— Philosophy and Medicine —
— APA Newsletter, Spring 2006, Volume 05, Number 2 —
APA NEWSLETTER ON
Philosophy and Medicine
Rosamond Rhodes & Mark Sheldon, Co-Editors Spring 2006 Volume 05, Number 2
— 2 —
— 3 —
FROM THE EDITORS
The Belmont Report, which articulated the principles for the ethical conduct of biomedical research in the U.S., is one of the most influential documents in the history of American bioethics. To commemorate the 25th anniversary of the Report, the APA Committee on Philosophy and Medicine sponsored a session to assess and evaluate that landmark document at the Eastern Division meeting in New York, December 28, 2005. We are fortunate to include a collection of papers from that session on “Research Ethics on the 25th Anniversary of the Belmont Report” in this issue of the Newsletter.
“Assessing the Belmont Report” by Tom L. Beauchamp reviews the history of the Report and explores six issues that may be seen as problems with the report. Beauchamp discusses the concept of “respect for persons”; the issue of balance between the rights and interests of subjects, the advancement of science, and the interests of society; the emphasis on protection of subjects; concerns over the usefulness of its abstract principles in guiding concrete judgments; the lack of direction in prioritizing principles; whether the Commission relied upon principles or casuistry in its own deliberations. “The Belmont Principle of Justice: An Idea Whose Time Has Come,” by Ruth Macklin, and “Justice in the Belmont Report and the Social Division of Labor,” by Alex John London, both explain why the Report’s discussion of justice needs to be developed and refined. Both authors make strong cases for taking a broader view of justice than what we find articulated in Belmont. For example, their remarks allow us to see that even though the selection of subjects may conform with the Belmont standards, a trial that depletes a community’s medical resources by diverting medical professionals to the conduct of a clinical trial may be unjustice for that reason. “Revisiting the Belmont Report: The Ethical Significance of the Distinction between Clinical Research and Medical Care,” by Franklin G. Miller, focuses on a different set of issues. Miller explains problems that emerge from the Report’s inadequate appreciation of the difference between clinical research and medical care and the consequent ascription of the ethics of medicine to clinical research. This carefully argued paper also explains the confusions that conflating the two activities promotes and the problems that emerge from accepting the therapeutic orientation of research as the model for distinguishing acceptable research projects from projects that should not be allowed. Together, this collection of papers that examine the Belmont Report in light of its history and our developing insight into bioethics constitutes a valuable contribution to the literature of research ethics.
This issue includes several additional treats. One is a narrative account of a physician’s efforts to honor his patients’ end-of-life requests. “Narrative Matters” by David Muller is a poignant and insightful account of persisting problems around the end of life. We also have “This is for My Grandmother,” a poem by Felicia Nimue Ackerman. This issue concludes with two excerpts from Bioethics: A Systematic Approach by Bernard Gert, Charles M. Culver, and the late K. Danner Clouser. This second edition of their work represents the authors’ continued effort to apply Gert’s account of common morality as a foundation for medical ethics. In the first excerpt (from Chapter 5), the authors engage in a critical discussion of “principlism” as presented by Beauchamp and Childress in Principles of Biomedical Ethics. Gert, Culver, and Clouser argue that such an approach is weak since it is not systematic. The authors’ approach is systematic in that it is grounded in common morality and, therein, provides a way of dealing with cases that is not ad hoc. The second excerpt (from Chapter 7) considers the definition of a mental disorder—whether the judgment that a mental disorder exists reflects value-free science, or the beliefs and values of a particular society. The authors suggest that values are involved, but they argue that these values are universal. These samples are intriguing invitations to explore the rest of their new volume.
As always, please continue to send along your announcements, letters, papers, poetry, and stories so that they can be shared, used, and enjoyed by all. Feel free to volunteer a book review. Contributions and queries should be sent to Rosamond at the address below. For ease in communication, please include your phone and fax numbers and email address.
