In lieu of an abstract, here is a brief excerpt of the content:The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President’s Council on Bioethics*Franklin G. Miller** (bio) and Robert D. Truog (bio)Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological (...) changes in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. Patients with profound neurological damage, leaving them incapable of breathing on their own and in an irreversible coma, could be maintained for some period of time with the aid of mechanical ventilation. The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment?In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation. [End Page 185] Because they are dead, it is appropriate, indeed imperative, to stop mechanical ventilation. And because they are dead, it becomes ethical to procure vital organs for transplantation before stopping what otherwise would be life-sustaining treatment. Remarkably, this innovative neurological determination of death became, with little debate or controversy, the established position in medical ethics and the law throughout the United States.The Harvard Committee articulated the diagnosis of “irreversible coma,” but merely asserted that this condition constituted death. No explanatory rationale was provided. It fell to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to provide an authoritative rationale in its 1981 report, Defining Death. The second paragraph of the report set the stage as follows: “The question addressed here is not inherently difficult or complicated. Simply, it is whether the law ought to recognize new means for establishing that the death of a human being has occurred” (President’s Commission 1981, p. 3). The Commission claimed that “death is a unitary phenomenon” (p. 7) and that the determination of death by neurological criteria, in terms of the absence of all brain function, is consistent with the traditional conception of death as the cessation of vital functioning of the organism as a whole. The key issue is the integrative functioning of the human organism, which ceases to exist, according to the Commission, when the whole brain, including higher cortical areas and the brain stem, fails to function. Although “brain-dead” patients do not appear to be dead—i.e., the reality of their death is “masked” by the activity of mechanical ventilation—the patient’s body has irreversibly lost all capacity for integrative functioning. In the words of the Commission: “When artificial means of support mask this loss of integration as measured by the old methods [cessation of respiration and heart beat], brain-oriented criteria and tests provide a new window on the same phenomenon” (p. 33). The President’s Commission was instrumental in developing and establishing “The Uniform Definition of Death Act”: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead” (p. 2).Although the question posed by the President’s Commission was easy to articulate, the answer, over time, has proved complicated and controversial. The coherence and cogency of determining death by neurological criteria has been challenged. Various experts have demonstrated that “brain-dead” patients maintained on mechanical ventilation display a range of vital, integrative, functioning, which conflicts with the judgment that they are dead (Truog and... (shrink)

Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...) the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to confuse participating in research with receiving personalized medical care. This .. (shrink)

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

The established view regarding ‘brain death’ in medicine and medical ethics is that patients determined to be dead by neurological criteria are dead in terms of a biological conception of death, not a philosophical conception of personhood, a social construction or a legal fiction. Although such individuals show apparent signs of being alive, in reality they are dead, though this reality is masked by the intervention of medical technology. In this article, we argue that an appeal to the distinction between (...) appearance and reality fails in defending the view that the ‘brain dead’ are dead. Specifically, this view relies on an inaccurate and overly simplistic account of the role of medical technology in the physiology of a ‘brain dead’ patient. We conclude by offering an explanation of why the conventional view on ‘brain death’, though mistaken, continues to be endorsed in light of its connection to organ transplantation and the dead donor rule. (shrink)

