Medicine and Law

This paper argues that in the absence of general duties to rescue a woman may, at any time, terminate an unintended pregnancy even if the foetus is a person. However the rights of the foetus restrict the procedures one may use. In particular only an evictionist procedure may be used. Furthermore the argument presented does not rely on any act of balancing the rights of the woman against the rights of the foetus. There is no “clash of rights” involved. This (...) paper also replies to the objection that this line of reasoning leads to the implausible conclusion that one may evict a trespasser even if this causes his death. -/- In this paper I assume that every person (including, for the sake of argument, the foetus) has an exclusive right to control her own body (Control Self-Ownership, CSO). This right excludes the possibility of general enforceable duties to rescue. However it does not, unlike full self-ownership, prevent the State from taxing individuals to help others. -/- Firstly I argue that there are two different ways to terminate the pregnancy. The first and most common is an abortion, this will result in the death of the foetus in the process. The second one is an eviction, this merely involves the removal of the foetus from the womb. Depending on the state of the pregnancy the foetus may or may not survive the eviction. -/- Secondly I argue that, assuming the foetus does not have an acquired to remain within the womb, it would be a violation of the rights CSO of the woman to prohibit her from evicting the foetus, even if this results in its death. -/- Thirdly I argue that the foetus would not have the right to remain within the womb in case of unintended pregnancy. This is because, to hold otherwise, would impose a non-voluntary positive obligation on the woman, in contravention with her rights to control her body. -/- Fourthly I argue that to allow the woman to have an abortion, even when an eviction is not possible, would amount to a violation of the rights of the foetus. Hence an eviction is a procedure which respects the rights of both the foetus and the woman. As such this solution does not result in a “clash of rights”, which may have to be resolved on consequentialist grounds. -/- Finally I argue that the reasoning of this paper does not require us to hold that one may evict a trespasser from one's property if this will result in his death. -/- Therefore, those who want to prohibit women from having an abortion need to show that the foetus is a person. For those who wish to prohibit women from evicting the foetus the burden is an even greater one: they must in addition show that there are strong (enforceable) positive duties to rescue (this would amount to a denial of CSO). This however raises difficulties for those who would wish to prohibit evictions in countries, like the US and England and Wales, where the law does not normally recognise such duties. By prohibiting only evictions without making failure to assist those in danger (even at great cost to oneself) a crime they would be violating equality before the law. (shrink)

The increasing use of opioid treatment agreements (OTAs) 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 be addressed by simply minimizing 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. (shrink)

When an abortion is performed, someone dies. Are we killing an innocent human person? Widespread disagreement exists. However, it’s not necessary to establish personhood in order to establish the wrongness of abortion: a substantial chance of personhood is enough. We defend The Don’t Risk Homicide Argument: abortions are wrong after 10 weeks gestation because they substantially and unjustifiably risk homicide, the unjust killing of an innocent person. Why 10 weeks? Because the cumulative evidence establishes a substantial chance (a more than (...) 1 in 5 chance) that preborn humans are persons around this stage of development. We submit evidence from our bad track record, widespread disagreement about personhood (after 10 weeks gestation), problems with theories of personhood, the similarity between preborn humans and newborn babies, gestational age miscalculations, and the common intuitive responses of women to their pregnancies and miscarriages. Our argument is cogent because it bypasses the stalemate over preborn personhood and rests on common ground rather than contentious metaphysics. It also strongly suggests that society must do more to protect preborn humans. We discuss its practical implications for fetal pain relief, social policy, and abortion law. (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)

