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Machine intelligence already helps medical staff with a number of tasks. Ethical decision-making, however, has not been handed over to computers. In this proof-of-concept study, we show how an algorithm based on Beauchamp and Childress' prima-facie principles could be employed to advise on a range of moral dilemma situations that occur in medical institutions. We explain why we chose fuzzy cognitive maps to set up the advisory system and how we utilized machine learning to train it. We report on the difficult task of operationalizing the principles of beneficence, non-maleficence and patient autonomy, and describe how we selected suitable input parameters that we extracted from a training dataset of clinical cases. The first performance results are promising, but an algorithmic approach to ethics also comes with several weaknesses and limitations. Should one really entrust the sensitive domain of clinical ethics to machine intelligence?

In situations like the one presented here (Johnson et al. 2020), adolescent participants should be allowed to consent independently, without parental permission being required or even solicited.The...

Johan Bester (2020) complicates the principle of beneficence in an important sense by showing that both objective wellbeing and subjective value judgments need to be weighed when physicians are see...

Johan Bester’s target article (2020) explores conceptions of well-being before proposing a hybrid objective-subjective approach in an effort to illuminate beneficence in medicine. Bester is entirel...

In this article, I argue that (1) transgender adolescents should have the legal right to access puberty-blocking treatment (PBT) without parental approval, and (2) the state has a role to play in publicizing information about gender dysphoria. Not only are transgender children harmed psychologically and physically via lack of access to PBT, but PBT is the established standard of care. Given that we generally think that parental authority should not go so far as to (1) severally and permanently harm a child and (2) prevent a child from access to standard physical care, then it follows that parental authority should not encompass denying gender-dysphoric children access to PBT. Moreover, transgender children without supportive parents cannot be helped without access to health care clinics and counseling to facilitate the transition. Hence there is an additional duty of the state to help facilitate sharing this information with vulnerable teens.

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.

For many years the prevailing paradigm for medical decision making for children has been the best interest standard. Recently, some authors have proposed that Mill's "harm principle" should be used to mediate or to replace the best interest standard. This article critically examines the harm principle movement and identifies serious defects within the project of using Mill's harm principle for medical decision making for children. While the harm principle proponents successfully highlight some difficulties in present-day use of the best interest standard, the use of the harm principle suffers substantial normative and conceptual problems. A medical decision-making framework for children is suggested, grounded in the four principles. It draws on the best interest standard, incorporates concepts of harm, and provides two questions that can act as guide and limit in medical decision making for children.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals.

Contemporary biomedical ethics and environmental ethics share a common ancestry in Aldo Leopold's and Van Rensselaer Potter's initial broad visions of a connected biosphere. Over the past five decades, the two fields have become strangers. Public health ethics, a new subfield of bioethics, emerged from the belly of contemporary biomedical ethics and has evolved over the past 25 years. It has moved from its traditional concern with the tension between individual autonomy and community health to a wider focus on social justice and solidarity. Public health has a broad focus that includes individual, community, and environmental health. Public health ethics attends to these broad commitments reflected in the increasing concern with the connectedness of health of individuals to the health of populations, to the health of animals, to the health of the environment; it is well situated to reconnect all three "fields" of ethics to promote a healthier planet.

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it.

Nocebo effects occur when an adverse effect on the patient arises from the patient's own negative expectations. In accordance with informed consent, providers often disclose information that results in unintended adverse outcomes for the patient. While this may adhere to the principle of autonomy, it violates the doctrine of "primum non nocere," given that side-effect disclosure may cause those side effects. In this article we build off previous work, particularly by Wells and Kaptchuk ( 2012 ) and by Cohen ( 2013 ), to suggest ethical guidelines that permit nondisclosure in the case when a nocebo effect is likely to occur on of the basis of nonmaleficence. We accept that that autonomy vis-à-vis informed consent must be forestalled, but salvage much of its role by elaborating a practical clinical approach to postencounter follow-up. In doing so, we reconcile a clinically practicable process of determining conditions of disclosure with long-standing ethical commitments to patients.

We appreciate the thoughtful commentary on our piece, “Partnering with patients to bridge the gap in consent for acute care research” (Dickert et al. 2020). We are encouraged by the support for the...

