In this article I argue that Levinas can be read as a critic, not just of Heideggerian being, but also of being-with. After pointing out that the publication of the Black Notebooks only makes this criticism more interesting to revisit, I first of all discuss passages from both earlier and later writings in which Levinas explicitly takes issue with Heidegger’s claim that there is no self outside of a specific socio-historical community. I then explain how these criticisms are reflected (...) in Levinas’s own account, arguing that Levinasian subjectivity and alterity are precisely defined by their not belonging to a larger unity; to the extent that they partake in a multi-personal collectivity, this does not take the form of a traditional community. In the final section, I look into a different and seemingly opposing argument Levinas makes against Heidegger: on the basis of the latter’s reflections on death, he argues that Dasein is anti-social rather than overly immersed in the socio-historical. Arguing that this rests on a misreading of Being and Time, I use this opportunity to raise questions about Levinas’s interpretation of Heidegger and his “otherwise than being-with” more generally, for Levinas’s account runs into several problems as well. Yet as I will conclude, this in fact offers a valuable insight, not just for the present-day reception of Heidegger, but also for thinking community today. It indicates that a radical break with human situatedness does not automatically fare better than a firmly enrooted account of existence. (shrink)

Objective: Contemporary ethical accounts of the patient-provider relationship emphasise respect for patient autonomy and shared decision making. We sought to examine the relative influence of involvement in decisions, confidence and trust in providers, and treatment with respect and dignity on patients’ evaluations of their hospital care.Design: Cross-sectional survey.Setting: Fifty one hospitals in Massachusetts.Participants: Stratified random sample of adults discharged from a medical, surgical, or maternity hospitalisation between January and March, 1998. Twelve thousand six hundred and eighty survey recipients responded.Main outcome (...) measure: Respondent would definitely be willing to recommend the hospital to family and friends.Results: In a logistic regression analysis, treatment with respect and dignity 3.4, 99% confidence interval 2.8 to 4.2) and confidence and trust in providers were more strongly associated with willingness to recommend than having enough involvement in decisions . Courtesy and availability of staff , continuity and transition , attention to physical comfort , and coordination of care were also significantly associated with willingness to recommend.Conclusions: Confidence and trust in providers and treatment with respect and dignity are more closely associated with patients’ overall evaluations of their hospitals than adequate involvement in decisions. These findings challenge a narrow emphasis on patient autonomy and shared decision making, while arguing for increased attention to trust and respect in ethical models of health care. (shrink)

This is the first book to undertake an applied postmedia and philosophical approach to the work of Felix Guattari. It provides a way to understand philosophically issues in contemporary technology, social life and consumer culture in Asia.

A commentary on “A Rationale in Support of Uncontrolled Donation after Circulatory Determination of Death,” from the January‐February 2013 issue.

Many believe that the ethical problems of donation after cardiocirculatory death (DCD) have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: (...) irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD. (shrink)

The shift away from paternalistic decision-making and toward patient-centered, shared decision-making has stemmed from the recognition that in order to practice medicine ethically, health care professionals must take seriously the values and preferences of their patients. At the same time, there is growing recognition that minor and seemingly irrelevant features of how choices are presented can substantially influence the decisions people make. Behavioral economists have identified striking ways in which trivial differences in the presentation of options can powerfully and predictably (...) affect people's choices. Choice-affecting features of the decision environment that do not restrict the range of choices or significantly alter the incentives have come to be known as “nudges.” Although some have criticized conscious efforts to influence choice, we believe that clinical nudges may often be morally justified. The most straightforward justification for nudge interventions is that they help people bypass their cognitive limitations—for example, the tendency to choose the first option presented even when that option is not the best for them—thereby allowing people to make choices that best align with their rational preferences or deeply held values. However, we argue that this justification is problematic. We argue that, if physicians wish to use nudges to shape their patients’ choices, the justification for doing so must appeal to an ethical and professional standard, not to patients’ preferences. We demonstrate how a standard with which clinicians and bioethicists already are quite familiar—the best-interest standard—offers a robust justification for the use of nudges. (shrink)

We thank the authors of commentaries for their thoughtful discussion of our target article. Here we briefly summarize the points made in the target article (Nair-Collins and Joffe 2023). Then we em...