Background: This research explores how public awareness and attitudes toward donation and transplantation policies may contribute to Spain's success in cadaveric organ donation. Materials and Methods: A representative sample of 813 people residing in Andalusia (Southern Spain) were surveyed by telephone or via Internet between October and December 2018. Results: Most participants trust Spain's donation and transplantation system (93%) and wish to donate their organs after death (76%). Among donors, a majority have expressed their consent (59%), and few nondonors have (...) expressed their refusal (14%). Only a minority are aware of the presumed consent system in force (28%) and feel sufficiently informed regarding the requirements needed to be an organ donor (16%). Participants mainly consider that relatives should represent the deceased's preferences and be consulted when the deceased's wishes are unknown, as is the case in Spain. Conclusion: Public trust in the transplant system may contribute to Spain's high performance in organ donation. High levels of societal support toward organ donation and transplantation do not correspond with similar levels of public awareness of donation and transplantation policies in Spain. (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)

Informed consent, when given by proxy, has limitations: chiefly, it must be made in the interest of the patient. Here we critique the standard approach to parental consent, as present in Canada and the UK. Parents are often asked for consent, but are not given the authority to refuse medically beneficial treatment in many situations. This prompts the question of whether it is possible for someone to consent if they cannot refuse. We present two alternative and philosophically more consistent frameworks (...) for paediatric proxy consent. The first allows meaningful consent (parents may say ‘yes’ or ‘no’ to treatment), provided that parents are medically informed/competent and intend the health and well-being of their child. In the second solution, medical practitioners or the state consent for treatment, with parents only being consulted to help give insight to the child’s circumstances. While we contend that either of these two options is superior to the insincerity of the present paradigm, we suggest that the first solution is preferable. (shrink)

Since 1968, a brain-based criterion of death has been adopted in medical practice and passed into law or national guidelines in most countries worldwide. In some countries, such as Australia, Spain, and the United States, death can be determined by either the circulatory and respiratory criterion or by the neurological criterion. This practice corresponds to recommendations by the World Health Organization and the World Medical Association. In the USA, 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)

In his ‘When conscientious objection runs amok: A physician refusing human immunodeficiency virus (HIV) preventative to a bisexual patient’, Brummett has argued that Catholic physicians (or indeed any other healthcare practitioner) should not be able to raise conscientious objections to HIV pre-exposure prophylaxis for bisexual patients, as this constitutes discrimination. Brummett argues that such a conscientious objection represents an instance of conscience creep, which he argues is undesirable. Here I re-analyse the case presented by Brummett using a teleological framework and (...) making reference to Catholic teaching on cooperation with evil. While I agree with Brummett that in this case the physician should not have had the right to conscientiously object, I argue that the teleological framework offers advantages over the argument Brummett has presented. I also comment on why only considering empirically measurable harm as a publicly defensible reason for one to hold a conscientious objection is problematic, as well as on the difficulties associated with cases of discrimination in a pluralistic society. (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.

UK maternity policy makes great fanfare about providing person-centered care, built around what the pregnant woman or birthing person needs. Maternity Voices Partnerships involving healthcare professionals and women are supposed to guide policy and practice at the local level. UK consent law prioritizes the pregnant person's own conception of the risks and factors that are material to her care. The COVID-19 pandemic has shown how tenuous a hold these laudable principles actually have when the going gets tough.

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)

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)

The case of Alta Fixsler, where a judge ruled that withdrawing life sustaining care was in her best interest rather than transferring her to Israel, as her parents wanted, is the latest in a series of controversial paediatric best interest decisions. Using this case, as well as some other recent cases, I argue that the UK exhibits a high degree of medico-legal paternalism in best interest decisions, even though paternalism seems to be ubiquitously negatively perceived in medical ethics. Firstly, I (...) explain what I mean by medico-legal paternalism and defend my claim that this phenomenon is present in the UK. I then argue that at least philosophically (rather than legally) such a situation is impossible to justify in a secular state and that how we treat paediatric best interest decisions is very different from other areas of medical law. Lastly, I discuss proposals that aim to rectify this situation. (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)

In this paper, I argue that medical school admissions should be limited to statistically relevant factors. My argument rests primarily on three assumptions. A state professional school should maximize production. If a state professional school should maximize production, then it should maximize production per student. If a state professional school should maximize production per student, then, within the optimum budget, a state medical school should maximize quality-adjusted medical services per graduate. I put forth a tentative equation for ranking applicants as (...) a way of maximizing quality-adjusted medical services per graduate. This way of ranking is cheaper than the way admissions is currently done. Hence, the proposal is practically as well as theoretically appealing. (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)

