to provide information and to stimulate public discussion (OPTN, 2015). See also the OPTN Ethics Committee’s white paper Ethics of Deceased Organ Donor Recovery (OPTN, 2016).

² A footnote in this white paper emphasizes that these same principles appear in different wording in a number of books in bioethics and transplantation ethics. It identifies “alternative formulations of essentially the same list of principles” in Beauchamp and Childress (2013) and Veatch and Ross (2015) (OPTN, 2015). The white paper’s emphasis on the essential “sameness” of the principles, despite varied formulations, can be maintained only if it is also recognized that there are different interpretations of the meaning, scope, and weight of these principles in concrete situations.

³ The rough consensus concerning several ethical principles does not mean that each public body simply adopts, adapts, and applies that consensus. Reflecting on the work of the Presidential Commission for the Study of Bioethical Issues, commissioner Daniel Sulmasy (2017) contends that this commission’s principles, similar though they are to the Belmont Report’s principles, emerged more inductively as the commission sought to address the issues raised by synthetic biology.

⁴ 45 C.F.R. 46.

Nevertheless, ethical principles usually also go beyond the laws and regulations that attempt to embody them.

• Some ethical principles may entail actions that are not mandated by laws and regulations;
• Some may fill in gaps where laws and regulations are incomplete or indeterminate; and
• Some may provide reasons to criticize and revise laws and regulations, especially as technological and social conditions change.

The last occurred both with the UAGA in its revisions since the original 1968 version and with the Common Rule in its 2017 revision (to take effect in 2018). The Notice of Proposed Rule Making for the Common Rule indicated that the recommended revisions had resulted from reassessing the core ethical principles in the context of current technological and social changes, and it requested public comment on “whether the proposals strike a reasonable balance among the core ethical principles. A better balance among the core principles should increase the strength of the partnership between the research enterprise and the public” (Federal Register, 2015, pp. 53941–53942).

Even within a rough consensus about several ethical principles, differences may arise in the interpretations of what these principles imply for establishing or revising laws, regulations, policies, or practices. Rarely does anyone claim that the principle of respect for persons, for instance, is irrelevant to organ donation/transplantation or to research involving human subjects, but different interpretations of its range of application and its weight may thwart agreement on what this principle implies for specific projects. As such, appeals to this principle (or to other principles) do not automatically produce unanimous judgments about complex practices such as organ donor intervention research. Much depends on developing a clear understanding of this research, of what is required for it to succeed, and of how various options in its pursuit might fulfill these principles. 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.

ETHICAL PRINCIPLES

The ethical principles most relevant and important for the committee’s task are respect for persons, beneficence, fairness, validity, and trustworthi-

ness. This section begins by attending to three of these—respect for persons, beneficence, and fairness—versions of which appear in the Belmont Report and in Ethical Principles in the Allocation of Human Organs, as well as in many other sources.⁵ Then it considers scientific validity, which can be viewed as a subset of beneficence (utility) but which can be defended as an independent principle. The section closes with attention to trustworthiness in the form of an ethically trustworthy system of organ donation, transplantation, and research that can elicit and sustain public trust and thus promote organ donation and participation in research.

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. This principle, as this report interprets it, has several features and implications⁶:

• Respect for the dignity, worth, and value of each human being. In line with Immanuel Kant’s ethics, this includes the right, among

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⁵ In its report, Moral Science: Protecting Participants in Human Subjects Research, the Presidential Commission for the Study of Bioethical Issues (2011b), established under President Barack Obama, noted that the rules in the Common Rule (and in the similar version for the U.S. Food and Drug Administration) reflect widely accepted principles of ethics. These principles are rooted in longstanding values that find expression in many sources of moral philosophy; theological traditions; and codes, regulations, and rules. They are the bulwark of ethically sound science, or “moral science,” as the Commission terms it. Each generation may re-examine how these principles are contextually applied and understood. And, their application or implementation may vary depending on the level of risk that a subject faces. Medical research that poses risk of physical injury rightly raises more concerns than does routine social survey research, for example. Nonetheless, the same ethical principles govern all of these activities, and serve as enduring guideposts that must not be ignored (Presidential Commission for the Study of Bioethical Issues, 2011b, p. 3).

⁶ Several of these specifications of respect for persons for deceased organ donation were articulated in Organ Donation: Opportunities for Action (IOM, 2006). The committee for the current report drew some formulations, with modifications, from that report.

