Medicine and Law

El derecho a una muerte digna es ampliamente ignorado por el ordenamiento jurídico brasileño. Esta invisibilidad del proceso de finitud y sus consecuencias son el objeto de este estudio, que tiene como objetivo realizar una encuesta exploratoria para identificar los puntos relevantes que deben desarrollarse para garantizar un proceso de finitud digno. Se analizaron 50 publicaciones a través de una encuesta online y física de obras publicadas hasta marzo de 2023. Los estudios analizados expresan preocupación por los dilemas éticos de (...) la atención a seres humanos en finitud, pero no analizan las formas de pro-tección a la finitud existentes ni cuáles son las áreas que aún necesitan regulación para hacer efectiva esta atención. Se espera que esta investigación contribuya a fortalecer la visión crítica de la finitud, considerando la protección actual de la finitud, los límites jurídicos del Estado y los posibles pasos futuros para avanzar en los estudios aplicados a la actualización práctica del sistema jurídico brasileño. (shrink)

O direito à morte digna é majoritariamente ignorado pelo ordenamento brasileiro. Essa invisibilidade do processo de finitude e suas consequências são tema deste estudo, que objetiva realizar um levanta-mento exploratório para identificar pontos relevantes que devem ser desenvolvidos para garantir um processo de finitude digno. Foram analisadas 50 publicações, mediante levantamento online e físico de obras publicadas até março de 2023. Os estudos analisados expressam preocupação com dilemas éticos do cuidar do ser humano em finitude, mas não analisam formas existentes (...) de tutela da finitude nem quais searas ainda são carentes de normatização para dar eficácia a esse cuidado. Espera-se que esta pesquisa contribua para fortalecer o olhar crítico ao tema, considerando as atuais tutelas da fini-tude, os limites legais do Estado e os potenciais passos futuros para fazer avançar os estudos aplicados à atualização prática do ordenamento brasileiro. (shrink)

BACKGROUND Patients with chronic pain face significant barriers in finding clinicians to manage long-term opioid therapy (LTOT). For patients on LTOT, it is increasingly common to have them sign opioid treatment agreements (OTAs). OTAs enumerate the risks of opioids, as informed consent documents would, but also the requirements that patients must meet to receive LTOT. While there has been an ongoing scholarly discussion about the practical and ethical implications of OTA use in the abstract, little is known about how clinicians (...) use them and if OTAs themselves modify clinician prescribing practices. OBJECTIVE To determine how clinicians use OTAs and the potential impacts of OTAs on opioid prescribing. DESIGN We conducted qualitative analysis of four focus groups of clinicians from a large Midwestern academic medical center. Groups were organized according to self-identified prescribing patterns: two groups for clinicians who identified as prescribers of LTOT, and two who did not. PARTICIPANTS 17 clinicians from General Internal Medicine, Family Medicine, and Palliative Care were recruited using purposive, convenience sampling. APPROACH Discussions were recorded, transcribed, and analyzed for themes using reflexive thematic analysis by a multidisciplinary team. KEY RESULTS Our analysis identified three main themes: (1) OTAs did not influence clinicians’ decisions whether to use LTOT generally but did shape clinical decision-making for individual patients; (2) clinicians feel OTAs intensify the power they have over patients, though this was not uniformly judged as harmful; (3) there is a potential misalignment between the intended purposes of OTAs and their implementation. CONCLUSION This study reveals a complicated relationship between OTAs and access to pain management. While OTAs seem not to impact the clinicians’ decisions about whether to use LTOT generally, they do sometimes influence prescribing decisions for individual patients. Clinicians shared complex views about OTAs’ purposes, which shows the need for more clarity about how OTAs could be used to promote shared decision-making, joint accountability, informed consent, and patient education. (shrink)

Introduction: Sexual harassment involves an assortment of coercive behaviors, including physical force, intimidation, and various forms of compulsion, including verbal harassment and forced penetration [1]. Sexual abuse can happen to both men and women. In the United Kingdom(UK), the problem of child sexual abuse (CSA) has epidemic proportions and is a global public health issue [2]. 53,874 incidents were reported under the 2012 Protection of Children from Sexual Offences Act as of 2021 [3]. to their ignorance about puberty, sexuality, and (...) fundamental human biological changes, adolescents have a very difficult time addressing their SRH demands. These underlying causes contribute to high rates of teen pregnancy, STIs, sexual assault, poor negotiating skills, forced marriage, and high fertility rates [4]. -/- Methods: The study used a quantitative technique and a descriptive cross-sectional design. Students at Jahangir Nagar University and the American International University of Bangladesh were the intended target group. Jahangir Nagar University and American International University of Bangladesh served as the study locations. The six-month trial period ran from January 2022 through June 2022. For this investigation, primary sources of data were used. The study unit was the individual student. Non-probability (purposive) sampling techniques were used for the investigation. -/- Results: The majority of survey participants (N=81) 62.2% were aged between 19 and 21 years old, and there was a statistically significant difference in age between students at public and private universities. None of our study participants suffered from any kind of sexual abuse, though they mentioned hearing about it. Regarding the view of sexual abuse, public universities 23% of those polled claimed sexual abuse as a justification for sharing inappropriate photos. At private universities, the response rate for crude jokes is 32.5%. Only the least number of public (2%) and private university (10%) students took part in sexual abuse-related awareness or training programs. Regarding the rights to receive training for prevention and safeguarding from sexual abuse, only 28% of the public and 40% of the private university students replied in affirmative. -/- Conclusion: Sexual harassment is a sensitive issue, though due to various reasons, the rate of reporting and providing justice to the victims is delayed all over the world including Bangladesh. There social, religious, and policy lacking in this context. -/- . (shrink)