Professional sport in the United States has widely adopted biometric technologies, dramatically expanding the monitoring of players' biodata. These technologies have the potential to prevent injuries, improve performance, and extend athletes' careers; they also risk compromising players' privacy and autonomy, the confidentiality of their data, and their careers. The use of these technologies in professional sport and the consumer sector remains largely unregulated and unexamined. We seek to provide guidance for their adoption by examining five areas of concern: (1) validity and interpretation of data; (2) increased surveillance and threats to privacy; (3) risks to confidentiality and concerns regarding data security; (4) conflicts of interest; and (5) coercion. Our analysis uses professional sport as a case study; however, these concerns extend to other domains where their use is expanding, including the consumer sector, collegiate and high school sport, the military, and commercial sectors where monitoring employees is viewed as useful for safety or to maximize labor potential.

In their article “Empowerment Failure: How Shortcomings in Physician Communication Unwittingly Undermine Patient Autonomy,” authors Ubel, Scherr, and Fagerlin (2017) demonstrate that physicians oft...

Governments must determine the legal procedures by which their residents are registered, or can register, as organ donors. Provided that governments recognize that people have a right to determine what happens to their organs after they die, there are four feasible options to choose from: opt-in, opt-out, mandated active choice, and voluntary active choice. We investigate the ethics of these policies' use of nudges to affect organ donor registration rates. We argue that the use of nudges in this context is morally problematic. It is disrespectful of people's autonomy to take advantage of their cognitive biases since doing so involves bypassing, not engaging, their rational capacities. We conclude that while mandated active choice policies are not problem free-they are coercive, after all-voluntary active choice, opt-in, and opt-out policies are potentially less respectful of people's autonomy since their use of nudges could significantly affect people's decision making.

This article discusses the response of our ethics consultation service to an exceptional request by a patient to have his implantable cardioverter defibrillator (ICD) removed. Despite assurances that the device had saved his life on at least two occasions, and cautions that without it he would almost certainly suffer a potentially lethal cardiac event within 2 years, the patient would not be swayed. Although the patient was judged to be competent, our protracted consultation process lasted more than 8 months as we consulted, argued with, and otherwise cajoled him to change his mind, all to no avail. Justifying our at times aggressive paternalistic intervention helped us to reflect on the nature of autonomy and the dynamics of the legal, moral, and personal relationships in the clinical decision-making process.

Cognitive scientists have identified a wide range of biases and heuristics in human decision making over the past few decades. Only recently have bioethicists begun to think seriously about the implications of these findings for topics such as agency, autonomy, and consent. This article aims to provide an overview of biases and heuristics that have been identified and a framework in which to think comprehensively about the impact of them on the exercise of autonomous decision making. I analyze the impact that these biases and heuristics have on the following dimensions of autonomy: understanding, intentionality, absence of alienating or controlling influence, and match between formally autonomous preferences or decisions and actual choices or actions.

Several factors related to fetal risk render it more or less acceptable in justifying constraints on the behavior of pregnant women. Risk is an unavoidable part of pregnancy and childbirth, one that women must balance against other vital personal and family interests. Two particular issues relate to the fairness of claims that pregnant women are never entitled to put their fetuses at risk: relative risks and relatives' risks. The former have been used-often spuriously-to advance arguments against activities, such as home birth, that may incur risk; the latter implicate the nature of relationships in determining the acceptability of coercing or precluding activities. Motivated reasoning by clinicians and judges leads to inaccurate risk assessments, and judgments based on false claims to objectivity. Such judgments undermine the moral and legal standing of pregnant women and do not advance the interests of fetuses, pregnant women, families, or states.

Critical-care decision making is highly complex, given the need for health care providers and organizations to consider, and constructively respond to, the diverse interests and perspectives of a variety of legitimate stakeholders. Insights derived from an identified set of ethics-related considerations have the potential to meaningfully inform inclusive and deliberative policy development that aims to optimally balance the competing obligations that arise in this challenging, clinical decision-making domain. A potential, constructive outcome of such policy engagement is the collaborative development of an as-fair-as-possible dispute resolution process that incorporates an appropriated-justified, defensible critical-care obligation threshold.

Background: Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children’s perspective on participating in trials. Purpose: To understand the experiences and motivations of young people who took part in clinical trials. Methods: Qualitative interview study of 25 young people aged 10-23 invited to take part in clinical trials. Interviews were audio or video recorded and analyzed using framework analysis. Results: Young peoples’ motivations were both personal benefit and helping others. Both incentives appeared to be more complex than expected. We introduce the terms ‘network of exchange’ and ‘intergenerational solidarity’ to describe these motivations. Conclusion: To improve recruitment, professionals should be more open about research opportunities, provide better information, and give young people feedback after the trial has ended.

