BackgroundIn Saudi clinical settings, benevolent family care that reflects strongly held sociocultural values is commonly used to justify overriding respect for patient autonomy. Because the welfare of individuals is commonly regarded as inseparable from the welfare of their family as a whole, these values are widely believed to obligate the family to protect the welfare of its members by, for example, giving the family authority over what healthcare practitioners disclose to patients about their diagnoses and prognoses and preventing them from (...) making informed decisions about their healthcare.DiscussionFamily dominance over the healthcare decisions of competent patients is ethically problematic when the family prevent healthcare practitioners from disclosing diagnoses and prognoses to patients who have the capacity to consent and make decisions in their own best interests. Thus, the author holds that sociocultural values ought to be respected only when they do not prevent competent patients from knowing their diagnoses and prognoses or prevent them from making their own decisions.ConclusionHealthcare practitioners should not allow patients’ families to control what can or cannot be disclosed to competent patients. This is particularly important when patients are approaching death so that they may address their material and spiritual wishes—among other needs—as they prepare for death. Justification for this position is drawn from the Maqasid Al-Shariah-based Islamic bioethics approach, from which it is possible to argue that the harm of withholding diagnoses and prognoses from patients who are imminently dying outweighs the potential benefits. (shrink)

The twin ideas at the heart of the social contract tradition are that persons are naturally free and equal, and that genuine political obligations must in some way be based on the consent of those obligated. The Lockean tradition has held that consent must be in the form of explicit choice; Kantian contractualism has insisted on consent as rational endorsement. In this paper I seek to bring the Kantian and Lockean contract traditions together. Kantian rational (...) class='Hi'>justification and actual choice are complementary devices through which our freedom and equality can be reconciled with moral and political authority. We should not think that there is simply one way by which relations of moral and political authority can be reconciled with our status as free and equal. I defend three distinct devices through which freedom and authority may be reconciled: justification to others, social choice and promise. All three are aspects of the ?consent tradition? broadly construed. (shrink)

In a community that takes rights seriously, consent features pervasively in both moral and legal discourse as a justifying reason: stated simply, where there is consent, there can be no complaint. However, without a clear appreciation of the nature of a consent-based justification, its integrity, both in principle and in practice, is liable to be compromised. This book examines the role of consent as a procedural justification, discussing the prerequisites for an adequate (...) class='Hi'>consent -- in particular, that an agent with the relevant capacity has made an unforced and informed choice, that the consent has been clearly signalled, and that the scope of the authorisation covers the act in question. It goes on to highlight both the Fallacy of Necessity (where there is no consent, there must be a wrong) and the Fallacy of Sufficiency (where there is consent, there cannot be a wrong). Finally, the extent to which the authority of law itself rests on consent is considered. If the familiarity of consent-based justification engenders confusion and contempt, the analysis in this book acts as a corrective, identifying a range of abusive or misguided practices that variously under-value or over-value consent, that fictionalise it or that are fixated by it, and that treat it too casually or too cautiously. In short, the analysis in Consent in the Law points the way towards recognising an important procedural justification for precisely what it is as well as giving it a more coherent application. (shrink)

Community engagement is increasingly defended as an ethical requirement for biomedical research. Some forms of community engagement involve asking the consent of community leaders prior to seeking informed consent from community members. Although community consent does not replace individual consent, it could problematically restrict the autonomy of community members by precluding them from research when community leaders withhold their permission. Community consent is therefore at odds with one of the central principles of bioethics: respecting autonomy. (...) This raises the question as to how community consent can be justified or even required. This paper aims to provide an answer to this question by arguing, based on the work of Taylor and Kymlicka, that community practices are important for the identity and autonomy of community members. When these practices are incompatible with a solitary focus on individual informed consent, they need to be protected by making these decision‐making practices (including asking permission to community authorities) part of the consent process. Since these decision‐making practices are important for the autonomy of community members, community consent with the goal of protecting these practices is not necessarily in conflict with autonomy. (shrink)

