Franklin Miller

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...

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of ‘total brain failure’ or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …

Although established in the law and current practice, the determination of death according to neurological criteria continues to be controversial. Some scholars have advocated return to the traditional circulatory and respiratory criteria for determining death because individuals diagnosed as ‘brain dead’ display an extensive range of integrated biological functioning with the aid of mechanical ventilation. Others have attempted to refute this stance by appealing to the analogy between decapitation and brain death. Since a decapitated animal is obviously dead, and ‘brain death’ represents physiological decapitation, brain dead individuals must be dead. In this article we refute this ‘decapitation gambit.’ We argue that decapitated animals are not necessarily dead, and that, moreover, the analogy between decapitation and the clinical syndrome of brain death is flawed

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured

: 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

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..

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

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

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...

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.

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.

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