Some patients who have been diagnosed as “dead by neurologic criteria” continue to exhibit certain brain functions, most commonly, neuroendocrine functions. This preservation of neurologic function after the diagnosis of “brain death” or “brainstem death” is an ongoing source of controversy and concern in the medical, bioethics, and legal literatures. Most obviously, if some brain function persists, then it is not the case that all functions of the entire brain have ceased and hence, declaring such a patient to be “dead” (...) would be a false positive, in any nation with so-called “whole brain death” laws. Furthermore, and perhaps more concerning, the preservation of any brain function necessarily entails the preservation of some amount of brain perfusion, thereby raising the concern as to whether additional areas of neural tissue may remain viable, including areas in the brainstem. These and other considerations cast significant doubt on the reliability of diagnosing either “brain death” or “brainstem death.”. (shrink)

This chapter compares biology with the practices of economics to determine the extent to which mainstream economic theory can be regarded as ‘scientific’. This survey of practice in the two disciplines shows that biological theory is derived from description and experimentation. In contrast, the ideal in mainstream economics is to derive theory from axioms. When economic theory is compared with the available evidence, a disjunction is found between the empirical findings and conventional theory. The disjunction is explained by a fundamental (...) mismatch between the evidence and the basic theoretical categories and structure. The central issue is the relationship of evidence to theory: to put it simply, which should come first? The conclusion is that regularities that emerge from a comparative historical perspective, including use of econometric, statistical, and qualitative studies, could provide the type of evidence that could form a secure foundation for theorising in economics. (shrink)

According to international scientific medical consensus, death is a biological, unidirectional, ontological state of an organism, the event that separates the process of dying from the process of disintegration. Death is not merely a social contrivance or a normative concept; it is a scientific reality. Using this paradigm, the international consensus is that, regardless of context, death is operationally defined as “the permanent loss of the capacity for consciousness and all brainstem function. This may result from permanent cessation of circulation (...) or catastrophic brain injury. In the context of death determination, ‘permanent’ refers to loss of function that cannot resume spontaneously and will not be restored through intervention.” The word “permanent” replaces “irreversible” (used in the United States’ 1980 Uniform Declaration of Death Act) in this new definition, arguably invented to allow donation after circulatory determination of death (DCDD) while still complying with the dead donor rule. I will show that this invention fails, for at least four reasons. (shrink)

Ariane Lewis reviewed medicolegal challenges to Death by Neurologic Criteria (DNC) in the United Kingdom in order to identify and discuss the ethical issues raised (Lewis 2024). Here I briefly clar...

French philosopher Bernard Stiegler’s teacher, the great Jacques Derrida, when speaking of the nature of the life of Aristotle, questioned the need for biography and anecdote. Philosophy excludes b...

Health care workers often perform, promote, and advocate use of public funds for animal research ; therefore, an awareness of the empirical costs and benefits of animal research is an important issue for HCW. We aim to determine what health-care-workers consider should be acceptable standards of AR methodology and translation rate to humans.

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New England Journal of Medicine. (...) The oversight system is based on a foundation, first implemented by the U.S. Public Health Service in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report. (shrink)

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

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. (shrink)

In thinking the passage from the “all-human cerebrum” to what one might call the contemporary “all-too-human” cerebrum in neo-liberal societies and beyond to the “all-too-transhuman” cerebrum in the cybernetic society, in contrasting Wells’s idea of a new world order with the dystopia of the disordering un-world, in considering the prospects of a “world brain” faced with the realities of the “global mnemotechnical system”, in highlighting the differences between the global and authoritarian instrument of “control” in Wells and the descriptions of (...) the control society by Deleuze, and finally, in critiquing the “unifying of the general intelligence services of the world” in Wells and the capturing of the “general intellect”, this paper maps the contemporary prospects of the “world brain” against the backdrop of the worldweariness of the present. (shrink)