A very common but untested assumption is that potential children would consent to be exposed to the harms of existence in order to experience its benefits. And so, would-be parents might appeal to the following view: Procreation is all-things-considered permissible, as it is morally acceptable for one to knowingly harm an unconsenting patient if one has good reasons for assuming her hypothetical consent—and procreators can indeed reasonably rely on some notion of hypothetical consent. I argue that this (...) view is in error. My argument appeals to a consent-based version of anti-natalism advanced by Seana Valentine Shiffrin. Anti-natalism is the view that it is always wrong to bring people into existence. While, like Shiffrin, I stop short of advocating a thoroughgoing anti-natalism, I nevertheless argue that procreators cannot appeal to hypothetical consent to justify exposing children to the harms of existence. I end by suggesting a more promising route by which this justification might be achieved. (shrink)

When formulating a policy related to food in a heterogeneous context within a nation or between nations, oppositional positions are more or less explicit, but always have to be overcome. It is interesting to note, though, that such elements as culture and religion have seldom been the focus in discussions about methods of decision-making in food policy. To handle discrepancies between oppositional positions, one solution is to narrow differences between partners, another to accept one partner or position as dominant. In (...) a solid and lasting policy, any of these options has to be agreed upon by all the partners involved. In this article, I argue that context sensitivity and a shared picture of the situation are necessary bases for a solid food policy. Two methods for policy discussion are elaborated on and religious slaughter is given as an example of a heterogeneous setting with strongly diverging ideals. Several aspects have to be respected from the outset, such as culture, religion, and value systems. This condition is partly met in a model of informed consent and in a consensus model. The informed consent model is regarded as insufficient, because it lacks both methods of dealing with hierarchies and the goal of finding a shared and nuanced picture of the situation. A consensus model meets these tasks but might on the other hand, among other things, be too difficult to follow and to administer. For both models, some difficulties with justification of decisions arise. Five essential elements emanating from a combination of these models are suggested as a basis for a decision process regarding food policies: respect for each discussion partner, context sensitivity, respect for arguments including emotions, a shared picture of the situation, and finally relating theory and practice. (shrink)

Informed consent is valid only if the person giving it is competent. Although allegedly informed consents are routinely tendered, there are nonetheless serious problems with the concept of competence as it stands. First, conceptual work upon competence is incomplete: the concept is unanalyzed and no logic of competence has been identified. It is thus virtually impossible to reliably discern who is competent. ;Traditional work on competence has explicated three dichotomies from which the necessary conditions for the possibility of competence (...) will be identified, viz., that competence is either a global or a specific notion; is present in varying degrees or in virtue of a threshold; and may or not include appeals to consequences. Past efforts have failed to notice a fourth dichotomy: competence as an affective or cognitive notion. Failure to designate the appropriate arms of these dichotomies is responsible for there being, at present, no reliable test for competence. The inadequacies of a highly regarded particular test for competence, the mental status examination, are examined in light of this failure. ;Competence is located within the rule-governed practice of informed consent. That practice and hence, competence, is justified through a Kantian analysis of respect for persons. This analysis reveals that the logic of competence requires assessment in terms of specific rather than global concerns; degrees of ability rather than a threshold; both cognitive and affective abilities; and no appeal to consequences. ;Based upon the analyses of consent as an example of decision making within the practice of informed consent and of respect for persons, the capacities which jointly comprise competence are identified. These are the capacities to receive, recognize, and retrieve information; to reason about, relate to oneself, and rank options; to choose among alternatives; and, under certain circumstances, to defend one's choice. ;Identification of the logic of competence and explication of and justification for the capacities that comprise competence to consent provide a conceptual foundation for the crucial concept of competence that the informed consent process currently lacks. It should facilitate construction of a test for competence. (shrink)

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If (...) the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill’s conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill’s conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy. (shrink)

