Hypothetical consent is puzzling. On the one hand, it seems to make a moral difference across a wide range of cases. On the other hand, there seem to be principled reasons to think that it cannot. In this article I put forward reasonably precise formulations of these general suspicions regarding hypothetical consent; I draw several distinctions regarding the ways in which hypothetical consent may make a moral difference; I distinguish between two autonomy-related concerns, nonalienation (...) and sovereignty; and, utilizing these distinctions, I show that—and in a preliminary way, when—the objections to the moral significance of hypothetical consent fail. (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.

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)

A commonly accepted criticism of the social contract approach to justifying political authority targets the notion of hypothetical consent. Hypothetical contracts, it is argued, are not binding; therefore hypothetical consent cannot justify political authority. I argue that although hypothetical consent may not be capable of creating political obligation, it has the power to legitimate political arrangements.

This article starts by examining the appeal to hypothetical consent as used by law and economics writers. I argue that their use of this kind of argument has no moral force whatever. I then briefly examine, through some remarks on Rawls and Scanlon, the conditions under which such an argument would have moral force. Finally, I bring these considerations to bear to criticize the argument of judge Frank Easterbrook's majority opinion in Flamm v. Eberstadt.

Hypothetical Consent Situations are widely employed in normative argument as if they help to justify normative claims or to explain normative facts. Historically, however, there is plenty of suspicion about them. In this light, there is a tendency to prefer theories of political obligation that do not depend upon hypothetical consent to explain political obligations – those that appeal, for instance, a general moral principle or to actual consent. This paper makes no full-throated defense of (...) hypothetical consent. But it does try to identify more carefully than is usually done what sorts of cases they represent and to show that at least two concerns about them are unwarranted. (shrink)

Epistemology, as I understand it, is a branch of philosophy especially concerned with general questions about how we can know various things or at least justify our beliefs about them. It questions what counts as evidence and what are reasonable sources of doubt. Traditionally, episte-mology focuses on pervasive and apparently basic assumptions covering a wide range of claims to knowledge or justified belief rather than very specific, practical puzzles. For example, traditional epistemologists ask “How do we know there are material (...) objects?” and not “How do you know which are the female beetles?” Similarly,moralepistemology, as I understand it, is concerned with general questions about how we can know or justify our beliefs about moral matters. Its focus, again, is on quite general, pervasive, and apparently basic assumptions about what counts as evidence, what are reasonable sources of doubt, and what are the appropriate procedures for justifying particular moral claims. (shrink)

The so-called Substituted Judgment Standard is one of several competing principles on how certain health care decisions ought to be made for patients who are not themselves capable of making decisions of the relevant kind. It says that a surrogate decision-maker, acting on behalf of the patient, ought to make the decision the patient would have made, had the latter been competent. The most common way of justifying the Substituted Judgment Standard is to maintain that this standard protects patients’ right (...) to autonomy, or self-determination, in the situation where they are no longer able to exercise this right on their own. In this paper we question this justification, by arguing that the most commonly suggested moral reasons for allowing and encouraging people to make their own choices seem not to apply when the patient’s decision-making is merely hypothetical. We end with some brief sketches of possible alternative ways of justifying the Substituted Judgment Standard. (shrink)

Our decision-making is often subject to framing effects: alternative but equally informative descriptions of the same options elicit different choices. When a decision-maker is vulnerable to framing, she may consent under one description of the act, which suggests that she has waived her right, yet be disposed to dissent under an equally informative description of the act, which suggests that she has not waived her right. I argue that in such a case the decision-maker’s consent is simply irrelevant (...) to the permissibility of proceeding. I then consider two alternative views. According to the first, people susceptible to framing are able to give valid consent so long as they are sufficiently informed. This suggestion, I argue, maintains an overly narrow focus on mere quantity of information to the exclusion of other choice-affecting factors. A second response, which appeals to hypothetical consent, is likewise of little use in resolving the moral problem posed by framing effects. I conclude that if susceptibility to framing undermines the validity of consent, we may have good reason to reconsider whether consent has the rights-waiving function commonly attributed to it. (shrink)

