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

Alan Wertheimer’s book, Consent to Sexual Relations, is an important investigation of consent to sex. The book contains many interesting and insightful arguments and does a nice job of distinguishing the considerations that are relevant to moral and legal consent. The book is both broad and narrow. It is broad in that it discusses a broad array of interesting issues, including the psychology of rapists, the types of psychological harm that rape victims suffer, the moral status (...) and nature of consent, and the conditions that make consent invalid. The book is also narrow in that it focuses on issues surrounding consent to sexual relations, rather than the broader issue of rape and other sex crimes. Wertheimer’s analysis has some defects. The first defect relates to his claim that sex to which the participants have validly consented is not immune to moral evaluation. The second defect involves Wertheimer’s model of morally valid consent. Wertheimer adopts an interest model of morally valid consent to sex whereby valid consent is the conclusion of moral argumentation about whether it’s in someone’s interest to hold that she (or the relevant class of persons) has validly consented in that type of situation. (shrink)

Increased knowledge of the gene–disease associations contributing to common cancer development raises the prospect of population stratification by genotype and other risk factors. Individual risk assessments could be used to target interventions such as screening, treatment and health education. Genotyping neonates, infants or young children as part of a systematic programme would improve coverage and uptake, and facilitate a screening package that maximises potential benefits and minimises harms including overdiagnosis. This paper explores the potential justifications and risks of genotyping children (...) for genetic variants associated with common cancer development within a personalised screening programme. It identifies the ethical and legal principles that might guide population genotyping where the predictive value of the testing is modest and associated risks might arise in the future, and considers the standards required by population screening programme validity measures . These are distinguished from the normative principles underpinning predictive genetic testing of children for adult-onset diseases—namely, to make best-interests judgements and to preserve autonomy. While the case for population-based genotyping of neonates or young children has not yet been made, the justifications for this approach are likely to become increasingly compelling. A modified evaluative and normative framework should be developed, capturing elements from individualistic and population-based approaches. This should emphasise proper communication and genuine parental consent or informed choice, while recognising the challenges associated with making unsolicited approaches to an asymptomatic group. Such a framework would be strengthened by complementary empirical research. (shrink)

When consent to medical treatment is described as ‘valid’, it might simply mean that it has a sound basis, or it could mean that it is legally valid. Where the two meanings are regularly interchanged, however, it can lead to aspects of the sound basis or the legal requirements being neglected. This article looks at how the term is used in a range of guidance on consent to treatment and argues for consistency.

The law of informed consent to medical treatment has recently been extensively overhauled in England. The 2015 Montgomery judgment has done away with the long-held position that the information to be disclosed by doctors when obtaining valid consent from patients should be determined on the basis of what a reasonable body of medical opinion agree ought to be disclosed in the circumstances. The UK Supreme Court concluded that the information that is material to a patient’s decision should (...) instead be judged by reference to a new two-limbed test founded on the notions of the ‘reasonable person’ and the ‘particular patient’. The rationale outlined in Montgomery for this new test of materiality, and academic comment on the ruling’s significance, has focused on the central ethical importance that the law now accords to respect for patient autonomy in the process of obtaining consent from patients. In this paper, we dispute the claim that the new test of materiality articulated in Montgomery equates with respect for autonomy being given primacy in re-shaping the development of the law in this area. We also defend this position, arguing that our revised interpretation of Montgomery’s significance does not equate with a failure by the courts to give due legal consideration to what is owed to patients as autonomous decision-makers in the consent process. Instead, Montgomery correctly implies that doctors are ethically obliged to attend to a number of relevant ethical considerations in framing decisions about consent to treatment, which include subtle interpretations of the values of autonomy and well-being. Doctors should give appropriate consideration to how these values are fleshed out and balanced in context in order to specify precisely what information ought to be disclosed to a patient as a requirement of obtaining consent, and as a core component of shared decision-making within medical encounters more generally. (shrink)

Sex and dementia is becoming an increasingly important topic in applied ethics. By the year 2030, more than 74.7 million people are expected to be diagnosed with dementia worldwide; many of these people may want to engage in sex. The question of how to manage cases of sex and dementia is occurring more frequently in practical cases because of our aging population. The primary reason that sex and dementia is ethically complex is because sexual consent is both legally and (...) morally significant, yet many people with dementia may be unable to consent in accordance with current standards. In this dissertation, I introduce three frameworks that could be used to approach cases of sex and dementia. The first framework is that of relational autonomy and supported decision-making; this framework tries to enable people with dementia to make autonomous sexual decisions with support. The next approach is a framework of advance sexual consent, which considers the relevance of prior autonomous sexual decisions. The third framework focuses on prioritizing well-being above a person’s capacity to make autonomous decisions and to consent to sex. I assess each framework and consider their positive and negative nuances. The overall goal is to balance the right to sexuality while at the same time protecting people with dementia from undue harm. Ultimately, this dissertation shows that cases of sex and dementia ought to be managed on a case-by-case basis; one framework will not work for every context. In order to approach situations on a case-by-case basis, I contend that a process of weighing and balancing norms and principles is necessary. I use Beauchamp and Childress’s method of weighing and balancing to propose a systematic procedure. This process takes various factors into account in order to determine how to proceed in an ethically defensible manner. According to an approach of weighing and balancing, sexual acts would not be immediately barred based on a person’s inability to consent; rather, a person’s present convictions, the sexual activity to which they want to participate, the possibility of experiencing undue harm, their prior wishes and values, their capacity to make autonomous decisions with support, etc. would all be considered. Overall, this dissertation contributes to the complex topic of sex and dementia and offers a starting point for further discussion on how to approach these cases in practice. (shrink)