The coronavirus pandemic has brought to public attention a variety of questions long debated in medical ethics, but now given both added urgency and wider publicity. Among these is triage, with its origins in deciding which individual lives are to be saved on a battlefield, but now also concerned with the allocation of scarce resources more generally. On the historical battlefield, decisions about whom to treat first – neither those who would survive without treatment, nor those who would not survive (...) even with treatment, but those who needed treatment to survive – was facilitated by military discipline and the limited effectiveness of treatments available. In the allocation of scarce resources today, by contrast, such decisions are subject to intense public and political scrutiny, and the range of effective treatments available has immeasurably diminished the proportion of ‘those who would not survive even with treatment’. If triage decisions are to be made, they now need to be justified in the arena of public opinion by moral arguments which are also politically persuasive. A number of different aspects of what is required for this endeavour are examined in the first five contributions to this issue of the Journal. In ‘Should age matter in COVID-19 triage? A deliberative study ’1, Kuylen and colleagues report on a deliberative study of public views in the UK, in which participants ‘generally accepted the need for triage but strongly rejected ’fair innings’ and ’life projects’ principles as justifications for age-based allocation,…preferring to maximise the number of lives rather than life years saved’; and concerned that in any resolution ‘utilitarian considerations of efficiency should be tempered with a concern for equality and vulnerability’. A similar concern to temper utilitarian considerations, in this case with an Aristotelian view of the common good as ‘the good life for …. (shrink)

This chapter surveys attempts to provide liberal justification for specific rights available to Indigenous citizens of democratic societies. The most important of these, by Will Kymlicka, relied on the equal right of all citizens to the good of cultural membership to argue for specific rights to protect minority cultures. After noting that Rawls’s political liberalism offers other resources to argue for specific constitutional or legal rights for colonised Indigenous citizens, the chapter turns to consider James Tully’s argument for an (...) inter-cultural constitutionalism based on the principles of recognition, consent and continuity. Finally, the chapter refers to the work of Robert A. Williams Jr in order to suggest that the conditions of a just and fair colonial constitution are similar to the conditions of a just and stable political society in which there are incommensurable comprehensive moral views. (shrink)

We would not be far wide of the mark if we suggested that the prevailing social ideology is structured round the presumption that interpersonal and political relationships ought to be, and for the most part are, based on the mutual consent of the parties involved. Liberal democratic theory has secured for consent a crucial role in the justification of political obligation and authority. In law, the maximvolenti non fit injuria,to the one who consents no wrong is (...) done, constitutes a defence in cases where one person invades the interests of another. In the bioethical field, there is a preoccupation with the formulation of a standard of ‘informed consent’ in patient-doctor and subject-researcher relationships. And in the broader domain of ethical theory there is an influential view that consensual acts do not differ in moral quality from selfregarding behaviour. (shrink)

Compared with data that is initially collected for research purposes, the mandatory authorization of a government database for secondary use deserves greater scrutiny because it consists of information that is collected initially for administrative purposes. Using the case of Taiwan’s National Health Insurance (NHI) Database as an example, this paper analyzes the ethical issues that emerge when the research participants are “participated” in studies without their consent, according to the current policy. The proponents of secondary use for research purposes (...) maintain that the authorized use of the NHI Database is necessary for public interests, while the opponents argue that the potential lack of democratic accountability and the infringement on people’s rights to privacy and information autonomy is unwarranted. Drawing on the solidarity‐based approach, this paper proposes a temporal solution as a possible reform direction for better ethical justification of the secondary use of the NHI Database. (shrink)

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. (...) We analyse the moral values essential to valid consent – autonomy, voluntariness, non-manipulation, and non-exploitation – and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. (shrink)

The necessity of consent is widely justified on the basis of the principle of respect for autonomy. Also, it is widely believed that shared decision making (SDM) is the practical device to seek patients’ consent for medical treatment. In this essay, I argue that SDM, while necessary, is insufficient for consent; because, in the paradigm of evidence-based medicine, SDM is contingent upon other practices to identify appropriate treatments that form the subjects of SDM. Indeed, case law (...) emphasises normative decision-making practices that precede SDM. Furthermore, case law supplies a nuanced understanding of SDM, which includes not only exchange of information but also attention to human vulnerability that persists despite formal retention of decision-making capacity. In addition, the law marks out a space in which people with capacity are absolutely entitled to self-determination. Thus, a four-step framework of decision making can be induced from legal doctrine. This legal framework corresponds to a construct of respect for autonomy that draws upon feminist theory. Feminist scholars have objected to the focus on individuals in traditional theories of autonomy; instead, they insist that people have to be considered in the context of their social influences and relationships. Feminists separate out four ideas of autonomy, and these ideas can be used to construct a four-layered model of respect for autonomy, in which each layer corresponds sequentially to a step in the legal framework of decision making. This model of respect for autonomy provides both conceptual clarity and theoretically robust justification for doctors’ various obligations in decision-making practices for consent. (shrink)