Rosamond Rhodes & Mark Sheldon, Co-Editors
Address Mail to:
Rosamond Rhodes
Box 1108
Mount Sinai School of Medicine
One Gustave Levy Place
New York, NY 10029
Phone: 212-241-3757
Fax: 212-241-5028
Email: rosamond_rhodes@mssm.edu
Mark Sheldon
Department of Philosophy
Northwestern University
Evanston, IL 60208
Phone: 847-491-8918
Email: sheldon@northwestern.edu
FROM THE CHAIR:
On Face Time and Face Transplants
David DeGrazia
George Washington University
Reflecting the geographical diversity of the APA, the Committee on Philosophy and Medicine is fairly spread out around the country. This makes it somewhat difficult to meet in person. Happily, though, five of us—Gary Seay, Mary Rorty, Rosamond Rhodes, Bob Baker, and I—were able to get together over breakfast during the Eastern Division meeting in New York last December. (Lee Brown, Mark Sheldon, and Ben Rich were unable to attend.) While email communication is sufficient for many purposes, I was very grateful for the opportunity for some face time with committee members. Among the themes we discussed were the following.
The Committee’s webpage could use updating and amplification. For example, it contains information gathered from a survey of bioethics programs, but the survey was conducted in 1997. We might conduct another survey through the Newsletter on Philosophy and Medicine, or we might simply provide links to webpages that already have the sorts of information philosopher-bioethicists are likely to find helpful. Additionally, we could provide links to other organizations of interest, such as the American Society for Bioethics and Humanities (ASBH) and the Association for Practical and Professional Ethics (APPE).
Speaking of allied organizations, we began to consider more extensive collaboration with the ASBH. At the recent Eastern Division meeting, we ran a panel on the 25th anniversary of the Belmont Report, which we had also run at the October ASBH meeting in Washington, D.C. We know that there are many scholars who are interested in the topics of our panels but do not attend both APA and ASBH meetings. We may decide to make such panel-sharing between the two organizations a regular affair.
Future panels were also discussed. Some topics—such as enhancement technologies and the genetic testing of children for adult-onset diseases—have been around for a while but are very rich ethically and are continually energized by technological advances. Other topics, such as neuroethics and nanoethics, seem newer. And then there are topics that are truly new. The best example mentioned at our breakfast discussion was face transplants—although I suspect the likely title for such a panel, “Old Problems with a New Face,” would be more interesting than the issues themselves. In the next few months, we will select some philosophically rich themes related to bioethics as topics for upcoming panels. Stay tuned.
ARTICLES
Assessing the Belmont Report
Tom L. Beauchamp
Georgetown University
The Belmont Report was published in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its goal was to provide a framework of moral principles that would serve as the backbone of the federal oversight system in the United States, so that meaningful protection was afforded to research subjects. The National Commission published seventeen reports and appendix volumes. Several went directly to the Secretary of the Department of Health, Education, and Welfare (DHEW) and became codified in federal regulations (US 45 CFR 46). The Belmont Report is not itself a regulatory document, only the Commission’s framework of moral principles.
This framework of principles is still today referred to as “the Belmont principles.” The Commission identified three general principles as underlying the conduct of research: “respect for persons,” “beneficence,” and “justice.” The organizing conception in the Report is that respect for persons applies to informed consent, beneficence applies to risk-benefit assessment, and justice applies to the selection of subjects. The principle of respect for persons demands that the choices of autonomous persons not be overridden or otherwise disrespected and that persons who are not adequately autonomous be protected by the consent of an authorized third party likely to appreciate the subject’s circumstance and who will look after his or her best interests. The principle of beneficence is an abstract norm that includes rules such as “do no harm,” “maximize possible benefits and minimize possible harms,” and “balance benefits against risks.” The principle of justice requires fairness in the distribution of both the burdens and the benefits of research.
The Belmont Report makes no pretense to render its principles specific and practical for institutions that conduct research. That objective was to be accomplished by the other sixteen volumes on research ethics. Belmont commissioners and staff were keenly aware that this framework is too indeterminate by itself to decide practice or policy or to resolve moral conflicts.