In his recent book Democratic Authority, David Estlund defends a strikingly new and interesting account of political authority, one that makes use of a distinctive kind of hypothetical consent that he calls ‘normative consent’: a person can come to have a duty to obey another when it is the case that, were she given the chance to consent to the duty, she would have a duty to consent to it. If successful, Estlund’s account promises to (...) provide what has arguably so far remained elusive: the basis for the authority of suitably democratic laws. In this paper, I argue that, despite its promise, the account Estlund develops is, in a crucial respect, incoherent: the principle of normative consent that he offers relies on a claim about a hypothetical situation, but the hypothetical situation at issue is one that, according to the principle itself, is morally impossible. (shrink)

Researchers have explored questions concerning public participation and consent in geoengineering governance. Yet, the notion of consent has received little attention from researchers, and it is rarely discussed explicitly, despite being prescribed as a normative requirement for geoengineering research and being used in rejecting some geoengineering options. As it is noted in the leading geoengineering governance principles, i.e. the Oxford Principles, there are different conceptions of consent; the idea of consent ought to be unpacked more carefully (...) if, and when, we invoke it in the discussion. This article offers a theoretical reflection on different conceptions of consent and their place in geoengineering governance. More specifically, I discuss three models of consent, i.e. explicit consent, implied consent and hypothetical consent, and assess their applicability to geoengineering governance. Although there are different models of consent, much discussion of geoengineering governance has committed only to explicit consent. I note that such a commitment springs from a specific ideal political order. Accordingly, we should be wary of any naïve commitment to it so long as the political order we hope for remains open to debate. Finally, I illustrate two approaches to introduce consent into a geoengineering governance framework. (shrink)

Consent theories of political obligation draw upon the unique powers consent exhibits in everyday dealings, but they are frustrated by the "problem of massive nonconsent." Expansions of what is counted as consent, such as tacit or hypothetical consent, have seemed untrue to the core concept of giving willing consent. David Estlund proposes a novel conception, "normative consent," to address the problem of massive nonconsent while being true to "the idiom of consent." This (...) comment details consent’s virtues and shows that consent theories cannot claim enough of them to vindicate political obligation. (shrink)

In this paper, I examine global public reason as a method of justifying a global state. Ultimately, I conclude that global public reason fails to justify a global state. This is the case, because global public reason faces an unwinnable dilemma. The global public reason theorist must endorse either a hypothetical theory of consent or an actual theory of consent; if she endorses a theory of hypothetical consent, then she fails to justify her principles; and (...) if she endorses a theory of actual consent, her theory will lead to a highly unstable political system. On either side of the dilemma, global public reason faces untenable implications. Although similar criticisms have been advanced against domestic public reason, my argument is not repeating points made before me. My argument is new, in that it raises these objections specifically against global public reason, and in that it shows how, due to increased diversity of belief in the global arena, these problems are more pressing for global public reason than they are for domestic public reason. (shrink)

Obtaining informed consent from patients prior to a medical or surgical procedure is a fundamental part of safe and ethical clinical practice. Currently, it is routine for a significant part of the consent process to be delegated to members of the clinical team not performing the procedure (eg, junior doctors). However, it is common for consent-taking delegates to lack sufficient time and clinical knowledge to adequately promote patient autonomy and informed decision-making. Such problems might be addressed in (...) a number of ways. One possible solution to this clinical dilemma is through the use of conversational artificial intelligence using large language models (LLMs). There is considerable interest in the potential benefits of such models in medicine. For delegated procedural consent, LLM could improve patients’ access to the relevant procedural information and therefore enhance informed decision-making. In this paper, we first outline a hypothetical example of delegation of consent to LLMs prior to surgery. We then discuss existing clinical guidelines for consent delegation and some of the ways in which current practice may fail to meet the ethical purposes of informed consent. We outline and discuss the ethical implications of delegating consent to LLMs in medicine concluding that at least in certain clinical situations, the benefits of LLMs potentially far outweigh those of current practices. (shrink)