Il problema apparentemente insolubile di una giustificazione non circolare dell’induzione diverrebbe più abbordabile se invece di chiederci solo cosa ci assicura che un fenomeno osservato si riprodurrà in modo uguale in un numero potenzialmente infinito di casi futuri, ci chiedessimo anche come si spiega che esso si sia manifestato fin qui in modo identico e senza eccezioni in un numero di casi finito ma assai alto. E’ questa l’idea della giustificazione abduttiva dell’induzione, avanzata in forme diverse da Armstrong, Foster e (...) BonJour: serie talmente regolari di fenomeni sono da un punto di vista logico talmente improbabili che se il mondo fosse puramente casuale (se cioè gli eventi si presentassero con frequenza proporzionale alla loro probabilità logica) esse non potrebbero verificarsi se non per una coincidenza miracolosa. Pertanto, tali regolarità si spiegano solo assumendo che siano prodotte da meccanismi o necessità nomiche; ma se questo è il caso, è corretto concludere che tali regolarità persisteranno anche in futuro senza eccezioni, e dunque le inferenze induttive su di esse sono giustificate. Anche Kornblith argomenta dall’effettivo successo delle inferenze induttive all’esistenza di regolarità oggettive in natura; mentre Sankey parte dall’ uniformità della natura per giustificare l’induzione. Congiungendo le due argomentazioni, dunque, si ottiene di nuovo una giustificazione dell’induzione in base all’argomento del “se non è un miracolo …”. Un ostacolo su questa via è specificare in che senso la natura sia uniforme (dato che ovviamente non lo è in ogni suo aspetto) e di quali regolarità possiamo aspettarci che persistano senza eccezione anche in futuro (dato che evidentemente non tutte lo fanno: l’acqua non bolle sempre a 100°, la pressione non è sempre funzione della temperatura, e così via). Entrano qui in gioco le conoscenze di sfondo e la ripetizione delle osservazioni in condizioni diverse, che ci mostrano quali circostanze siano rilevanti al verificarsi del fenomeno dato. In tal modo, le nostre descrizioni delle regolarità naturali convergono su descrizioni che specificano sia le condizioni individualmente necessarie e congiuntamente sufficienti, sia tutti gli argomenti delle funzioni che costituiscono tali regolarità. Ciò consente di formulare i principi di Uniformità della Natura e di Induzione in modo non generico (e dunque, a seconda della formulazione, vuoto o eccessivo), ma circostanziato: così essi asseriscono, rispettivamente, che la natura è uniforme negli aspetti evidenziati dalle descrizioni su cui convergiamo grazie alle osservazioni ripetute, e che solo queste descrizioni possono essere induttivamente generalizzate. Ciò consente anche di risolvere enigmi alla Goodman, quali: poiché le osservazioni ci hanno mostrato (solo) il verificarsi di una data regolarità fino al momento presente t, come possiamo presumere che essa si verificherà anche dopo t? La risposta è che osservazioni e conoscenza di sfondo non ci dicono che vi sia alcun limite temporale tra le condizioni necessarie della regolarità data. (shrink)

In a recent critique of informed consent, Robert Veatch argues that the practice is in principle unable to attain the goals for which it was developed. We argue that Veatch's focus on the theoretical impossibility of determining patients' best interests is misapplied to the practical discipline of medicine, and that he wrongly assumes that the patient-physician communication fails to provide the knowledge needed to insure the patient's best interests. We further argue that Veatch's suggested alternative, value-based patient-professional pairing, (...) is, on his own terms, impossible to implement. Finally, we reexamine the philosophical and practical justifications for informed consent and conclude that the practice should be retained. (shrink)