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...) Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:“Unduly Iterative Ethical Review?”Franklin G. MillerMadam:Renée C. Fox and Nicholas A. Christakis have written a provocative article, “Perish and Publish: Non-Heart-Beating Organ Donation and Unduly Iterative Ethical Review” (KIEJ, December 1995). The language of their argument and some of the implicit assumptions on which it rests deserve critical scrutiny. They describe the articles presenting and commenting on the University of Pittsburgh protocol as “disquieting” because the display “trial-and-error (...) ethics.” To dismiss “trial-and-error ethics” implies that we antecedently possess all the moral knowledge we need to evaluate and regulate developments in medicine. Should we summarily reject experimentation in ethics, particularly with respect to complex issues involving scientific and technological changes? For if we need to reconsider and possibly revise what counts as moral knowledge, the proposing an experimental approach to the ethics of a novel practice, which is presented publicly and made open to revision, as in the Pittsburgh protocol, may be precisely the best way to proceed.Fox and Christakis resort to invidious insinuation in their criticism of ethicists who have written, and journals that have published, articles about non-heart-beating organ donation. Publication on this issue has given ethicists the opportunity of “adding numerous items to their vitae.” Their appraisal of the vitae-boosting behavior represents an interesting rhetorical specimen: “Although there is nothing inherently dishonorable about this it does create tension between two motives: conviction about the importance of perfecting ethical conduct, on the one hand, and the desire to advance one’s professional career, on the other” (p. 340). I am not sure what the authors mean by “perfecting ethical conduct.” Yet they suggest that a group of reputable scholars, who have taken diverse positions on the ethics of non-heart-beating organ donation, have come perilously close to venality.Finally, in order to avoid further legitimating what they consider to be an ethically objectionable practice, the authors advocate that journals exercise “restraint” in publishing articles about this topic. Perhaps in a future pronouncement they will enlighten us about how enforcing a publication policy that avoids the vice of “unduly iterative ethical review” might work without compromising freedom of discussion. Moral dogmatism and censorship have a long history of association.Franklin G. MillerCenter for Biomedical Ethics University of Virginia Charlottesville, VACopyright © 1996 The Johns Hopkins University Press... (shrink)

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...) this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President’s Council on Bioethics*Franklin G. Miller** (bio) and Robert D. Truog (bio)Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological (...) changes in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. Patients with profound neurological damage, leaving them incapable of breathing on their own and in an irreversible coma, could be maintained for some period of time with the aid of mechanical ventilation. The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment?In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation. [End Page 185] Because they are dead, it is appropriate, indeed imperative, to stop mechanical ventilation. And because they are dead, it becomes ethical to procure vital organs for transplantation before stopping what otherwise would be life-sustaining treatment. Remarkably, this innovative neurological determination of death became, with little debate or controversy, the established position in medical ethics and the law throughout the United States.The Harvard Committee articulated the diagnosis of “irreversible coma,” but merely asserted that this condition constituted death. No explanatory rationale was provided. It fell to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to provide an authoritative rationale in its 1981 report, Defining Death. The second paragraph of the report set the stage as follows: “The question addressed here is not inherently difficult or complicated. Simply, it is whether the law ought to recognize new means for establishing that the death of a human being has occurred” (President’s Commission 1981, p. 3). The Commission claimed that “death is a unitary phenomenon” (p. 7) and that the determination of death by neurological criteria, in terms of the absence of all brain function, is consistent with the traditional conception of death as the cessation of vital functioning of the organism as a whole. The key issue is the integrative functioning of the human organism, which ceases to exist, according to the Commission, when the whole brain, including higher cortical areas and the brain stem, fails to function. Although “brain-dead” patients do not appear to be dead—i.e., the reality of their death is “masked” by the activity of mechanical ventilation—the patient’s body has irreversibly lost all capacity for integrative functioning. In the words of the Commission: “When artificial means of support mask this loss of integration as measured by the old methods [cessation of respiration and heart beat], brain-oriented criteria and tests provide a new window on the same phenomenon” (p. 33). The President’s Commission was instrumental in developing and establishing “The Uniform Definition of Death Act”: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead” (p. 2).Although the question posed by the President’s Commission was easy to articulate, the answer, over time, has proved complicated and controversial. The coherence and cogency of determining death by neurological criteria has been challenged. Various experts have demonstrated that “brain-dead” patients maintained on mechanical ventilation display a range of vital, integrative, functioning, which conflicts with the judgment that they are dead (Truog and... (shrink)

We seek to change the conversation about brain death by highlighting the distinction between brain death as a biological concept versus brain death as a legal status. The fact that brain death does not cohere with any biologically plausible definition of death has been known for decades. Nevertheless, this fact has not threatened the acceptance of brain death as a legal status that permits individuals to be treated as if they are dead. The similarities between “legally dead” and “legally blind” (...) demonstrate how we may legitimately choose bright-line legal definitions that do not cohere with biological reality. Not only does this distinction bring conceptual coherence to the conversation about brain death, but it has practical implications as well. Once brain death is recognized as a social construction not grounded in biological reality, we create the possibility of changing the social construction in ways that may better serve both organ donors and recipients alike. (shrink)

