One way of increasing the supply of organs available for transplant would be to switch to an opt-out system of donor registration. This is typically assumed to operate on the basis of presumed consent, but this faces the objection that not all of those who fail to opt out would actually consent to the use of their cadaveric organs. This paper defuses this objection, arguing that people's actual, explicit or implicit, consent to use their organs is (...) not needed. It borrows David Estlund's notion of ‘normative consent’ from the justification of political authority and applies it to the case of organ donation. According to this idea, when it is wrong to withhold consent to something, the moral force of that lack of consent may be null and void. If it is wrong of a person to refuse to donate their cadaveric organs to others, then it may be that their actual consent is not needed. This supports an opt-out system, which provides protection for those who have genuine reasons to refuse donation, and spares the worries as to what the deceased would actually have wanted. (shrink)

Recently, David Boonin has put forward several objections to Carlos S. Nino's 'Consensual Theory of Punishment'. In this paper I will defend Nino against the 'explicit denial objection'. I will discuss whether Boonin's interpretation of Nino as a tacit consent theorist is right. I will argue that the offender's consent is neither tacit nor express, but a special category of implicit consent. Further, for Nino the legal-normative consequences of an act (of crime) are 'irrevocable', i.e. one (...) cannot (expressly and successfully) deny liability to them. I will suggest an explanation for Nino's irrevocability claim. (shrink)

That consent could wholly explain – either descriptively or normatively – the legitimacy of the structure of political community and it’s most important and influential institutions and practices is deeply implausible. There are two general sorts of considerations adduced against such a proposition. First, history simply refutes it: force is an essential feature of the founding of any political society, and arguably, for its continued existence, and power relations, in all their complexity, are imperfectly tracked by consent. Moreover, (...) there are deep questions about what people are actually consenting to, given the plurality and changing nature of political collectivities over time. Second, in modern societies (perhaps in just any complex human society) our conduct is shaped and governed in so many ways so as to influence not only the options we have, but also the interests, desires and capabilities constitutive of our ability to act in relation to them in the first place. This undermines any easy connection between the presence of consent and my being free. A familiar conundrum for consent as a standard of legitimacy is that if it means literally that individual consent is required for non-arbitrariness in public decision-making, then public decision-making – indeed almost any form of collective action –becomes almost impossible. If only tacit or implicit consent is required, then we can find it everywhere, and thus nowhere, and the standard is empty. (shrink)

The received view in medical contexts is that informed consent is both necessary and sufficient for patient autonomy. This paper argues that informed consent is not sufficient for patient autonomy, at least when autonomy is understood as a "relational" concept. Relational conceptions of autonomy, which have become prominent in the contemporary literature, draw on themes in the thought of Charles Taylor. I first identify four themes in Taylor's work that together constitute a picture of human agency corresponding to (...) the notion of agency implicit in relational accounts of autonomy. Drawing on these themes, I sketch two arguments against the position that informed consent secures autonomy. The first is that informed consent is an "opportunity" concept whereas autonomy is an "exercise" concept; the second is that informed consent requires merely weak evaluation and not strong evaluation. On Taylor's analysis of agency, strong evaluation is required for agency and for autonomy. (shrink)

According to an often repeated definition, economics is the science of individual choices and their consequences. The emphasis on choice is often used – implicitly or explicitly – to mark a contrast between markets and the state: While the price mechanism in well-functioning markets preserves freedom of choice and still efficiently coordinates individual actions, the state has to rely to some degree on coercion to coordinate individual actions. Since coercion should not be used arbitrarily, coordination by the state needs to (...) be legitimized by the consent of its citizens. The emphasis in economic theory on freedom of choice in the market sphere suggests that legitimization in the market sphere is “automatic” and that markets can thus avoid the typical legitimization problem of the state. In this paper, I shall question the alleged dichotomy between legitimization in the market and in the state. I shall argue that it is the result of a conflation of choice and consent in economics and show how an independent concept of consent makes the need for legitimization of market transactions visible. Footnotes1 For helpful comments and suggestions I am most grateful to Marc Fleurbaey, Alain Marciano, Herlinde Pauer-Studer, Thomas Pogge, Hans Bernhard Schmid, to seminar or conference participants in Aix-Marseille, Tutzing, Paris, and Amsterdam, and to two anonymous referees. (shrink)

Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported (...) ethical justification via a principle of respect for patient autonomy is presented as being vacuous. Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy. Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model. (shrink)

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence-based decision-support contain (...) implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

This paper argues that libertarian political philosophers, including Robert Nozick, have erred in neglecting the problem of political obligation and that they ought to embrace an actual consent theory of political obligation and state legitimacy. It argues as well that if they followed this recommendation, their position on the subject would be correct. I identify the tension in libertarian (and especially Nozick's) thought between its minimalist and its consensualist strains and argue that, on libertarianism's own terms, the consensualist strain (...) ought to prevail. I then describe the form of the consent theory that I recommend to libertarians. The paper concludes with an extended defense of this form of consent theory against contemporary liberal-egalitarian criticisms of it (both explicit and implicit), including those of Dworkin, Rawls, and their followers. Footnotesa Earlier versions of this essay were presented at the University of Michigan, Virginia Commonwealth University, and Brown University. For their lively discussions and helpful suggestions for the improvement of this essay, I am grateful to those audiences and to my fellow contributors to this volume. And for their careful reading and comments, I thank the editors of Social Philosophy and Policy. (shrink)