The legal requirements and justifications for collecting patient-identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population-based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient-identifiable data without patient consent for research (...) purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient-identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient-identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support. (shrink)

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I provide (...) support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests. (shrink)

Deep brain stimulation as investigational intervention for symptomatic relief from Alzheimer disease has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical. We performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the analysis (...) of research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients. The results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely. Based on our empirical analysis, we argue that clinical research on interventions of risk class III should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period. (shrink)

What is the foundation of consent in the criminal law? Classically liberal commentators have offered at least three distinct theories. J.S. Mill contends we value consent because individuals are the best judges of their own interests. Joel Feinberg argues an individual’s consent matters because she has a right to autonomy based on her intrinsic sovereignty over her own life. Joseph Raz also focuses on autonomy, but argues that society values autonomy as a constituent element of individual (...) well-being, which it is the state’s duty to promote. The criminal law’s approach to the problem of non-contemporaneous consent—prospective consent and retrospective consent—casts a unique light on the differences among these three justifications. Peter Westen claims neither Mill’s nor Feinberg’s justifications for consent fully explains how non-contemporaneous consent is treated in the criminal law. Specifically, Mill’s “self-interest” conception explains the criminal law’s limited recognition of prospective consent, but cannot explain its total rejection of retrospective consent. Conversely, Feinberg’s “sovereign autonomy” conception explains why the criminal law rejects retrospective consent, but cannot explain why the law recognizes irrevocable prospective consent only in limited circumstances. I resolve this dilemma by explaining that Raz’s “autonomy is good” conception is consistent with both the criminal law’s limited recognition of irrevocable prospective consent and its total rejection of retrospective consent. This suggests the existing criminal law embodies Raz’s theory that it is the duty of the state to promote morality, in particular the moral good of individual well-being through living autonomously. In contrast, the criminal law’s treatment of consent would have to be modified if it were to reflect Mill’s “self-interest” conception, or Feinberg’s “sovereign autonomy” conception. (shrink)

The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health (...) research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. (shrink)

Is Female Genital Cosmetic Surgery for an adolescent with Body Dysmorphic Disorder ever ethically justified? Cosmetic genital surgery for adolescent girls is one of the most ethically controversial forms of cosmetic surgery and Body Dysmorphic Disorder is typically seen as a contraindication for cosmetic surgery. Two key ethical concerns are that Body Dysmorphic Disorder undermines whatever capacity for autonomy the adolescent has; and even if there is valid parental consent, the presence of Body Dysmorphic Disorder means that cosmetic surgery (...) will fail in its aims. In this article, we challenge, in an evidence-based way, the standard view that Body Dysmorphic Disorder is a contraindication for genital cosmetic surgery in adolescents. Our argument gathers together and unifies a substantial amount of disparate research in the context of an ethical argument. We focus on empirical questions about benefit and harm, because these are ethically significant. Answers to these questions affect the answer to the ethical question. We question the claim that there would be no benefit from surgery in this situation, and we consider possible harms that might be done if treatment is refused. For an adolescent with Body Dysmorphic Disorder, the most important thing may be to avoid harm. We find ourselves arguing for the ethical justifiability of cosmetic labioplasty for an adolescent with Body Dysmorphic Disorder, even though we recognize that it is a counter intuitive position. We explain how we reached our conclusion. (shrink)

Background: In 2006, the Centers for Disease Control and Prevention (CDC) recommended three changes to HIV testing methods in US healthcare settings: (1) an opt-out approach, (2) removal of separate signed consent, and (3) optional HIV prevention counseling. These recommendations led to a public debate about their moral acceptability. Methods: We interviewed 25 members from the fields of US HIV advocacy, care, policy, and research about the ethical merits and demerits of the three changes to HIV testing methods. We (...) performed a qualitative analysis of the participant responses in the interviews and summarized the major themes. Results: In general, arguments in favor of the methods were based upon their ultimate contribution to increasing HIV testing and permitting the consequent benefits of identifying those who are HIV infected and linking them to further care. Conclusions: The prevailing theme of ethical concern focused on suspicions that the methods might not be properly implemented, and that further safeguards might be needed. (shrink)

Hypothetical contracts have been said to be not worth the paper they are not written on. This paper defends hypothetical consent theories of justice, such as Rawls's, against the view that they lack justificatory power. I argue that while hypothetical consent cannot generate political obligation, it can generate political legitimacy.

