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)

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

Ben Saunders claims that actual consent is not necessary for organ donation due to ‘normative consent’, a concept he borrows from David Estlund. Combining normative consent with Peter Singer's ‘greater moral evil principle’, Saunders argues that it is immoral for an individual to refuse consent to donate his or her organs. If a presumed consent policy were thus adopted, it would be morally legitimate to remove organs from individuals whose wishes concerning donation are (...) not known. This paper disputes Saunders' arguments. First, if death caused by the absence of organ transplant is the operational premise, then, there is nothing of comparable moral precedence under which a person is not obligated to donate. Saunders' use of Singer's principle produces a duty to donate in almost all circumstances. However, this premise is based on a flawed interpretation of cause and effect between organ availability and death. Second, given growing moral and scientific agreement that the organ donors in heart-beating and non-heart-beating procurement protocols are not dead when their organs are surgically removed, it is not at all clear that people have a duty to consent to their lives being taken for their organs. Third, Saunders' claim that there can be good reasons for refusing consent clashes with his claim that there is a moral obligation for everyone to donate their organs. Saunders' argument is more consistent with a conclusion of ‘mandatory consent’. Finally, it is argued that Saunders' policy, if put into place, would be totalitarian in scope and would therefore be inconsistent with the freedom required for a democratic society. (shrink)

In an earlier article, I argued that David Estlund's notion of ‘normative consent’ could provide justification for an opt-out system of organ donation that does not involve presumptions about the deceased donor's consent. Where it would be wrong of someone to refuse their consent, then the fact that they have not actually given it is irrelevant, though an explicit denial of consent may still be binding. My argument has recently been criticised by Potts et al, (...) who argue that such a policy would involve taking organs from people whose organs should not be taken and would be a recipe for totalitarianism. The present response seeks to rebut both the ethical and political objections. I argue that people can indeed be under a moral obligation to donate their organs, even if they are not technically dead at the time and their donation does not save anyone else's life. Moreover, I argue that an opt-out system—unlike mandatory donation—is not totalitarian because it preserves the right of individuals to act morally wrongly, by opting out when they have no good moral reason to do so. The policy I propose is neither immoral nor totalitarian. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 23-24, August 2011.

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical (...) research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

This paper extends Alan John Simmons?s conceptual distinction between Lockean and Kantian conceptions of legitimacy that he applied to the question of the legitimacy of states, to the issue of legitimacy of public decisions. I criticise the consent conception of legitimacy defended by Simmons, and I defend the Rawlsian version of the justificatory conception of legitimacy from his objection. The approach of this paper is distinctive because the two conceptions are assessed by investigating, using the method of reflective equilibrium, (...) their respective prescriptions concerning the treatment of antisocial personality disorder and epidemiologic measures. I argue that the method of reflective equilibrium does not support the consent conception. Considering the issues of treatment of APD and of epidemiologic measures, I argue that the consent conception of legitimacy is not well-equipped for the evaluation of norms that are not strictly self-regarding. This causes a deficit of prescriptions for relevant social responses. Further, by considering the case of responses to epidemics, I argue that such a conception can avoid harmful consequences only by recurring to additional, and independent, premises. This does not cause incoherence but reduces the coherence of a normative system. Finally, the consent conception is not equipped to support social cooperation in an optimal way, which has proved to be necessary in critical conditions, like a pandemic. On the other hand, I argue that the method of reflective equilibrium supports the Rawlsian version of justificatory conception of legitimacy, because of its advantages in handling the indicated issues. In addition, I maintain that this justificatory conception is respectful of freedom and equality of agents as moral self-legislators, and, thus, it is not vulnerable to Simmons?s main criticism. (shrink)

In many jurisdictions, adolescents acquire the right to consent to treatment; but in some cases their refusals – e.g. of life-saving treatment – may not be respected. This asymmetry of adolescent consent and refusal seems puzzling, even incoherent. The aim here is to offer an original explanation, and a justification, of this asymmetry. Rather than trying to explain the asymmetry in terms of a variable standard of competence – where the adolescent is competent to consent to, but (...) not refuse, certain interventions – the account offered here focuses more closely on the normative power to render actions permissible. Where normative powers are shared they can readily give rise to an asymmetry between consent and refusal. We then turn to why it is justifiable that normative powers be shared in adolescence. Transitional paternalism holds that the acquisition of normative powers by competent adolescents should not be an instant one, achieved in a single step, but that there should be a transitional period where paternalistic protection is rolled back, but not entirely withdrawn until a later date. Transitional paternalism could be implemented without generating the asymmetry between consent and refusal but, it is argued, the asymmetric version of transitional paternalism is to be preferred insofar as it offers a greater respect for the adolescent's decisions than the symmetrical alternative. (shrink)

Voluntariness is a necessary condition of valid consent. But determining whether a person consented voluntarily can be difficult, especially when people are subjected to coercion or manipulation, placed in a situation with no acceptable alternative other than to consent to something, or find themselves in an abusive relationship. This book presents a novel view on the voluntariness of consent, especially medical consent, which the author calls Interpersonal Consenter-Consentee Justification (ICCJ). According to this view, consent is (...) voluntary if and only if the process by which it has been obtained aligns with principles of interpersonal justification. ICCJ is distinctive because it explains voluntary consent neither as a 'psychological' concept indicative of the inner states of a person's mind (e.g. willingness or reluctance) nor as a 'circumstantial' concept indicative of a person's set of options. Rather, ICCJ explains the voluntariness of consent as an 'interpersonal' concept requiring the absence of illegitimate control within the interaction between the person giving consent and the person receiving it. In so doing, ICCJ further develops the notion of interpersonal justification, known from contractualist theories in moral philosophy, and introduces it to the debate on consent. The author employs a top-down approach, defending ICCJ's key characteristics on the basis of general theoretical arguments, as well as a bottom-up approach, supporting ICCJ in its application to clinical challenges such as nudging and manipulation, living organ donation, and clinical trials. Voluntary Consent will appeal to researchers and advanced students in normative ethics, bioethics, philosophy of law, behavioural psychology, and medicine. (shrink)

In this case study, I consider Mr. A, a Jehovah’s Witness with chronic vertebral osteomyelitis in need of surgical debridement. Prior to proceeding to the OR, he was unwilling either to explicitly consent to or refuse blood transfusion, while indicating he was open to transfusion intraoperatively, if the team judged it necessary. Ethics was consulted to determine if it would be morally justifiable for the team to proceed with blood transfusion during the course of surgery without Mr. A’s documented (...) consent to being transfused. I argue that in this case, what might be termed indirect consent—namely, delegating decision-making regarding some possible course of action without explicitly consenting to the course of action itself—may be sufficient for discharging the clinician’s ethical obligation to obtain consent. Identifying information has been changed or omitted to protect patient confidentiality. (shrink)

Clinical biobanks processing data of participants in the European Union fall under the scope of the General Data Protection Regulation, which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party —an EU advisory body currently known as the European Data Protection Board. Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines (...) suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a “one size fits all” approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent. (shrink)

Modern Western medical individualism has had a significant impact on health care in China. This essay demonstrates the ways in which such Western-style individualism has been explicitly endorsed in China’s 2010 directive: The Basic Norms of the Documentation of the Medical Record. The Norms require that the patient himself, rather than a member of his family, sign each informed consent form. This change in clinical practice indicates a shift toward medical individualism in Chinese healthcare legislation. Such individualism, however, is (...) incompatible with the character of Chinese familism that is deeply rooted in the Chinese ethical tradition. It also contradicts family-based patterns of health care in China. Moreover, the requirement for individual informed consent is incompatible with numerous medical regulations promulgated in the past two decades. This essay argues that while Chinese medical legislation should learn from relevant Western ideas, it should not simply copy such practices by importing medical individualism into Chinese health care. Chinese healthcare policy is properly based on Chinese medical familist resources. (shrink)

Let me begin by admitting that I am wary of any comprehensive definition of consent. This bias stems from my professional concentration on criminal law, in which nouons of freedom and responsibility play vital roles in a wide range of contexts. In each context, however, one discovers that freedom means something different. A voluntary act is any bodily movement not caused by external force or nervous disorder. On the other hand, a voluntary act, however horrific its results, ordinarily may (...) be punished only if the actor was subjectively aware that the act was wrong. In any event, a voluntary act may be excused as the product of duress if another person procures the actor's cooperation in the crime by an illegal threat that would overcome the resistance of a person of ordinary firmness. (shrink)

This chapter contains sections titled: The Problem of Normative Power Consent and Choice Promise, Consent and Normative Interests Permissive Interests.

It is widely accepted that consent is a normative power. For instance, consent can make an impermissible act permissible. In the words of Heidi Hurd, it “turns a trespass into a dinner party... an invasion of privacy into an intimate moment.” In this chapter, I argue against the assumption that consent has such robust powers for moral transformation. In particular, I argue that there is a wide range of sex that harms or wrongs victims despite being (...) consensual. Moreover, these cases are not limited to those where con- sent is vitiated by background conditions. I start by calling this category of consensual sex Bad Sex. I then distinguish subspecies of this category, including psychological pressure, social coercion, and epistemically unsafe sex. I end by responding to an objection on which we should treat at least some subspecies of Bad Sex as rape. Though this alternative proposal is often motivated by ameliorative and strategic considerations, I argue that such considerations actually count against collapsing the categories of Bad Sex and rape. (shrink)

There is an ongoing debate about the “ontology” of consent. Some argue that it is a mental act, some that it is a “hybrid” of a mental act plus behaviour that signifies that act; others argue that consent is a performative, akin to promising or commanding. Here it is argued that all these views are mistaken—though some more so than others. We begin with the question whether a normatively efficacious act of consent can be completed in the (...) mind alone. Standard objections to this “mentalist” account of consent can be rebutted. Here we identify a much deeper problem for mentalism. Normatively transformative acts of consent change others’ reasons for acting in a distinctive—“robust”—way. Robust reason-changing involves acts aimed at fulfilling a distinctive kind of reflexive and recognition-directed intention. Such acts cannot be coherently performed in the mind alone. Consent is not a mental act, but nor is it the signification of such an act. Acts of consent cannot be “completed” in the mind, and it is a mistake to view consent behaviour as making known a completed act of consent. The robust reason-changing account of consent developed here shares something with the performative theory, but is not saddled with a label whose home is philosophy of language. Certain kinds of performative utterance may change reasons robustly, but not all robust reason-changing involves or requires acts of speech, and consent can be effected by a wide range of behavioural acts. (shrink)

The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures.

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

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)

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

An episiotomy is ‘an intrapartum procedure that involves an incision to enlarge the vaginal orifice,’1 and is primarily justified as a way to prevent higher degrees of perineal trauma or to facilitate a faster birth in cases of suspected fetal distress. Yet the effectiveness of episiotomies is controversial, and many professional bodies recommend against the routine use of episiotomies. In any case, unconsented episiotomies are alarmingly common, and some care providers in obstetric settings often fail to see consent as (...) necessary in context. In their article, ‘The ethics of consent during labour and birth: episiotomies,’ van der Pijl et al reiterate that consent is necessary for episiotomies. They specify, further, that the antenatal period is crucial for exchanging information, establishing trust between the birthing subject and provider, and exploring the birthing subject’s—rather than the care provider’s—values and preferences regarding episiotomies. They recommend an individualised approach, which would enable birthing subjects to choose how and when they want to give consent. I applaud van der Pijl et al on their practicable recommendations regarding consent for episiotomies. This is certainly a step in the right direction where respect for birthing subjects’ bodily autonomy and integrity is concerned. Still, we must be reminded that consent alone is not coextensive with autonomy. The conditions for securing informed consent in healthcare does not guarantee that one’s decision is truly reflective of their values. After all, even valid consent does not rule out ‘normatively significant external influence’.2 Consent acquisition for obstetric procedures present no …. (shrink)

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may (...) have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children (...) of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely (...) Western model. Empirical studies show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences. Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians' behaviors. (shrink)

In this case study, I consider Mr. A, a Jehovah’s Witness with chronic vertebral osteomyelitis in need of surgical debridement. Prior to proceeding to the OR, he was unwilling either to explicitly consent to or refuse blood transfusion, while indicating he was open to transfusion intraoperatively, if the team judged it necessary. Ethics was consulted to determine if it would be morally justifiable for the team to proceed with blood transfusion during the course of surgery without Mr. A’s documented (...) consent to being transfused. I argue that in this case, what might be termed indirect consent—namely, delegating decision-making regarding some possible course of action without explicitly consenting to the course of action itself—may be sufficient for discharging the clinician’s ethical obligation to obtain consent. Identifying information has been changed or omitted to protect patient confidentiality. (shrink)

In addition to protecting agents’ autonomy, consent plays a crucial social role: it enables agents to secure partners in valuable interactions that would be prohibitively morally risk otherwise. To do this, consent must be observable: agents must be able to track the facts about whether they have received a consent-based permission. I argue that this morally justifies a consent-practice on which communicating that one consents is sufficient for consent, but also generates robust constraints on what (...) sorts of behaviors can be taken as consent- communicating. (shrink)

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that (...) current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