Parmi les différents types d’implicite, les implicatures portent sur le niveau du contenu, les présuppositions et les topicalisations sur le niveau de la responsabilité, en provoquant ce que Givón appelle la unchallengeability d’une information, c’est-à-dire la difficulté pour le destinataire d’y appliquer un “défi” cognitif qui puisse aboutir au doute sur sa vérité. Cette fonction des implicites se trouve de façon massive dans les textes persuasifs. L’article vise à quantifier l’implicitation du contenu et de la responsabilité dans quelques textes de (...) propagande politique et commerciale, au moyen d’un système d’indices d’implicitation assignés aux dites catégories. On propose ce procédé comme un exemple du rôle que l’analyse linguistique peut jouer pour l’amélioration des conditions de transparence et de garantie dans la pratique de la communication commerciale, et dans les processus où se forme le consentement démocratique. (shrink)

This paper analyses the intertwinement of legal philosophy and political theory in the British intellectual framework between the late 19th and early 20th centuries, with specific regard to Harold Laski's works. I will try to illustrate the transition from 19th-century utilitarianism to H. L. A. Hart and Isaiah Berlin as evolving through important debates which include Laski's contribution. I will argue that a discussion of “juridical” obligation, i.e., the conditions of legal validity, may lie implicitly in these concerns that Laski (...) and other early 20th-century British authors had about “political” obligation—viz., about the nature of the state and its claim to obedience. By approaching Laski's theories and their genealogy through a legal-philosophical perspective, I will contend that this debate about political obligation anticipates to a considerable extent some of the most renowned conceptions of obligation in 20th-century British legal theory. (shrink)

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers’ personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects’ autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict (...) between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers’ job and (ii) that subjects should be told of researchers’ views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed. (shrink)

The Centers for Disease Control and Prevention (CDC) recently recommended that HIV screening should become routine for all adults in the United States. Implicit in the CDC proposal is the notion that pre-test counseling would be more limited than at present, and that written informed consent to screening would no longer be required. If widely implemented, routine testing would mark a tremendous shift in the US HIV screening strategy. There are a number of considerations used to determine what (...) screening tests should be routine, and HIV fits the bill in almost every regard. Yet the stigma associated with HIV infection remains, making the CDC's recommendation highly controversial. Will minimizing requirements for pre-test counseling and special written informed consent lead to unexpected or unwanted HIV testing, or do these stringent counseling and consent requirements needlessly scare people away? Will widespread and routine testing be associated with declining stigmatization, or will it drive some patients away from seeking desperately needed health care? These are high stakes questions, and we're about to find out the answers. (shrink)

Recent interpretation stresses the narrow role of consent in locke: it is a ground, Not of legitimacy but of legitimate revolt. Locke is less precise. In rejecting filmer's claim that birth imposes absolute political obligations locke implicitly denies its determination of the locus as well as the degree of those obligations. Using consent to limit political absolutism, Thus inadvertently raised the question of its direct link with citizenship, Hence locke's confused discussion of tacit and express consent. Locke (...) leaves the issue unresolved, Making the common patriarchal assumption that the location, If not the degree of political obligation, Can be inferred from birth. (shrink)

When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject (...) one ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child. (shrink)

The General Data Protection Regulation imposes, at European level, a need to seek express or explicit consent for the processing of health data. In the framework of biomedical research, some favor the use of express ‘broad’ consent, whereas other maintain, or wish to maintain the use of presumed or implicit consent, often referred to as ‘non-opposition’ in conditions in which such consent is still authorized. In our view, broad consent and presumed consent are (...) likely to prove to be easy solutions in the short term but much less relevant in the long term, for both hospital and patients, if the bioethical objective remains the improvement of patient quality of life and/or survival, regardless of the disease considered. Dynamic consent could be the best way to achieve this objective because only this type of consent could improve hospital transparency and increase patient confidence by allaying certain fears. (shrink)

Informed consent is one of the most important ethical and legal principles in the United States, including Texas, and reflects a profound respect for individuals and their ability to make decisions in their own best interest. It is also a critical underpinning of medical practice, although how it is actually carried out has not been well studied. A survey was conducted in the private practices and a hospital in the Texas Medical Center in Houston, Texas to ascertain how physicians, (...) patients and patient's family members perceive and demonstrate the elements of informed consent. In-depth interviews of twelve physicians, three patients and three family members were carried out. For physicians, consent was an explicit and implicit aspect of virtually all medical practice. Physicians would seek patient input concerning medical decisions whenever possible and might also discuss care choices with families. However, they often made decisions based upon what they perceived as the patient's best interests. Patients expected the physician to involve them in the decision process, but whether they turned to family members, or even others to assist them, varied considerably. Although Texas physicians respect the competent patient as the primary decision maker, they may bypass a formal surrogate decision maker to gain input from others, including their own view of what is in the patient's best interest. (shrink)

The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion (...) that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically. (shrink)

Children's consent to treatment remains a contentious topic, with confusing legal precepts and advice. This paper proposes that informed consent in children should be regarded as shared between children and their families, the balance being determined by implicit, developmentally based negotiations between child and parent--a "family rule" for consent. Consistent, operationalized procedures for ethically obtaining consent can be derived from its application to both routine and contentious situations. Therefore, use of the "family Rule" concept can (...) consistently define negligent procedure in obtaining consent from children, and could be used as a unifying framework in the development of new professional guidelines. A "guideline"-based approach to children's consent to treatment may offer greater individuality than a "rights"-based approach, though careful training and oversight will be needed for it to be effective. (shrink)