The risk posed to the community by possible xenozoonosis after xenotransplantation suggests that some form of 'community consent' is required before whole organ animal-to-human xenotransplantation should take place. I argue that this requirement places greater obstacles in the path of ethical xenotransplantation than has previously been recognised. The relevant community is global and there are no existing institutions with democratic credentials sufficient to establish this consent. The distribution of the risks and benefits from xenotransplantation also means that (...) class='Hi'>consent is unlikely to be forthcoming. Proceeding on the basis of hypothetical consent to a package of global health measures that includes xenotransplantation, as Rothblatt has recently advocated, is more problematic than she acknowledges. Given that it may place the lives of citizens of poor nations at risk to benefit the citizens of wealthy nations, xenotransplantation raises significant questions of international justice. (shrink)

We often assume that hypothetical approval – either in the form of preferences or consent – under ideal conditions adds to the legitimacy of an arrangement or act. I want to show that this assumption, reasonable as it may seem, will also give rise to ethical problems. I focus on three problem areas: prudence, euthanasia and coercive psychiatric treatment. If we are to count as prudentially or morally␣relevant those preferences you would have if you were informed and rational, (...) we will run into difficulties in all these areas if your actual and rational preferences are at variance with each other. In the prudential sphere we may question the personal value of satisfying preferences that a person does not actually have. In this case our problem concerns the point of satisfying a rational preference in conflict with an actual one. In the cases of euthanasia and coercive care it concerns instead whether it would be morally right to do such a thing. I doubt there is a simple solution to our problem. In this paper at most I prepare the way for a solution or for wiser decisions in the hard cases, by pointing out what they will have to deal with. (shrink)

I discuss conditions for the validity of proxy consent to treatment on behalf of an incompetent person. I distinguish those incompetents who, when previously competent, expressed an opinion on the treatment in question from those who were never competent or who, though previously competent, never expressed an opinion on the proposed treatment. In the former case valid proxy consent usually requires respecting the stated wishes of the patient. The latter case is more difficult. I consider a widely-held principle (...) which appeals to the counterfactual wishes of the incompetent person. I argue that it is unacceptable and propose in its place a principle having to do with the best interests of the patient. Keywords: proxy consent, informed consent, competence, hypothetical wishes, substituted judgment, counterfactual wishes CiteULike Connotea Del.icio.us What's this? (shrink)

This paper explores the extent to which behavioral public policies can be both efficient and democratic by reflecting on the conditions under which individuals could rationally consent to them. Consent refers to a moral requirement that a behavioral public policy should respect what I call a person’s value autonomy and conception of the good. Behavioral public policies can take many forms. Based on a social choice framework, I argue that fully paternalistic and prudential behavioral public policies are unlikely (...) to trigger a hypothetical form of rational consent. Non-fully paternalistic behavioral public policies with partially non-prudential motivations are less problematic in this perspective. In any case, a public deliberative stage preceding the implementation of policies seems to be the best democratic way to justify them. (shrink)

Bajo el rótulo de "contractualismo" se agrupan diversas teorías que sostienen que la obligatoriedad de las normas descansa en el consentimiento de quienes están vinculados por ellas. No obstante, esta caracterización general obvia diferencias cruciales entre las distintas teorías contractualistas. Se analizan diversas tipologías para iluminar dichas diferencias y alcanzar una caracterización más exacta del contractualismo. Se concluye que la distinción entre consentimiento hipotético e ideal, al que recurren algunas versiones, torna imposible la formulación de una definición unívoca de contractualismo. (...) "Contractualism" refers to the diverse theories that maintain that the obligatory nature of norms rests on the consent of those bound by them. However, this general characterization overlooks crucial differences among the different contractualist theories. The article analyzes diverse typologies in order to highlight these differences and reach a more precise characterization of contractualism. It concludes that the distinction between hypothetical and ideal consent made by some of these versions makes it impossible to formulate a univocal definition of contractualism. Sob o título de "contratualismo", agrupam-se diversas teorias que sustentam que a obrigatoriedade das normas descansa no consentimento dos que estão vinculados por elas. Contudo, essa caracterização geral torna óbvias diferenças cruciais entre as diferentes teorias contratualistas. Analisam-se diversas tipologias para iluminar essas diferenças e alcançar uma caracterização mais exata do contratualismo. Conclui-se que a diferença entre consentimento hipotético e ideal, à qual recorrem algumas versões, torna impossível a formulação de uma definição unívoca de contratualismo. (shrink)