Despite the wide acceptance of the authority and contribution of this framework for research ethics, several issues have been or can be raised about the adequacy of the Belmont principles. Six possible problems are worthy of discussion still today.
(1) The principles are arguably run together in the way they are expressed, rather than standing as independent principles. The principle of respect for persons is the most suspicious case. It appears to blend two independent principles: a principle of respect for autonomy and a principle of protecting and avoiding the causation of harm to incompetent (nonautonomous) persons. The Commission says that it is attempting to protect both autonomous persons and those with “diminished autonomy,” i.e., those who are incapable of self-determination. Both are persons, it says, and both are entitled to protection. The problem is whether there is any meaningful way to justify protections for persons who are incapable of self-determination except by appeal to the principle of beneficence. If not, then the Commission has adopted an incoherent position in thinking that the principle of respect for persons and the principle of beneficence are independent principles.
(2) The Commission was repeatedly concerned that it had become too easy in the biomedical world to use utilitarian justifications of research. The Nazi Experiments, Tuskegee, and the Jewish Chronic Disease Hospital cases all seemed to present a very utilitarian view of social beneficence that justified using human subjects on grounds of benefit to the broader public. However, the Commission has been itself accused of having inadequate internal controls in its moral framework to protect subjects against abuse when there was the promise of major benefit for society. For example, the Commission’s report on children has been criticized for an unjustifiable utilitarian justification of research that placed children at undue risk. Whatever the merits of this criticism, the Belmont Report was written, in part, to ensure that we appropriately balance appeals to social utility in the justification of research. That is, a major purpose of the report was to properly balance the rights and interests of subjects with those of science and society. It may, of course, be doubted that the Commission actually did determine how best to control utilitarian balancing, but it is also reasonable to doubt that any general solution to this problem has ever been provided.
(3) The Belmont Report, and the National Commission more generally, can also be criticized for being overly protective of subjects and not utilitarian enough to meet the needs of certain classes of persons. The emphasis of the Commission was on the protection of subjects from research injury. Research participation was conceived as a burden accepted to advance the public good. The notion that research is not always viewed by subjects as burdensome was underexamined. The AIDS epidemic altered this assumption, perhaps forever. Whereas Belmont was protectionist, AIDS activists sought not protection from but inclusion in the research process. They wanted justice and respect for their autonomy, but not along the lines staked out in the Belmont Report. They wanted to be able to choose unapproved drugs. Justice, they thought, should allow them access to clinical trials. Whether this viewpoint constitutes an expansion in the scope and use of the Belmont principles, rather than a confrontation with these principles, remains a vital question still today.
(4) The Belmont Report has also been criticized for its abstractness and inability to resolve or otherwise treat practical moral problems. The Report anticipates this criticism and cautions that its principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is [only] to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects. The Commission is warning readers that they should not expect to be able to use Belmont principles as a checklist of federal regulations or as guidelines like recipes in cooking. Nonetheless, several critics have asked whether these principles are in any meaningful respect practical, or even useful. The concern is that the Belmont principles underdetermine almost all moral judgments because there is too little content in abstract principles to determine concrete judgments. This criticism merits careful attention, but it is also reasonable to ask whether any system of principles, rules, or general guidelines escape this problem. The criticism no doubt holds for unspecified principles, but does it hold for principles that have been well specified for a context? This question too has never been satisfactorily resolved.
(5) The Belmont Report has also been faulted on grounds that it gives no indication of how to prioritize or weigh its principles. Some think that the Commission should have argued that one or more of its principles has priority—for example, that considerations of respect for persons and justice take priority over considerations of social benefit. Critics often support a model of basic moral principles and protections that cannot be violated under any circumstances, even if there is a clear and substantial benefit for society. Such restrictions on or prioritizing of principles are emphatically not envisioned in the Belmont Report. The Commission holds that its principles are more or less weighty depending upon the particular circumstances in which the principles are to be applied—a balancing theory. That is, no principle in the basic analytical framework is allowed to have an ordered priority over any other principle. This is a defensible conception, though little is done to defend it in the report itself.
