Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)
In their article, “The job of ‘ethics committees’”, Andrew Moore and Andrew Donnelly argue that current guidance documents provide that institutional research review committees ) perform two different and distinct functions, namely, a regulative review and an ethical review. They argue for separating those functions and for eliminating the ethics review role from IRBs. Instead, they want IRBs to focus exclusively on determining whether research proposals conform to governing regulations. In their argument, Moore and Donnelly correctly note that regulatory requirements (...) and ethical requirements can conflict. That point is correct, but hardly surprising. After all, regulations are general and the research proposals are specific, so an individual proposal may not conform to the general formulation of the rule and yet be consistent with ethics. Thus, a rule may generally be regarded as expressing a relevant moral consideration while providing a conclusion that does not appropriately reflect an ethical determination in the specific case. This inconsistency need not amount to what Moore and Donelly characterise as a ‘repellent’ or an ‘unconscionable’ review decision. Moore and Donnelly are also concerned that IRB decisions may differ from each other in their review of the same proposal. Again, they are correct in recognising that such inconsistent outcomes would be less likely if IRBs were to focus exclusively on whether proposals conformed to the regulations. That said, I reach the opposite conclusion. As I see it, IRBs present us with a good example of when the possibility of inconsistency is a relatively small consideration in comparison to the important values that are served by IRBs considering their protocol reviews in light of ethics and conforming to regulations. Allow me to explain. The authors and endorsers of research ethics …. (shrink)
The use of organs obtained from executed prisoners in China has recently been condemned by every major transplant organization. The government of the People's Republic of China has also recently made it illegal to provide transplant organs from executed prisoners to foreigners transplant tourists. Nevertheless, the extreme shortage of transplant organs in the U.S. continues to make organ transplantation in China an appealing option for some patients with end-stage disease. Their choice of traveling to China for an organ leaves U.S. (...) transplant programs with decisions about how to respond to the needs of patients who return after transplantation. By discussing two cases that raised this dilemma, we argue for upholding medicine's commitments to traditional principles of beneficence and nonjudgmental regard in sorting out the policies that a transplant program should adopt. We also explain how position statements that aim for the high ground of moral purity fail to give appropriate weight to the needs and suffering of present and future patients in the U.S. and in China. (shrink)
Currently, some of the most significant moral issues involving genetic links relate to genetic knowledge. In this paper, instead of looking at the frequently addressed issues of responsibilities professionals or institutions have to individuals, I take up the question of what responsibilities individuals have to one another with respect to genetic knowledge. I address the questions of whether individuals have a moral right to pursue their own goals without contributing to society's knowledge of population genetics, without adding to their family's (...) knowledge of its genetic history, and without discovering genetic information about themselves and their offspring. These questions lead to an examination of the presumed right to genetic ignorance and an exploration of a variety of social bonds. Analyzing cases in light of these considerations leads to a surprising conclusion about a widely accepted precept of genetic counseling, to some ethical insights into typical problems, and to some further unanswered questions about personal responsibility in the face of genetic knowledge. (shrink)
Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician''s responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient''s decisions and a surrogate''s and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional (...) capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate''s decision. They have to assess the surrogate''s decisional capacity and attitude toward the patient as well as the reasons that support the surrogate''s decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment. (shrink)
Because the process of moving from moral principles and facts to action-guiding moral conclusions has not been articulated clearly enough to be useful in a practical way, we designed a systematic approach to aid learners and clinicians in their application of ethical principles to the resolution of clinical dilemmas. Our model for clinical moral reasoning is intended to provide a clear and replicable structure that makes the thought process involved in reasoning about clinical cases explicit. In this paper we present (...) the model and demonstrate how it can be used in three clinical cases. (shrink)
a This paper is a revised and shortened version of my chapter, “Justice in Allocations for Terrorism, Biological Warfare, and Public Health” in Public Health Ethics, edited by Michael Boylan, Kluwer; 2004. Portions of this material were presented at the International Bioethics Retreat, Pavia, Italy, June 2003, and at the meetings of the Association for Politics and the Life Sciences, Philadelphia, September 2003.
Because medicine can preserve and restore health and function, it has been widely acknowledged as a basic good that a just society should provide its members. Yet there is wide disagreement over the scope of what is to be provided, to whom, how, when and why. In this uniquely comprehensive book some of the best-known philosophers, doctors, lawyers, political scientists, and economists writing on the subject discuss the concerns and deepen our understanding of the theoretical and practical issues that run (...) through the contemporary debate. The first section lays a broad theoretical basis for understanding the subject of justice, particularly as it relates to the distribution of health care. The second section critically examines how medical care is distributed in different countries around the world and the particular advantages and injustices associated with those systems. The third section draws attention to the special needs of different social groups and the specific issues of justice that are raised by the impact of various policies on health care distribution. The concluding section delves into the dilemmas that confront those designing health care systems - the politics, the priorities, and the place of desires as opposed to needs in a socially just scheme. (shrink)
In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.
