What makes placebo-controlled trials unethical?

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.     

论临床试验中的治疗性误解及对策

研究和临床治疗在根本目的、基本方法、风险的正当性,以及应遵循的伦理原则等多方面都存在着根本性的区别。在临床试验的理论与实践中,混淆治疗与研究两者的区别,就会造成治疗性误解,从而违背科研伦理的知情同意原则,损害受试者的利益。以研究和治疗的区分为出发点,对治疗性误解的原因、引起的主要伦理问题及对策加以讨论。     

Callicott's Land Communitarianism

In his most recent collection of papers, J. Baird Callicott has continued to advance a communitarian environmental ethic inspired by the mid–century "land ethic" writings of Aldo Leopold. One subject of concern is a dilemma. Either: the position is open to a charge of "eco–fascism" because it holds that only one maximal community fundamentally matters and interests of smaller communities and individuals can be swamped by a fundamental concern with the whole. Or: it is a "paper tiger" because it says that many communities fundamentally matter, but offers no advice about how we are settle prima–facie conflicts of obligations tied to our various communities. Callicott now offers two new second–order priority principles designed to steer the communitarian position through the dilemma. I outline the relevant parts of his new position. However, I argue that one of the principles ends up offering no coherent advice over the priority of the very communities that inspire interest in the position of Leopold. Callicott proposes that the more intimate and venerable of our communities should have priority, but these elements can come apart in the relevant cases     

Risk and Trust in Public Health: A Cautionary Tale

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.     

EDUCATING PHYSICIANS FOR MORAL EXCELLENCE IN THE TWENTY-FIRST CENTURY

Medical professionals are a community of highly educated individuals with a commitment to a core set of ideals and principles. This community provides both technical and ethical socialization. The ideal physician is confident, empathic, forthright, respectful, and thorough. These ideals allow us to define broadly "the excellence" of being a physician. At the core of these ideals is the ability to be empathic. Empathy exhibits itself in attributes of an individual's moral character and also in actions that actualize and support communal life. Empathy, however, can be diminished or even lost and must be nurtured on an ongoing basis. The development of ethical physicians is strongly linked to experiences in the training period. Moral traits are situation-sensitive psychological and behavioral dispositions. The clinical environment of medical training programs can be so intense as to lead to conditions that may actually deprofessionalize trainees. Creating a clinical environment that is ethically nurturing and sustaining is an indispensable component of practicing medicine.     

Therapy at the Cultural Interface: Implications of African Cosmology for Traumatic Stress Intervention

The topic of intercultural or multicultural therapy continues to stimulate much debate in the field of psychotherapy. Intercultural counseling training emphasizes respect for cultural beliefs as a core dimension of appropriate intervention. This paper addresses the limitations of this perspective in guiding therapists when faced with a clinical situation in which the non-challenging of cultural belief systems seems counter-therapeutic. The discussion is focused around critical observations of circumstances in which conventional African wisdom, as understood by clients presenting for trauma counseling, appeared to be counterproductive for their recovery in terms of western intervention principles. In psychotherapy for traumatic stress and traumatic bereavement, such tensions appear to arise particularly strongly because of the inevitable search for meaning in the face of extraordinary life events. Focusing on meaning making, cognitive intervention, schema realignment and reframing within trauma therapy, the paper explores ethical considerations and areas of potential conflict with reference to theory and clinical case material. Some strategies for therapeutic engagement are proposed.     

Telemedicine in Primary Health: The Virtual Doctor Project Zambia

Physician-researchers are bound by professional obligations stemming from both the role of the physician and the role of the researcher. Currently, the dominant models for understanding the relationship between physician-researchers' clinical duties and research duties fit into three categories: the similarity position, the difference position and the middle ground. The law may be said to offer a fourth "model" that is independent from these three categories. These models frame the expectations placed upon physician-researchers by colleagues, regulators, patients and research participants. This paper examines the extent to which the data from semi-structured interviews with 30 physician-researchers at three major pediatric hospitals in Canada reflect these traditional models. It seeks to determine the extent to which existing models align with the described lived experience of the pediatric physician-researchers interviewed. Ultimately, we find that although some physician-researchers make references to something like the weak version of the similarity position, the pediatric-researchers interviewed in this study did not describe their dual roles in a way that tightly mirrors any of the existing theoretical frameworks. We thus conclude that either physician-researchers are in need of better training regarding the nature of the accountability relationships that flow from their dual roles or that models setting out these roles and relationships must be altered to better reflect what we can reasonably expect of physician-researchers in a real-world environment.     

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

Randomization is the "gold standard" design for clinical research trials, and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This paper analyzes the ethical tensions that arise from conducting these studies, and examines the moral psychology of this design from the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis.     

Clinical Audit and Reform of the UK Research Ethics Review System

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue.     