(6) One former Commissioner, Albert Jonsen, and one staff member, Stephen Toulmin, have questioned whether the National Commission actually used its framework of Belmont principles to support or defend its own bioethical conclusions. They have argued that the Commissioners believed and published as principlists but actually worked as casuists. This thesis is not a criticism of the Commission’s substantive work but, rather, a methodological comment on the use and limits of its principles. These authors hold that the Commission’s actual moral deliberations proceeded more by the consideration of influential cases than by appeal to universal principles. It is probably correct to say that principles were of a lesser importance than readers might suppose when they read the Belmont Report. They are important general guidelines, but overrated ones if revered for their practicality. From this perspective, the Commission should be thought of as using principles primarily as very general guiding ideals that must be substituted by others forms of practical reasoning. Belmont itself does not seem to claim more.
Finally, the Belmont Report is one of the few documents that has influenced almost every sphere of activity in bioethics: moral theory and general standards of research ethics, government regulatory activity, bioethics consultation, and even medical practice. Its influence has arguably been as extensive in practice as in theory. In federal regulatory oversight and law, Belmont has at times assumed a near canonical role as the groundwork of federally funded research. Of course, the Belmont principles found their way into every document the National Commission published, and these became the backbone of federal law governing research involving human subjects.
The legacy of Belmont may be most enduring in areas of practice. Federal regulations require that all institutions receiving federal funds for research espouse a statement of principles for the protection of human subjects. Virtually all such institutions have subscribed to the Belmont principles as the basis of their efforts to assess research protocols. Professional associations too have widely recognized the authority and historical significance of the Belmont principles.
Whatever the influence and enduring legacy of Belmont, it is not clear that scientists who today are involved in research with human subjects are very conversant with the Belmont principles, just as their predecessors a few decades ago lacked a working knowledge of the Nuremberg Code. Even if the National Commission and its Belmont Report succeeded in embedding important principles in the heart of research ethics, its principles may be more revered than understood and practiced.
The Belmont Principle of Justice: An Idea Whose Time Has Come
Ruth Macklin
Albert Einstein College of Medicine
A New York City firefighter learned that he had chronic myelogenous leukemia, a disease with a terrible prognosis and for which there is no cure. But then he enrolled in a research study that was testing an experimental drug manufactured by the giant pharmaceutical company Novartis. The drug worked, is now on the market, and the firefighter is still taking it. The company supplies the drug to him for free because he participated in the clinical trial.1
In contrast, consider the policy of the Eastern Cooperative Oncology Group (known as ECOG), which is one of the largest clinical cancer research organizations in the United States, conducting clinical trials in all types of adult cancers. The organization is funded primarily by the National Cancer Institute. The informed consent document for research studies sponsored by ECOG says: “The drug will be supplied free of charge to you during the trial. However, if the drug becomes approved for marketing while you are still enrolled in the trial, you or your insurance company will have to pay for it.”
What do these two stories have to do with the Belmont Report? The answer is: everything and nothing. They have everything to do with a question about justice, one of the fundamental ethical principles identified in Belmont. That question is: What, if anything, is owed to research subjects when the clinical trial in which they are enrolled is ended? However, the two stories have nothing to do with the principle of justice as articulated in the Belmont Report. Accordingly, the title of this presentation is somewhat misleading. It is true that attention to justice in research is an idea whose time has come. Since Belmont identifies justice as one of the three fundamental principles of research ethics, it marked an important ethical milestone in the research enterprise. Justice in research had rarely, if ever, been discussed prior to Belmont.