This article is about the information relevant to decision-making capacity in refusal of life-prolonging medical treatment cases. We examine the degree to which the phenomenology of the options available to the agent—what the relevant states of affairs will feel like for them—forms part of the capacity-relevant information in the law of England and Wales, and how this informational basis varies across adolescent and adult medical treatment cases. We identify an important doctrinal phenomenon. In the leading authorities, the courts appear to (...) count the first-personal phenomenology of the available options among the information that adolescents seeking to refuse life-prolonging treatment must understand and appreciate in order to possess capacity; adults are not held to this (higher) standard. We evaluate this differential treatment in light of philosophical work on transformative choice—decisions involving options whose sensory character, and effect on our values and preferences, are grasped only through experience itself. (shrink)

In response to the spread of COVID-19, governments across the world have, with very few exceptions, enacted sweeping restrictive lockdown policies that impede citizens’ freedom to move, work, and assemble. This paper critically responds to the central arguments for restrictive lockdown legislation. We build our critique on the following assumption: public policy that enjoys virtually unanimous support worldwide should be justified by uncontroversial moral principles. We argue that that the virtually unanimous support in favor of restrictive lockdowns is not adequately (...) justified by the arguments given in favor of them. Importantly, this is not to say that states ought not impose restrictive lockdown measures, but rather that the extent of the acceptance of these measures is not proportionate to the strength of the arguments for lockdowns. -/- We begin by exploring the case for restrictive lockdowns. We first argue that several of the principles that are used to justify the lockdowns yield unexpectedly revisionary implications for other political problems that many would be unwilling to accept. We then outline what we consider the strongest argument for a lockdown—namely, that its net welfare benefits are great enough to defeat the moral presumption against restricting citizens’ civil liberties to move, work, and assemble. However, we give a number of reasons for doubting that the lockdown’s net welfare benefits are, in fact, sufficiently high to defeat the presumption against it. (shrink)

The Uniform Determination of Death Act (UDDA) provides that “an individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead.” We show that the UDDA contains two conflicting interpretations of the phrase “cessation of functions.” By one interpretation, what matters for the determination of death is the cessation of spontaneous functions only, regardless of their generation by artificial means. By the (...) other, what matters is the cessation of both spontaneous and artificially supported functions. Because each UDDA criterion uses a different interpretation, the law is conceptually inconsistent. A single consistent interpretation would lead to the conclusion that conscious individuals whose respiratory and circulatory functions are artificially supported are actually dead, or that individuals whose brain is entirely and irreversibly destroyed may be alive. We explore solutions to mitigate the inconsistency. (shrink)

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest (...) treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical—they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles. (shrink)

This study examines the ethical and legal issues faced by girls/women requesting abortions who were victims of rape, aspects which have received little attention to date. This is a retrospective study using an approach and legal issues relating to incidents of unwanted pregnancy resulting from rape as reported in Turkish newspapers from 2010 to 2018. A total of 95 articles were discovered and categorized. These were then evaluated for content and analyzed in terms of the ethical issues related to the (...) cases. Of the articles,14 involved rape-related pregnancy cases. The six cases chosen for analysis in this study were carefully selected from newspaper reports between 2010-2018. The victims who requested abortions were between 9 and 26 weeks pregnant and aged 14-26 years old. Turkish courts approved only two of the victims' requests. The cases in this study were evaluated by the authorities solely on legal grounds. The stress experienced by victims of rape is exacerbated by compulsory pregnancy; the fact that these victims were not allowed to terminate their pregnancies resulted in their further punishment. Requests for abortions should be assessed not only in terms of legality but also based on medical and especially ethical issues. (shrink)