Drawing on an array of sources, from Deleuze and Guattari’s philosophy through to non-philosophy, this paper concerns itself with the manifestation of the concepts of hope and despair in utopian thought and continental philosophy and the experience of hopelessness, despair and exhaustion in the contemporary moment. I aim to demonstrate such pressing concerns through a comparison of Japanese philosopher Kojin Karatani and Japanese fiction writer Ryū Murakami with the American science fiction-thriller film directed by Michael Bay, The Island. What is (...) explored in these works is the dialectic of exhaustion and possibility. The focus of the paper is on the fecund moment inhering in the incapacity of thought to think the possibility of utopia. In terms of the philosophy of education, this hones in on the perceived lack of vision of such a possibility among youth and the failure of the university qua institution to proffer an alternative world to its cohort. To demon... (shrink)

In what follows I distinguish «postmodern animism» from my preferred term «postmedia animism», which I propose is a better term to express a minor, virtual, contrarian art and media. In the time of planetary trauma, ecological devastation and collapse, this term will serve as a heuristic concept to trace the passage from pandemic, panic, catastrophe and crisis to the series pandemonium, delirium and the carnivalesque. My gambit is to invoke a rebellious and affirmative Yōkai imaginary (妖怪, ghost, phantom, strange apparition) (...) in order to contest passive forms of «transcendental narcissism» or «transcendental miserabilism».This we shall designate s an aesthetics of existence. In particular, I will analyse the relationship between natural disasters and politics within the Japanese imagination through reference to Namazu-e (鯰絵, woodblock prints depicting catfish), and their political effects in the aftermath of the earthquake of October 1855 (安政江戸地震, Ansei Edo Jishin) in the Edo period of Japanese history (FIG 1). My intention is to show that this historic art form, which grew out of trauma, demonstrates a fabulatory, dissensual and political aesthetics of resistance and creativity. It is an imaginary which appears conspicuously absent in our contemporary moment. (shrink)

Les questions de communication sont au coeur des «perceptions du risque» car la grande majorité des risques ne seraient connus que de ceux qui l'expérimentent n'eut été les médias. Le champ historiquement individualiste de la «perception du risque» a manifesté peu d'intérêt pour le contenu des mass media et leur rôle dans la construction d'une pensée sur le risque. Bien au contraire, le processus de «l'information» sur le risque était situé dans la pensée individuelle, la question centrale étant: pourquoi certains (...) risques sont-ils grossis par les individus tandis que d'autres sont minimisés? Les médias jouent un rôle essentiel dans l'amplification de certains risques et les récepteurs de l'information sont considérés comme passifs devant les stimuli médiatiques. Il faut en fait nuancer l'approche pour saisir la dimension profonde de l'appréhension du risque. En passant de la notion de «perception du risque» à celle de «représentation du risque», on peut davantage cerner les liens entre médias et pensée profonde.Issues of communication lie at the heart of "risk perception" since the vast majority of risks would be known to only those who experience them were it not for the mass media. The historically individualist field of "risk perception" has tended to pay little attention to the contents of the mass media and the role these played in constructing risk-related thinking. Rather, the processing of risk "information" was situated within individual’s minds with the central question being: why are some risks overplayed by certain individuals while others more serious risks are underplayed? The media are seen to play a major role in the amplification of certain risks with those who receive such information being viewed as rather passive followers of media signals. The starting point of this paper is the need for a more nuanced approach to the lay dimension of the apprehension of risks. The paper outlines how a shift from "risk perception" to "risk representation" highlights the links between media and lay thinking. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, they (...) do not necessarily invalidate consent by phase 1 trial participants. (shrink)

The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but (...) it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...) mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

Young adults are currently the loneliest group in Western countries. In particular, young adults of lower socio-economic status living in the most deprived areas are loneliest in the United Kingdom. This mixed-methods study explored the experience of loneliness among this under-explored demographic in London. Using a novel free association technique, the experience of loneliness was found to be characterized by: a sense of isolation, negative emotions and thoughts, coping and a positive orientation to aloneness. An exploration of these themes revealed (...) that: one can feel isolated or excluded even when surrounded by people; the experience of loneliness is accompanied by a set of interrelated feelings and thoughts like rumination; and technological and/or non-technological outlets can be used to cope. Social media play both a positive and negative role in loneliness, and loneliness is not always experienced negatively. The quantitative data indicated that this sample was lonely. By providing insight into young adults’ loneliness, the findings indicate what types of interventions are likely to diminish it. (shrink)

It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data (...) Practices framework. The framework outlines six principles relevant to the collection and use of personal data—minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion—and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices. (shrink)

In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota Supreme Court case, Warren v. Dinter, offers the opportunity to reassess whether the majority rule is truly serving the best interests of patients.