Tom Regan argued that animal sports cannot be morally permissible because they are cruel and the animals do not voluntarily participate. While Regan is correct about actual animal sports, we should ask whether substantially revised animal sports could be permissible. We can imagine significant changes to certain animal sports, such as horse racing, that would avoid cruelty and even allow the animals to make their own choices. Where alternative options are freely available, we can consider the horses to have preference (...) autonomy in that they make their own decisions, and we could thereby claim that we have their hypothetical consent. Though this scenario would be sufficient to constitute permissible animal games, these activities could not amount to sports because the events would be unpredictable with the animals not following the rules in the precise way that sport requires. Therefore, permissible animal sports are not possible. (shrink)

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a (...) video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor–patient interaction was respectful. (shrink)

BackgroundInformed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with (...) participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.MethodsTwo online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.ResultsLikelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).ConclusionsThese findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment. (shrink)

Objective: Obtaining informed consent for resuscitation research, especially in the newborn, is problematic. This study aimed to evaluate parental preferences for hypothetical consent procedures in neonatal resuscitation research.Design: Mail-out survey questionnaire.Setting/participants: Randomly selected parents who had received obstetrical or neonatal care at a tertiary perinatal centre.Main outcome measures: Parental levels of comfort regarding different methods of obtaining consent in hypothetical resuscitation research scenarios.Results: The response rate was 34%. The respondents were a group of highly educated (...) women with a higher family income than would be expected in the general population. In terms of results, parents valued the impact the research would have on their baby and the importance of a positive interaction with the physicians conducting the research study. Parents felt most comfortable with prospective consent in the setting of prenatal classes or prenatal visits with a physician, but they were somewhat uncomfortable with prospective consent upon admission to hospital after labour had begun. Parents were uncomfortable with waived consent, deferred consent, and opting out, no matter when during the pregnancy consent was requested.Conclusion: This pilot study reports parental preferences for prenatal information and consent for such research trials of neonatal resuscitation. A low response rate and potentially skewed demographics of the respondents prevent generalisability of this result. Interview studies should be performed to better determine parental preferences for informed consent in a more representative population. (shrink)

Greater public awareness of the occurrence of sexual assault has led to the creation of mobile phone apps designed to facilitate consent between sexual partners. These apps exhibit serious practical shortcomings in realistic contexts; however, in this paper I consider the hypothetical case in which these practical shortcomings are absent. The prospect of this viable consent app creates an interesting challenge for consequentialism – one that is comparable to the objection that the theory justifies killing innocent persons (...) to prevent large numbers of less serious harms like experiencing brief, painful headaches. I outline and reject the most straightforward way for consequentialists to address this challenge, and I argue that the empirical calculations at stake reveal something rarely appreciated: consequentialists ought to sometimes favour reinforcing deontological constraints in common-sense morality rather than seeking to undermine them. (shrink)

The Japanese Medical Act section 21 states that doctors must report unnatural deaths to the police, even though the term “unnatural death” is not defined by law. However, many doctors are reluctant to report potential therapeutic deaths . The Japanese Society of Legal Medicine has submitted guidelines for unnatural death, including PTD. These define a PTD as an unexpected death, the cause of which is unknown, but which is potentially related to medical practice. Such deaths are “reportable” to the coroner (...) in the UK. In this study, we addressed the question of whether physicians would report each of eight hypothetical PTDs. Although the clinical societies declare that doctors must report deaths due to gross negligence, 60% of the participants said that they would not report gross negligence involving an overdose in cases where they had obtained informed consent or had provided an explanation after the death occurred. This can be accounted for by the mistaken belief on the part of the participants that obtaining informed consent exempts Japanese physicians from the duty of reporting PTDs. The attitude of Japanese physicians is caused by the death investigation system, which is designed to discover whether a crime has been committed rather than focusing on the cause of death. Accordingly, the Japanese Government has decided to commission a pilot study from an independent organisation in which medical specialists will investigate PTDs in order to prevent deaths occurring as a result of gross negligence. (shrink)