• other rights, to be treated not merely as a means, as an instrument, to others’ ends (Kant, 1993).
• Respect for each individual’s choices and preferences with regard to health care decisions and research participation. In the case of the latter, research participants bear risk in the context of research protocols that are primarily designed to advance medical knowledge. Participants are respected by a robust process of informed consent before they are enrolled in studies. When potential participants lack capacity,⁷ respect for persons generally entails not exposing an individual to research procedures that exceed minimal risk—except where those risks are exceeded by the direct benefits to that individual. Surrogates’ decisions about a currently non-autonomous person’s participation in research should track that person’s prior wishes, if known, or his or her values, when identifiable, as well as his or her overall best interests.
• Avoidance of undue pressure and coercion on a person’s decisions, including decisions about whether to accept medical care, enroll in research, or donate organs.
• Respect for each competent person’s right to decide whether to donate his or her organs and other biological materials after death for transplantation, research, education, etc. The individual’s exercise of what is sometimes called “precedent autonomy” occurs within the UAGA, which provides the legal framework for the donation of biological materials. (Chapter 3 will spell out the way in which this right is embodied in the UAGA.)
• Recognizing the priority of a decedent’s previously stated preferences, while being sensitive to the feelings and wishes of his or her family.
• Appropriate reliance on family and other surrogate decision makers when the decedent did not formally indicate his or her wishes through a registry, donor card, or other means. In general, surrogate decision makers, chosen by the decedent or authorized by law, should make their decisions in accord with the deceased person’s preferences when known or, when those preferences are unknown, in accord with the person’s values, when identifiable.
• Respect for a person’s bodily remains following death.
• Avoidance of disrespectful practices and language. Once common terms such as “harvesting organs” or “cadaveric donors”

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⁷ The Belmont Report specifies the principle of respect for persons in two rules: (1) “individuals should be treated as autonomous agents,” and (2) “persons with diminished autonomy are entitled to protection” (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).

• have become problematic because they are now considered to be disrespectful toward donors and their families or surrogates (see Chapter 1 and IOM, 2006). Another arguably disrespectful phrase is “to consent a person” or “consenting a person.” Indeed, in medical practice and in research, it has become common to hear someone say “I consented him” with reference to having sought and received an individual’s consent for a procedure or for research participation. It is easy to understand why “consenting” a patient or research subject has become a convenient shorthand expression. However, professionals do not and, indeed, cannot “consent” others. And, from the standpoint of respect for persons, only individuals, their families, or other surrogates can consent to participation in research. Professionals provide the opportunity, information, and the like for consent, but consent remains the individual’s or surrogate’s prerogative, just as organ donation is the individual’s or surrogate’s prerogative.
• Respect for personal privacy and confidentiality.

Beneficence

The principle of beneficence includes duties not to harm others, to prevent harm to and remove harm from others, and to provide positive benefits. Some ethical frameworks distinguish a principle of beneficence from a principle of non-maleficence (Beauchamp and Childress, 2013), but the Belmont Report, instead, explicates the principle of beneficence through two complementary rules: (1) do not harm, and (2) maximize possible benefits and minimize possible harms (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). The second rule points to the necessity and importance of balancing prospective benefits against possible harms (risks), 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).

Beneficence or utility requires consideration of the ratios of probable benefits versus risks, costs, etc., in analyzing and assessing different policies, practices, and actions, all with the aim of producing a net balance of good. Sometimes this principle is implemented through formal analytical methods such as risk–benefit analysis or cost–benefit analysis. Other times it is implemented in less formal ways. In most frameworks, beneficence or utility is only one principle among several, and it is not always triumphant. It too must be balanced against other principles such as fairness or equity (U.S.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979; OPTN, 2015).

Criteria for organ allocation incorporate consideration of the probable success of the transplantable organs for potential recipients on the waiting list. After all, the aim is to benefit patients who need an organ transplant because they are critically ill. Success can be defined in various ways, such as graft survival, length of patient survival, or quality of life post-transplant, the latter two of which are sometimes expressed in quality-adjusted life years. The probability of success may hinge on a variety of factors related to a patient’s condition, blood type, size of the organ, tissue match, etc. However the potential benefits are defined, they need to be balanced against the risks, in light of the patient’s overall condition, the quality of the available organ, and the like. What might be called medical utility—as distinguished from social utility, that is, the maximization of social welfare—is thus important, but it is not the only ethical consideration in play. For some organs the waiting time for a transplant may be important, while for others the urgency of medical need may be crucial. The assignment of points for different factors builds in and features, but is not limited to, medical utility; it also includes other principles such as fairness.