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. (shrink)

In this experimental piece of writing I want to think about the pedagogy of contact and the plight of the hikikomori or social recluse in Japan. I am interested in exploring how the hikikomori practices a kind of contactlessness or what I will call a deadly ipseity of desire. What does it mean to resist contact, to be without contact, to be without desire? What does it mean to risk contact, to risk being tactile with the other, to risk affirming (...) one’s desires? I want to generate a discussion about what has happened to desire, to its promise and possibility and why it is so difficult to anticipate or forecast what is to come. For me the BwO of hikikomori is the ruin of desire, the collapse of desire, a disaster of desire. I am pursuing a line of thought which highlights the loss of the possibility of processual schizophrenic breakthrough and in its place the becoming-autistic of the self, the perilous breakdown of the self. (shrink)

BackgroundHappiness is becoming increasingly relevant in recent research, including adolescents. Many studies are using the single-item measure for adolescent happiness, however, its validity is not well known. We aimed to examine the validity of this measure among adolescents in three countries from distinct European regions – Eastern, Southern, and Western.Materials and MethodsThe analysis included data from Health Behaviour in School-aged Children study from three countries and three last surveys. The total sample comprised 47,439 schoolchildren. For validity, the indicators reflecting subjective (...) health, life satisfaction, quality of life, well-being, social support, health complaints, bullying, and self-directed violence were assessed. The calculations were conducted in the total sample and by gender, age, survey year, and country.ResultsThe different indicators of concurrent and convergent validity revealed consistent correlations with happiness, with better well-being, health, and subjective perceptions being related to higher happiness. Meanwhile, health complaints, bullying behaviors, and self-directed violence were related to lower happiness. The subgroup differences were consistent across gender, age groups, countries, and survey rounds. The extent of differences was more expressed among girls.ConclusionThe single item for adolescent happiness measurement features a consistent pattern of validity concerning indicators of concurrent and convergent validity. Higher self-reported happiness is associated with better mental and physical health and well-being, and less expressed negative factors. In addition, among girls the correlations tend to be stronger than boys. (shrink)

BackgroundTo determine whether the public and scientists consider common arguments in support of animal research convincing.MethodsAfter validation, the survey was sent to samples of public, Amazon Mechanical Turk, a Canadian city festival and children’s hospital), medical students, and scientists. We presented questions about common arguments to justify the moral permissibility of AR. Responses were compared using Chi-square with Bonferonni correction.ResultsThere were 1220 public [SSI, n = 586; AMT, n = 439; Festival, n = 195; Hospital n = 107], 194/331 medical (...) student, and 19/319 scientist [too few to report] responses. Most public respondents were <45 years, had some College/University education, and had never done AR. Most public and medical student respondents considered ‘benefits arguments’ sufficient to justify AR; however, most acknowledged that counterarguments suggesting alternative research methods may be available, or that it is unclear why the same ‘benefits arguments’ do not apply to using humans in research, significantly weakened ‘benefits arguments’. Almost all were not convinced of the moral permissibility of AR by ‘characteristics of non-human-animals arguments’, including that non-human-animals are not sentient, or are property. Most were not convinced of the moral permissibility of AR by ‘human exceptionalism’ arguments, including that humans have more advanced mental abilities, are of a special ‘kind’, can enter social contracts, or face a ‘lifeboat situation’. Counterarguments explained much of this, including that not all humans have these more advanced abilities [‘argument from species overlap’], and that the notion of ‘kind’ is arbitrary [e.g., why are we not of the ‘kind’ ‘sentient-animal’ or ‘subject-of-a-life’?]. Medical students were more supportive of AR at the end of the survey.ConclusionsResponses suggest that support for AR may not be based on cogent philosophical rationales, and more open debate is warranted. (shrink)