In this clearly written, impressively researched, and engaging book, Alan Wertheimer makes a distinctive and important contribution to the contemporary literature on the nature and value of consent to sexual relations. Wertheimer’s effort is two-fold. First, and as an informative yet logically distinct backdrop, he provides a specific theory of sexual desire and behavior, viz., evolutionary psychology. Second, he identifies and defends moral and legal principles of valid consent to sex. In chapter-length discussions, Wertheimer shows why matters of (...) consent are significantly more complex than many, including influential feminist scholars, recognize, and in so doing lays the groundwork for the theoretical core of his book: a rights-based theory of sexual coercion. This theory provides powerful grounds for determining when conduct constitutes coercion of the sort that nullifies consent and, when combined with numerous and often-ingenious hypothetical cases, teases out principles of moral and legal consent that are both coherent and reasonable. As a result of this combination of considerations, Wertheimer’s book is unique among recent efforts in this area and the analyses and arguments presented should be of great interest to social psychologists as well as those working in normative ethics and jurisprudence. (shrink)

This article discusses the legitimacy argument on which many liberals ground their demand for restraining the use of religious convictions in processes of political deliberation and decision making. According to this argument the exercise of political power can only be justified by 'neutral' grounds, i.e. grounds that are able to find reciprocal, hypothetical consent. The author argues that this understanding of political legitimacy is not distinctive of the liberal tradition. His thesis is that reciprocal, hypothetical consent (...) is not sufficient and only in a certain, restricted sense necessary for justifying the use of political power. (shrink)

Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other’s altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14 to 17 years of age and 91% of their parents were (...) mothers, a majority of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents’ statements of altruism more frequently than adolescents responded to parents’ statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation. (shrink)

This paper focuses on a hypothetical case that represents an intervention request familiar to those who work with individuals with intellectual disability. Stacy has autism and moderate intellectual disability. Her parents have requested treatment for her hand flapping. Stacy is not competent to make her own treatment decisions; proxy consent is required. There are three primary justifications for proxy consent: the right to an open future, substituted judgment, and the best interest standard. The right to an open (...) future justifies proxy consent on the assumption of future autonomy whereas substituted judgment justifies proxy consent via reference to past autonomy. Neither applies. Stacy has not been, nor will she be, competent to make her own treatment decisions. The best interest standard justifies proxy consent on the grounds of beneficence. It is unlikely that hand flapping harms Stacy. None of the three primary means of justifying proxy consent apply to Stacy’s case. (shrink)

Objective: To assess the knowledge of four groups of individuals regarding who is legally authorised to consent to health care or research involving older patients.Design: A provincewide postal survey.Setting: Province of Quebec, Canada.Participants: Three hundred older adults, 434 informal caregivers of cognitively impaired individuals, 98 researchers in aging and 136 members of research ethics boards .Measurements: Knowledge was assessed through a pretested postal questionnaire comprising five vignettes that describe hypothetical situations involving an older adult who requires medical care (...) or is solicited for research. The respondent had to identify the person who is legally authorised to provide consent.Results: Nearly 80% of all respondents provided the correct answer when the hypothetical scenario depicted a person who was competent to consent or incompetent but legally represented. Knowledge was worse for the scenario describing a research situation that involved an incompetent adult without a legal guardian.Conclusion: The observed lack of knowledge raises doubts about the ability of current legislation to truly protect the rights of older adults with diminished decision making capacity. It points to the need for educational programmes aimed at increasing public awareness of the legislation put in place for those requiring special protection. (shrink)

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing (...) consent procedures that best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest. (shrink)

On the basis of the characterization of autonomy set out by Beauchamp and Childress in Principles of Biomedical Ethics, we first explore some of the parameters along which autonomy may vary in degree through a series of hypothetical examples drawn from various settings; and, second and in more detail, we examine how the range of autonomy is affected through informed consent to various medical diagnostic tests. Our conclusions are (1) that there are significant implications for patient autonomy inherent (...) in new and forthcoming diagnostic modalities, and (2) that attention should be paid to these implications in formulating policies for both clinical practice and research. We close with (a) some specific policy recommendations for clinical practice and research, and (b) some metaphysical speculations raised by our explorations. (shrink)

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios (...) based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation. (shrink)