The focus of the discussion in the Belmont Report is on distributive justice. The conception of justice that applies to the two stories is more appropriately termed justice as reciprocity. The New York City firefighter not only received a drug that benefited him during a clinical trial; the manufacturer continued to make the drug available to him when the trial was concluded and the drug was on the market. Novartis reciprocated the subject’s participation in the research—from which the company stood to make a huge profit—by providing the medication to him free of charge. In contrast, the Eastern Cooperative Oncology Group informs the cancer patients enrolled in the research it sponsors that not only is there no plan to make a successful product available to them after their participation is concluded, but also, if the drug becomes approved by the FDA while patients are still research subjects participating in the study, they or their insurance company will have to pay for the medication that may still be needed. Not only do they not get the drug free of charge after their participation in the research is concluded, but they may actually have to pay out of pocket for the drug while they are still enrolled as subjects. No reciprocity there.
In explaining what justice requires in the research context, the Belmont Report states that “research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.”2 This is a classic statement of distributive justice, the conception that mandates a fair distribution of the benefits and burdens of research. Yet in Belmont, the application of justice is limited to the question of a fair selection of participants. It does not address what is owed to them in the form of post-trial benefits when research is completed. The Belmont conception of justice could be fulfilled in one of two possible ways: either exclude as subjects in research those individuals or groups unlikely to be the beneficiaries of subsequent applications of the research, or else seek to ensure that those individuals or groups that serve as research subjects actually do receive the benefits of future applications.
The Belmont Report was written at a time when participation in research was considered a risky business. Even many years later, Madison Powers repeated that perception in describing the role of justice in the research enterprise. Powers wrote: “The focus on protecting the vulnerable from the imposition of greater health-related risks is precisely the animating concern of the dominant norm of justice in research as protection.”3 Now, however, twenty-five years after Belmont appeared, ethical concerns about justice in research have added two new dimensions. The first is mandating access to clinical trials for groups that had been traditionally under-represented in research (chiefly women and minorities), and the second is attention to the question of what is owed to research subjects after their participation in a drug study has ended.
Justice in Expanding Access to Research
With the emergence of AIDS in the early 1980s and the first clinical trials of experimental medications, the presumption shifted sharply from the need to protect people from research risks to that of an “inclusionist” perspective. Early in the epidemic, AIDS activists in the United States clamored to get into clinical trials and argued forcefully for more research and the opportunity to enroll more people in trials, and the FDA responded with mechanisms to provide expanded access.4 As Beauchamp and Childress wrote: “In the 1970s and early 1980s, the emphasis was on protecting individuals from risks associated with research. Beginning in the 1980s, the emphasis shifted to increasing access to participation in research.”5 An Institute of Medicine study conducted in 1992-1993 noted that “attention has turned away from the problem of unduly subjecting certain groups to disproportionate risks and toward the problem of denying the benefits of research to certain classes of people who have not frequently been the subjects of research.”6
The Institute of Medicine (IOM) study focused on the inclusion of women in research. The published report said that
For the overall biomedical research agenda to comply with the requirements of justice, studies must not only include women as well as men, but also women and men from different age cohorts and different racial and ethnic groups. If clinical studies are intended to benefit the population as a whole, then the systematic exclusion of women from such studies places them at an unfair disadvantage.7
The disadvantage identified by the IOM study on women and health research was the relative absence of research findings on major diseases, such as heart disease, that pertain to specifically to women. The injustice in the case of women and people with HIV/AIDS was the lack of research and the consequent failure to obtain contributions to knowledge that would benefit those groups.
Most recently, the presumption emerged to include children in all clinical research—not limited only to studies that focus on diseases of childhood.8 This latest move, as it turns out, is in direct opposition to what Belmont says about fair selection of subjects. In the section that addresses the application of the fundamental principles, Belmont says: “it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children).” Here again is a reflection of the dominant perception at that time of research as risky. According to that perception, it is only fair that the less vulnerable (adults) serve as research subjects before the more vulnerable (children).
Access to Post-trial Benefits of Research
The twin ethical concerns in any research are an imposition of undue risks or other burdens and the absence of expected benefits. Although risks to subjects remain an enduring worry, the failure to share in the benefits of research when successful products or contributions to knowledge result has only recently been acknowledged as a major ethical concern. However, this concern has been voiced mostly in connection with international research, in particular, in clinical trials sponsored by industrialized countries or industry and conducted in resource-poor countries. Curiously, however, this feature has been largely, if not entirely, ignored in the United States, where a substantial portion of low-income people cannot afford many expensive medications on the market. There is some evidence that such patients enter trials to obtain care and treatment otherwise unavailable to them outside the research context.