Building upon previous research on the therapeutic object, specifically the objet re-petit-ive abc, which draws from Lacan, Winnicott, and Guattari, I explore the generation, contribution, and erosion of knowledge in the so-called smart city. I will investigate how digital pedagogical objects, functioning as transitional objects, can serve as therapeutic purposes both within and outside institutional settings. I examine the notions of the dérive and psychogeography and compare them with Bernard Stiegler’s concept of the “journey of knowledge” and then delve into (...) the curation of “negentropic forms of knowledge” and the mnemonic technique of the dérive. Taking ecological and ecosophical perspectives into account, I consider mnemonic techniques as a means to critically reflect upon the urban landscape and its transformation into a technical milieu. My overall goal is to contemplate the possibility of a Stieglerian and/or Guattarian détournement (philosophical hijacking) of the smart city. (shrink)

The main goal of publicly funded biomedical research is to generate social value through the creation and application of knowledge that can improve the well-being of current and future people. Prioritising research with the greatest potential social value is crucial for good stewardship of limited public resources and ensuring ethical involvement of research participants. At the National Institutes of Health (NIH), peer reviewers hold the expertise and responsibility for social value assessment and resulting prioritisation at the project level. However, previous (...) research has shown that peer reviewers place more emphasis on a study’s methods (‘Approach’) than on its potential social value (best approximated by the criterion of ‘Significance’). Lower weighting of Significance may be due to reviewers’ views on the relative importance of social value, their belief that social value is evaluated at other stages of the research priority-setting process or the lack of guidance on how to approach the challenging task of assessing expected social value. The NIH is currently revising its review criteria and how these criteria contribute to overall scores. To elevate the role of social value in priority setting, the agency should support empirical research on how peer reviewers approach the assessment of social value, provide more specific guidance for reviewing social value and experiment with alternative reviewer assignment strategies. These recommendations would help ensure that funding priorities align with the NIH’s mission and the obligation of taxpayer-funded research to contribute to the public good. (shrink)

Background: Ethics consultants (ECs) are increasingly expected to possess core knowledge and skills. Few data address whether ECs actually possess recommended core knowledge. We aimed to measure pediatric ECs’ understanding of ethical principles, identify knowledge gaps, and explore associations between experience/training and knowledge in pediatric ethics consultations. Methods: We identified the 2 ECs most knowledgeable in pediatric ethics from each of 45 freestanding children's hospitals and an equal number of general teaching hospitals in the United States. This yielded a sample (...) of 159 eligible pediatric ECs. Pediatric ECs were sent a survey measuring ethics training, characteristics of the ethics consultation service, and EC knowledge, as assessed by a previously validated scale entitled the Test of Residents’ Ethics Knowledge for Pediatrics (TREK-P). Of 102 completed surveys received, 99 were used in the analysis. Results: Seventy-three percent of ECs had completed ≥1 formal training modality, most commonly bioethics mini-courses, master's degrees, or certificate programs (20–30% each). Respondents infrequently received salary support (32%) or had a budget (28%) to support ethics work. The median TREK-P score was 19 (interquartile range [IQR] 17–21). Forty percent of subjects scored ≥20, surpassing the threshold of adequate performance proposed in previous work. Median scores were significantly higher among ECs with formal training in ethics but did not differ significantly by other variables. In secondary analyses, high scores (≥20) were significantly more common among ECs receiving salary support (55% vs. 33%, p = 0.04) and who had formal ethics training (47% vs. 22%, p = 0.02). Items pertaining to privacy, genetic testing, and assent, were answered incorrectly by >33% of ECs. Conclusions: High scores on a validated ethics knowledge scale were more common among ECs with salary support or formal ethics training. The study highlights knowledge gaps that warrant consideration as EC becomes a professionalized endeavor. (shrink)

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes of (...) all patients within an institution or region independent of their individual participation in trials. We further contend that this “infrastructure effect” can yield particular benefits for patients in low- and middle-income countries. The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. (shrink)

We’re grateful for the thoughtful and incisive commentaries on our article, “Ethical Responsibilities for Companies that Process Personal Data” (McCoy et al. 2023). In the article, we propose the E...

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. (shrink)