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)

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)

America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. How can the allocation of scarce treatments for COVID-19 and similar public health threats fairly and legally respond to these racial disparities? Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that this prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who (...) have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. I argue that, to pass muster under current law, policymaking in this area must recognize a crucial distinction: prioritizing minority communities, such as hard-hit neighborhoods, without regard to individual race is typically legal, but prioritizing individuals on the basis of their racial identity faces is likely not. I also explain how prioritization on the basis of Native American status is allowable and legally distinct from prioritization on the basis of individual race. -/- In Part II, I provide a brief overview of current and proposed COVID-19 treatments and identify documented or likely scarcities and disparities in access. In Part III, I argue that randomly allocating scarce medical interventions, as some propose, will not effectively address disparities: it both permits unnecessary deaths and concentrates those deaths among people who are more exposed to infection. In Part IV, I explain why using individual-level racial classifications in allocation is precluded by current Supreme Court precedent. Addressing disparities will require focusing on factors other than race, or potentially considering race at an aggregate rather than individual level. I also argue that policies prioritizing members of Native American tribes can succeed legally even where policies based on race would not. In Part V, I examine two complementary strategies to narrow racial disparities. One would prioritize individuals who live in disadvantaged geographic areas or work in hard-hit occupations, potentially alongside race-sensitive aggregate metrics like neighborhood segregation. These approaches, like the policies school districts adopted after the Supreme Court rejected individualized racial classifications in education, would narrow disparities without classifying individuals by race. The other strategy would address the starkly disparate racial impact of deaths early in life by limiting the use of age-based exclusions from vaccine or treatment access that explicitly deprioritize the prevention of early deaths and so disparately exclude minorities, and by considering policies that prioritize the prevention of early deaths. (shrink)

In this Correspondence, I argue that given that scarcity has existed both for critical care resources and for vaccines, allocating critical care resources to prioritize the prevention of early COVID-19 deaths (i.e. COVID-19 deaths among younger patients) could valuably counterbalance the disproportionate exclusion of minority patients and those with life shortening disabilities that age-based vaccine allocation produces. -/- Covid-19 deaths early in life have overwhelmingly befallen minorities and people with life-shortening disabilities. Policies preventing early deaths prevent an outcome widely recognized (...) as worse—dying earlier in one’s life rather than later—while counteracting intersecting forms of injustice. Ultimately, prohibiting the use of age as a tiebreaker in critical care allocation, as Brown et al. propose, will worsen disparities and is not mandated by law. (shrink)

In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one’s home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies. In Part II, I identify two types of tailored policies--activity-based and (...) group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and dining indoors. Group-based restrictions consider differences between groups with respect to risk and benefit. Examples are policies that treat children or senior citizens differently, policies that require travelers to quarantine when traveling to a new destination, and policies that treat individuals differently based on whether they have COVID-19 symptoms, have tested positive for COVID-19, have previous COVID-19 infection, or have been vaccinated against COVID-19. In Part III, I consider the public health law grounding of tailored policies in the principles of “least restrictive means” and “well-targeting.” I also examine how courts have analyzed tailored policies that have been challenged on fundamental rights or equal protection grounds. I argue that fundamental rights analyses typically favor tailored policies and that equal protection does not preclude the use of tailored policies even when imperfectly crafted. In Part IV, I consider three critiques of tailored policies, centering on the claims that they produce inequity, cause harm, or unacceptably limit liberty. I argue that we must evaluate restrictions comparatively: the question is not whether tailored policies are perfectly equitable, wholly prevent harm, or completely protect liberty, but whether they are better than untailored ones at realizing these goals in a pandemic. I also argue that evaluation must consider indirect harms and benefits as well as direct and apparent ones. (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.