Access to post-trial benefits in the form of successful products of research could readily be subsumed under the concept of distributive justice. Since successful products that result from research clearly count as benefits, Belmont’s statement of justice in research is applicable: “Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of ‘fairness in distribution’ or ‘what is deserved’. An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.” If any benefit is “deserved,” it is that of subjects receiving a medical product they still need after their participation in research has concluded.
An equally appropriate conception of justice is justice as reciprocity. In its report on international research, the National Bioethics Advisory Commission (NBAC) describes that conception as follows:
Justice as reciprocity…is concerned with what people deserve as a function of what they have contributed to an enterprise or to society. In the context of clinical trials, justice as reciprocity could mean that something is owed to research participants even after their participation in a trial has ended, because it is only through their acceptance of risk and inconvenience that researchers are able to generate findings necessary to advance knowledge and develop new medical interventions.9
There is nothing in the U.S. Code of Federal regulations governing research that addresses the question of post-trial benefits to research subjects. However, other international guidelines do include such provisions. Probably the best known of these is the Declaration of Helsinki. One provision states that “At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”10 Another strong requirement is found in a guidance document for preventive HIV/AIDS vaccine research: “Any HIV preventive vaccine demonstrated to be safe and effective…should be made available as soon as possible to all participants in the trials in which it was tested.”11
Both of these documents include a statement about post-trial benefits to research subjects that looks very much like an ethical obligation. Yet, since both statements are written in the passive voice, it is not clear on whom that obligation rests. In the case of the New York City firefighter, the company undertook the obligation, fulfilling the requirement of justice as reciprocity. The article that reported the case of the firefighter did not mention whether Novartis made the drug available to all of the research subjects in its clinical trial; presumably, it would be an injustice if some but not all eligible participants were given the drug without charge after the trial ended. The Eastern Cooperative Oncology Group would likely defend its policy by noting that neither it nor the National Cancer Institute operates under a mandate to provide medical services. It would then fall to the manufacturer of whatever product or combination of medications were provided to patients to supply them with a successful product that resulted from the trial.
The Belmont Report included what was at the time a pioneering step by identifying justice as one of the fundamental ethical principles for research involving human beings. That it did not go far enough in explicating and applying that principle can be understood and excused. Times change, perceptions change, and the research enterprise has changed. The increased attention to matters of justice in the past quarter century is a form of moral progress; Belmont was an early progressive step along that road.
Endnotes
1. Gina Kolata. “Slowly, Cancer Genes Tender Their Secrets,” New York Times, December 27, 2005, F1.
2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979), 5.
3. Madison Powers. “Justice Theories in a Research Context.” In Beyond Consent, edited by Jeffrey P. Kahn, Anna C. Mastroianni, and Jeremy Sugarman (New York: Oxford University Press, 1998), 151.
4. R. J. Levine. “The Impact of HIV Infection on Society’s Perception of Clinical Trials,” Kennedy Institute of Ethics Journal, 4 (1994): 93-98.
5. T. L. Beauchamp and J. F. Childress. Principles of Biomedical Ethics, fifth edition (New York: Oxford University Press, 2001), 203.
6. A. C. Mastroianni, R. Faden, and D. Federman (eds). Women and Health Research (Washington, DC: National Academy Press, 1994), 77.
7. Ibid.
8. http://grants.nih.gov/grants/guide/notice-files/not98-024.html
9. National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (Bethesda, MD, 2001), 59.
10. World Medical Association, 1964, as amended by the WMA 52nd General Assembly, Declaration of Helsinki (Edinburgh, Scotland, 2000).
11. Joint United Nations Programme on HIV/AIDS (UNAIDS), Ethical Considerations in HIV Preventive Vaccine Research (2000), 13.