This article intervenes in a critical debate about the use of consent to distinguish sex from rape. Drawing from critical contract theories, it argues that sexual consent is a cruel optimism that often operates to facilitate, rather than alleviate, sexual violence. Sexual consent as a cruel optimism promises to simplify rape allegations in the popular cultural imagination, confounds the distinction between victims and agents of sexual violence, and establishes certainty for potential victimizers who rely on it to (...) convince themselves and others that their partners implicitly or explicitly agreed to sex. In each of these cases, the power of consent rests in its tendency to obscure sexual violence in a set of questions around victimhood and agency, rather than to clarify whether or when it has occurred. Following in the critical contract tradition, this article argues that the optimistic attachment to the clarifying power of consent helps to explain the persistent commitment to better sexual consent as a ‘solution’ to the problems of rape and sexual violence, and that this ‘solution’ is insufficient to the task. (shrink)

In this paper we argue that ‘informed’ consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and (...) using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance‐theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants’ decision to consent. We do not prescribe a standard, formal approach to decision‐making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front‐line of genomic science. (shrink)

At first glance, the first informed consent case to be decided by the High Court of Australia appears to be little more than a clear and simple description of the substantive law accepted in most American jurisdictions - although that is no small accomplishment in and of itself. In Rogers v. Whitaker, the highest court in Australia succinctly and persuasively rejected informed consent as a species of battery law, accepted it as a form, of ordinary professional negligence law, (...) and adopted the “American” patient-oriented standard for measuring the breach of a healthcare professional's duty to her or his patients. On second look, however, the opinion is an even more significant one because it reveals that the law of informed consent is now based on principles broad enough to create a duty on the part of healthcare providers to offer adequate health education to all of their patients. In Implicitly recognizing the physician's duty to educate her or his patients, the High Court's judgment is consistent with a view increasingly held In the medical and ethical communities that teaching patients about how to maintain their health is just as much a part of the doctor's function as diagnosing and treating disease. It may have taken 2,500 years for medicine to progress from, the Hippocratic notion that physicians should apply treatment to patients who are kept in blissful Ignorance of their condition and Its remedy, but there Is little doubt that medicine finally has entered a post-Hippocratic era. (shrink)

When doing research among vulnerable populations, researchers are obliged to protect their subjects from harm. We will argue that traditional ethical guidelines are not sufficient to do this, since they mainly focus on direct harms that can occur: for example, issues around informed consent, fair recruitment and risk/harm analysis. However, research also entails indirect harms that remain largely unnoticed by research ethical committees and the research community. Indirect harms do not occur during data collection, but in the analysis of (...) the data, and how the data is presented to the scientific and wider societal community. Highly stigmatized research subjects, like substance‐dependent parents, are especially at risk of encountering indirect harm, because the prejudice against them is so persistent. In this paper we discuss two forms of indirect harm. First, researchers have to be aware how their results will be preceived by society. Even when subjects are presented in an objective way, further, out of porportion stigmatization can occur. Researchers sometimes try to counteract this by whitewashing their results, at the risk of downplaying their respondents’ problems. The second risk researchers face is that their own normative judgements influence how they question such parents, report results and interpret statements. Researchers’ own normative judgements may influence the way they present their subjects. This article reviews a broad range of research that exhibits such indirect harms, discussing how and why indirect harms occur and formulating corresponding recommendations on how to prevent them. (shrink)

Concerns are frequently raised about the extent to which formal consent procedures actually lead to “informed” consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation (...) is largely implicit, however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness. (shrink)

This paper aims to provide an in-depth examination of the fundamental elements of rape, specifically focusing on intention and consent, within the context of “deceiving someone into having sex”. The analysis will involve exploring model cases and scrutinising the intentions of both the deceiver and the deceived in relation to consent. Through conceptual analysis, the concept of “deceiving someone into having sex” will be clarified, drawing insights from typical applications of this concept. Additionally, this paper will critically evaluate (...) the main arguments against these conceptualisations of “deceiving someone into having sex”. This is done to demonstrate the flaws that undermine these arguments, thus highlighting the insufficiency of these approaches in fully discrediting the concept. Moreover, it will be argued that deceiving someone into having sex can be regarded as a form of coercion, and thus rape, aligning with the established criteria for identifying rape cases. In conclusion, this paper argues that the conception of “deceiving someone into having sex” as a form of rape challenges the narrow framework through which we traditionally understand rape, necessitating the recognition that the scope of the concept of rape extends beyond our previous limits. (shrink)

This paper describes how language contributes to the oppression and exploitation of animals by animal product industries. Critical Discourse Analysis, a framework usually applied in countering racism and sexism, is applied to a corpus of texts taken from animal industry sources. The mass confinement and slaughter of animals in intensive farms depend on the implicit consent of the population, signaled by its willingness to buy animal products produced in this way. Ideological assumptions embedded in everyday discourse and that (...) of the animal industries manufacture and maintain this consent. Through analysis of texts, this paper attempts to expose these assumptions and discusses implications for countering the domination and exploitation of animals. (shrink)