Those who read only the introductory section of “Physician Obligation in Disaster Preparedness and Response,” the statement from the AMA's Council on Ethical and Judicial Affairs, apparently an elaboration on CEJA Opinion 3-I-04, E-9.067, will find an expression of laudable professional responsibility in the face of a disaster. There the AMA authors explicitly acknowledge “that unique responsibilities beyond planning rest on the shoulders of the medical profession”. They also declare that, “physicians are needed to care for victims. In some instances, (...) this will require individual physicians to place their health or their lives at risk”. As the AMA authors note, these responsibilities have been accepted at least since the writing of Thomas Percival in 1803 and endorsed by the AMA in posting their 1847 code. The commitments are also asserted in the preamble of the AMA's most current Principles of Medical Ethics, which states that “a physician must recognize responsibility to patients, first and foremost,” and again in Principle VIII, which states that “[a] physician shall, when caring for a patient, regard responsibility to the patient as paramount”. (shrink)
The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and our microbiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how (...) much we are a part of our environment. The understanding that microbes are not only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly. This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiome research challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examples from the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group. (shrink)
Over the past 15 years, medical schools have paid some attention to the importance of developing students' communication skills as part of their medical education. Over the past decade, medical ethics has been added to the curriculum of most U.S. medical schools, at least on paper. More recently, there has been growing discussion of the importance of professionalism in medical education. Yet, the nature and content of these fields and their relationship to one another remains confused and vague, and that (...) lack of clarity, in turn, impairs the effectiveness of medical education. This ambiguity invites serious contention over who should design and teach the curriculum as well as when, where, and how it should be taught. (shrink)
Medicine needs our trust. We need to be able to rely on individual clinicians and researchers, and we need to be able to have confidence in hospitals and clinics. Yet the organization of our healthcare institutions is not designed to promote that trust. In fact, the structure of our medical institutions seems to undermine our faith.
This paper offers a constructivist account of bioethics as an alternative to previous discussions that explained the ethics of medicine by an extrapolation of principles or virtues from ordinary morality. Taking medicine as a higher and special calling, I argue that the practice of medicine would be impossible without the trust of patients. Because trust is a necessary condition for medical practice, the ethics of the profession must provide the principles for guiding physician behavior and the profession toward promoting trust (...) and being trustworthy. In a phrase, that principle is “seek trust and deserve it.” I sketch out how the concept of trust provides a different justification for common sense principles of bioethics and explain how the concept of trust provides reasonable guidance for resolving moral conflicts within medicine. The trust-seeking approach provides a new and unexpected ordering of some traditional medical values, it reveals the weightiness of previously undervalued bioethical precepts, and illuminates the centrality of some largely ignored obligations of medicine. It also has the power to guide clinical practice and to inform the profession about standards for medical institutions. (shrink)
This paper focuses on S.A. Loyd's positive account of Hobbes's moral theory as presented in chapters 5 and 6 of her new book. My discussion challenges Lloyd's reciprocity interpretation of Hobbes's moral theory. In the paper I also take issue with Lloyd's account of the derivation of his moral theory and her account of moral obligation. I offer my own definitional reading of the derivation of the Laws of Nature and my own analysis of how Hobbes explains obligation in terms (...) of assent. (shrink)
Volumes have been written arguing the morality of abortion. A crucial premise in many of these arguments concerns the status of the fetus; specifically, that the fetus has or does not have a right to life. Opponents of abortion typically argue that fetuses are persons and hence have an inviolable right to life. Advocates of the right to abortion typically maintain that fetuses are not persons and hence have no right to life.
As early as 1981 Gorlin and Zucker produced a film, AComplicatingFactor:Doctors'FeelingsasaFactorinMedicalCare and in a 1983 paper on the subject they described one of the important epiphenomena of the encounter between doctor and patient—namely, the reaction of the physician to the patient and how this affects both the physician and the quality of the relationship. At that time they were concerned with the physicians' ability to reckon with their own reactions to patients who presented with problems or personality traits that complicated (...) the doctor-patient relationship. Some patients were hateful or unlikable, some denied their disease state, some became unusually dependent on the physician, some were intimidating to the doctor. Their behavior evoked responses that tended to complicate the doctor-patient relationship with distancing, unusual identification, or hostility. That publication recognized and explained the problem and went on to suggest a process of achieving emotional awareness and mastery to help physicians maintain their appropriate role. (shrink)
People who discuss medical ethics or bioethics come to very different conclusions about the levels of agreement in the field and the implications of consensus among health care professionals. In this paper I argue that these disagreements turn on a confusion of two distinct senses of medical ethics. I differentiate (1) medical ethics as a subject in applied ethics from (2) medical ethics as the professional moral commitments of health care professions. I then use the distinction to explain its significant (...) implications for medical ethics education. Drawing on the recent work of John Rawls, I also show the centrality of philosophy in medical ethics by illustrating how contemporary philosophy can be used to construct an ethical framework for the medical professions. (shrink)
Traditional moral theories of rights and principles have dominated medical ethics discussions for decades. Appeals to utilitarian consequences, as well as the principles of respect for autonomy, beneficence, and justice, have provided the standard vocabulary and filled the literature of the field.Recently on the bioethics scene, however, there has been some discussion of virtue, and, particularly within the nursing ethics literature, appeals are being made to the feminist ethics of care. This intimation of a shift in the wind may have (...) to do with postmodern doubt, or it may be attributable to the claim that virtue theory and the ethics of care are more appropriate to private interaction; theories of rights and justice are best applied to the political domain of public policy. (shrink)
Hobbes presents the fifth Law of Nature, Mutual Accommodation, in Leviathan, Chapter XV. Although a great deal of scholarly attention has been devoted to the first four Laws of Nature, hardly any mention of the fifth appears in the literature. This paper explains the fifth Law as a central piece of Hobbes's theory and thereby reveals his progressive inclinations. Drawing upon relevant passages in Leviathan I show how Hobbes's view of property allocation and reallocation derives from this Law and how (...) attention to mutual accommodation directs sovereigns to constrain their grasping inclinations and curb their disposition to overextend legislative authority. (shrink)
a This paper is a revised and shortened version of my chapter, “Justice in Allocations for Terrorism, Biological Warfare, and Public Health” in Public Health Ethics, edited by Michael Boylan, Kluwer; 2004. Portions of this material were presented at the International Bioethics Retreat, Pavia, Italy, June 2003, and at the meetings of the Association for Politics and the Life Sciences, Philadelphia, September 2003.