A dogma accepted in many ethical, religious, and legal frameworks is that the reasons behind conscientious objection (CO) in healthcare cannot be evaluated or judged by any institution because conscience is individual and autonomous. This paper shows that this background view is mistaken: the requirement to reveal and explain the reasons for conscientious objection in healthcare is ethically justified and legally desirable. Referring to real healthcare cases and legal regulations, this paper argues that these reasons should be evaluated either ex (...) ante or ex post and defends novel conceptual claims that have not been analyzed in the debates on CO. First, a moral threshold requirement: CO is only justified if the reasons behind a refusal are of a moral nature and meet a certain threshold of moral importance. Second, this paper considers the rarely discussed conceptual similarities between CO in healthcare and the legal regulations concerning military refusals that place the burden of proof on conscientious objectors. This paper concludes that conscientious objection in healthcare can be accommodated only in some cases of destroying or killing human organisms. (shrink)

The increasing use of opioid treatment agreements has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current (...) way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot simply be addressed by minimising physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable. There are no data in this work. (shrink)

Some people oppose abortion on the grounds that fetuses have full moral status and thus a right to not be killed. We argue that special obligations that hold between mother and fetus also hold between parents and their children. We argue that if these special obligations necessitate the sacrifice of bodily autonomy in the case of abortion, then they also necessitate the sacrifice of bodily autonomy in the case of organ donation. If we accept the argument that it is obligatory (...) to override a woman’s bodily autonomy for the sake of an unborn child’s survival, we must continue to override the bodily autonomy of parents to ensure the survival of their living children, until the parent no longer has a special obligation to their child to the same degree as their special obligation to the fetus. And if the life of a child is truly more important than the bodily autonomy of its parents, as must be the case to force women to carry unwanted pregnancies to term, this should remain true until such a time that their children are no longer considered their responsibility. Thus, parity of reasoning suggests that policies compelling the gestation of a fetus should be accompanied by policies compelling organ donation. (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation (...) of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

The pelvic exam is used to assess the health of female reproductive organs and so involves digital penetration by a physician. However, it is common practice for medical students to acquire experience in administering pelvic exams by performing them on unconscious patients without prior authorization. In this article, we argue that such unauthorized pelvic exams (UPEs) are sexual assault. Our argument is simple: in any other circumstance, unauthorized digital penetration amounts to sexual assault. Since there are no morally significant differences (...) between UPEs and other instances of digital penetration, UPEs are sexual assault. So, insofar as one is against sexual assault, one should be against UPEs. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since most (...) of the recommendations do not come with ethical justifications, analysing them requires that one traces back these criteria to their underlying theories of distributive justice. In the literature, COVID-19 triage has been portrayed as a value conflict solely between utilitarian and egalitarian elements. While these two accounts are indeed the main antipodes, I shall show that in fact all four classic theories of distributive justice are involved: utilitarianism, egalitarianism, libertarianism, and communitarianism. Detecting these in the documents and classifying the suggested criteria accordingly enables one to understand the balancing between the different approaches to distributive justice—which is crucial for both managing the current pandemic and in preparation for the next global health crisis. (shrink)

Goal: To assess public knowledge and attitudes towards the family’s role in deceased organ donation in Europe. -/- Methods: A systematic search was conducted in CINHAL, MEDLINE, PAIS Index, Scopus, PsycINFO, and Web of Science on December 15th, 2017. Eligibility criteria were socio-empirical studies conducted in Europe from 2008 to 2017 addressing either knowledge or attitudes by the public towards the consent system, including the involvement of the family in the decision-making process, for post-mortem organ retrieval. Screening and data collection (...) were performed by two or more independent reviewers for each record. -/- Results: Of the 1482 results, 467 studies were assessed in full-text form, and 33 were included in this synthesis. When the deceased has not expressed any preference, a majority of the public support the family's role as a surrogate decision-maker. When the deceased expressly consented, the respondents' answers depend on whether they see themselves as potential donors or as a deceased's next-of-kin. Answers also depend on the relationship between the deceased and the decision-maker(s) within the family, and on their ethnic or cultural background. -/- Conclusions: Public views on the authority of the family in organ donation decision-making require further research. A common conceptual framework and validated well-designed questionnaires are needed for future studies. The findings should be considered in the development of Government policy and guidance regarding the role of families in deceased organ donation. (shrink)

Objectives To increase postmortem organ donation rates, several countries are adopting an opt-out (presumed consent) policy, meaning that individuals are deemed donors unless they expressly refused so. Although opt-out countries tend to have higher donation rates, there is no conclusive evidence that this is caused by the policy itself. The main objective of this study is to better assess the direct impact of consent policy defaults per se on deceased organ recovery rates when considering the role of the family in (...) the decision-making process. This study does not take into account any indirect effects of defaults, such as potential psychological and behavioural effects on individuals and their relatives. -/- Design Based on previous work regarding consent policies, we created a conceptual model of the decision-making process for deceased organ recovery that included any scenario that could be directly influenced by opt-in or opt-out policies. We then applied this model to internationally published data of the consent process to determine how frequently policy defaults could apply. -/- Main outcome measures We measure the direct impact that opt-in and opt-out policies have per se on deceased organ recovery. -/- Results Our analysis shows that opt-in and opt-out have strictly identical outcomes in eight out of nine situations. They only differ when neither the deceased nor the family have expressed a preference and defaults therefore apply. The direct impact of consent policy defaults is typically circumscribed to a range of 0%–5% of all opportunities for organ recovery. Our study also shows that the intervention of the family improves organ retrieval under opt-in but hinders it under opt-out. -/- Conclusions This study may warn policy makers that, by emphasising the need to introduce presumed consent to increase organ recovery rates, they might be overestimating the influence of the default and underestimating the power granted to families. (shrink)

El consentimiento informado del paciente se inserta en el ámbito de su autonomía decisoria. Aunque presenta un sustrato corporal, este aparece combinado con elementos de índole moral que presuponen una noción concreta de persona como libre y autónoma. Tanto de las definiciones doctrinales como del material normativo se desprende que se trata de una posición jurídica subjetiva del paciente, alternativamente calificada como una “pretensión” o “derecho subjetivo en sentido estricto”, en términos hohfeldianos; un “derecho negativo de defensa”, o una “inmunidad”. (...) En España, el Tribunal Constitucional ha vinculado el consentimiento informado del paciente al derecho fundamental a la integridad física y moral (15 CE), lo cual permite plantear el análisis en clave iusfundamental. Con todo, se advierten dudas e incompatibilidades entre la explicación habitual del consentimiento informado, su fundamento constitucional y su regulación jurídica. El objetivo del presente libro consiste en proporcionar una definición integral del consentimiento informado como derecho subjetivo del paciente y como manifestación de un derecho fundamental, a partir de una óptica poliédrica que aporta certeza en la práctica asistencial y jurídica. // The patient's right to informed consent is inserted within the scope of his decisional autonomy. Although it has a bodily background, it is combined with features of moral nature, which presupposes a concrete notion of the person as free and autonomous. Both, doctrinal approaches and normative legal material show that it is a subjective legal position of the patient, being alternatively qualified as a Hohfeldian “claim” or a “subjective right in a strict sense”; a "negative right" or an "immunity." The Spanish Constitutional Court has linked the informed consent of the patient to the fundamental right to physical and moral integrity (15 CE), which allows us to propose a fundamental rights-based analysis. Nonetheless, doubts and inconsistencies are perceived between the customary explanation of informed consent, its constitutional foundation and its legal regulation. The aim of this book is to provide a comprehensive definition of informed consent as subjective right of the patient and expression of a fundamental right, from a multi-fold perspective that provides certainty in both legal and health care practice. (shrink)

According to the High Court in England and Wales, the primary purpose of legal interventions into the lives of vulnerable adults with mental capacity should be to allow the individuals concerned to regain their autonomy of decision making. However, recent cases of clinical decision making involving capacitous vulnerable adults have shown that, when it comes to medical law, medical ethics and clinical practice, vulnerability is typically conceived as opposed to autonomy. The first aim of this paper is to detail the (...) problems that arise when the courts and health care practitioners respond to the vulnerability of capacitous adults on the basis of such an opposition. It will be shown that not only does the common law approach to vulnerability fail to adequately capture the autonomy of capacitous vulnerable adults, the conception of vulnerability and autonomy in oppositional terms leads to objectionably paternalistic health care responses that undermine the autonomy of vulnerable patients as well as clinical and legal interventions that violate their autonomy. In response, the second aim of this paper is to show that the concepts of autonomy and vulnerability are necessarily entwined and, on that basis, the focus should be on promoting the autonomy of capacitous vulnerable adults where possible. In order to make this case, the paper explains the limitations of standard approaches to the autonomy of vulnerable adults and, in their place, offers a conception of legitimate, self-authorised autonomy that is fundamentally dependent on intersubjective practices of recognition. (shrink)

The High Court continues to exercise its inherent jurisdiction to make declarations about interventions into the lives of situationally vulnerable adults with mental capacity. In light of protective responses of health care providers and the courts to decision-making situations involving capacitous vulnerable adults, this paper has two aims. The first is diagnostic. The second is normative. The first aim is to identify the harms to a capacitous vulnerable adult’s autonomy that arise on the basis of the characterisation of situational vulnerability (...) and autonomy as fundamentally opposed concepts or the failure to adequately acknowledge the conceptual relationship between them at common law. The second part of this aim is to draw upon developments in analytic feminist philosophy to illustrate how standard approaches to autonomy are ill-equipped to capture the autonomy issues of capacitous vulnerable adults when their decisions regarding care and treatment are at stake. The second (normative) aim is to develop an account of self-authorised, intersubjective autonomy on the basis of analytic feminist insights into the relational practices of recognition. This account not only attempts to capture the autonomy of capacitous vulnerable adults and account for the necessary harms to their autonomy that arise from standard common law responses to their situational vulnerability, it is also predicated on the distinctions between mental capacity, the satisfaction of conditions for informed consent and the exercise of autonomy, meaning that it is better placed to fulfil the primary aim of the inherent jurisdiction – to facilitate the autonomy of vulnerable adults with capacity. (shrink)

Several European countries are approving legislative reforms moving to a presumed consent system in order to increase organ donation rates. Nevertheless, irrespective of the consent system in force, family's decisional capacity probably causes a greater impact on such rates. In this contribution we have developed a systematic methodology in order to analyse and compare European organ procurement laws, and we clarify the weight given by each European law to relatives' decisional capacity over individual's preferences (expressed or not while alive) regarding (...) the destination of his or her organs after death. In this sense, the results constitute the first comprehensive and comparative legislative mapping on European transplantation laws. (shrink)

This paper analyses the arguments for and against what we have called automatic organ procurement model in relation to the organs of the deceased. For this purpose, this work provides empirical evidence to assess the potential impact of this model on donation rates and on public opinion. Specifically, we examine first the reasons supporting this model, with special reference to utilitarian and justice arguments. On the other hand, we analyse both the approaches based on the violation of pre mortem and (...) post mortem interests opposing this theoretical model and the rejection the model would generate in the population. Finally, we point out the aspects that, in our opinion, should be exhaustively regulated if this model were implemented. In particular, we refer to the legal status of the human body, the treatments for end-of-life patients, the incentives for health professionals and the recognition of the right to conscientious objection. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.

Background Consent policies for post-mortem organ procurement (OP) vary throughout Europe, and yet no studies have empirically evaluated the ethical implications of contrasting consent models. To fill this gap, we introduce a novel indicator of governance quality based on the ideal of informed support, and examine national differences on this measure through a quantitative survey of OP policy informedness and preferences in seven European countries. -/- Methods Between 2017–2019, we conducted a convenience sample survey of students (n = 2006) in (...) Austria (AT), Belgium (BE), Denmark (DK), Germany (DE), Greece (GR), Slovenia (SI) and Spain (ES), asking participants about their donation preferences, as well as their beliefs and views about the policy in place. From these measures, we computed indices of informedness, policy support, and fulfilment of unexpressed preferences, which we compared across countries and consent systems. -/- Results Our study introduces a tool for analyzing policy governance in the context of OP. Wide variation in policy awareness was observed: Most respondents in DK, DE, AT and BE correctly identified the policy in place, while those in SI, GR and ES did not. Respondents in opt-out countries (AT, BE, ES and GR) tended to support the policy in place (with one exception, i.e., SI), whereas those in opt-in countries (DE and DK) overwhelmingly opposed it. These results reveal stark differences in governance quality across countries and consent policies: We found a preponderance of informed opposition in opt-in countries and a general tendency towards support–either informed or uninformed–in opt-out countries. We also found informed divergence in opt-in countries and a tendency for convergence–either informed or uninformed–among opt-out countries. -/- Conclusion Our study offers a novel tool for analyzing governance quality and illustrates, in the context of OP, how the strengths and weaknesses of different policy implementations can be estimated and compared using quantitative survey data. (shrink)

Adolescents are routinely treated differently to adults, even when they possess similar capacities. In this article, we explore the justification for one case of differential treatment of adolescents. We attempt to make philosophical sense of the concurrent consents doctrine in law: adolescents found to have decision-making capacity have the power to consent to—and thereby, all else being equal, permit—their own medical treatment, but they lack the power always to refuse treatment and so render it impermissible. Other parties, that is, individuals (...) who exercise parental responsibility or a court, retain the authority to consent on an adolescent’s behalf. We explore four defences of the doctrine. We reject two attempts to defend the asymmetry in the power to consent to and refuse medical treatment by reference to transitional paternalism. We then consider and reject a stage of life justification. Finally, we articulate a justification based on the distinctiveness of adolescent well-being. (shrink)

This essay experiments with Kant’s writings on rational religion distilled through the Strange Case of Dr Jekyll and Mr Hyde as canonical confrontations with primal problems of evil. It suggests boundaries between Stevenson’s characters and their occupations comparable to the those conflicted in the Kantian university, namely, law, medicine, theology, and philosophy (which makes a short anticipatory appearance in his earlier text on rational religion). With various faculties it investigates diffuse comprehensions—respectively, legal crime, biogenetic transmission, and original sin—of key ethical (...) modes: will, inheritance, incorporation, freedom, duty, obligation, love, living, and killing to conclude on the possible logic of evil (or evils of logic) collateral and possibly innate to Kant’s comprehension of radical evil. (shrink)

If medical complicity is understood as compliance with a directive to act against the professional's best medical judgment, the question arises whether it can ever be justified. This paper will trace the contours of what would legitimate a directive to act against a professional's best medical judgment (and in possible contravention of her oath) using Joseph Raz's service conception of authority. The service conception is useful for basing the legitimacy of authoritative directives on the ability of the putative authority to (...) enable subjects to comply better with reasons that already apply to them. Hence, the service conception bases the legitimacy of practical authority on a certain kind of greater knowledge or expertise. This helps to focus the conundrum regarding complicity on the clash of expertise between the medical expert and the governing body tasked with coordinating behaviour and otherwise devising rules for the social good. The ethical dilemma presented by a hypothetically legitimate directive to act against a professional's best medical judgment also serves to highlight the moral dimension of one's duty to obey a legitimate authority. (shrink)

Aryeh Goldberg compellingly argues for a Narrative Coherence Standard (NCS) to bolster existing methods of assessing patients' mental capacity. But his account fails to distinguish between the cognitive abilities of children and adults; consequently, worries may be raised about the scope of the NCS, in particular when we consider child patients. In this article, I argue the NCS cannot plausibly apply to children. Since children's self-conception does not arrive fully formed — but rather is a product of both incomplete cognitive (...) development and socializing factors — I claim children may not possess a sufficiently intimate knowledge of self, and therefore a sufficiently coherent sense of self, as Goldberg demands. Therefore, we should either revise the NCS to accommodate children, adopt an incremental view of consent, or revert to the relevant form of the MacArthur competence criteria to establish children’s capacity to consent. (shrink)

Shared Decision Making (‘SDM’) is one of the most significant developments in Western health care practices in recent years. Whereas traditional models of care operate on the basis of the physician as the primary medical decision maker, SDM requires patients to be supported to consider options in order to achieve informed preferences by mutually sharing the best available evidence. According to its proponents, SDM is the right way to interpret the clinician-patient relationship because it fulfils the ethical imperative of respecting (...) patient autonomy. However, there is no consensus about how decisions in SDM contexts relate to the principle of respect for autonomy. In response, I demonstrate that in order to make decisions about what treatment they will or will not receive, patients will be required to meet different conditions depending on the approach proponents of SDM take to understanding personal autonomy. Due to the fact that different conceptions of autonomy yield different obligations, I argue that if physicians and patients satisfied all the conditions described in standard accounts of SDM, then SDM would undermine patient autonomy. (shrink)

It is well documented that people with moderate-to-severe traumatic brain injury (TBI) can undergo personality changes, including becoming more impulsive in terms of how they behave. Legal guidance and academic commentary support the view that impulsiveness can render someone decisionally incompetent as defined by English and Welsh law. However, impulsiveness is a trait found within the healthy population. Arguably, impulsiveness is also a trait that gives rise to behaviours that should normally be tolerated even when they cause harm to the (...) person enacting the behaviours. The purpose of this paper is to show why both of these considerations present as significant challenges to the law in England and Wales. (shrink)

According to many of its proponents, shared decision making ("SDM") is the right way to interpret the clinician-patient relationship because it respects patient autonomy in decision-making contexts. In particular, medical ethicists have claimed that SDM respects a patient's relational autonomy understood as a capacity that depends upon, and can only be sustained by, interpersonal relationships as well as broader health care and social conditions. This paper challenges that claim. By considering two primary approaches to relational autonomy, this paper argues that (...) standard accounts of SDM actually undermine patient autonomy. It also provides an overview of the obligations generated by the principle of respect for relational autonomy that have not been captured in standard accounts of SDM and which are necessary to ensure consistency between clinical practice and respect for patient autonomy. (shrink)

Two chapters -- "Common Arguments about Abortion" and "Better (Philosophical) Arguments About Abortion" -- in one file, from the open access textbook "Introduction to Ethics: An Open Educational Resource" edited by Noah Levin. -/- Adults, children and babies are arguably wrong to kill, fundamentally, because we are conscious, aware and have feelings. Since early fetuses entirely lack these characteristics, we argue that they are not inherently wrong to kill and so most abortions are not morally wrong, since most abortions are (...) done early in pregnancy before consciousness and feeling develop in the fetus. Furthermore, since the right to life is not the right to someone else’s body, fetuses might not have the right to the pregnant woman’s body, and so she has the right to not allow the fetus use of her body; this further justifies abortion, at least, until technology allows for the removal of fetuses to other wombs. Since morally permissible actions should be legal, abortions should be legal. -/- In the course of arguing for these claims, we: -/- discuss how to best define abortion; dismiss many common “question-begging” arguments that merely assume their conclusion, instead of giving genuine reasons for them; refute some often-heard “everyday arguments” about abortion; explain why some influential philosophical arguments against abortion are unsuccessful; provide some positive arguments that at least early abortions are not wrong; briefly discuss the ethics and legality of later abortions, and more. -/- Little of this discussion should be taken as absolute “proof” of anything, as this is merely a reasoned introduction to the issues: much more needs to be discussed, always. (shrink)