This article explores the moral significance of consent in an unjust world by developing the view that the validity of consent depends on its causes. It defends the view that the causes of consent make it valid or invalid. It then shows how this idea helps us to distinguish different ways in which consent might matter morally where it has problematic causes. Finally, it uses this analysis to explore the moral significance of a range of (...) problematic causes of consent, including objectification, arranged marriage, and third-party threats of violence. (shrink)

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

The development of highly humanoid sex robots is on the technological horizon. If sex robots are integrated into the legal community as “electronic persons”, the issue of sexual consent arises, which is essential for legally and morally permissible sexual relations between human persons. This paper explores whether it is conceivable, possible, and desirable that humanoid robots should be designed such that they are capable of consenting to sex. We consider reasons for giving both “no” and “yes” answers to (...) these three questions by examining the concept of consent in general, as well as critiques of its adequacy in the domain of sexual ethics; the relationship between consent and free will; and the relationship between consent and consciousness. Additionally we canvass the most influential existing literature on the ethics of sex with robots. (shrink)

In both popular and scholarly discussions, sexual consent is gaining traction as the central moral consideration in how people should treat one another in sexual encounters. However, while the concept of consent has been indispensable to oppose many forms of sexual violence, consent-based sexual ethics struggle to account for the phenomenological complexity of sexual intimacy and the social and structural pressures that often surround sexual communication and behavior. Feminist structural critique and social research on the prevalence of (...) violation even within consensual sex suggest that consent is insufficient to ground responsibility; a more fundamental orientation toward the value of sexual agency provides a better foundation for sexual ethics. Using feminist critical theory, phenomenology, and black feminist thought, this dissertation develops a socially situated and relational notion of sexual agency and diagnoses how such agency is neglected in prevailing discussions of consent in moral philosophy and legal theory. I argue that the ethical question of responsibility to another in a sexual encounter—apart from juridical considerations—should be reframed around the value of each person’s socially situated practices of agency. Preceding and extending beyond the obligation to gain valid consent for an action, responsibility demands adapting one’s intentions and behaviors in response to the wider range of another’s communicative expressions of agency. However, communicative expressions can be ambiguous or overdetermined by social context and cultural norms; they often offer only provisional traces of agency. To address this inherent uncertainty in intimacy, I propose drawing on insights from Emmanuel Levinas about the dynamic, open-ended nature of relationality, responsibility, and communication. Responsibility toward another does not depend on securing certainty about their “yes” or “no,” but requires responding continuously under conditions of uncertainty and ambiguity, adapting behaviors and intentions to make room for another’s agency despite its opacity. (shrink)

Consent governs innumerable everyday social interactions, including sex, medical exams, the use of property, and economic transactions. Yet little is known about how ordinary people reason about the validity of consent. Across the domains of sex, medicine, and police entry, Study 1 showed that when agents lack autonomous decision-making capacities, participants are less likely to view their consent as valid; however, failing to exercise this capacity and deciding in a nonautonomous way did not reduce consent (...) judgments. Study 2 found that specific and concrete incapacities reduced judgments of valid consent, but failing to exercise these specific capacities did not, even when the consenter makes an irrational and inauthentic decision. Finally, Study 3 showed that the effect of autonomy on judgments of valid consent carries important downstream consequences for moral reasoning about the rights and obligations of third parties, even when the consented-to action is morally wrong. Overall, these findings suggest that laypeople embrace a normative, domain-general concept of valid consent that depends consistently on the possession of autonomous capacities, but not on the exercise of these capacities. Autonomous decisions and autonomous capacities thus play divergent roles in moral reasoning about consent interactions: while the former appears relevant for assessing the wrongfulness of consented-to acts, the latter plays a role in whether consent is regarded as authoritative and therefore as transforming moral rights. (shrink)