For a state to be legitimate is for it to be permissible for the state to issue and enforce its commands (mostly laws), and for this to be permissible “owing to the process by which they were produced” (2).1 For a state to have authority is for it to have the power to morally require or forbid actions through commands, or the power to create duties (2).2 It seems that a state’s being democratic—in somewhat like the way in which the (...) democracies we are familiar with are democratic—has something to do with its having both authority and legitimacy. But what, exactly? There is, after all, nothing obvious about the relation between democracy on the one hand and legitimacy and authority on the other. One may think that consent has something to do with it. But this would be wrong, because most of those supposedly under the authority of the state haven’t consented to anything of relevance (9). Implicit consent, if it is too implicit, so that the agent may not realize she is consenting, is no substitute for real consent, and if it is more explicit than that then, again, hardly anyone has consented to the state’s authority, not even in democracies (9). And most hypothetical consent theories fall prey to their own difficulties. So consent theory of the typical kind cannot ground political legitimacy and authority. (A very atypical kind of consent will nevertheless eventually emerge victorious.). (shrink)

The tension between the need for critique and its (often unperceived) limits through our given common sense, a tension Charles S. Peirce describes as critical common sense, hasn’t lost its actuality. Vague certainty is one root of this tension, which the paper unfolds by distinguishing two forms: while the first one grounds common sense as a form of life, the second one, self-certainty, represents the purpose of endeavors, and it serves, speaking with Pierre Bourdieu, as a form of distinction (1). (...) As part of an indifference towards power structures of exclusion, vague certainties contribute to what Judith Butlers describes as the violent derealization of others, which is being discussed in the light of the Black Lives Matter and Me Too movement. (Self-)certainty, as is being shown, is not (merely) an epistemological matter, but encompasses the fields of the political and aesthetic. Accordingly, as a crucial part of political critique and practices to counter (self-)certainties, a differentiation of doubting is required – the paper proposes four different kinds: authoritarian, anti-authoritarian, acknowledging and imaginative doubting. They help understand the political struggles of re-realizing formerly derealized positions within society (2). Particularly through imaginative doubting, some shortcomings within Peirce’s notion of the self (and, for that matter, within the pragmatist notion of doubting) are being overcome by showing how to link it to creative processes of abduction, which in turn have consequences for political matters by unsettling implicit consent, or, in the words of Jacques Rancière, the partition of the sensible (3). (shrink)

Much has been written about climate change from an ethical view in general, but less has been written about it from a libertarian point of view in particular. In this paper, I apply the libertarian moral theory to the problem of climate change. I focus on libertarianism’s implications for our individual emissions. I argue that even if our individual emissions cause no harm to others, these emissions cross other people’s boundaries, although the boundary-crossings that are due to our ‘subsistence emissions’ (...) are implicitly consented to by others, there is no such consent to our ‘non-subsistence emissions’, and there is no independent justification for these emissions. Although offsetting would provide such a justification, most emitters do not offset their non-subsistence emissions. Therefore, these emissions violate people’s rights, which means that they are impermissible according to libertarianism’s non-aggression principle. (shrink)

In her commentary, Alderson makes four major criticisms of the family rule. She claims that: consent must be explicit; that consenting parties should be reasonably equal; that the concept of a family rule adds little to current understanding, and that the effect of applying the concept in practice will be to impair the consenting process. However, there are other important examples of implicit consent in daily life, and consent between unequals is common and unexceptionable. The family (...) rule establishes an unequivocal ethical base for the role of children, parents and practitioners in the consenting process, which is sorely needed. This base structures practitioners' interventions towards children in an appropriately empowering manner. Therefore, Alderson's critical objections fail. (shrink)

This study analyses the development of the relation between natural rights theories and the moral valuation of capital punishment in the European enlightenment up to Beccaria. The theories of Grotius, Hobbes and Cumberland are three eminent theoretical options in early modern natural law theory. In different ways they all approved capital punishment: Grotius proposed that the criminal forfeited his right to life through his criminal deed qua implicit consent or reciprocity. Hobbes saw the individual right to life of (...) the citizen as finally not binding for the state. And in Cumberland’s sight the right to live was only conditional on its maximizing effect on the collective welfare as he understood it. It was not until Beccaria published his famous book on crime and punishment that an enlightened natural law author rejected the legitimacy of the death penalty. Beccaria’s arguments concerning capital punishment are investigated in this study in the light of the foregoing debate based on natural rights. (shrink)

“Informed consent” implicitly links the transmission of information to the granting of permission on the part of patients, tissue donors, and research subjects. But what of the corollary, informed refusal? Drawing together insights from three moments of refusal, this article explores the rights and obligations of biological citizenship from the vantage point of biodefectors—those who attempt to resist technoscientific conscription. Taken together, the cases expose the limits of individual autonomy as one of the bedrocks of bioethics and suggest the (...) need for a justice-oriented approach to science, medicine, and technology that reclaims the epistemological and political value of refusal. (shrink)

Disclosure in clinical practice is aimed at promoting patient autonomy, usually culminating in patient choice (e.g., to consent to an operation or not, or between different medications). In medical ethics, there is an implicit background assumption that knowing more about (X) automatically translates to greater, or more genuine, autonomy with respect to one's choices involving (X). I challenge this assumption by arguing that in rare cases, withholding information can promote a patient's autonomy (understood as the capacity for rational (...) choice in alignment with one's values and goals). (shrink)