In Western countries today, a growing number of women delay motherhood until their late 30s and even 40s, as they invest time in pursuing education and career goals before starting a family. This social trend results from greater gender equality and expanded opportunities for women and is influenced by the availability of contraception and assisted reproductive technologies (ART). However, advanced maternal age is associated with increased health risks, including infertility. While individual medical solutions such as ART and elective egg freezing can promote reproductive autonomy, they entail significant risks and limitations. We thus argue that women should be better informed regarding the risks of advanced maternal age and ART, and that these individual solutions need to be supplemented by a public health approach, including policy measures that provide women with the opportunity to start a family earlier in life without sacrificing personal career goals.

Prahbu and colleagues (2017) depict a multilayered phenomenon that concerns end-of-life decisions in the two different fields of emergency medicine and transplant medicine. The authors highlight a ...

In a reversal of the usual constraints of informed consent, cardiopulmonary resuscitation is one of the few medical interventions that individuals will receive—in many cases with little or no warni...

We are gratified that our target article (Chen and Wasserman 2017) generated so much commentary from thoughtful scholars. We take this opportunity to clarify our framework, address some misundersta...

Chen and Wasserman (2017) propose a strategy to enable informed consent of prospective parents who seek to undergo unrestricted noninvasive prenatal whole genome sequencing (NIPW). Chen and Wasserm...

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.

Bioethicists invoke a duty to rescue in a wide range of cases. Indeed, arguably, there exists an entire medical paradigm whereby vast numbers of medical encounters are treated as rescue cases. The intuitive power of the rescue paradigm is considerable, but much of this power stems from the problematic way that rescue cases are conceptualized-namely, as random, unanticipated, unavoidable, interpersonal events for which context is irrelevant and beneficence is the paramount value. In this article, I critique the basic assumptions of the rescue paradigm, reframe the ethical landscape in which rescue obligations are understood, and defend the necessity and value of a wider social and institutional view. Along the way, I move back and forth between ethical theory and a concrete case where the duty to rescue has been problematically applied: the purported duty to regularly return incidental findings and individual research results in genomic and genetic research.

In this commentary, we identify several ways in which the process of registering people as organ donors in the United States departs from the conditions ordinarily thought to be requirements for au...

We begin by thanking those who provided open peer commentaries for their thoughtful and often insightful responses. An initial observation is that despite more than 40 years of rumination in the bi...

When retrospectively analyzing their reasoning in relation to a case of a patient who wanted and eventually had his implantable cardioverter defibrillator (ICD) removed, Pullman and Hodgkinson (201...

Even liberalism's most vocal proponents rarely ascribe to what Charles Taylor called the “utterly facile moral psychology of traditional empiricism, according to which human agents possess the full...

The principle of respect for autonomy and the underlying concept of autonomy implied by this ethical principle have been cornerstones of medical ethics and clinical practice since the later part of...

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership.

The target article by Klugman and colleagues (2018) provides a stimulating account of a novel application of digital medicine. These issues arise from an emerging area of bioethics, namely, the dig...

The impassioned and well-reasoned essays in this edition of the journal all agree with two claims: (1) children have moral claims that should be protected and recognized, and (2) we need ongoing di...

The balance between our responsibilities toward the child patient and our responsibilities toward the parents is a precarious one (Hansen 2016). Countries that have ratified the United Nations (UN)...

In their article “Doctors, Patients, and Nudging in the Clinical Context—Four Views on Nudging and Informed Consent,” Thomas Ploug and Soren Holm argue that nudging is inconsistent with autonomy pr...

Ploug and Holm offer an impassioned defense of informed consent in the face of perceived encroachment from nudging practices. The authors conclude unequivocally that “Nudging in the clinical contex...

In his article ‘Placebo Effects and Informed Consent’, Mark Alfano (2015) discusses a number of interesting points. I critically examine some of his main arguments and ideas in what follows and the...

Informed consent, as Alfano (2015) recognizes, has been routinely idealized within philosophical debate: Philosophers typically present a psychologically sanitized formulation of the temporal seque...

Ploug and Holm's (2015) insightful article criticizes recent views—mainly those advanced by Saghai (2013) and me (Cohen 2013)—that allow “nudging” patients while obtaining their informed consent (I...

With the rapid development of next-generation sequencing (NGS) technologies, among them whole exome and whole genome sequencing, it is now possible and affordable to sequence genomes in a short per...