Research involving human participants must pass a risk–benefit analysis and assessment in which the probable and possible harms to participants are evaluated against the probable benefits to future patients (as well as to research subjects if the research offers the possibility of benefit to them). It is important not only to minimize harmful effects (e.g., damage to organs) but also to evaluate risks in relation to the potential benefits for future organ 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. Careful attention should be paid to identifying when recipients of non-target organs need to receive human research subject protections (see the discussion in Chapter 3). Possible effects on the overall allocation of organs also merit attention. In addition to beneficence/utility, considerations of fairness must be brought into the distribution of benefits and risks and into the allocation of research organs. Subsequent chapters will further discuss these issues and propose a mechanism for monitoring these possible effects in terms of beneficence/utility and fairness.

Fairness

Determining what is due to individuals or groups involves a cluster of principles, including fairness, equity, impartiality, and justice. In making such determinations, it is common to distinguish the formal criterion of justice from material criteria of justice. The formal criterion dictates that

similar cases should be treated similarly and dissimilar cases should be treated dissimilarly (Beauchamp and Childress, 2013). Similarly situated persons are all entitled to treatment according to the same standards and through the same procedures and processes.

By contrast, material criteria of justice identify the relevant similarities and dissimilarities among individuals and groups and thus determine how specific benefits and risks, costs, and burdens should be distributed (Childress, 2001). For example, debates about allocating scarce medical resources have focused on which material criteria are morally relevant, such as urgency of need, probability of success, societal contribution, or ability to pay. Agreement can usually be reached that certain criteria, such as race or gender, are unacceptable because they are based on morally irrelevant characteristics to that specific discussion, but securing agreement on the morally relevant characteristics for allocation is more difficult (Childress, 2001).

At least since the publication of the 1986 report of the U.S. Task Force on Organ Transplantation, donated organs have been viewed as a scarce national resource (U.S. Task Force on Organ Transplantation, 1987). Organ procurement and transplant teams act as trustees of donated organs on the behalf of the public. Their authority over the distribution process is not absolute, but rather falls within acceptable material criteria for distribution (Childress, 2001). In general terms, the criteria for organ allocation focus on medical need, the probability of successful outcomes (medical utility), and time spent waiting by the potential recipients. Depending in part on the organ under consideration, there are debates about how much weight should be given to each of these factors (Ubel and Loewenstein, 1996; Neuberger et al., 1998; Tong et al., 2010). Allocation algorithms are devised to operationalize weighted criteria, and they are updated as science advances, technologies improve, evidence emerges about disparities and inequities, and other critical changes.

Considerations of fairness also shape who should be involved in formulating the material criteria for organ allocation. Participatory justice requires the involvement of affected stakeholders in setting distributive criteria. The idea that donated organs belong to the community implies that public participation is crucial in the deliberative processes for determining allocation criteria (U.S. Task Force on Organ Transplantation, 1987). UNOS has followed through accordingly: its organ allocation policies are developed in public, with public input, and subjected to public scrutiny (OPTN, 2017). This is vitally important for public trust. 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

family members of organ donors as well as potential transplant recipients and members of their families.

Several fairness concerns arise in the context of organ donor intervention research. As in all research, the current recipients of research organs bear some risks for future organ transplant recipients. Hence, there should be a fair distribution of probable benefits and risks between present and future generations. Another question of fairness concerns current candidates on the waiting list who are either unwilling to accept an organ involved in research or not eligible for a specific research protocol and thus may experience a longer wait for a transplant, thereby incurring an increased risk of serious and extended morbidity or even death before they receive a transplant. This situation raises not only questions of fairness in organ allocation but also questions about whether the situation creates undue pressure that infringes on the principle of respect for persons.

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. While the research is not designed to benefit the recipients of non-target organs, now or in the future, the fact that these recipients bear some risks, as noted earlier, provides a rationale based on fairness for viewing them as potential research participants with the institutional review board making decisions regarding informed consent.

There is uncertainty surrounding some of these possible effects, at least for now. Thus, systematic oversight and monitoring, examined in Chapter 4, will be required to determine whether the potential negative effects actually occur for candidates on the waiting list for a particular target organ or for recipients of non-target organs; if they do, OPTN/UNOS, along with other appropriate organizations, will need to determine the best course of action to ensure the fair distribution of benefits and risks. Nevertheless, it may be possible to anticipate and address some issues of fair distribution in advance. For example, oversight should include attention to divergent views among transplant teams about whether they, acting on behalf of their patients, would be willing to accept target or non-target organs subjected to a particular type of intervention.