Medical Research Council, Capetown, South Africa Nasheen Naidoo Medical Research Council, Capetown, South Africa Shamagonam James Medical Research Council, Durban, South Africa Priscilla Reddy Medical Research Council, Capetown, South Africa * Corresponding author: 306 Arnold House, School of Public Health & Health Sciences, University of Massachusetts, Amherst, MA 01003, USA. Tel.: (413) 545 1005; Email: Buchanan{at}schoolph.umass.edu ' + u + '@' + d + ' '//--> . Abstract The analysis presented here lays out the ethical warrants for requiring community oversight (...) of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. CiteULike Connotea Del.icio.us What's this? (shrink)

Journal of Social Philosophy, EarlyView.

I defend a modified rights-based unjust threat account for morally justified killing in self-defense. Rights-based moral justifications for killing in self-defense presume that human beings have a right to defend themselves from unjust threats. An unjust threat account of self-defense says that this right is derived from an agent’s moral obligation to not pose a deadly threat to the defender. The failure to keep this moral obligation creates the moral asymmetry necessary to justify a defender killing the unjust (...) threat in self-defense. I argue that the other rights-based approaches explored here are unfair to the defender because they require her to prove moral fault in the threat. But then I suggest that the unjust threat account should be modified so that where the threat is non-culpable or only partially culpable, the defender should seek to share the cost and risk with the threat in order for both parties to survive. (shrink)

Justifying intellectual property on the basis of labour is an understandably popular strategy, but there is a tension in basing some intellectual property claims on labour that has gone largely unnoticed in treatments of the subject: many forms of innovation cause people to lose their jobs, which seriously hampers the ability of those who lose work to productively use their own labour. This article shows that even under Lockean and other labour‐based justifications of intellectual property rights those who claim (...) property rights to innovations of this type have special obligations to compensate those who lose work because of their inventions. By examining the problem that such innovations create, I hope to contribute to larger debates about automation and the job losses it often brings. Lockean and other labour‐based theories of intellectual property are generally taken to secure strong, noninstrumental rights to intellectual property if they are successful. So, if even these theories imply that those who profit from the innovations driving automation have special obligations to those left jobless by it, that is strong evidence that they do in fact have such obligations. (shrink)

The ‘family consent’ process has been placed at the centre of Chinese clinical practice. Although there has been critical analysis of how the process functions in relation to the autonomy and rights of patients, there has been little examination of the perceptions and attitude of patients and their families and the medical professionals, in relation to moral dilemmas that arise in real cases in the bioethical discourse. When faced with a consent form in an emergency situation, the family (...) member's capacity to act is reduced, as he/she becomes enmeshed in the hospital structure of tacit, socially-imposed rules. In a questionnaires based on a real death case in 2008, 70.9% of the surveyed medical professionals (n = 3,665) disagreed with performing surgery without the consent of the family even if the patient's life was in danger, while 36.6% of the surveyed patients (n = 1,198) hold the same position. This work demonstrates the weakness of the family consent process as a safeguard of patient's autonomy. Finally, I argue that saving the patient's life should be the overriding obligation rather than the respect for the surrogate's autonomous choice at such a decisive moment. (shrink)