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)

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)

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 de la presente tesis doctoral 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 decision-making autonomy. Although it has a bodily background, it is combined with features of moral nature, which presupposes a concrete notion of 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 doctoral thesis 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)

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)

A legal analysis on the informed consent of the patient primarily requires considering the common law, regardless of solutions provided by the malpractice statutes and a promising constitutional protection route, despite the ascertainment of some preventable shortcomings. This paper aims to offer a comprehensive review on the genesis, advancement and basis of the U.S. legal protection of the informed consent in the healthcare extent, to afterwards carry out a brief comparative study with the Spanish regulation.

We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...) daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination. (shrink)

This Essay explains why model policies proposed or adopted in response to the COVID-19 pandemic that allocate scarce medical resources by using medical evidence to pursue two core goals—saving more lives and saving more years of life—are compatible and consonant with disability law. Disability law, properly understood, permits considering medical evidence about patients’ probability of surviving treatment and the quantity of scarce treatments they will likely use. It also permits prioritizing health workers, and considering patients’ post-treatment life expectancy. These factors, (...) when based on medical evidence and not inaccurate stereotypes, are legal to consider even if they disadvantage some patients with specific disabilities. It then discusses the ethical advantages of triage policies that use medical evidence to save more lives and years of life, which I call “evidence-based triage,” focusing on the benefits of these policies for patients with disabilities. In doing so, I explain why recent critiques err by treating people with disabilities as a monolith, overlooking the political disadvantages of less-visible victims, and treating the social origins of scarcity as a justification for saving fewer lives. Evidence-based triage parallels other policy responses to the COVID-19 pandemic, like physical distancing and postponement of medical procedures, which may burden patients with specific disabilities or medical conditions but are nevertheless justified because they save more patients. (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)

Recently, debate over whether health care providers should have a protected right to conscientiously refuse to offer legal health care services—such as abortion, elective sterilization, aid in dying, or treatments for transgender patients—has grown exponentially. I advance a modified compromise view that bases respect for claims of conscientious refusal to provide specific health care services on a publicly defensible rationale. This view requires health care providers who refuse such services to disclose their availability by other providers, as well as to (...) arrange for referrals or facilitate transfers of care. This requirement raises the question of whether providers are being forced to be complicit in the provision of services they deem to be morally objectionable. I conclude by showing how this modified compromise view answers the most significant objections mounted by critics of the right to conscientious refusal and safeguards providers from having to offer services that most directly threaten their moral integrity. (shrink)

This book makes an important contribution to ongoing efforts in the fields of medical law and bioethics to answer the challenges posed by the limitations of the principle of respect for autonomy, especially as these pertain to human research ethics. The principle of respect for autonomy seems to have become firmly embedded in human research ethics since its inclusion in the 1947 Nuremberg Code, which was a response to atrocities committed by Nazi doctors. Nonetheless, there is an increasing awareness of (...) the limitations of the principle of respect for autonomy and the underlying conceptualisations of human autonomy. (shrink)

This book makes an important contribution to ongoing efforts in the fields of medical law and bioethics to answer the challenges posed by the limitations of the principle of respect for autonomy, especially as these pertain to human research ethics. The principle of respect for autonomy seems to have become firmly embedded in human research ethics since its inclusion in the 1947 Nuremberg Code, which was a response to atrocities committed by Nazi doctors. Nonetheless, there is an increasing awareness of (...) the limitations of the principle of respect for autonomy and the underlying conceptualisations of human autonomy. (shrink)

Since the end of World War II, most guidelines governing human research seem to have relied on the principle of respect for autonomy as a key, though not sole, criterion in assessing the moral validity of research involving human participants.1 One explanation for this apparent reliance on respect for autonomy may be that respect for autonomy, made effective through the practice of obtaining informed consent, functions as a useful proxy when dealing with competent adults for the more complex principle of (...) respect for human dignity that underpins much of the moral discourse in this area. If this explanation holds, then assessment of the moral licitness of research involving human individuals whose autonomy is limited in some way requires a deeper analysis of the ‘thicker’ concepts of human dignity, since we cannot rely on respect for autonomy to do the work of respect for human dignity where autonomy (understood as a capacity to consent based on adequate information) is not present, is limited or is compromised. (shrink)