Machine generated contents note: CHAPTER 1 HEALTH CARE PROFESSIONALS AND HIV: The Duty To WarnI -- CHAPTER 2 EMERGENCY CARE AND HIV: Treatment Policy and -- Pracice17 -- CHAPTER 3 A REVOLUTIONARY POLICY? Mandatory Disclosure of HIV -- Serostaus29 -- CHAPTER 4 MINORS AND HEALTH CARE: The Limits of Consent and -- Confidentiality39 -- CHAPTER 5 THE RIGHTS TO REFUSE AND DEMAND MEDICAL -- TREATMENT: The Bounds ofAutonomy andFutli{y47 -- CHAPTER 6 RELIGIOUS FREEDOM AND THE RIGHT TO REFUSE CARE: (...) -- What Are The Limits?65 -- CHAPTER 7 ASSISTED REPRODUCTIVE TECHNOLOGY: The Business of -- Making Babies 89 -- CHAPTER 8 TWINS AND TRANSPLANTS: Choosing Who Lives 113 -- CHAPTER 9 FREE ABORTION SERVICES AND FETAL TISSUE RESEARCH: -- Freedom of Choice and Coercion123 -- CHAPTER 10 PROPERTY RIGHTS, BODY PARTS, AND REPRODUCTION: -- Who Owns the Human Body? - 139 -- CHAPTER 11 OUTBREAK IN AMERICA: The Policy of Public Verses Private -- Interests 153 -- APPENDIX A CONFIDENTIALITY OF HIV TEST RESULTS: California Health -- and Safety Code Sections 120975 Through 121020169 -- APPENDIX B HEALTH CARE PROFESSIONALS AND HIV: Texas Health and -- Safety Code Section 58.204 175 -- APPENDIX C TARASOFF v, THE REGENTS OF THE UNIVERSITY OF -- CALIFORNIA: Supreme Court of California177 -- APPENDIX D THE RIGHTS OF MINORS TO CONSENT TO HEALTH CARE: -- California Family Code Sections 6903 Through 6929183 -- APPENDIX E FEDERAL DRUG AND ALCOHOL ABUSE CONFIDENTIALITY -- REGULATIONS: Title 42 Code of Federal Regulations Part 2 187 -- APPENDIX F CHILD ABUSE REPORTING LAWS: Caitfornia Penal Code -- Sections 11164 Through 11166 193. (shrink)

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc., wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration. The new drug is expected to receive FDA approval in 2 or more years. The company (...) decides to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs. (shrink)

In this article, John Locke's accounts of political liberty and legitimate government are read as expressions of a normative demand for non-arbitrariness. I argue that Locke locates infringements of political liberty in dependence on the arbitrary will of another, whether or not interference or restraint actually takes place. This way Locke is tentatively placed in that tradition of republican thought recently brought to our attention by Pettit, Skinner and others. This reading shifts the focus on legitimacy and identifies the independent (...) moral argument for legitimate government as ruling for the good of the people. Consent is left with a hypothetical role to play. (shrink)

One of the most familiar arguments for expressivist metaethics is the claim that the rival theory, moral realism, cannot provide a satisfying explanation of why moral properties supervene on natural properties. Non-cognitivism, however, has its own problems explaining supervenience. Expressivists try to establish supervenience either by second-order disapproval of type-inconsistent moral evaluations or by pragmatic considerations. But disapproval of inconsistency is merely a contingent attitude that people happen to have; and pragmatic justification does not allow for appraisers to take their (...) own moral attitudes seriously enough. What has been overlooked is a third alternative. The metaethical theory that can best account for supervenience is neither realist nor non-cognitivist but an objectivist version of constructivism. On the constructivist theory, right and wrong are determined by the principles that people would (hypothetically) consent to under ideal conditions. Type-consistency is a required feature of any principles regulating our conduct, if they are to be freely agreed to by ideally rational people. (shrink)

This chapter contains sections titled: Can a Serial Killer Ever Be Good? Dexter on Trial Four Ethical Tests Dexter Dreams Darkly: An Overview of Showtime's Dexter Morgan Killing to Maximize Happiness Kant's Dark Champion A Virtuous Devil or a Moral Monster? Hypothetical Consent: Would You Want Dexter in Your Neighborhood? Closing Arguments.