Scholars disagree about the proper justification of human rights and which rights qualify as human rights. While some argue for a very limited set of human rights, others defend more comprehensive accounts. In this paper I suggest that a defence of a comprehensive set of human rights can be strengthened by combining constructivist deontological and well-being based teleological justifications. To this end, I discuss two prominent proponents of constructivism and the well-being approach: Rainer Forst and Simon Caney. Forst (...) criticises teleological justifications for grounding human rights in non-universalizable conceptions of the good, such as autonomy, that can reasonably be rejected by others. Constructivism, in contrast, does not rest on any particular idea of the good life and thus allows for greater ethical plurality. I reject this specific criticism, arguing that Caney’s approach ultimately allows for the same plurality. I also highlight that constructivism on its own cannot justify rights of people who are not (yet) able to reason. The well-being approach provides substantive arguments for the rights of these individuals. However, these arguments are made with the framework provided by constructivism. I hold, contra Caney, that Forst’s right to justification is primary in that it is the unavoidable basis from which justice issues can be dealt with in a reasonable way and that the main function of human rights is to protect the equal moral status of persons. I conclude that Forst’s constructivist and Caney’s well-being approach are complementary rather than rivalrous: when combined they provide a more robust justification for a comprehensive set of human rights than considered separately. (shrink)

The claim that indigenous communities are entitled to have intellectual property rights (IPRs) to both their plant varieties and their botanical knowledge has been put forward by writers who wish to protect the plant genetic resources of indigenous communities from uncompensated use by biotechnological transnational corporations. We argue that while it is necessary for indigenous communities to have suchrights, the entitlement argument is an unsatisfactory justification for them. A more convincing foundation for indigenous community IPRs is the autonomy theory (...) developed by Will Kymlicka. (shrink)

Adaptive preferences give rise to puzzles in ethics, political philosophy, decision theory, and the theory of action. Like our other preferences, adaptive preferences lead us to make choices, take action, and give consent. In 'False Consciousness for Liberals', recently published in The Philosophical Review, David Enoch (2020) proposes a criterion by which to identify when these choices, actions, and acts of consent are less than fully autonomous; that is, when they suffer from what Natalie Stoljar (2014) calls an (...) 'autonomy deficit'. According to Enoch, such actions are not protected in the usual way against interference by others; there is not the same prohibition against trying to prevent someone from acting in a particular way when that action is motivated by such adaptive preferences and is an attempt to satisfy them. In this note, I raise two concerns about Enoch's criterion. (shrink)

Le modèle de la justice comme équité est élaboré sur des éléments centraux (en particulier: le consentement éclairé des citoyens). Les fonctions de ce modèle chez Rawls sont: un accord rationnel autour de libertés individuelles, un principe raisonnable de maximisation de la stabilité sociale et la fondation de principes, acceptables du point de vue des personnes défavorisées. Notre objectif consiste à mettre à l'épreuve une semblable conception de la justice politique libérale, avec sa composante la moins libérale : la balance (...) à partir de laquelle il est bon de punir. Constatant que la criminalisation est l'intrusion la plus importante de l'Etat dans la sphère autonome de l'individu, l'éthique ausculte les principes normatifs du droit pénal. Justifier une peine amène à des finalités de rétribution et de prévention, qui sont véhiculées par la signification de " punir ". Notre méthode se veut une pesée éthique de la signification des idées et des mots ; notre objectif général est une discussion de ce qu'est une évaluation normative par des principes et des règles. Notre approche de Rawls consiste à repositionner le cadre de ce qui peut être légitimement interdit, face à la liberté discrétionnaire de l'individu. (shrink)

This paper considers whether victims can justify what appears to be unnecessary defensive harming by reference to an honour-based justification. I argue that such an account faces serious problems: the honour-based justification cannot permit, first, defensive harming, and second, substantial unnecessary harming. Finally, I suggest that, if the purpose of the honour based justification is expressive, an argument must be given to demonstrate why harming threateners, as opposed to opting for a non-harmful alternative, is (...) the most effective means of affirming one’s honour. Along the way, I also suggest why I think that internalism about the constraints on defensive harming (the view that the satisfaction of the necessity constraint is a necessity condition of a threatener’s liability) is correct. Most importantly, externalism implies that threateners can be liable to suffer gratuitous harm. I take this to be an unattractive consequence of the view. (shrink)

This paper demonstrates that a rationale for a circumscribed form of desire-based justification can be developed out of a contemporary Kantian account as a natural extension of that account. It maintains that certain of Christine Korsgaard's recent arguments establish only that desires must have certain features antithetical to instrumentalism in order to justify. Other arguments purport to establish the standard (stronger) result: that because desires do not have these features, they cannot justify. Her arguments for this strong result, (...) it contends, cannot be reconciled with central commitments in her epistemology and philosophy of mind. The consistent implementation of these commitments opens up a surprising space within what is still readily recognizable as a Kantian ethics--the space for desire-based justification. (shrink)

The case (Dawson et al. 2024) describes an Institutional Review Board (IRB) chair who seeks consultation about waiving the requirement that investigators obtain prospective, informed consent for co...