A basic question of medical ethics is whether the norms governing medical practice should be understood as the application of principles and rules of the common morality to medicine or whether some of these norms are internal or proper to medicine. In this article we describe and defend an evolutionary perspective on the internal morality of medicine that is defined in terms of the goals of clinical medicine and a set of duties that constrain medical practice in pursuit of these (...) goals. This perspective is developed by means of a critical examination of the essentialist conception of the internal morality of medicine advocated by Edmund Pellegrino and the critique of internal morality approaches by Robert Veatch and Tom Beauchamp. (shrink)

The practice of voluntary physician‐assisted death as a last resort is compatible with doctors' duties to practice competently, to avoid harming patients unduly, to refrain from medical fraud, and to preserve patients' trust. It therefore does not violate physicians' professional integrity.

Cosmetic surgery is a fast-growing medical practice. In 1997 surgeons in the United States performed the four most common cosmetic procedures443,728 times, an increase of 150% over the comparable total for 1992. Estimated total expenditures for cosmetic surgery range from $1 to $2 billion. As managed care cuts into physicians' income and autonomy, cosmetic surgery, which is not covered by health insurance, offers a financially attractive medical specialty.

What makes an act of killing morally wrong is not that the act causes loss of life or consciousness but rather that the act causes loss of all remaining abilities. This account implies that it is not even pro tanto morally wrong to kill patients who are universally and irreversibly disabled, because they have no abilities to lose. Applied to vital organ transplantation, this account undermines the dead donor rule and shows how current practices are compatible with morality.

Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic (...) surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent. (shrink)

Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic (...) surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent. (shrink)

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they (...) believed it had a higher price. (shrink)

: Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor-patient relationship.

In The Healer's Power, Howard Brody placed the concept of power at the heart of medicine's moral discourse. Struck by the absence of “power” in the prevailing vocabulary of medical ethics, yet aware of peripheral allusions to power in the writings of some medical ethicists, he intuited the importance of power from the silence surrounding it. He formulated the problem of the healer's power and its responsible use as “the central ethical problem in medicine.” Through the prism of power he (...) refracted a wide range of ethical problems, from informed consent to truth-telling, from confidentiality to futility, from the physician's fantasies to the physician's virtues. At times this prism shed new light on old problems, enabling us to see from an unexpected angle the elements of which the problem was composed. At other times it exposed issues of ethical significance that had been neglected in the bioethics literature. (shrink)

: Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology (...) to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception. (shrink)

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...) that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

Accepted medical practice already violates the dead donor rule. Explicitly jettisoning the rule—allowing vital organs to be extracted, under certain conditions, from living patients—is a radical change only at the conceptual level. But it would expand the pools of eligible organ donors.

Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including (...) patients’ motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. (shrink)

Bioethics is a hybrid discipline. As a theoretical enterprise it stands for untrammeled inquiry and argument. Yet it aims to influence medical practice and policy. In this article we explore tensions between these two dimensions of bioethics and examine the merits and perils of a “Socratic” approach to bioethics that challenges “the conventional wisdom.”.

: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...) a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions. (shrink)

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold (...) that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)

This book assembles the contributions of a distinguished group of scholars concerning the ethics of consent in theory and practice.