Slightly modified excerpt from the section 13.4 Zusammenfassung und Ausblick (translated into englisch): This chapter is based on an analysis of ethical debates on epigenetics and genome editing, debates, in which ethical arguments relating to future generations and justice play a central role. The analysis aims to contextualize new developments in genetic engineering, such as genome and epigenome editing, ethically. At the beginning, the assumptions of "genetic determinism," on which "genetic essentialism" is based, of "epigenetic determinism" as well as "genetic" (...) and "epigenetic exceptionalism" are analyzed and critically discussed. The remarks on the ethical discourse on epigenetics show that the notion of "epigenetic determinism" can sometimes be discerned not only in popular scientific discourse but also in ethical discourse. Ethical debates on epigenetics, however, have distanced themselves from this deterministic understanding. As a result, the focus in the ethical discourse on epigenetics shifts from responsibility for one's own health and that of subsequent generations to justice. What is meant here is justice, for example, in terms of access to healthy environmental conditions, regardless of whether these contribute to health with or without epigenetic agency. An analysis of the discourse on genome editing reveals that it is primarily germline interventions that are being ethically examined, with a concentration on the aspect of inheritance. The question is whether this is accompanied by an implicit "genetic determinism" or even a "genetic essentialism": the determinism could lie in the centrality of the aspect of heritability, since only genetic information is inherited. Does the aspect of heritability and genome modification play a more decisive role in debates on genome editing than the safety issue? Is the problem of embryos and their potential offspring not being able to consent to germline intervention given such a high priority because it is a genetic intervention? Under such a premise of "strong genetic determinism" supplemented by "epigenetic determinism," not only genome editing but also epigenome editing would be ethically relevant precisely because it too would have an influence on the genome. How this influence of genome editing and epigenome editing is ethically evaluated in each case therefore depends initially on whether the assumptions of "genetic" and "epigenetic determinism" are advocated. These assumptions are increasingly viewed critically in ethical discourse because they cannot be confirmed from a scientific perspective. In popular scientific debates in particular, however, they seem to persist, which ultimately also influences the public discussion. Since a broad public discussion is required especially on genome editing, a reflective approach to the various "-isms" analyzed in this chapter is central. DOI: 10.5771/9783748927242. (shrink)

One of the ethical issues that has been raised recently regarding emerging neurotherapies is that people will be coerced explicitly or implicitly in the workplace or in schools to take cognitive enhancing drugs. This article builds on this discussion by showing how the law may pressure people to adopt emerging neurotherapies. It focuses on a range of private law doctrines that, unlike the criminal law, do not come up very often in neuroethical discussions. Three doctrines—the doctrine of mitigation, the standard (...) of care in negligence, and child custody determinations in family law—are addressed to show how the law may pressure people to consent to treatment by offering a choice between accepting medical treatment and suffering a legal disadvantage. The doctrines considered in this article apply indirect pressure to submit to treatment, unlike court-ordered medical treatment, which applies direct pressure and is not addressed here. The outcome of this discussion is to show that there is a greater range of social pressures that may encourage the uptake of novel neurotherapies than one might initially think. Once treatments that were developed and offered with therapeutic benefits in mind become available, their existence gives rise to unintended legal consequences. This certainly does not mean we should cease developing new therapies that may be of tremendous benefit to patients, but it does raise some questions for physicians and for legal policy-makers. How should physicians, who are required by medical ethical principles to obtain valid consent to treatment, react to a patient’s reluctant consent that is driven by legal pressure? From the legal policy perspective, are our legal doctrines satisfactory or should they be changed because, for example, they unduly promote the collective interest over individual freedom to reject medical treatment or because they channel us toward economically efficient treatments to the detriment of more costly but potentially superior approaches of dealing with behavioural problems? (shrink)

Sex offenders are sometimes offered or required to undergo pharmacological interventions intended to diminish their sex drive (anti-libidinal interventions or ALIs). In this paper, we argue that much of the debate regarding the moral permissibility of ALIs has been founded on an inaccurate assumption regarding their intended purpose—namely, that ALIs are intended solely to realise medical purposes, not correctional goals. This assumption has made it plausible to assert that ALIs may only permissibly be administered to offenders with their valid (...) class='Hi'>consent, in line with the approach taken to most other interventions with a medical aim. However, we argue that, contrary to this assumption, the state's intention in relation to at least some ALIs is, at least in part, to achieve correctional objectives. We evaluate two legal regimes for ALI provision—section 645 of the California Penal Code and the mental health regime in England and Wales. In each case, we identify the state's implicit purpose in imposing ALIs and argue that the Californian and English regimes both serve as counterexamples to the view that ALIs are intended solely for medical purposes. While the moral implications of our argument are not straightforward, it raises the question whether consent is required for permissible imposition of ALIs, and more generally, whether the moral permissibility of crime-preventing interventions using medical means should be assessed against the standards of medical ethics or against those of criminal justice ethics. (shrink)

Open Access: Social media participation undermines individual autonomy in ways that ought to concern ethicists. Discussions in the philosophical literature are concerned primarily with egregious conduct online such as harassment and shaming, keeping the focus on obvious ills to which no one could consent; this prevents a wider understanding of the risks and harms of quotidian social media participation. Two particular concerns occupy me: social media participation carries the risks of (1) negatively formative experiences and (2) continuous partial attention (...) due to our habituation to the variable rewards that social media platforms provide. Although social media offer benefits as well as risks, self-knowledge of whether one benefits more than one suffers from one’s social media participation is vexed by the very processes involved in participating. We are not as free to leave social media as we are to enter. I conclude with a consideration and rejection of the objections that the ubiquity of the practice indicates implied consent to risks, and that users of social media can simply choose not to use such communication technologies at all. I argue that we cannot be said to consent to enter into social media usage meaningfully, even implicitly, and we do not all have equally easy options to avoid the contexts that provide the stimuli of persistent desires. (shrink)

