Franklin Miller

Background It has been suggested that researchers are obliged to offer summary findings to research participants to demonstrate respect for persons, and that this may increase public trust in, and awareness of, the research enterprise. Yet little research explores researchers' attitudes and practices regarding the range of initiatives that might serve these ends. Methods Results of an international survey of 785 eligible authors of genetics research studies in autism or cystic fibrosis are reported. Results Of 343 researchers who completed the survey (44% response rate), the majority agreed that their team should (i) inform participants of summary findings (90.7%) and (ii) ensure they gain an awareness of developments in the field (86.9%). Additionally, the majority reported that in practice, their team (i) informs participants of summary findings (69.4%) and (ii) provides other types of relevant non-results information (eg, state of science in the field, opportunities for research participation) (67.9%). Conclusion Researchers endorsed the obligation of communicating with research participants by providing summary findings and other research-related information in equal measure. In light of these findings, it is suggested that while the provision of summary results may contribute to efforts to discharge the obligation of respect for persons, it may be neither a necessary nor a sufficient means to this end

John McMillan's article raises numerous important points about the ethics of surgical castration of sex offenders.1 In this commentary, we focus solely on and argue against the claim that the offer of release from detention conditional upon surgical castration is a coercive offer that compromises the validity of the offender's consent. We take no view on the question as to whether castration for sex offenders is ethically permissible. But, we reject the claim that it is ethically permissible only if competing ethical considerations outweigh worries about coercion. For in the situation described, the proposal is not coercive at all.McMillan states that if offenders agree to castration because they fear long-term detention, then ‘it seems, intuitively, as if agreeing to be castrated under these conditions makes the decision coerced in some way.’1 He adds that if castration is ‘the only way that they will be released back into the community, the status of this decision as a genuine expression of their autonomy is questionable.’1 In defence of his claim, he uses two analogies that he borrows from Joel Feinberg. First, if a governor offers to commute a death sentence if the prisoner agrees to participate in a medical experiment, then ‘it's clear that the governor is coercing the prisoner.’1 Second, if a millionaire offers to give a woman $1 000 000 …

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.

Despite strong growth in scientific investigation of the placebo effect, understanding of this phenomenon remains deeply confused. We investigate critically seven common conceptual distinctions that impede clear understanding of the placebo effect: (1) verum/placebo, (2) active/inactive, (3) signal/noise, (4) specific/nonspecific, (5) objective/subjective, (6) disease/illness, and (7) intervention/context. We argue that some of these should be eliminated entirely, whereas others must be used with caution to avoid bias. Clearing away the conceptual underbrush is needed to lay down a path to understanding and harnessing placebo effects in clinical medicine

What is a good death? How does one live well in the face of (potentially) terminal illness? Philosophical analysis has a great deal to offer in approaching these puzzling and deep questions. Perhaps more can be gleaned of cultural and personal significance, however, from narratives of those who have been forced to face these questions in their lives and in their writings. The greatest yield, I suggest, comes from combining narrative with philosophical reflections.Commentators have frequently contrasted the way we die today with deaths in the past (Callahan 1993, 2003; Hardwig 2009). Before the first half of the 20th century, people mainly died from infectious diseases, with a rapid onset and swift progression to ..

The practice of transplantation of vital organs from “brain-dead” donors is in a state of theoretical disarray. Although the law and prevailing medical ethics treat patients diagnosed as having irreversible total brain failure as dead, scholars have increasingly challenged the established rationale for regarding these patients as dead. To understand the ethical situation that we now face, it is helpful to revisit the writings of the philosopher Hans Jonas, who forcefully challenged the emerging effort to redefine death in the late 1960s.

Background: Expanded newborn screening generates incidental results, notably carrier results. Yet newborn screening programmes typically restrict parental choice regarding receipt of this non-health serving genetic information. Healthcare providers play a key role in educating families or caring for screened infants and have strong beliefs about the management of incidental results. Methods: To inform policy on disclosure of infant sickle cell disorder (SCD) carrier results, a mixed-methods study of healthcare providers was conducted in Ontario, Canada, to understand attitudes regarding result management using a cross-sectional survey (N = 1615) and semistructured interviews (N = 42). Results: Agreement to reasons favouring disclosure of SCD carrier results was high (65.1%–92.7%) and to reasons opposing disclosure was low (4.1%–18.1%). Genetics professionals expressed less support for arguments favouring disclosure (35.3%–78.8%), and more agreement with arguments opposing disclosure (15.7%–51.9%). A slim majority of genetics professionals (51.9%) agreed that a reason to avoid disclosure was the importance of allowing the child to decide to receive results. Qualitatively, there was a perceived “duty” to disclose, that if the clinician possessed the information, the clinician could not withhold it. Discussion: While a majority of respondents perceived a duty to disclose the incidental results of newborn screening, the policy implications of these attitudes are not obvious. In particular, policy must balance descriptive ethics (ie, what providers believe) and normative ethics (ie, what duty-based principles oblige), address dissenting opinion and consider the relevance of moral principles grounded in clinical obligations for public health initiatives

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.