My starting point is what I call the Normative Authority Conception of justification, where S is justified in their belief that p at t (to some degree n) if and only if their believing that p at t is not ruled out by epistemic norms that have normative authority over S at t. With this in mind, this paper develops an account of doxastic justification by first developing an account of the normative authority of epistemic norms. Drawing from (...) work in political philosophy, I argue that (a) the cognitive and evaluative commitments and concerns behind our actual practices of holding each other and ourselves accountable for our beliefs reveal which epistemic norms we have consented to be under, and that (b) it is because we have consented to be under the authority of these norms – by actually holding ourselves and others accountable to them – that they in turn have normative authority over us. By connecting the authority of epistemic norms to the authority we have over ourselves in this way, the resulting account of doxastic justification (i) explains why it can be appropriate to criticize, resent, or sanction someone for having unjustified beliefs, (ii) avoids the phenomena of normative alienation and normative parochialism, and (iii) respects the social and collective nature of epistemic justification. (shrink)

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

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their (...) underlying assumptions may be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. (shrink)

Disease control has increasingly shifted towards large scale, disease specific, public health interventions. The emerging problems of HIV, hepatitis, malaria, typhoid, tuberculosis, childhood pneumonia, and meningitis have made community based trials of interventions a cost effective long term investment for the health of a population. The authors conducted this study to explore the complexities involved in obtaining informed consent to participation in rural north India, and how people there make decisions related to participation in clinical research.

Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. (...) The main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)

This essay indicates that Confucian family-based ethics is by no means a stumbling block to organ donation in China. We contend that China should not change to an opt-out consent system in order to enhance donation because a “hard” opt-out system is unethical, and a “soft” opt-out system is unhelpful. We argue that the recently-introduced familist model of motivation for organ donation in mainland China can provide a proper incentive for donation. This model, and the family priority right (...) that this model supports, is ethically justifiable in terms of Confucian family-based ethics. (shrink)

Consent's capacity to legitimise actions and claims is limited by conditions such as coercion, which render consent ineffective. A better understanding of the limits to consent's capacity to legitimise can shed light on a variety of applied debates, in political philosophy, bioethics, economics and law. I show that traditional paternalist explanations for limits to consent's capacity to legitimise cannot explain the central intuition that consent is often rendered ineffective when brought about by a rights violation (...) or threatened rights violation. I argue that this intuition is an expression of the same principles of corrective justice that underlie norms of compensation and rectification. I show how these principles can explain and clarify core intuitions about conditions which render consent ineffective, including those concerned with the consenting agent's option set, his mental competence, and available information. (shrink)

Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those (...) approached, the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that require consent for participation. (shrink)

What justifies our beliefs about what other people say? According to epistemic inferentialism​, the justification of comprehension-based beliefs depends on the justification of other beliefs, e.g., beliefs about what words the speaker uttered or even what sounds they produced. According to epistemic non-inferentialism, the justification of comprehension-based beliefs ​does not depend on the justification of other beliefs. This paper offers a new defense of epistemic non-inferentialism. First, I discuss three counterexamples to epistemic non-inferentialism provided (...) recently by Brendan Balcerak Jackson. I argue that only one of Balcerak Jackson’s counterexamples is effective, and that it is effective against only one version of epistemic non-inferentialism, viz. language comprehension dogmatism. Second, I propose an alternative version of epistemic non-inferentialism, viz. comprehension-process reliabilism, which is immune to these counterexamples. I conclude that we should follow Balcerak Jackson in his rejection of language comprehension dogmatism but not all the way to the endorsement of epistemic inferentialism. Comprehension-process reliabilism is superior to both these alternatives. (shrink)