作为分支学科的心理传记学：当前困境与应对

通过近百年的发展,心理传记学作为心理学的一个分支学科逐渐被认可。然而,在科学社会学和科学哲学的视角下,作为分支学科的心理传记学当前还面临以下两大困境：研究对象的非匿名性和知情同意难以实施使得研究的伦理风险受到前所未有的挑战;该领域如何实现学科共同体间的代际传递……在总结国内外研究成果的基础上,本研究回顾解决该领域伦理困境的相应方案和分支学科研究成果如何获得学科共同体的社会承认的尝试性方案,并为推进该领域知识形成自己独特的分支学科范式提出相应的建议。     

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent.     

Evaluating the therapeutic misconception

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.     

Embracing the “Nation”

The idea of the “nation” has played only a small role in modern political philosophy because of its apparent irrationalism and amoralism. David Miller, however, sets out to show that these charges can be overcome: nationality is a rational element of one’s cultural identity, and nations are genuinely ethical communities. In this paper I argue that his project fails. The defence against the charge of irrationalism fails because Miller works within a framework of ethical particularism which leads to a position of metaethical relativism. A consequence of this relativism is that a community’s moral principles and boundaries of exclusion cannot be rationally justified to those constructed as “outsiders”. The defence against the charge of amoralism fails because Miller does not so much provide an argument to show that nations are ethical communities as assume they are; we are therefore left without resources to discriminate between ethical and unethical nations. I apply these problems to Miller’s treatment of the question of immigration, arguing that it shows that his version of “liberal” nationalism has a tendency to collapse towards a conservative position on such issues. This should not give us any great confidence that the nation, as Miller presents it, should be embraced by modern political philosophy. This revised version was published online in August 2006 with corrections to the Cover Date.     

Scientist-administrators at the National Institute of Child Health and Human Development as contributors to the scientific enterprise

At the National Institute of Child Health and Human Development (NICHD), as in other government research supporting agencies, scientist-administrators who are "program staff" work to accomplish their organization's set of research priorities using established mechanisms for supporting research. At the same time, the definition of their work is given to their interpretation, which, in turn, is guided by their understanding of their scientific discipline and their commitment to it. The tension that may arise between the organization-guided role and the science-guided role is more apparent than real because the major responsibility of "program staff" within the Institute is to cultivate a grant portfolio addressing scientific issues relevant to the mission of the Institute and exemplifying the most advanced research concepts and methodologies. When the overlap between the mission of the Institute and the direction of science is small, the push to increase it leads to new and imaginative solutions that benefit both the Institute and the science.     

Research as therapy, therapy as research: Ethical dilemmas in new-paradigm research

Ethical dilemmas are raised by changes in research paradigms which encourage the development of a relationship between researcher and participant. In such contexts it becomes increasingly difficult to tell the difference between a therapeutic relationship and a research interview. The rapid development of research within the therapeutic world of counselling and clinical psychology poses further ethical issues relating to the use of clients as participants in research studies. It is concluded that there must be an increased awareness of these issues and a need to accept responsibility for relationships with both participants and clients.     

The ethics of enforced medical treatment: the balance model

ABSTRACT When is it right to enforce medical treatment on a patient who is refusing that treatment? English law recognises two ethical principles as of paramount importance: the autonomy of the patient; and the consequences of not treating compared with treating. The law, by and large, operates these principles in succession. Thus, in the case of a patient refusing treatment, the law asks first, is the patient competent? Only if the answer is no, are the consequences considered. We criticise the position taken by English law and argue, first, that competence is a graded and not a binary concept, and secondly, that the two ethical principles should be applied not sequentially but at the same time. These two ideas form what we have called the balance model. This model could be used for an empirical study of individuals’ ethical beliefs, and in particular to test the hypothesis that the ethical beliefs of most individuals conform to the balance model rather than to the position taken by English law.     

Four observations about “six domains of research ethics”

Stimulated by Kenneth Pimple's "Six Domains of Research Ethic", this paper examines four aspects of the responsible conduct of research and scientists' social responsibilities. I argue that scholars and decision-makers concerned with the responsible conduct of research should take notice of the rapidly growing body of scholarship on the social organization of science and the behavior of scientists, integrating that work with ethical principles. Of particular concern are the increasing heterogeneity and interdisciplinary of research, the ambivalences in the practice of peer review, the social tensions of research life, and the heightened concern for social and economic returns from federal research investments. In all, the paper echoes and develops Pimple's call for integrative thinking about the responsible conduct of research.     

Secret médical en santé au travail

The occupational physicians are obliged, like any doctor, to respect the ethical obligations imposed on their profession, including in the exercise of the missions specific to occupational medicine and contained in the Labor Code. The occupational physician is not isolated and works in a multidisciplinary team of a health service at work. He must communicate with other health professionals, but also with employers, representative bodies of staff. Medical confidentiality holds a special place in the triangular relationship between the occupational physician, the employee and the employer. The medical practice in the field of occupational health requires that many provisions of the Labor Code be followed, including the respect of the secret of manufacture and the position of advising employers and employees. The occupational physician must communicate with the employer in order to best achieve his mission, but in practice, it may be difficult for the occupational doctor to make his recommendations heard to improve the working conditions of employees without power, when he cannot argue his opinions on medical information.     

When clinical care is like research: the need for review and consent

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients.