Theron Pummer has argued that contrastive consent is necessary for the phenomenon of "secondary permissibility". I argue that it is not, and I undermine the motivation for thinking that it is.

If Badguy threatens Goodguy with harm, and Goodguy consents to giving his money to Badguy (to avoid the harm), Goodguy’s consent is invalid because coerced. But if under Badguy’s coercive threat Goodguy proceeds to consent to paying someone else (or to hiring a bodyguard), the consent may very well be valid. The challenge is to explain this difference. In this paper I argue that the way forward is to recognize that the content of consent is (...) class='Hi'>contrastive – one doesn’t just agree to giving the money; rather, one consents to giving-the-money-rather-than-some-alternative. And then the normative upshot of the relevant consent depends on what the morally relevant contrast is, which in turn depends on who is (before the relevant interaction) entitled to what against whom. We have, I think, independent reasons to understand consent contrastively, and once we do, we can solve the puzzle of third party coercion with ease. (shrink)

Consider three cases: -/- Turn: A trolley is about to kill five innocent strangers. You can turn the trolley onto me, saving the five and killing me. -/- Hurl: A trolley is about to kill five innocent strangers. You can hurl me at the trolley, saving the five and paralyzing me. -/- TurnHurl: A trolley is about to kill five innocent strangers. You can turn the trolley onto me, saving the five and killing me. You can instead hurl me at (...) the trolley, saving the five and paralyzing me. -/- Most find the following four claims intuitively plausible: -/- (1) It is permissible to turn the trolley onto me in Turn. (2) It is impermissible to hurl me at the trolley in Hurl. (3) It is impermissible to turn the trolley onto me in TurnHurl. (4) It is permissible to hurl me at the trolley in TurnHurl. -/- But how does turning go from permissible to impermissible, and hurling from impermissible to permissible, when both alternatives are available? I argue that such “secondary permissibility” claims are explained by contrastive consent. Even if I do not consent to being harmed, it is likely I’ll consent to being hurled at the trolley rather than being turned onto. (shrink)

This paper considers the moral status of bystanders affected by medical research trials. Recent proposals advocate a very low threshold of permissible risk imposition upon bystanders that is insensitive to the prospective benefits of the trial, in part because we typically lack bystanders' consent. I argue that the correct threshold of permissible risk will be sensitive to the prospective gains of the trial. I further argue that one does not always need a person's consent to expose her to (...) significant risks of even serious harm for the sake of others. That we typically need the consent of participants is explained by the fact that trials risk harmfully using participants, which is very hard to justify without consent. Bystanders, in contrast, are harmed as a side-effect, which is easier to justify. I then consider whether the degree of risk that a trial may impose on a bystander is sensitive to whether she is a prospective beneficiary of that trial. (shrink)

Anger and disgust may have distinct roles in sexual morality; here, we tested hypotheses regarding the distinct foci, appraisals, and motivations of anger and disgust within the context of sexual offenses. We conducted four experiments in which we manipulated whether mutual consent (Studies 1–3) or desire (Study 4) was present or absent within a counter-normative sexual act. We found that anger is focused on the injustice of non-consensual sexual acts, and the transgressor of the injustice (Studies 1 and 3). (...) Furthermore, the sexual nature of the act was not critical for the elicitation of anger—as anger also responded to unjust acts of violence (Study 3). By contrast, we hypothesised and found that disgust is focused on whether or not a person voluntarily engaged in, desired or consented to a counter-normative sexual act (Studies 2–4). Appraisals of abnormality and degradation were the primary appraisals of disgust, and the sexual nature of the act was a critical elicitor of disgust (Study 3). A final study ruled out victimisation as the mechanism of the effect of consent on disgust and indicated that the consenter's sexual desire was the mechanism (Study 4). Our results reveal that anger and disgust have differential roles in consent-related sexual offenses due to the distinct appraisals and foci of these emotions. (shrink)

Informed consent is a central concept in the literature on the ethics of clinical care and human subjects research. There is a broad consensus that ethical practice in these domains requires the informed consent of patients and subjects. The requirements of informed consent in these domains, however, are matters of considerable controversy. Some argue that the requirements of informed consent have been inflated, others that they have not been taken seriously enough. This essay argues that both (...) sides are partly right. To advance this argument, the essay distinguishes a general doctrine of informed consent from what it characterizes as “models of informed consent.” A general doctrine articulates a set of requirements for informed consent and then adjusts these requirements to fit the context in which they are to be applied. In contrast, different models of informed consent impose different requirements in different contexts. The essay contends that different models of informed consent are needed for clinical care and clinical research. It outlines these two models, articulates the rationale for distinguishing them, and considers and rebuts the objection that clinical care and clinical research are too deeply intertwined in contemporary medicine for the models approach to apply to them. (shrink)

The debate on the ‘right to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here (...) and to what extent they can provide a normative basis for informed consent. This paper provides an analysis of informed consent in the context of ‘epistemic interventions’: interventions which involve the communication of information. First, I offer an analysis of the concept of a ‘right not to know’ in the context of consent to epistemic interventions. I argue that the scope of the consent is determined by the extent to which this intervention can be seen as an infringement of the private sphere. After that I show how this analysis affects the scope and standards of informed consent. (shrink)

This article provides an overview of recent contributions to the debate on the ethical use of previously collected biobank samples, as well as a country report about how this issue has been regulated in Spain by means of the new Biomedical Research Act, enacted in the summer of 2007. By contrasting the Spanish legal situation with the wider discourse of international bioethics, we identify and discuss a general trend moving from the traditional requirements of informed consent towards new models (...) more favourable to research in a post‐genomic context. (shrink)

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of (...) a clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65).ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures).ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)

This article provides an overview of recent contributions to the debate on the ethical use of previously collected biobank samples, as well as a country report about how this issue has been regulated in Spain by means of the new Biomedical Research Act, enacted in the summer of 2007. By contrasting the Spanish legal situation with the wider discourse of international bioethics, we identify and discuss a general trend moving from the traditional requirements of informed consent towards new models (...) more favourable to research in a post-genomic context. (shrink)

We thank Lucy Frith for her thought-provoking response1 to our paper, where we argued that it would be ethically acceptable to contact an anonymous egg donor to help facilitate diagnostic genetic testing for a donor-conceived child.2 While we read Frith’s commentary with interest, we still think that the egg donor should be contacted in the case that we describe. Frith raises concerns as to whether contact would constitute ‘ overriding consent ’, thus ’ potentially set(ting) a dangerous precedent ’ (...) for existing gamete donors and donor-conceived children. In contrast, we consider that contacting the egg donor would not override her consent, as her views on contact in the instance that has now arisen were never sought. Our view is that given we do not currently know what she might want, contacting her is a more legitimate way of respecting her autonomy than trying to anticipate her likely answer. We strongly agree with Frith’s suggestion that future consent discussions around gamete donation should make explicit ‘ the possibility of being contacted in the future if there is a relevant reason for doing so ’. Frith expresses a concern that contact would constitute ‘ overriding [the egg donor’s] consent ’, meaning that we have to ‘ justify contacting the egg donor against her previously stated wishes not to be contacted ’. However, our argument is that the egg donor was never asked whether or not she was happy to be contacted in the circumstances that have now arisen. Thus, there is no consent to be overridden, given that she never gave or withheld it in the first place. Frith rightly acknowledges that her arguments therefore ‘ [do] not fully address [our] main worry that the donor’s wishes are essentially unknown, as she was not asked about this specific situation and …. (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)

Worries about the possibility of consent recall a more familiar problem about promising raised by Hume. To see the parallel here we must distinguish the power of consent from the normative significance of choice. I'll argue that we have normative interests, interests in being able to control the rights and obligations of ourselves and those around us, interests distinct from our interest in controlling the non-normative situation. Choice gets its normative significance from our non-normative control interests. By contrast, (...) the possibility of consent depends on a species of normative interest that I'll call a permissive interest, an interest in its being the case that certain acts wrong us unless we declare otherwise. In the final section, I'll show how our permissive interests underwrite the possibility of consent. (shrink)

This paper focuses on the position of consent in prevailing models of hegemony. It is argued that the commonly invoked consent assumption is a weakness in the hegemony construct that demands review. Consent is purportedly a crucial element of the hegemony dynamic, yet is often overlooked in favour of dominance and resistance. To illustrate this, the paper provides a genealogical account of the consent premise as it is formulated in notable models of political hegemony. This reveals (...) a declining interest in the purportedly crucial consent element of the hegemony construct, accompanied by a reductive view of language and discourse. Next, the paper contrasts the collective consent premise with modern notions of individual sexual consent. This highlights the connection between the consent assumption and hegemonic masculinity. It is observed that if hegemony is based on modes of control and the lack of meaningful choice, it is not founded on consensus. Rather, it is postulated that such conditions might aptly be described as a form of tolerance. This concept is outlined here as a means of departure towards theorizing how hegemonic domination might be actualized discursively without the requirement of consent. In this respect, the paper responds to proponents of post-hegemony by arguing that it is not the concept of hegemony that is outmoded, but rather how it is secured. (shrink)

BackgroundHealth data holds great potential for improved treatments. Big data research and machine learning models have been shown to hold great promise for improved diagnostics and treatment planning. The potential is tied, however, to the availability of personal health data. In recent years, it has been argued that data from health records should be available for health research, and that individuals have a duty to make the data available for such research. A central point of debate is whether such secondary (...) use of health data requires informed consent.Main bodyIn response to recent writings this paper argues that a requirement of informed consent for health record research must be upheld. It does so by exploring different contrasting notions of the duty of easy rescue and arguing that none of them entail aperfectduty to participate in health record research. In part because the costs of participation cannot be limited to 1) the threat of privacy breaches, but includes 2) the risk of reduced trust and 3) suboptimal treatment, 4) stigmatization and 5) medicalisation, 6) further stratification of solidarity and 7) increased inequality in access to treatment and medicine. And finally, it defends the requirement of informed consent by arguing that the mere possibility of consent bias provides a rather weak reason for making research participation mandatory, and that there are strong, independent reasons for making.ConclusionArguments from the duty of easy rescue in combination with claims about little risk of harm and potential consent bias fail to establish not only aperfectduty to participate in health record research, but also that participation in such research should be mandatory. On the contrary, an analysis of these arguments indicates that the duty to participate in research is most adequately construed as animperfectduty, and reveals a number of strong reasons for insisting that participation in health records research is based on informed consent. (shrink)

The focus of this article is on elderly patients’ and nursing staff perceptions of informed consent in the care of elderly patients/residents in five European countries. The results suggest that patients and nurses differ in their views on how informed consent is implemented. Among elderly patients the highest frequency for securing informed consent was reported in Finland; the lowest was in Germany. In contrast, among nurses, the highest frequency was reported in the UK (Scotland) and the lowest (...) in Finland. In a comparison of patients’ and nurses’ perceptions, nurses had more positive views than patients in all countries except Finland. Patients with less need for nursing interventions in Greece and Spain gave their consent less often. The German and Greek patients were older, and the results also point to an association between this and their lower frequency of giving consent. In Spain, patients who were married or who had a family member or friend to look after their personal affairs were more likely to be included in the group whose consent was sought less often. This is the fourth of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented. (shrink)

This article provides an overview of recent contributions to the debate on the ethical use of previously collected biobank samples, as well as a country report about how this issue has been regulated in Spain by means of the new Biomedical Research Act, enacted in the summer of 2007. By contrasting the Spanish legal situation with the wider discourse of international bioethics, we identify and discuss a general trend moving from the traditional requirements of informed consent towards new models (...) more favourable to research in a post‐genomic context. (shrink)

The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the roots of (...) Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as “qualified relatives” who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families. (shrink)

What is it for a state, constitution or set of governmental institutions to have political legitimacy? This paper raises some doubts about two broadly liberal answers to this question, which can be labelled ?Kantian? and ?libertarian?. The argument focuses in particular on the relationship between legitimacy and principles of justice and on the place of consent. By contrast with these views, I suggest that, without endorsing the kind of voluntarist theory, according to which political legitimacy is simply created by (...) individual consent, an adequate understanding of political legitimacy should take much more account than most philosophical theories tend to do of the attitudes and beliefs of citizens and the social and political context in which they have saliency. This also involves acknowledging the limits of theory in determining criteria of political legitimacy. (shrink)

Locke's Two Treatises of Government is (primarily) a work of practical (or applied) ethics rather than (as commonly supposed) political philosophy or (as some recent historians have argued) political propaganda. The problem is the oath of allegiance to James II. So interpreting it makes political obligation resemble the special moral obligations of profession rather than the general obligations of morality. Political obligation is the formal moral obligation to law that comes from voluntary participation in law-making (directly or through representatives one (...) helps to choose), a form of express consent. Ordinary moral obligations to law, those arising from considerations of justice, are, in contrast, much the same for ordinary residents as for foreign visitors. This is the domain of tacit consent. The right to organise a political society, including the right to exclude, derives from the natural right of free association. (shrink)

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this (...) concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (shrink)

Within medical ethics, there is widespread agreement that morally valid consent includes an understanding condition. Disagreement centers on what is meant by that understanding condition. Tom Dougherty proposed that this understanding condition should be divided into the two mutually exclusive categories of descriptive information and contextual information. Further, Dougherty argues that each type of information is necessary to satisfy the understanding condition. In contrast, I argue that when the deontic aspect of valid consent is in view, each type (...) of information can be sufficient to satisfy the understanding condition on its own. Moreover, by analyzing delegation, which is conceptually related to consent since both are morally transformative actions, I show that delegation often depends not on descriptive or contextual information but on trust. So, I argue that trustworthiness can also be a type of information that does the same work as descriptive and contextual information in satisfying the understanding condition for valid consent. (shrink)

According to the Behavioral View of consent, consent must be expressed in behavior in order to release someone from a duty. By contrast, the Mental View of consent is that normatively efficacious consent is entirely mental. In previous work, I defended a version of the Behavioral View, according to which normatively efficacious ‘consent always requires public behavior, and this behavior must take the form of communication in the case of high-stakes consent’. In this essay, (...) I respond to two arguments by proponents of the Mental View. First, Larry Alexander, Heidi Hurd and Peter Westen have argued that my view has mistaken implications concerning the culpability of different actors. I counter that my version of the view does not have these implications, as it leaves us free to draw moral and legal distinctions between different offences involving non-consensual behavior. Second, Larry Alexander and Kimberly Ferzan have argued for an analogy between consent and abandonment: on the grounds that the normative power to abandon resides in one’s will, Alexander and Ferzan concludes consent does too. I counter that abandonment requires behavior, and call into question the assumption that the ethics of property have much to teach us about the ethics of sexual consent. (shrink)

John Rawls wrote that people can voluntarily acquire political obligations to institutions only on the condition that those institutions are at least reasonably just. When an institution is seriously unjust, by contrast, attempts to create political obligation are “void ab initio.” However, Rawls's own explanation for this thought was deeply problematic, as are the standard alternatives. In this paper, I offer an argument for why Rawls's intuition was right and trace its implications for theories of authority and political obligation. These, (...) I claim, are more radical than is often thought. (shrink)

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed (...) consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism. (shrink)

The age of maturity of children to consent for medical research is under debate, as different authorities regard the capacity of young teenagers as either satisfactory or not to grant consent without parental participation in the process. The present paper contrasts the generally accepted guideline for ethics in paediatric research in Canada with what the same children are allowed and expected to be able to do as babysitters. This comparison reveals deep incongruences in the way the maturity of (...) the same children is appreciated for two different tasks. (shrink)

This book supports the emerging field of vascularized composite allotransplantation for face and upper-limb transplants by providing a revised, ethically appropriate consent model which takes into account what is actually required of facial and upper extremity transplant recipients. In place of consent as permission-giving, waiver, or autonomous authorization, this book imagines consent as an ongoing mutual commitment, i.e. as covenant consent. The covenant consent model highlights the need for a durable personal relationship between the patient/subject (...) and the care provider/researcher. Such a relationship is crucial given the recovery period of 5 years or more for VCA recipients. The case for covenant consent is made by first examining the field of vascularized composite allotransplantation, the history and present understandings of consent in health care, and the history and use of the covenant concept from its origins through its applications to health care ethics today. This book explains how standard approaches to consent are inadequate in light of the particular features of facial and upper limb transplantation. In contrast, use of the covenant concept creates a consent model that is more appropriate ethically for these very complex surgeries and long-term recoveries. (shrink)

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.” ). By contrast, the Office of Human Research Protections, (...) in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.”.In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible. (shrink)

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

We examined differences in the knowledge and beliefs that exist among nurse researchers in the USA (n = 119) regarding informed consent and the use of data from patients’ medical records. Using a mail survey, two domains of ethical knowledge and beliefs were assessed: the legal right to privacy and the moral right to privacy. More than half of the participants were very confident in their knowledge of institutional review board procedures, research ethics, informed consent, the legal right (...) to privacy, and the moral right to privacy. In contrast, most rated themselves as uncertain about US federal research regulations and there was wide variation in knowledge about current federal guidelines. Those who were more confident in their knowledge of or had more practical experience with research ethics, were no more likely to answer correctly a question about current federal guidelines regulating the use of patient data from medical records than those who reported less confidence or experience. (shrink)

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review (...) and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients. (shrink)

This paper identifies the legal and policy framework relating to the use of aborted fetuses in stem cell research and therapies and contrasts this with the collection of embryos for research. It suggests that more attention should be given to questions about the kind of consent sought by researchers from women and that there should be more transparency about how aborted fetuses are used. It reports on variability in current practices of research ethics committees and researchers and uncertainty about (...) the guidance available to them. It argues that there is a need for wide public discussion about the policy issues relating to fetal tissue use in stem cell research and the need for clarification of the law in this area. (shrink)

Background This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children’s consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from research interviews and observations in (...) two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families’ informed consent to surgery. Results The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices. Conclusion We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children’s rights. (shrink)

It is sometimes argued that autonomous decision-making requires that the decision-maker’s desires are authentic, i.e., “genuine,” “truly her own,” “not out of character,” or similar. In this article, it is argued that a method to reliably determine the authenticity (or inauthenticity) of a desire cannot be developed. A taxonomy of characteristics displayed by different theories of authenticity is introduced and applied to evaluate such theories categorically, in contrast to the prior approach of treating them individually. The conclusion is drawn that, (...) in practice, the authenticity of desires cannot be reliably determined. It is suggested that authenticity should therefore not be employed in informed consent practices in healthcare. (shrink)

Bioethicists involved in end‐of‐life debates routinely distinguish between ‘killing’ and ‘letting die’. Meanwhile, previous work in cognitive science has revealed that when people characterize behaviour as either actively ‘doing’ or passively ‘allowing’, they do so not purely on descriptive grounds, but also as a function of the behaviour’s perceived morality. In the present report, we extend this line of research by examining how medical students and professionals (N = 184) and laypeople (N = 122) describe physicians’ behaviour in end‐of‐life scenarios. (...) We show that the distinction between ‘ending’ a patient’s life and ‘allowing’ it to end arises from morally motivated causal selection. That is, when a patient wishes to die, her illness is treated as the cause of death and the doctor is seen as merely allowing her life to end. In contrast, when a patient does not wish to die, the doctor’s behaviour is treated as the cause of death and, consequently, the doctor is described as ending the patient’s life. This effect emerged regardless of whether the doctor’s behaviour was omissive (as in withholding treatment) or commissive (as in applying a lethal injection). In other words, patient consent shapes causal selection in end‐of‐life situations, and in turn determines whether physicians are seen as ‘killing’ patients, or merely as ‘enabling’ their death. (shrink)

The Standard View in research ethics maintains that, under certain conditions, investigators may deceive subjects and may enroll subjects without their consent. In contrast, it is always impermissible to coerce subjects to enroll, even when the same conditions are satisfied. This view raises a question that, as far as we are aware, has received no attention in the literature. Why is it always impermissible to undermine the validity of subjects’ consent through coercion, but it can be permissible to (...) undermine the validity of subjects’ consent through deception, and it can be permissible to enroll subjects without any consent at all? The present analysis suggests that the answer traces to the conditions on the appropriate treatment of subjects. This conclusion suggests that some requirements for human subjects research, and for valid consent more generally, trace not to the protection of subjects per se but to the proper behavior of agents. (shrink)

Background The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this (...) approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage. Methods This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items. Results A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use. Conclusions Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages. (shrink)

An increasing number of studies indicate that virtues affect brain structure. These studies might shed new light on some neuroethical perspectives suggesting that our brain network activity determines the acquisition and permanence of virtues. According to these perspectives, virtuous behavior could be interpreted as the product of a brain mechanism supervised by genes and environment and not as the result of free choice. In this respect, the neural correlates of virtues would confirm the deterministic theory. In contrast, I maintain that (...) these findings do not undermine the role of willpower and freedom while reinforcing an interactionist view of free will. If virtues affect our neural system, then the predictability of the virtuous behavior follows. The likelihood of our future (moral) actions is primarily virtue-dependent; therefore, the acquired naturality of virtuous behavior is a source of predictable behavioral patterns outlining expected actions, which I propose to call Hypotheses of Action (HAs). However, the predictability of an action indicates its likeliness and not its certainty or necessity. The neural traces of virtues can be interpreted as major indicators of HAs. It is always possible for the agents to depart from their more likely, virtue-induced actions, but their deviations from the virtuous behavioral pattern are rare, as it is rare for the vicious/non-virtuous person to behave well systematically. This implies a reaffirmation of the notions of veto and consent as they provide a universal practical power affecting the subject’s use of moral virtues. (shrink)

In an earlier article in this journal I argued that the question of whether heroin addicts can give voluntary consent to take part in research which involves giving them a choice of free heroin does not – in contrast with a common assumption in the bioethics literature – depend exclusively on whether or not they possess the capacity to resist their desire for heroin. In some cases, circumstances and beliefs might undermine the voluntariness of the choices a person makes (...) even if they do possess a capacity for self-control. Based on what I took to be a plausible definition of voluntariness, I argued that the circumstances and beliefs typical of many vulnerable heroin addicts are such that we have good reasons to suspect they cannot give voluntary consent to take part in such research, even assuming their desire for heroin is not irresistible. In a recent article in this journal, Uusitalo and Broers object to this on the grounds that I misdescribe heroin addicts' options set, that the definition of voluntariness on which I rely is unrealistic and too demanding, and, more generally, that my view of heroin addiction is flawed. I think their arguments derive from a misunderstanding of the view I expressed in my article. In what follows I hope therefore to clarify my position. (shrink)

Background This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children’s consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from research interviews and observations in (...) two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families’ informed consent to surgery. Results The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices. Conclusion We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children’s rights. (shrink)

This paper evaluates the Hong Kong approach to consent regarding the forgoing of life-sustaining treatment for incompetent elderly patients. It analyzes the contextualized approach in the Hong Kong process-based, consensus-building model, in contrast to other role-based models which emphasize the establishment of a system of formal laws and a clear locus of decisional authority.Without embracing relativism, the paper argues that the Hong Kong model offers an instructive example of how strategic ambiguities can both make good sense within particular cultural (...) context and serve important moral goals. (shrink)

James Sterba uses the Pauline Principle to argue that the occurrence of significant, horrendous evils is logically incompatible with the existence of a good God. The Pauline Principle states that (as a rule) one must never do evil so that good may come from it, and according to Sterba, this principle implies that God may not permit significant evils even if that permission would be necessary to secure other, greater goods. By contrast, I argue that the occurrence of significant evils (...) is logically compatible with the existence of a good God because victims of significant evils may themselves reasonably consent to their suffering. In particular, I argue that they may be able to accept their suffering if it turns out that there was no way for God to secure relevant greater goods (or prevent other, greater evils) except by way of allowing their suffering, and God also provides them with other compensating, heavenly comforts. After using this consent-based argument to address Sterba’s logical problem from evil, I briefly consider how this argument may also help address a related evidential problem from evil, which suggests that while it is possible that victims of significant evils would consent to their suffering, it is unlikely that they would do so. While I do not provide a definitive solution to this evidential problem of evil, I highlight one important example of a trade-off that God may need to make that would—along with the provision of compensating, heavenly comforts—potentially persuade victims of significant evils to consent to their suffering. Specifically, I argue that there may be a necessary trade-off that God needs to make between permitting significant evils (on the one hand) and protecting a certain, morally significant form of free will (on the other hand). (shrink)

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

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the (...) patient-preferred presentation of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

'God needs no instruments to act', Malebranche writes in Search 6.2.3; 'it suffices that He wills in order that a thing be, because it is a contradiction that He should will and that what He wills should not happen. Therefore, His power is His will' (450). After nearly identical language in Treatise 1.12, Malebranche writes that '[God's] wills are necessarily efficacious ... [H]is power differs not at all from [H]is will' (116). God's causal power, here, clearly traces only to His (...) volitions - not merely to the fact that He wills, but specifically to the content of His volitions ('"what" He wills'). Yet despite the obviously key role the ordinary notion of volitional content plays for Malebranche, recent writers have paid surprisingly little attention either to it or its exegetical implications. I hope to rectify this situation here. The plan of this paper is this: first, to borrow current work in the philosophy of mind to sketch the notion of an incomplete volition, i.e. one whose content is 'incomplete' in a sense to be explained; second, to show that Malebranche clearly allows and uses something like this notion; third, to apply the notion to Malebranche's doctrine of human freedom. In so doing, I believe, we can understand this doctrine in a new way, and one which: (i) is clearly consistent with his texts, and (ii) unlike other interpretations makes coherent sense out of the conflicting streams in his heroic attempt to reconcile his occasionalism - the doctrine that no finite substances have genuine causal powers - with our freedom; fourth, Contrast my interpretation with those of two recent writers: Sleigh et al. (1998) and Schmaltz (1996); and Fifth, Summarize the major results. (shrink)

Cet ouvrage vient conclure l’aventure d’un collectif – CONTRAST – animé par Benoît Eyraud et Livia Velpry pendant cinq ans sur les questions cruciales de la place du consentement et du recours à la contrainte en santé mentale. Après une présentation rapide du collectif, l’introduction générale (Livia Velpry et Pierre Vidal-Naquet) rappelle que la dynamique de promotion des droits initiée au début des années 2000 fait que l’avis des personnes “tend à devenir incontournable, voire un prérequis”...

Feminists are divided on whether consent should be employed in legal definitions of rape. Catharine MacKinnon has criticized the usefulness of consent in enabling legal systems to recognize and prosecute instances of rape (MacKinnon 1989, 2005, 2016). In a recent article in this journal, Lisa H. Schwartzman defends the use of affirmative consent in rape law against MacKinnon’s critique (Schwartzman 2019). In contrast to MacKinnon, Schwartzman claims our understanding of rape must include both force and consent (...) components. In this paper, I will argue in agreement with Schwartzman and against MacKinnon that the legal definition of rape should include an affirmative consent component. I will take Schwartzman’s discussion as my point of departure and consider whether she has responded adequately to MacKinnon’s criticisms of consent. I will argue that her responses are not fully adequate. In particular, she has not successfully rebutted the argument that an appeal to consent is unnecessary once we have accepted an expanded definition of coercion. I will then provide a more affirmative defense of affirmative consent in response to MacKinnon’s most challenging criticism. (shrink)

Orr and Siegler have recently defended a restrictive view concerning posthumous sperm retrieval and conception, which would limit insemination to those cases where the deceased man has provided explicit consent for such a procedure. The restrictive view dominates current law and practice. A permissible view, in contrast, would allow insemination and conception in all but those cases where the posthumous procedure has been explicitly refused, or where there is no reasonable evidence that the deceased person desired children. I describe (...) a phenomenology of procreative desires which supports the permissible view, and which is compatible with requirements concerning the interests of the decedent, concepts of medical infertility, and the welfare of the future child. The account illustrates how our current obsession with individual rights and autonomy can be self-defeating and repressive. (shrink)

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