Justice in the Belmont Report & The Social Division of Labor
Alex John London
Carnegie Mellon University
Although justice is, as Rawls puts it, “the first virtue of social institutions,”1 it arguably has been treated as the last virtue of research ethics. In comparison with the value of respect for autonomy and its corresponding requirement to secure the free and informed consent of research participants, the value of justice and its requirements have received far less philosophical and practical attention in the context of research ethics. For instance, a cursory search of PubMed for articles on justice and medical research yields 533 hits, whereas a search for informed consent and medical research yields 4,324. Similarly, whereas the requirements of informed consent have been clearly elaborated in terms that are operationally useful and action guiding, the requirements of justice tend to be spelled out in fairly general terms as requirements that like cases be treated alike, that processes and outcomes be fair, or that equals be treated equally. After the value of informed consent, the most significant moral attention in research ethics focuses on the requirement that the research present participants with only reasonable risks. In part, this is because there are inherent and long-acknowledged tensions at the heart of the research enterprise between the interests of trial participants and the methods and objectives of scientific research. In this regard there is at least a robust literature on the conflicting obligations of physician-researchers as well as a literature on clinical equipoise that represents a concerted effort to provide operationally useful guidance about when the risks within a particular clinical trial are reasonable.
In contrast to these other values, the elucidation of justice and its requirements in the context of research ethics is in its relative infancy. To a certain degree, this may be due to the fact that unlike respect for persons and beneficence or nonmaleficence, there is a significantly greater diversity to the views of what justice is and what it requires. Similarly, given the scope of justice as a value governing the interactions of different individuals or groups and the operations of various social institutions, the normative force of this value does not emanate from the role-related obligations of any particular profession. When combined with the aspiration of research ethics to function as a practical enterprise that does not get bogged down by the recapitulation of longstanding and divisive theoretical disagreements, something of an agnostic attitude toward the requirements of justice may actually appear to be a virtue of research ethics.2
In the brief discussion that follows, I argue that the desire to focus on what are viewed as more practical or pragmatic concerns and to remain agnostic about controversial issues of social justice has resulted in a lingering parochialism about issues of justice in the research context. I begin, therefore, by illustrating how the avoidance of substantive questions about social justice leads to a parochial approach to issues of justice in the Belmont Report. I then show how this avoidance may be at least partly responsible for the waning influence of some public consensus documents in research ethics. I also suggest that this parochialism may be responsible for generating a practical conflict that may threaten the moral mission of research ethics.
To be clear, there are various reasons for the avoidance of these larger issues in the Belmont Report, and my primary concern is not to impugn the merits of what was without doubt a fundamentally important and forward-looking document in its day. Rather, I am concerned with the Belmont Report insofar as it remains a living document that continues to shape much of the discourse in research ethics and which has not yet been superceded by a comparable moral framework. My criticisms, therefore, are intended to highlight the limitations of the treatment of justice that we find in the Belmont Report in order to underscore the need to broaden the discussion of justice in research ethics.
I conclude by suggesting that the one way to broaden the discussion of justice in research ethics is to begin with a conception of the clinical research enterprise as one social activity that takes place within a broader social division of labor that must be justifiable to the members of the community whose interests it is supposed to serve. Only within such a broader social perspective can we properly consider how our research priorities ought to be determined and evaluated, how the research endeavor should relate to other social institutions such as health care and public health institutions, and which stakeholders in addition to researchers and IRB members have responsibilities to ensure that clinical research is properly responsive to broader issues of social justice.
Agnosticism about Justice in the Belmont Report
The Belmont Report begins its discussion of justice by delineating a set of fundamental questions concerning both the scope and application of this value:
[a] Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. [b] Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? (letters in brackets added)
These questions deal with features of justice that are centrally relevant to its application in general and to the institutions and practices of clinical research in particular. After all, there are many different kinds of benefits that attach to the research enterprise at a variety of different levels. In order to know what the value of justice requires in practice we need a sharper sense of which of these benefits are relevant to the question that I have labeled (a) above. Unfortunately, the Belmont Report does not clarify or specify what the distinctive