Implicit metaphysical assumptions concerning the nature of sexual orientation are reflected in the language used to frame ethical debates concerning “reorientation” therapies. An alternative metaphysical construal is presented oncerning sexual orientation and sexual identity development and synthesis. This alternative construal allows for humility concerning what we know and do not know about sexual orientation, underscores the client's self-determination and autonomy, and demonstrates regard for personal and religious valuative frameworks. Rather than focusing on therapies aimed specifically at sexual reorientation, clinicians (...) would do well to provide clients with informed consent and to facilitate identity development and synthesis in keeping with their clients' requests for professional services. (shrink)

A fresh explication of the Thomist justification of self-defense casts off the hobbles of the principle of double effects to find a more secure footing in the historical development of subjective natural rights by medieval jurists, and a straight-forward application to the latent threat of death in childbirth posed by non-consensual pregnancy. By articulating the implicit Thomistic right to defensive abortion in terms of conditional rights bestowed in Creation as correlative to particular natural law duties, justly proportionate limits to (...) defensive abortion are identified, and balanced against the forfeited or reserved natural rights variously imputed to conceptus and embryo in non-consensual pregnancies. Subsequently, the varieties of involuntary consent are examined from a Thomist perspective with a view to their relevance in justifying recourse to a rehabilitated practice of defensive abortion when free and full consent to impregnation and childbirth is absent. (shrink)

Both modernist and post-modern social criticism of power presuppose that agents frequently consent to power relations, which a political theorist may wish to critique. This raises the question: from what normative position can one critique power which is, as a sociological fact, legitimate in the eyes of those who reproduce it? This paper argues that "symbolic violence" is a useful metaphor for providing such a normative grounding. In order to provide an epistemological basis of critique, it is further argued (...) that social actors have multiple interpretative horizons available to them as part of their everyday social practices. Thus, they are not caught in a preconstituted web of meaning from which there is no escape, as is sometimes implicit in the over-socialized perceptions of agency associated with post-modernism. (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.

This paper defends an ‘opt-out’ scheme for organ procurement, by distinguishing this system from ‘presumed consent’ (which the author regards as an erroneous justification of it). It, first, stresses the moral importance of increasing the supply of organs and argues that making donation easier need not conflict with altruism. It then goes on to explore one way that donation can be increased, namely by adopting an opt-out system, in which cadaveric organs are used unless the deceased (or their family) (...) registered an objection. Such policies are often labelled ‘presumed consent’, but it is argued that critics are right to be sceptical of this idea—consent is shown to be an action, rather than a mental attitude, and thus not something that can be presumed. Either someone has consented or they have not, whatever their attitude to the use of their organs. Thankfully, an opt-out scheme need not rest on the presumption of consent. Actual consent can be given implicitly, by one's actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent. Therefore, it is permissible to use the organs of someone who did not opt out, because they have—by their silence—actually consented. (shrink)

This paper focuses on the use of ‘black box’ AI in medicine and asks whether the physician needs to disclose to patients that even the best AI comes with the risks of cyberattacks, systematic bias, and a particular type of mismatch between AI’s implicit assumptions and an individual patient’s background situation.Pacecurrent clinical practice, I argue that, under certain circumstances, these risks do need to be disclosed. Otherwise, the physician either vitiates a patient’s informed consent or violates a more (...) general obligation to warn him about potentially harmful consequences. To support this view, I argue, first, that the already widely accepted conditions in the evaluation of risks, i.e. the ‘nature’ and ‘likelihood’ of risks, speak in favour of disclosure and, second, that principled objections against the disclosure of these risks do not withstand scrutiny. Moreover, I also explain that these risks are exacerbated by pandemics like the COVID-19 crisis, which further emphasises their significance. (shrink)

Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated (...) in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Theory of International Bioethics: Multiculturalism, Postmodernism, and the Bankruptcy of Fundamentalism 1Robert Baker (bio)AbstractThis first of two articles analyzing the justifiability of international bioethical codes and of cross-cultural moral judgments reviews “moral fundamentalism,” the theory that cross-cultural moral judgments and international bioethical codes are justified by certain “basic” or “fundamental” moral principles that are universally accepted in all cultures and eras. Initially propounded by the judges at the (...) 1947 Nuremberg Tribunal, moral fundamentalism has become the received justification of international bioethics, and of cross-temporal and cross-cultural moral judgments. Yet today we are said to live in a multicultural and postmodern world. This article assesses the challenges that multiculturalism and postmodernism pose to fundamentalism and concludes that these challenges render the position philosophically untenable, thereby undermining the received conception of the foundations of international bioethics. The second article, which follows, offers an alternative model—a model of negotiated moral order—as a viable justification for international bioethics and for transcultural and transtemporal moral judgments.Man in the Twentieth Century can not be circumscribed by the standards of any single culture.American Anthropological Association (1948) in a statement officially denouncing the 1948 United Nation’s Declaration of Human Rights.Recently... so-called “liberal” medicine has revived the old rights of a clinic understood in terms of a special contract, a tacit pact made between one man and another. This patient gaze has even been attributed the power of assuming [a role in clinical decision making].Miracles are not so easy to come by....Michel Foucault (1975, p. 5) [End Page 201]An Overview of the AnalysisInternational bioethics originated in the trauma of the Holocaust, specifically, in the 1946–1947 Nuremberg “Doctors Trial” when a tribunal of three American judges convicted Nazi medical researchers of “crimes against humanity.” In justifying their judgment, the Nuremberg Tribunal cited 10 principles for morally permissible research, which, they claimed, were based on “fundamental” principles that civilized societies “all agree” upon and accept as the foundations of their “moral, ethical, and legal” norms. Foremost among the principles was one stating that morally permissible human experiments require the informed voluntary consent of the subject. The Nuremberg judgment soon became associated with the ideal of human rights declared in the 1948 United Nations Charter. These two ideas—fundamental principles of morality and human rights—have been linked in all major formulations of international bioethics promulgated in the past 50 years, including the Council of Europe’s 1997 Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine (Council of Europe 1997; Dommel and Alexander 1997). In this paper, I explore the received justification for international bioethics—the idea that it is grounded in fundamental principles accepted in all societies—tracing it from its initial, almost off-hand, promulgation by the Nuremberg Tribunal, through its more thoughtful development by such bioethicists as Ruth Macklin, to its more complex use by the President’s Advisory Committee on Human Radiation Experiments.After a brief review of the evolution of the received justification, I discuss the viability of this justification in the face of the critique implicit in two important intellectual movements: multiculturalism and postmodernism. In the international context, multiculturalism asserts the claim that there are no common moral principles shared by all cultures. Postmodernism asserts a similar claim against all universal standards, moral and nonmoral. In the 1990s, bioethicists have attempted to respond to these claims in various ways. These responses are documented, analyzed, and then shown to be “bankrupt,” in the sense that they undercut the most important objective of moral fundamentalism: the justification of transcultural moral judgments, such as the condemnation of the Nazi doctors.A second article, which follows the present one in the same issue of the Kennedy Institute of Ethics Journal, revisits the contractarian tradition [End Page 202] of Hobbes and Locke, as it has been reinterpreted by David Gauthier (1986), John Rawls (1971, 1993), and Robert Nozick (1974), to develop the idea of negotiated moral order as the basis of international bioethics. When conceptualized as a negotiated moral order, international bioethics can accept the genuine insights... (shrink)