Conventional medical ethics and the law draw a bright line distinguishing the permitted practice of withdrawing life-sustaining treatment from the forbidden practice of active euthanasia by means of a lethal injection. When clinicians justifiably withdraw life-sustaining treatment, they allow patients to die but do not cause, intend, or have moral responsibility for, the patient's death. In contrast, physicians unjustifiably kill patients whenever they intentionally administer a lethal dose of medication. We argue that the differential moral assessment of these two practices (...) is based on a series of moral fictions – motivated false beliefs that erroneously characterize withdrawing life-sustaining treatment in order to bring accepted end-of-life practices in line with the prevailing moral norm that doctors must never kill patients. When these moral fictions are exposed, it becomes apparent that conventional medical ethics relating to end-of-life decisions is radically mistaken. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment (...) and informed consent. (shrink)

Some ethical issues facing contemporary medicine cannot be fully understood without addressing medicine's internal morality. Medicine as a profession is characterized by certain moral goals and morally acceptable means for achieving those goals. The list of appropriate goals and means allows some medical actions to be classified as clear violations of the internal morality, and others as borderline or controversial cases. Replies are available for common objections, including the superfluity of internal morality for ethical analysis, the argument that internal morality (...) is merely an apology for medicine's traditional power and authority, and the claim that there is no single, "core" internal morality. The value of addressing the internal morality of medicine may be illustrated by a detailed investigation of ethical issues posed by managed care. Managed care poses some fundamental challenges for medicine's internal morality, but also calls for thoughtful reflection and reconsideration of some traditionally held moral views on patient fidelity in particular. (shrink)

We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about (...) how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems. (shrink)

We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about (...) how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems. (shrink)

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one (...) that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research. (shrink)

Physicians commonly recommend ?placebo treatments?, which are not believed to have specific efficacy for the patient's condition. Motivations for placebo treatments include complying with patient expectations and promoting a placebo effect. In this article, we focus on two key empirical questions that must be addressed in order to assess the ethical legitimacy of placebo treatments in clinical practice: 1) do placebo treatments have the potential to produce clinically significant benefit? and 2) can placebo treatments be effective in promoting a therapeutic (...) placebo response without the use of deception? We examine evidence from clinical trials and laboratory experiments bearing on these two questions. The conclusion is reached that based on currently available evidence, it is premature to judge whether placebo treatments are ethically justifiable, with the possible exception of acupuncture for pain relief. (shrink)

Given the long-standing controversy about whether the brain-dead should be considered alive in an irreversible coma or dead despite displaying apparent signs of life, the ethical and policy issues posed when family members insist on continued treatment are not as simple as commentators have claimed. In this article, we consider the kind of policy that should be adopted to manage a family's insistence that their brain-dead loved one continues to receive supportive care. We argue that while it would be ethically (...) inappropriate to continue to devote scarce acute care resources to such patients in a hospital setting, it may not be ethically inappropriate for patients to receive these resources in certain other settings. Thus, if a family insists on continuing to care for their brain-dead loved at their home, we should not, from a policy perspective, interfere with the family's wishes. We also argue that healthcare professionals should make some effort to facilitate the transfer of brain-dead patients to these other settings when families insist on continued treatment despite being informed about the lack of any potential for recovery of consciousness. Our arguments are strengthened by the fact that patients in a persistent vegetative state, who, when correctly diagnosed, also have no potential for recovery of consciousness, are routinely transferred from hospitals to nursing homes or long-term care facilities where they continue to be ventilated, tube fed and to receive other supportive care. We also briefly explore the question of who should be responsible for the costs of such treatment at the long-term care facility. (shrink)

In a recent article in this Journal, Shlomo Cohen and Haim Shapiro introduce the concept of “comparable placebo treatments” —placebo treatments with biological effects similar to the drugs they replace—and argue that doctors are not being deceptive when they prescribe or administer CPTs without revealing that they are placebos. We critique two of Cohen and Shapiro’s primary arguments. First, Cohen and Shapiro argue that offering undisclosed placebos is not lying to the patient, but rather is making a self-fulfilling prophecy—telling a (...) “lie” that, ideally, will become true. We argue that offering undisclosed placebos is not a “lie” but is a straightforward case of deceptively misleading the patient. Second, Cohen and Shapiro argue that offering undisclosed CPTs is not equivocation. We argue that it typically is equivocation or deception of another sort. If justifiable, undisclosed placebo use will have to be justified as a practice that is deceptive in most instances. (shrink)