The purpose of this paper is to provide a justification of punishment which can be endorsed by free will skeptics, and which can also be defended against the "using persons as mere means" objection. Free will skeptics must reject retributivism, that is, the view that punishment is just because criminals deserve to suffer based on their actions. Retributivists often claim that theirs is the only justification on which punishment is constrained by desert, and suppose that non-retributive justifications must therefore endorse (...) treating the people punished as mere means to social ends. Retributivists typically presuppose a monolithic conception of desert: they assume that action-based desert is the only kind of desert. But there are also personhood-based desert claims, that is, desert claims which depend not on facts about our actions, but instead on the more abstract fact that we are persons. Since personhood-based desert claims do not depend on facts about our actions, they do not depend on moral responsibility, so free will skeptics can appeal to them just as well as retributivists. What people deserve based on the mere fact of their personhood is to be treated as they would rationally consent to be treated if all they had in view was the mere fact of their personhood. We can work out the implications of this view for punishment by developing a hypothetical consent justification in which we select principles of punishment in the Rawlsian original position, so long as we are careful not to smuggle in the retributivist assumption that it is under our control whether we end up as criminals or as law-abiding citizens once we raise the veil of ignorance. (shrink)

On a traditional interpretation of the substituted judgement standard a person who makes treatment decisions on behalf of a non-competent patient ought to decide as the patient would have decided had she been competent. I propose an alternative interpretation of SJS in which the surrogate is required to infer what the patient actually thought about these end-of-life decisions. In clarifying SJS it is also important to differentiate the patient's consent and preference. If SJS is part of an autonomy ideal (...) of the sort found in Kantian ethics, consent seems more important than preference. From a utilitarian perspective a preference-based reading of SJS seems natural. I argue that the justification of SJS within a utilitarian framework will boil down to the question whether a non-competent patient can be said to have any surviving preferences. If we give a virtue-ethical justification of SJS the relative importance of consent and preferences depends on which virtue one stresses-respect or care. I argue that SJS might be an independent normative method for extending the patient's autonomy, both from a Kantian and a virtue ethical perspective. (shrink)

Decision making for incompetent patients is a much-discussed topic in bioethics. According to one influential decision making standard, the substituted judgment standard, the decision that ought to be made for the incompetent patient is the decision the patient would have made, had he or she been competent. Although the merits of this standard have been extensively debated, some important issues have not been sufficiently explored. One fundamental problem is that the substituted judgment standard, as commonly formulated, is indeterminate in content (...) and thus offers the surrogate little or no guidance. What the standard does not specify is just how competent one should imagine the patient to be, and what else one ought to envision about the patient’s hypothetical outlook and the circumstances surrounding his or her decision making. The article discusses this problem of underdetermined decision conditions. (shrink)

This paper discusses the attempt in this issue of the journal by Peter Singer, John McKie, Helga Kuhse and Jeff Richardson, to defend QALYs against the argument from double jeopardy which I first outlined in 1987. In showing how the QALY and other similar measures which combine life expectancy and quality of life and use these to justify particular allocations of health care resource, remain vulnerable to the charge of double jeopardy I am able to clarify some of the central (...) issues concerning the value of life. In particular, the idea that the value of a life varies with its life expectancy and with its quality, understood in terms of its richness, variety, success etc, is subjected to special examination. It is shown how defenders of QALYs are committed to the view that so far from all lives being of equal value, all lives are necessarily of subtly different value. The paper then analyses the use to which the notorious 'veil of ignorance' has been put both by Singer et al and by others and shows how this device of John Rawls's cannot do the work so often assigned to it. The paper then considers the issue of hypothetical consent and the role that it can play in justifying disposing of the lives of people who have not in fact consented to their lives being disposed of in particular ways. Finally, the paper makes some points about the comprehensive nature of the data collection and storage which would be required by QALY advocates and points out the independent problems attaching to licensing such comprehensive collection and use of personal data. (shrink)

In "Rethinking Research Ethics," Rosamond Rhodes argues that everyone has a responsibility to participate in research ethics programs (Rhodes 2005). After discussing the moral underpinnings upon which such a claim might rest, this article brings up two concerns in response to Rhodes' claim. The first worry is pragmatic: Rhodes argues that the focus in research ethics should be on the hypothetical consent of idealized moral agents, an approach that is constrained by practical considerations. The second objection is that, (...) in most research studies, participants are paid, which undermines the accusation of free-riding for non-participants. (shrink)