Franklin Miller

: 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.

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.

The use of deception in research is generally permitted so long as participants are debriefed at the conclusion of their participation. Several authoritative research ethics guidelines allow investigators to omit debriefing under certain circumstances, however. Here we examine various justifications for forgoing debriefing in deceptive research, including concerns about subject pool contamination, the risk that revealing the deception will be harmful or distressing to participants, and issues of practicability. We conclude that, contrary to current practice, omitting debriefing is ethically acceptable only when debriefing is impracticable, the deception is innocuous, and no reasonable person would object to involvement in the research.

The problem of physician-assisted death, assisted suicide and active euthanasia, has been debated predominantly in the ethically familiar vocabulary of rights, duties, and consequences. Patient autonomy and the right to die with dignity vie with the duty of physicians to heal, but not to kill, and the specter of “the slippery slope” from voluntary euthanasia as a last resort for patients suffering from terminal illness to PAD on demand and mercy killing of “hopeless” incompetent patients. Another dimension of the debate over PAD concerns the evaluative question of what constitutes a good death. At stake are Issues of character and virtue in the face of death and dying and their Implications for legitimizing the practice of PAD. Critics of PAD argue that “natural” death in the context of comfort care, as provided by hospice programs, is the good death. In contrast, PAD amounts to an easy way out, an evasion of the ultimate human challenge and task of dying. Because hospice care is clearly preferable to PAD, the former should be encouraged and the latter remain prohibited

On June 16, 1966, the New England Journal of Medicine published “Ethics and Clinical Research” by Henry K. Beecher. Beecher’s account of 22 examples of unethical contemporary clinical research shook up the medical profession and helped pave the way for U.S. federal regulation of research involving human subjects. Five decades later, in this issue of Perspectives in Biology and Medicine, we pay tribute to the lasting significance of this whistle-blowing article and to the remarkable contributions of Henry Beecher. Beecher was a pioneer in anesthesiology as an academic discipline and in research on pain and the placebo effect. He was an early and influential champion of randomized placebo-controlled...

: 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.

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.

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..