Current guidelines on investigators' responsibilities to communicate research results to study participants may differ on whether investigators should proactively re-contact participants, the type of results to be offered, the need for clinical relevance before disclosure, and the stage of research at which results should be offered. Lack of consistency on these issues, however, does not undermine investigators' obligation to offer to disclose research results: an obligation rooted firmly in the principle of respect for research participants

Next SectionThere has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents

In the midst of the recent Ebola outbreak, scientific developments involving infection challenge experiments on nonhuman primates (NHPs) sparked hope that successful treatments and vaccines may soon become available. Yet these studies pose a stark ethical quandary. On the one hand, they represent an important step in developing novel therapies and vaccines for Ebola and the Marburg virus, with the potential to save thousands of human lives and to protect whole communities from devastation; on the other hand, they intentionally expose sophisticated animals to severe suffering and a high risk of death. Other studies that infect NHPs with a lethal disease in order to test interventions that may prove beneficial for humans pose the same ethical difficulty. Some advocates have argued that all research on primates should be phased out, and ethicists have questioned whether a moral justification of primate research is possible. A 2010 European Union directive banned virtually all research on great apes, and 2013 guidelines from the National Institutes of Health (NIH), based upon recommendations in an influential 2011 Institute of Medicine (IOM) report, eliminated most biomedical research with chimpanzees in the United States. But studies involving other NHPs face no comparable restrictions.Should research on NHPs other than great apes be subject to tighter restrictions than it currently is? In this article, we explore this general question in the context of one particular type of biomedical research: infection challenge studies. We advocate a presumptive prohibition on infection challenge experiments in NHPs, but we also argue that exceptions to this prohibition are permissible, subject to strict substantive and procedural safeguards, when necessary to avert substantial loss of human life or severe morbidity for a substantial number of people.

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

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

In lieu of an abstract, here is a brief excerpt of the content:Introduction to the Special SectionFranklin G. MillerHappy is a female elephant who has been confined at the Bronx Zoo for over 40 years. In 2018 the Nonhuman Rights Project sued the Wildlife Conservation Society, which manages the zoo, seeking habeas corpus for Happy in order to release her to an elephant sanctuary. Numerous amicus curiae briefs were filed in favor and against the petition on behalf of Happy. The case reached the highest court in New York State, which denied the petition of the plaintiff in June 2022.This special section includes views on the case of Happy by David DeGrazia, Martha Nussbaum, and Christine Korsgaard, three distinguished moral philosophers who have made significant contributions to animal ethics. The essays by Martha Nussbaum and Christine Korsgaard are drawn from the amicus briefs that they filed in the legal proceedings, which they agreed could be published here.Professor Nussbaum applies her "capabilities approach" as a foundation for promoting wellbeing and recognizing rights to Happy and to elephants in general. She argues that Happy is a being with a meaningful life and is entitled to be treated with respect and dignity, which is incompatible with her conditions of confinement at the zoo. Professor Korsgaard applies her understanding of the moral philosophy of Immanuel Kant to the case of Happy—a "cognitively sophisticated [End Page 1] animal" which, like human beings, should be treated as an end in herself and not merely as a means to the purposes of human beings. Professor DeGrazia, in an invited essay, analyzes the meanings of "person" and examines the pertinent characteristics of elephants that make them at least "borderline persons," with the moral status of possessing basic rights.While Happy remains confined at the Bronx Zoo, these three incisive contributions challenge readers to reflect on the ethical treatment of nonhuman animals, especially those with complex and rich capacities of intelligence and emotion. [End Page 2]Franklin G. MillerWeill Cornell Medical College, New YorkCopyright © 2023 Johns Hopkins University Press...

Hospice is the premiere end of life program in the United States, but its requirement that patients forgo disease-directed therapies and that they have a prognosis of 6 months or less means that it serves less than half of dying patients and often for very short periods of time. Palliative care offers careful attention to pain and symptom management, added support for patients and families, and assistance with difficult medical decision making alongside any and all desired medical treatments, but it does not include a comprehensive system of care as is provided by hospice. The practice of palliative care and hospice is filled with sometimes overt (requests for hastened death in an environment where such acts are legally prohibited) and other times covert (the delay in palliative care referral because the health care team believes it will undermine disease directed treatment) ethical issues. The contributors to this volume use a series of case presentations within each chapter to illustrate some of the palliative care and hospice challenges with significant ethical dimensions across the three overarching domains: 1) care delivery systems; 2) addressing the many dimensions of suffering; and 3) difficult decisions near the end of life. The contributors are among the most experienced palliative care, hospice and ethics scholars in North America and Western Europe. Each has been given relatively free reign to address what they feel are the most pressing ethical challenges within their domain, so a wide range of positions and vantage points are represented. As a result, the volume provides a very diverse ethical exploration of this relatively young field that can deepen, stretch, and at times confront any simple notion of the challenges facing patients, their families, professional caregivers, and policy makers.

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 ..

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 ..

Der folgende Artikel ist im Jahr 2003 unter dem Titel „Clinical Pragmatism: A Method of Moral Problem Solving“ in dem Sammelband „Pragmatic bioethics“ erschienen, welcher sich mit der Bedeutung der pragmatistischen Philosophie für die Praxis befasst. In dem vom Internisten und Bioethiker Joseph J. Fins, dem Thoraxchirurgen Matthew D. Bacchetta und dem Philosophen und Medizinethiker Franklin G. Miller verfassten Beitrag wird der pragmatistische Ansatz in der klinischen Ethik anhand eines Fallbeispiels gleichzeitig beschrieben, begründet und demonstriert. Obgleich die Denkrichtung der pragmatistischen Philosophie sowohl wissenschaftstheoretisch wie praktisch hoch bedeutsam ist – ohne diese ist weder die heutige sozialwissenschaftliche Forschung noch die angewandte, insbesondere die klinische Ethik denkbar –, werden pragmatistische Ansätze im deutschsprachigen Raum bis heute eher rudimentär rezipiert.

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.