The normative power of consent plays a central role in enabling individuals to permissibly interact with one another. However, in the philosophical literature, the relationship between consent and permissible action is not always well understood. In this article I outline an account of the normative effect of valid consent, in order to clarify this relationship. I first argue that consent’s primary moral significance lies in its effect upon our interpersonal moral relationships. Specifically, I argue (...) that valid consent serves to cancel a directed duty owed to the consenter. Other things being equal, this equips the consentee with a directed permission: they will no longer wrong the consenter by acting in the consented to manner. However, this account does not yet explain how consent impacts upon the all things considered permissibility of an action. On the assumption that all things considered permissibility is a function of an agent’s reasons for action, we require an account of consent’s effect on those reasons. I consider, and then reject, Michelle Dempsey’s recent suggestion that consent affects a consentee’s reasons for action by granting them an exclusionary permission. I propose that we should instead understand consent to function as a cancelling permission. (shrink)

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

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)

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

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely (...) Western model.Empirical studies show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences.Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians’ behaviors. (shrink)

What exactly do we need to do in order to make a promise, or to exercise some other normative power? On a view relied on by many philosophers writing on promising, consent, and related phenomena, the answer is that we must communicate a suitable kind of intention. On this view, power-conferring principles assert that specific normative consequences, determined in part by the content of the communicated intention, attach to such communicative acts, and these principles need not be (...) socially practised or accepted to be true. The paper offers a defense of this convention-independent view against the forceful challenge developed by Jed Lewinsohn in ‘The “Natural Unintelligibility” of Normative Powers’. Lewinsohn appeals to action-theoretic considerations to show that the relevant type of communicative act could not be performed under conditions of rationality and full information, and that therefore promissory power and other normative powers require the existence of social rules conferring such powers. The defense of the view targeted by Lewinsohn turns partly on the exact content of plausible constraints on the intelligibility of actions done with a particular aim, and partly on the question just how the social acceptance of power-conferring rules should be thought to matter. (shrink)

This article argues that the study conducted by Facebook in conjunction with Cornell University did not have sufficient ethical oversight, and neglected in particular to obtain necessary informed consent from the participants in the study. It establishes the importance of informed consent in Internet research ethics and suggests that in Facebook’s case, a reasonable shift could be made from traditional medical ethics ‘effective consent’ to a ‘waiver of normative expectations’, although this would require much-needed change to (...) the company’s standard practice. Finally, it gives some practical recommendations for how to implement such consent strategies, and how the ethical oversight gap between university-led research and industry-led research can be bridged, potentially using emerging Responsible Research and Innovation frameworks which are currently gathering momentum in Europe. (shrink)

ABSTRACT:This article provides a normative justification for unions. It discusses three arguments. The argument from consent justifies unions in some circumstances, but if the employer prefers to not bargain with unions, it may provide very little justification. The argument from contestability takes as its starting point the fact that employment contracts are incomplete contracts, where authority takes the place of complete contractual terms. This theory of contracts implies that consent to authority has been given under ignorance, and, (...) therefore, that authority cannot be justified by consent. Contestability is a mechanism that can handle this problem for consent theory. It demands transparency, channels for voice, and a forum where contestations can be evaluated. This idea can be implemented in firms in different ways, but the argument from the separation of powers implies that unions are uniquely suited to implement contestability, since they are organized outside of the employer’s domain of authority. (shrink)

ABSTRACT Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, involved (...) in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in‐depth interviews and 78 responses to open‐ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research. (shrink)

Broad genome‐wide testing is increasingly finding its way to the public through the online direct‐to‐consumer marketing of so‐called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision‐making with regard to the testing offer, we argue that (...) current practices of information provision are insufficient and that there is a place – and a need – for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies (...) in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Though historically important, the notion of tacit consent plays little role in contemporary discussions of political legitimacy. The idea, in fact, is often dismissed as obviously implausible. The ambition of this paper is to challenge this assumption and show that tacit consent can become a key ingredient in a theory of legitimacy. Instead of defining tacit consent through residence (where, according to John Locke or Plato's Socrates, staying in the country amounts to tacitly consenting to its system (...) of rule), the paper explores a different strategy, delimiting tacit consent as an absence of active dissent. The basic idea starts from the fact that widespread anti-government protests and demonstrations always carry a potent delegitimating force. Political legitimacy is therefore never permanent and unchangeable, regardless of the nature of the regime, and can be undermined at all times by active dissent from the population. Having established the relationship between dissent and delegitimation of political power, even the inverted, stronger claim is defended: the absence of active dissent (i.e., tacit consent) can, under certain circumstances, serve to legitimize political power. The paper sets up and defends several conditions that need to be met for the right normative mandate to be created by the population tacitly accepting the existing power arrangements. If those are fulfilled (especially when full freedom of expression and information is granted), tacit consent can become a vital element of political legitimacy. (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)