Validity

Validity refers to the approximate truth of inferences derived from measurements or research, or both (Shadish et al., 2015). Many research

activities are designed to generate evidence to support scientific and clinical decision making. For any research activity to fulfill that purpose, its output must provide a truthful representation of underlying causal processes and relationships. 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. For example, the Belmont Report states that research should “maximize possible benefits,” including benefits to society in the form of generalizable knowledge (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Whereas beneficence or utility can find expression in many ways (e.g., enhancing patient welfare or maximizing the number of individuals who benefit from knowledge), validity signals that research activities should be pursued in such a manner that the resulting findings provide a truthful representation of biological reality, including the merits of a particular treatment strategy. As a principle, validity identifies a condition toward which researchers should strive. It has significant implications even when the research is risk neutral or minimally risky and thus easily passes a risk/prospective benefit analysis. The principle of validity moves beyond risks to research subjects as balanced against benefits to them and to the society to include the risks to society of failing to produce valid research. It indicates that downstream users of knowledge have a claim on the reliability and comprehensiveness of the information generated from the research activity.

Whether viewed as a separate principle or as a requirement of beneficence/utility, validity indicates the need to design studies in a way that supports valid clinical inferences. For example, when comparing two treatments, the use of blinded treatment allocation minimizes the impact of observer bias on measurements; delivering treatments in studies in a manner that is consistent with the intended clinical scenarios is another way of maximizing the validity of clinical inferences in trials. The principle of validity also requires that studies be reported in ways that enable independent experts to make valid inferences. For example, detailing patient characteristics and flow through a trial, clearly describing methodologies, and reporting all outcomes and analyses will help independent experts formulate an accurate understanding of a study’s findings.

Growing evidence indicates that avoidable threats to validity are common in medical research. For example, a sizeable fraction of completed trials is never published, with studies that failed to meet their primary endpoint with statistical significance being published less frequently than studies that succeeded (Dickersin, 1990; Hakala et al., 2015). Many clinical trials—including those published in high-impact venues—alter their

primary endpoints (Mathieu et al., 2009; Vedula et al., 2009) or deviate from protocols (Chan et al., 2004) when publishing results. Such selective outcome reporting can lead to bias. Still another threat to validity stems from underpowered studies that lack adequate statistical power to answer their research questions (Halpern et al., 2002).

When conducting research, researchers must contend with numerous factors in experimental systems that interfere with accurate and precise estimates of treatment effects, including random variation, measurement error, and confounders. 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.

Trustworthiness

Trust is vitally important in organ donation and transplantation. Indeed, according to Kenneth Moritsugu, a member of the National Academies of Sciences, Engineering, and Medicine committee and a physician, who was involved in the donation of the organs of his deceased wife and, on another occasion, the organs of his deceased daughter, trust is “the heart” of organ donation and transplantation. He identified several types of trust:

• Trust that the health care team will do all it can to care for an individual who is very sick or injured.
• Trust that chaplains will bring comfort and solace when nothing more can be done to save a loved one.
• Trust that the designated requester from the organ procurement organization is accurately representing the decision that the deceased individual made to be an organ and tissue donor when he or she was of sound mind and body.
• Trust that the surgical team will recover those organs and tissues to the maximum extent medically possible and that they will treat the deceased individual with dignity and respect.
• Trust that the transplant team will carefully place the recovered organs and tissues to ensure that the grafts will be successful and benefit the recipient, that they will use the organs for the purpose for which they were donated, and that they will treat them, as well as the donor and the recipient, with dignity and respect.

• Trust that the post-transplant team will do what is necessary to nurture the newly transplanted recipient back to health.
• Trust that transplant recipient will be a careful caretaker of this gift of life.
• Trust that the recipient’s family and friends will continue to assist their loved one to return to a full life and that the recipient and family and friends alike will realize the great gift they have received.
• Trust that the community and society will fully appreciate the benefits of organ and tissue donation and transplantation.

Trust can be defined as confidence in others to act in certain ways. Confidence in others to act ethically presupposes their capacity to do so based on their knowledge, technical competence, and expertise, which together will enable them to handle complex situations such as organ donation, transplantation, and research. Such trust is important—but also fragile—throughout health care (Shore, 2006), but it is particularly important in organ donation/transplantation and in research involving human subjects. Neither organ transplantation nor human subjects research can proceed without the public’s trust. Absent such trust, individuals and families would not be willing to donate organs or to participate in research designed to generate generalizable knowledge.

Rather than attempting to manufacture public trust so that these important activities can proceed, the goal should be to design and implement trustworthy systems of organ donation, transplantation, and research that can appropriately sustain trust over time. A trustworthy system can serve as the basis for public trust that is warranted. Such a system attends to and embodies the other ethical principles examined in this chapter. Not only are these principles important in and of themselves, but a strong consequentialist reason also supports adherence to them: organ donation and transplantation and research with human subjects cannot succeed without demonstrated adherence to those principles as a basis for public trust.