This chapter argues that adequately facing and responding to medical error requires making space for blame. In vindicating blame as a response to medical error, this essay does not advocate a return to a “bad apple” blame culture in which unlucky practitioners are unfairly scapegoated. It does, however, defend the targeted feeling and expression of angry, and even resentful, blaming attitudes toward health-care providers who make at least certain kinds of mistakes. The chapter makes the case that the angry and (...) resentful feelings associated with blame reflect a conception of oneself as a person worthy of consideration, and that expressing these feelings allows victims and families to fight for their dignity and self-respect. Along the way, it distinguishes between shaming and blaming, explaining that blaming, unlike shaming, characteristically aims to draw offenders into a moral dialogue. As a result, a good blaming practice can provide a logic within which providers who make costly errors may seek forgiveness, reconciliation, and healing. (shrink)

English law is unambiguous that legal personality, and with it all legal rights and protections, is assigned at birth. This rule is regarded as a bright line that is easily and consistently applied. The time has come, however, for the rule to be revisited. This article demonstrates that advances in fetal surgery and (anticipated) artificial wombs do not marry with traditional conceptions of birth and being alive in law. These technologies introduce the possibility of ex utero gestation, and/or temporary existence (...) ex utero, and consequently developing human beings that are novel to the law. Importantly, therefore, the concepts of birth and born alive no longer distinguish between human beings deserving of legal protection in the way originally intended. Thus, there is a need for reform, for a new approach to determining the legal significance of birth and what being legally alive actually encompasses. Investigating the law of birth is of crucial importance, because of the implications of affording or denying the subjects of new reproductive technologies rights and protections. A determination of the legal status of the subject of fetal surgery or an artificial womb will determine what can and cannot be done to each entity. Moreover, the status afforded to these entities will drastically impact on the freedoms of pregnant women. (shrink)

Despite the lack of evidence for their effectiveness, the use of physical restraints for patients is widespread. The best ethical justification for restraining patients is that it prevents them from harming themselves. We argue that even if the empirical evidence supported their effectiveness in achieving this aim, their use would nevertheless be unethical, so long as well known exceptions to informed consent fail to apply. Specifically, we argue that ethically justifiable restraint use demands certain necessary and sufficient conditions. These conditions (...) are that the physician obtain informed consent for their application, that their application be medically appropriate, and that restraints be the least liberty-restricting way of achieving the intended benefit. It is a further question whether their application is ever medically appropriate, given the dearth of evidence for their effectiveness. (shrink)

In this article, I will be focusing specifically on cryopreservation and two of the American biotechnomedical tenets introduced by Robbie Davis-Floyd and Gloria St. John in their technocratic model of medicine: the “body as machine” and “death as defeat.” These axioms are embraced by both the biotechnomedical establishment as well as the cryopreservation communities when they discuss the future of humankind. In particular, I will be focusing on the political economy of cryopreservation as an embodiment of American neoliberalism—as well as (...) a Durkheimian death ritual—in the twenty-first century. Finally, I will theorize on a future populated by human beings from “the past” and the implications and consequences that may be caused by contemporary humans experiencing a temporal shift from traveling in deep time vis-à-vis cryopreservation. (shrink)

This paper summarizes the seminar AI in Medicine in Context: Hopes? Nightmares? that was held at the Centre for Ethics at the University of Toronto on October 17, 2017, with special guest assistant professor and neurosurgeon Dr. Sunit Das. The paper discusses the key points from Dr. Das' talk. Specifically, it discusses about Dr. Das' perspective on the ethical and moral issues that was experienced from applying artificial intelligence (AI) in law and how such issues can also arise when applying (...) AI to medicine, and concludes with a brief discussion on how such issues can be prevented. (shrink)

This article draws upon the civic republican tradition to offer new conceptual resources for the normative assessment of mental capacity law. The republican conception of liberty as non-domination is used to identify ways in which such laws generate arbitrary power that can underpin relationships of servility and insecurity. It also shows how non-domination provides a basis for critiquing legal tests of decision-making that rely upon ‘diagnostic’ rather than ‘functional’ criteria. In response, two main civic republican strategies are recommended for securing (...) freedom in the context of the legal regulation of psychological disability: self-authorisation techniques and participatory shaping of power. The result is a series of proposals for the reform of decisional capacity law, including a transition towards purely functional assessment of decisional capacity, surer legal footing for advanced care planning, and greater control over the design and administration of decision-making capacity laws by those with psychological disabilities. (shrink)

Under the current Mental Health Act of England and Wales, it is lawful to perform deep brain stimulation in the absence of consent and independent approval. We argue against the Care Quality Commission's preferred strategy of addressing this problematic issue, and offer recommendations for deep brain stimulation-specific provisions in a revised Mental Health Act.