BackgroundThe concept of evidence-based medicine has strongly influenced the appraisal and application of empirical information in health care decision-making. One principal characteristic of this concept is the distinction between "evidence" in the sense of high-quality empirical information on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10 years an increasing number of articles published in international journals have made use of the term "evidence-based ethics", making a systematic analysis and explication of (...) the term and its applicability in ethics important.DiscussionIn this article four descriptive and two normative characteristics of the general concept "evidence-based" are presented and explained systematically. These characteristics are to then serve as a framework for assessing the methodological and practical challenges of evidence-based ethics as a developing methodology. The superiority of evidence in contrast to other empirical information has several normative implications such as the legitimization of decisions in medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent on which sort of empirical information deserves the label "evidence" and which does not. In empirical ethics, which relies primarily on interview research and other methods from the social sciences, we still lack gold standards for assessing the quality of study designs and appraising their findings.ConclusionThe use of the term "evidence-based ethics" should be discouraged, unless there is enough consensus on how to differentiate between high- and low-quality information produced by empirical ethics. In the meantime, whenever empirical information plays a role, the process of ethical decision-making should make use of systematic reviews of empirical studies that involve a critical appraisal and comparative discussion of data. (shrink)

The purpose of this article is to illuminate the conceptualisations and applications of the Belmont Report’s key ethical principles of respect for persons, beneficence, and justice based on a document analysis of five of the most relevant disciplinary guidelines on internet research in the social sciences. These seminal documents are meant to provide discipline-specific guidance for research design and implementation and are regarded as key references when conducting research online. Our analysis revealed that the principles of respect and beneficence were (...) explicitly conveyed in the documents analysed, offering nuanced interpretations on issues of informed consent, privacy, and benefits and risks as well as providing recommendations for modifying traditional practices to fit the online setting. However, the invocations of the principle of justice were rather implicit and reflect an important shift from the Belmont Report’s protectionist ethical position towards more situational and dialogic approaches. With the rapidly evolving nature of internet technologies, this analysis is projected to contribute to the ongoing developments in research ethics in the social sciences by outlining the tensions and implications of the use of the internet as a methodological tool. We also seek to provide recommendations on how disciplinary associations can proceed to facilitate ethically sensitive internet research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religion and the Body in Medical ResearchCourtney S. Campbell (bio)AbstractReligious discussion of human organs and tissues has concentrated largely on donation for therapeutic purposes. The retrieval and use of human tissue samples in diagnostic, research, and education contexts have, by contrast, received very little direct theological attention. Initially undertaken at the behest of the National Bioethics Advisory Commission, this essay seeks to explore the theological and religious questions embedded (...) in nontherapeutic use of human tissue. It finds that the “donation paradigm” typically invoked in religious discourse to justify uses of the body for therapeutic reasons is inadequate in the context of nontherapeutic research, while the “resource paradigm” implicit in scientific discourse presumes a reductionist account of the body that runs contrary to important religious values about embodiment. The essay proposes a “contribution paradigm” that provides a religious perspective within which research on human tissue can be both justified and limited.The retrieval and use of human tissue samples for diagnostic, therapeutic, research, and educational purposes represent further developments in scientific study of the human body as a source of medical information. Following the completion of its examination of the ethical and policy issues pertaining to human cloning in the spring of 1997, the National Bioethics Advisory Commission (NBAC) returned to the set of questions for which it had been originally constituted, including ethical issues that arise in human subjects research. One issue that proved controversial for the human genetics subcommittee of NBAC was the scientific, philosophical, and legal status of tissue and other body parts (usually surgical specimens) that had been retrieved from patients (not research subjects) who had given general consent to the use of their body materials for research and educational purposes. The subcommittee addressed questions about the adequacy of general versus specific [End Page 275] consent, the scientific merits of identifiable versus anonymous samples and claims about patient confidentiality, and the justification for patient refusals and requests that the materials be returned to the patient or discarded rather than made available for scientific research. In an effort to better understand the ramifications of research on human tissue, the subcommittee commissioned several background papers that examined these questions from ethical, legal, research, and religious perspectives. What follows is a modified version of the report on religious considerations originally presented to the genetics subcommittee of NBAC.The central question examined in this article is whether tissue banking for purposes of research presents distinctive theological issues or prompts objections from religious communities or scholars. Religious discussion of human organs and tissues has focused largely on donation for therapeutic purposes (what I describe as the “donation paradigm”); hence, there is very little direct consideration of nontherapeutic uses of such tissue. It is possible, however, to describe implications and suggest inferences by considering (1) religious attitudes to the human body and to organs, tissues, and cells removed from the body, and (2) religious discussions of modes of transfer of body parts, such as donations, offerings, sales, and abandonment. By and large, this discussion will reflect themes that emerge from the central Western religious traditions, with some attention given to Eastern and Native perspectives.The Body: Religious Holism, Scientific Reductionism, Private PropertyThe human body as an organic totality has long been the subject of theological reflection and a symbol for religious communities. However, much less attention has been devoted to the religious status of organs, tissues, cells, and DNA. The reflection of religious scholars and communities on the status of body parts has been prompted by the necessity to confront practical questions in personal and public health and in communal life, such as justifications for surgery, autopsies, organ donation, or burial. Scientific and research interest in parts of the body can sometimes conflict with religious values about bodily integrity. Indeed, E. Richard Gold cites the “disparate claims of scientific investigation and religious belief on the body” as the exemplary case of incommensurate values regarding the body. According to Gold (1996, p. 149), “The body, from a scientific viewpoint, is a source of knowledge of physical development, aging, and disease. From a religious perspective, the body is understood [End Page 276] as a sacred object, being created in the image... (shrink)