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). In addition, respondents sometimes indicate, directly or indirectly, that they do not trust the organ donation and transplantation process. Specifically, some worry that registration as an organ donor carries risks. For instance, a 2010 survey by Donate Life Northwest reported that

• 52 percent of respondents believe that doctors may not try as hard to save their lives if the doctors know that they are registered as organ or tissue donors.

• 48 percent of respondents believe a black market exists in the United States for organs and tissue, up from 44 percent in 2009.
• 61 percent believe that brain dead persons can recover from their injuries (Donate Life Northwest, 2010).

The large percentage of respondents with beliefs about donation and transplantation that are inaccurate highlights the challenges that the donation and transplantation communities face and the hurdles that need to be overcome (IOM, 2006). Even when opinion surveys do not specifically ask about distrust or mistrust, reported beliefs such as these reflect limited trust.

A perception that organ allocation systems are unfair—for instance, a perception that some individuals receive preferential access to organs—can also dissuade people from donating their own or a relative’s organs. The public needs to be able to trust that the criteria for organ allocation are fair and that they are applied impartially. A 2012 national survey found that approximately 65 percent of the U.S. population agreed somewhat or strongly that the transplant system uses a fair approach to deceased organ distribution, with just over 20 percent strongly agreeing (HRSA, 2013). In this survey, confidence in the fairness of organ distribution aligned with an expressed willingness to donate among different age cohorts. 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.

Racial and ethnic minorities tend to have lower rates of organ donation (Goldberg et al., 2013) and to be less willing to participate in research (Cobb et al., 2014). Social and economic marginalization, as well as distrust in medical research that has its roots in historical abuses, have likely made members of minority groups less likely to participate willingly in organ donation and research (Shavers et al., 2000; Bratton et al., 2011). Mistrust among minorities has several targets, including the health care system with its lack of equity (Siminoff et al., 2006) and doctors, scientists, and the government (Corbie-Smith et al., 1999). There is reason to believe that such mistrust has been exacerbated by research scandals such as the notorious 40-year U.S. Public Health Service study of untreated syphilis in several hundred African American males in and around Tuskegee, Alabama. “The symbolic power of ‘Tuskegee’ works because of the revulsion” over the deception, lack of informed consent, and exploitation that marked this study (Reverby, 2009, p. 232).

Transparency is a crucial precondition for engendering and sustaining public trust. In the context of the current report, transparency requires enabling the public to understand clearly what is involved in organ donor intervention research in order to obviate possible suspicions that the re-

search might endanger the welfare or rights of organ donors or of transplant candidates and recipients. For this research to proceed and succeed, trust is needed on the part of prospective individual or surrogate donors of organs as well as on the part of prospective recipients who may become research subjects by accepting organs involved in research. Transparency needs to be accompanied by public education in a variety of forms and venues. Another potentially valuable step is engaging the public in developing standards and procedures. In line with UNOS’s efforts to obtain public input in setting the criteria and point systems for fairly allocating donated organs, public engagement has also been recommended for other policies regarding organ donation and transplantation (Sher, 2008). Beyond transparency and public engagement, strong oversight is also potentially important in creating and maintaining a trustworthy system. 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 donation 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.

CONCLUSION

This chapter has described several ethical principles that can structure deliberations, guide policy, and inform decisions about organ donor intervention research. These principles become particularly important in settings where legal and regulatory frameworks set minimum standards but are indeterminate in their applications or incomplete in their incorporation of ethical concerns. They are also important in cases where these legal and regulatory frameworks appear to need reassessment because they create unwarranted obstacles to progress in increasing the quantity and improving the quality of transplantable organs. Even though there is a rough consensus about the value of these broad principles, variations in interpretations of their meaning and implications arise, particularly as applied to such projects as organ donor intervention research. Moreover, within the consensus that these broad ethical principles are valuable, disagreements may also emerge about exactly how to balance these principles if they come into conflict in assessments of policies and practices.

The existence of possible differences in understanding the content and the weight of ethical principles in particular situations indicates that the committee’s task requires much more than the simple application of ethical principles. Instead, its task is inevitably one of interpretation as it considers different possible ways to undertake organ donor intervention research in

light of these principles and in light of the pertinent legal, regulatory, and policy frameworks as well as current institutional, organizational, and professional responsibilities, opportunities, and constraints. Throughout the report the committee has highlighted various aspects of this research that need further attention and modification to make it worthy of the public’s trust.

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