: 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.
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)
: 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.
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)
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)
: 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)
Traditionally, biomedical research has been devoted to improvement in the understanding and treatment or prevention of disease. Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer (Turner et al. 2003; Vastag 2004; Rose 2002). As with other biomedical interventions, research to assess the safety and efficacy of these enhancements in humans should be conducted (...) before their introduction into clinical practice.1 However, various concerns regarding the ethics of enhancement research could be raised. Those who .. (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)
: This paper presents a method of moral problem solving in clinical practice that is inspired by the philosophy of John Dewey. This method, called "clinical pragmatism," integrates clinical and ethical decision making. Clinical pragmatism focuses on the interpersonal processes of assessment and consensus formation as well as the ethical analysis of relevant moral considerations. The steps in this method are delineated and then illustrated through a detailed case study. The implications of clinical pragmatism for the use of principles in (...) moral problem solving are discussed. (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)
This book challenges fundamental doctrines of established medical ethics. It is argued that the routine practice of stopping life support technology causes the death of patients and that donors of vital organs (hearts, liver, lungs, and both kidneys) are not really dead at the time that their organs are removed for life-saving transplantation. Although these practices are ethically legitimate, they are not compatible with traditional medical ethics: they conflict with the norms that doctors must not intentionally cause the death of (...) their patients and that vital organs can be obtained only from dead donors. The aim of this book is to undertake an ethical examination that aims to honestly face the reality of medical practices at the end of life. This involves exposing the misconception that stopping life support merely allows patients to die from their medical conditions, that there is an ethical bright line separating withdrawal of life support from active euthanasia, and that determination of death of hospitalized patients prior to vital organ donation is consistent with the established biological conception of death. A novel ethical justification is required for procuring vital organs from still-living donors. It is contended that in the context of plans to withdraw life support, donors of vital organs are not harmed or wronged by organ procurement prior to death, provided that valid consent is obtained for stopping treatment and organ donation. In view of serious practical difficulties in facing the truth regarding organ donation, an alternative pragmatic account is developed for justifying current practices that relies on the concept of transparent legal fictions. In sum, it is the thesis of this book that to preserve the legitimacy of end-of-life practices, we need to reconstruct medical ethics. (shrink)
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)
Doctor–patient communication is a crucial component in any therapeutic encounter. Physicians use words to formulate diagnoses and prognoses, to disclose the risks and benefits of medical interventions, and to explain why, how, and when a therapy will be administered to a patient. Likewise, patients communicate to describe their symptoms, to make sense of their conditions, to report side effects, to explore other therapeutic options, and to share their feelings. Throughout the history of medicine, the ethics of the doctor–patient communication has (...) been traditionally grounded on considerations of paternalistic beneficence and nonmaleficence. In this respect, it was no different from the ethics regulating.. (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.”.
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)
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)
Controversies about the diagnosis and meaning of brain death have existed as long as the concept itself. Here we review the historical development of brain death, and then evaluate the various attempts to justify the claim that patients who are diagnosed as brain dead can be considered dead for all legal and social purposes, and especially with regard to procuring their vital organs for transplantation. While we agree with most commentators that death should be defined as the loss of integration (...) of the functioning of the organism as a whole, we conclude that patients diagnosed as brain dead have not, in fact, lost this integrated functioning. We close with reflections on the implications of this conclusion generally and particularly with regard to organ transplantation, and briefly make reference to alternative approaches to justifying the procurement of transplantable organs that do not depend upon a flawed approach to the diagnosis of death. (shrink)
: The "therapeutic misconception," described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic (...) misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials. (shrink)
: Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This (...) framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely. (shrink)
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.
: This response to Lynn Jansen's critique of clinical pragmatism concentrates on two themes: (1) contrasting approaches to moral epistemology and (2) the connection between theory and practice in clinical ethics. Particular attention is paid to the status of principles and the role of consensus, with some closing speculations on how Dewey might view the current state of bioethics.
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)
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)
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)
The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...) to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry. (shrink)
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)
Despite growing scientific interest in the placebo effect and increasing understanding of neurobiological mechanisms (Finniss et al. 2010), theoretical conceptualization of the placebo effect remains primitive (Miller, Colloca, and Kaptchuk 2009). Mechanistic research on this phenomenon appears largely free-floating, with little guidance by any systematic theoretical paradigm. A partial explanation is the pervasive conceptual confusion that characterizes thinking about the placebo effect. The philosopher of science Adolf Grunbaum noted that "the medical and psychiatric literature on placebos and their effects is (...) conceptually bewildering, to the point of being a veritable Tower of Babel" (Grunbaum 1994, p. 286). .. (shrink)