This chapter examines the explicit and implicit roles that the concept of beneficence plays in the guidelines that govern biomedical research involving humans. We suggest that the role beneficence is actually playing in the guidelines is more comprehensive than is commonly assumed. The broader conceptualisation of beneficence proposed here clarifies the relationship of beneficence to respect for autonomy. It does this by showing how respect for autonomy is at the service of beneficence rather than in tension with it.

Respect for autonomy has become a fundamental principle in human research ethics. Nonetheless, this principle and the associated process of obtaining informed consent do have limitations. This can lead to some groups, many of them vulnerable, being left understudied. This book considers these limitations and contributes through legal and philosophical analyses to the search for viable approaches to human research ethics. It explores the limitations of respect for autonomy and informed consent both in law and through the examination of cases (...) where autonomy is lacking (infants), diminished (addicts), and compromised (low socio-economic status). It examines alternative and complementary concepts to overcome the limits of respect for autonomy, including beneficence, dignity, virtue, solidarity, non-exploitation, vulnerability and self-ownership. It takes seriously the importance of human relationality and community in qualifying, tempering and complementing autonomy to achieve the ultimate end of human research - the good of humankind. (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)

The English cases of Charlie Gard and Alfie Evans involved a conflict between the desires of their parents to preserve their children’s lives and judgments of their medical teams in pursuit of clinically appropriate therapy. The treatment the children required was clearly extraordinary, including a wide array of advanced life-sustaining technological support. The cases exemplify a clash of worldviews rooted in different philosophies of life and medical care. The article highlights the differing perspectives on parental authority in medical care in (...) England, Canada, and the United States. Furthermore, it proposes a solution that accommodates for both reasonable parental desires and professional medical opinion. This is achieved by looking at concepts of extraordinary therapy, best interest, reasonable parenthood and medical objections. (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)

In this chapter I explicate and evaluate the concept of medical error. Unlike standard philosophical approaches to analyzing medical phenom- ena in the abstract, I instead address medical error specifi cally within the context of an embodied social world. I illustrate how, as a deeply contex- tual concept, medical error is inextricably tied to the social conditions— and concrete, powerful interests—of the particulars in which it is found. -/- I begin with an analysis that demonstrates the relational quality of medi- (...) cal error, as a functional, outcome-oriented concept, evaluating the origin and context of the term’s emergence, and connecting it to a similarly contextual concept, “standard of care.” I move on to note the concern- ing implications of medical error identifi cation and measurement when viewed through an intersectional standpoint. To do so, I discuss what intersectional approaches can help reveal about our contemporary social world of medicine and public health. Intersectional approaches, as I will explain, focus on how intersections of social identity can unmask social structures that negatively impact groups and individuals. It appears, as -/- I will suggest, that disparities in social goods (e.g., social standing, edu- cation, wealth) complicate our identification of medical error, itself, and compound concerns of equity and access to medical goods for those who have diminished expectations for health. (shrink)

Scholars have mostly analyzed information from mental health practitioners, attorneys, and institutions to critique mental health practices in the War on Terror. These sources offer limited insights into the suffering of detainees. Detainee accounts provide novel information based on their experiences at Guantánamo. Mohamedou Ould Slahi’s Guantánamo Diary is the only text from a current detainee that provides a first-person account of his interrogations and interactions with health professionals. Despite being advertised as a diary, however, it has undergone redaction from (...) American government officials. This article examines Slahi’s account of his interrogations and representations of mental health at Guantánamo and considers its role within the narrative function of the nation. At stake is the right of detainees to narrate, scholars to critique medical practices in the War on Terror, and the nation’s attempts to control its narration. (shrink)