Anna Smajdor offers a fresh perspective on why assent is morally required in research practices involving people who (are considered to) lack the capacity to consent.1 Smajdor holds that seeking (and documenting) assent can be a mechanism to recognise those who (are considered to) lack the capacity to consent as participants ‘in our moral sphere’.1 Smajdor suggests that this approach can function as a counter to the ‘reifying’ attitudes (often) taken towards people who (are judged to) lack the (...) capacity to consent.1 Smajdor’s approach also offers novel resources to overcome what Giles Birchley characterise as ‘the problems of the binary approach to incapacity’.2 Particularly in the context of dementia research, Smajdor’s proposal can be seen as a promising direction for going beyond the conventional (primarily) ‘protective’ approach taken by research ethics committees.3 The conventional approach asks researchers to obtain autonomous authorisation from research participants and (at times, implicitly) relies on the assumption that the ability to give consent is the only autonomy-related ability or, in other words, the assumption that the inability to give consent indicates vulnerability due to non-autonomy/non-agency. But this assumption, as Smajdor notes, seems problematic. The ability to assent (or dissent) is also an autonomy-related ability. Many …. (shrink)

Libertarian philosophy asserts that only the initiation of physical force against persons or property, or the threat thereof, is inherently illegitimate. A corollary to this assertion is that all forms of speech, including fraudulent advertising, are not invasive and therefore should be considered legitimate. On the other hand, fraudulent advertising can be viewed as implicit theft under the theory of contract: if a seller accepts money knowing that his product does not have some of its advertised characteristics, he acquires (...) the property title to the customer’s money without voluntary consent, which is theft. The balance between these two logical extensions of property rights—the right of free speech and the right of contract—lies somewhere in the area of communication philosophy, and can be explained through understanding the role of communication in human interactions. Advertising is a form of communication that may convey important information about the conditions of the proposed contract. These conditions are expressed in particular words that may have different meanings in different circumstances. Therefore to determine whether a particular example or “misinterpretation” is mere sophistry or a type of fraud, the judicial system has to approach each issue on a case-by-case basis. The border between legal and illegal should be determined by precedents and by expectations based on commonly accepted definitions of terms—what people commonly understand by the words and other forms of communication they use. (shrink)

There is a gap between health economic evaluation methods and the value judgments of coverage decision makers, at least in Germany. Measuring preference satisfaction has been claimed to be inappropriate for allocating health care resources, e.g. because it disregards medical need. The existing methods oriented at medical need have been claimed to disregard non-consequentialist fairness concerns. The aim of this article is to propose a new, contractarian argument for justifying needs-based economic evaluation. It is based on consent rather than (...) maximization of some impersonal unit of value to accommodate the fairness concerns. This conceptual paper draws upon contractarian ethics and constitution economics to show how economic evaluation can be viewed as an institution to overcome societal conflicts in the allocation of scarce health care resources. For this, the problem of allocating scarce health care resources in a society is reconstructed as a social dilemma. Both disadvantaged patients and affluent healthy individuals can be argued to share interests in a societal contract to provide technologies which ameliorate medical need, based on progressive funding. The use of needs-based economic evaluation methods for coverage determination can be interpreted as institutions for conflict resolution as far as they use consented criteria to ensure the social contract’s sustainability and avoid implicit rationing or unaffordable contribution rates. This justifies the use of needs-based evaluation methods by Pareto-superiority and consent. The view of economic evaluation presented here may help account for fairness concerns in the further development of evaluation methods. This is because it directs the attention away from determining some unit of value to be maximized towards determining those persons who are most likely not to consent and meeting their concerns. Following this direction in methods development is likely to increase the acceptability of health economic evaluation by decision makers. (shrink)