This is a volume of twelve essays concerning the fundamental tension in personalised medicine between individual choice and the common good.

Second edition of Property in the Body, containing about fifty percent new and updated material, including a chapter on surrogacy.

In this article, I address what kinds of claims are of the right kind to ground conscientious refusals. Specifically, I investigate what conceptions of moral responsibility and moral wrongness can be permissibly presumed by conscientious objectors. I argue that we must permit HCPs to come to their own subjective conclusions about what they take to be morally wrong and what they take themselves to be morally responsible for. However, these subjective assessments of wrongness and responsibility must be constrained in several (...) important ways: they cannot involve empirical falsehoods, objectionably discriminatory attitudes, or unreasonable normative beliefs. I argue that the sources of these constraints are the basic epistemic, relational, and normative competencies needed to function as a minimally decent health-care professional. Finally, I consider practical implications for my framework, and argue that it shows us that the objection raised by the plaintiffs in Zubik v. Burwell is of the wrong sort. (shrink)

In many jurisdictions, an offender’s remorse is considered to be a relevant factor to take into account in mitigation at sentencing. The growing philosophical interest in the use of neurointerventions in criminal justice raises an important question about such remorse-based mitigation: to what extent should technologically facilitated remorse be honoured such that it is permitted the same penal significance as standard instances of remorse? To motivate this question, we begin by sketching a tripartite account of remorse that distinguishes cognitive, affective (...) and motivational elements of remorse. We then describe a number of neurointerventions that might plausibly be used to enhance abilities that are relevant to these different elements of remorse. Having described what we term the ‘moral value’ view of the justification of remorse-based mitigation, we then consider whether using neurointerventions to facilitate remorse would undermine its moral value, and thus make it inappropriate to honour such remorse in the criminal justice system. We respond to this question by claiming that the form of moral understanding that is incorporated into a genuinely remorseful response grounds remorse’s moral value. In view of this claim, we conclude by arguing that neurointerventions need not undermine remorse’s moral value on this approach, and that the remorse that such interventions might facilitate could also be authentic to the recipient of the neurointerventions that we discuss. (shrink)

An abundance of data unequivocally shows that exercise can be an effective tool in the fight against obesity and its associated co-morbidities. Indeed, physical activity can be more effective than widely-used pharmaceutical interventions. Whilst metformin reduces the incidence of diabetes by 31% (as compared with a placebo) in both men and women across different racial and ethnic groups, lifestyle intervention (including exercise) reduces the incidence by 58%. In this context, it is notable that a group of prominent medics and exercise (...) scientists recently sent a well-publicised letter to the General Medical Council and Medical Schools Council calling for the introduction of evidence-based lifestyle education into all medical curricula. The letter warns that there is a lack of understanding of the impact that exercise and nutrition can have on physical health amongst doctors. In the absence of an educational overhaul, the signatories warn that the government is likely to fail to reach its goal of preventing tens of thousands of premature deaths from heart disease and cancer by 2020. Whilst we agree with the need to address this apparent lack of understanding, we argue that the ethical justification of doing so is not limited to this broadly beneficence-based justification. There is also a justification grounded in the duty of non-maleficence, that is, the duty to avoid unreasonably harming patients. This duty requires that doctors refrain from (i) preventing patients from undergoing beneficial treatment without good reason, (ii) exposing patients to unreasonable risks and (iii) reducing the therapeutic effect of an effective medical intervention. This requires an understanding of the physical impact of exercise. (shrink)

It is widely accepted among medical ethicists that competence is a necessary condition for informed consent. In this view, if a patient is incompetent to make a particular treatment decision, the decision must be based on an advance directive or made by a substitute decision-maker on behalf of the patient. We call this the competence model. According to a recent report of the United Nations (UN) High Commissioner for Human Rights, article 12 of the UN Convention on the Rights of (...) Persons with Disabilities (CRPD) presents a wholesale rejection of the competence model. The High Commissioner here adopts the interpretation of article 12 proposed by the Committee on the Rights of Persons with Disabilities. On this interpretation, CRPD article 12 renders it impermissible to deny persons with mental disabilities the right to make treatment decisions on the basis of impaired decision-making capacity and demands the replacement of all regimes of substitute decision-making by supported decision-making. In this paper, we explicate six adverse consequences of CRPD article 12 for persons with mental disabilities and propose an alternative way forward. The proposed model combines the strengths of the competence model and supported decision-making. (shrink)