American jurisprudence currently applies two incompatible validity standards to determine which laws are enforceable. The natural law tradition evaluates validity by an uncertain standard of divine law, and its methodology relies on contradictory views of human reason. Legal positivism, on the other hand, relies on a methodology that commits the analytic fallacy, separates law from its application, and produces an incomplete model of law. These incompatible standards have created a schism in American jurisprudence that impairs the delivery of justice. (...) This dissertation therefore formulates a new standard for legal validity. This new standard rejects the uncertainties and inconsistencies inherent in natural law theory. It also rejects the narrow linguistic methodology of legal positivism. In their stead, this dissertation adopts a pragmatic methodology that develops a standard for legal validity based on actual legal experience. This approach focuses on the operations of law and its effects upon ongoing human activities, and it evaluates legal principles by applying the experimental method to the social consequences they produce. Because legal history provides a long record of past experimentation with legal principles, legal history is an essential feature of this method. This new validity standard contains three principles. The principle of reason requires legal systems to respect every subject as a rational creature with a free will. The principle of reason also requires procedural due process to protect against the punishment of the innocent and the tyranny of the majority. Legal systems that respect their subjects' status as rational creatures with free wills permit their subjects to orient their own behavior. The principle of reason therefore requires substantive due process to ensure that laws provide dependable guideposts to individuals in orienting their behavior. The principle of consent recognizes that the legitimacy of law derives from the consent of those subject to its power. Common law custom, the doctrine of stare decisis, and legislation sanctioned by the subjects' legitimate representatives all evidence consent. The principle of autonomy establishes the authority of law. Laws must wield supremacy over political rulers, and political rulers must be subject to the same laws as other citizens. Political rulers may not arbitrarily alter the law to accord to their will. Legal history demonstrates that, in the absence of a validity standard based on these principles, legal systems will not treat their subjects as ends in themselves. They will inevitably treat their subjects as mere means to other ends. Once laws do this, men have no rest from evil. (shrink)

As a fiqh (Islamic jurisprudence) term, the concept of “ignorance” ex-presses uncertainties in legal transactions and, in Islamic law, is accepted as a situation that negatively impacts the legitimacy of contracts. If the sale is deferred, clarification of the delivery time of the price to be paid for the goods sold, the number of installments, etc. during the contract is considered essential for the validity of the transactions in order not to damage the principle of mutual consent in (...) purchase and sale transactions and to avoid conflicts between the parties. However, not every uncertainty is considered an obstacle to the validity of the contract, and minor uncertainties that do not lead to disputes are tolerated. The fiqh sources of four Islamic sects contain many examples of these uncertainties. This study firstly examines the effect of ignorance on the validity of purchasing contracts in Islamic law using the issues in classical fiqh sources and then analyses the housing sales contract of TOKI’s (housing development administration of Turkey) “my first house social housing project” in this context from a fiqh perspective. In addition, the study addresses the related housing sales contract in terms of the juristic preference method by considering the aspect of meeting an important need of society and realizing the purpose of this project. Then, while evaluating the issue from a juris-prudential point of view, the study discusses that the absolute and strict interpretation of the rule of “ignorance renders the contract void,” which is adopted by ignoring the public interest, does not produce favorable results. (shrink)

The escalating integration of Artificial Intelligence (AI) in clinical settings carries profound implications for the doctrine of informed consent, presenting challenges that necessitate immediate attention. China, in its advancement in the deployment of medical AI, is proactively engaging in the formulation of legal and ethical regulations. This paper takes China as an example to undertake a theoretical examination rooted in the principles of medical ethics and legal norms, analyzing informed consent and medical AI through relevant (...) literature data. The study reveals that medical AI poses fundamental challenges to the accuracy, adequacy, and objectivity of information disclosed by doctors, alongside impacting patient competency and willingness to give consent. To enhance adherence to informed consent rules in the context of medical AI, this paper advocates for a shift towards a patient‐centric information disclosure standard, the restructuring of medical liability rules, the augmentation of professional training, and the advancement of public understanding through educational initiatives. (shrink)

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

Autonomy is a concept that holds much appeal to social and legal philosophers. Within a medical context, it is often argued that it should be afforded supremacy over other concepts and interests. When respect for autonomy merely requires non-intervention, an adult’s right to refuse treatment is held at law to be absolute. This apparently simple statement of principle does not hold true in practice. This is in part because an individual must be found to be competent to make a (...) valid refusal of consent to medical treatment, and capacity to decide is not an absolute concept. But further to this, I argue that there are three relevant understandings of autonomy within our society, and each can demand in differing cases that different courses of action be followed. Judges, perhaps inadvertently, have been able to take advantage of the equivocal nature of the concept to come tacitly to decisions that reflect their own moral judgments of patients or decisions made in particular cases. The result is the inconsistent application of principle. I ask whether this is an unforeseen outcome or if it reflects a wilful disregard for equal treatment in favour of silent moral judgments in legal cases. Whatever the cause, I suggest that once this practice is seen to occur, acceptable justification of it in some cases is difficult to find. (shrink)

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of (...) presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death. (shrink)

A controversy in political philosophy and applied ethics concerns the validity of duty‐imposing powers, that is, rights entitling one person to impose new duties on others without their consent. Many philosophers have criticized as unplausible any such moral right, in particular that of appropriating private property unilaterally. Some, finding duty‐imposing powers weird, unfamiliar or baseless, have argued that principles of justified acquisition should be rejected; others have required them to satisfy exacting criteria. I investigate the many ways in (...) which we regularly impose duties on one another without prior consent. I show that doing so is not weird, and I offer criteria which demarcate the reasonable from the worrisome aspects of duty‐imposing powers. (shrink)

This article has two broad purposes. First, as a political philosopher who has been interested in the concepts of coercion and exploitation, I want to consider just what the analysis of the concept of consent can bring to the question, what sexually motivated behavior should be prohibited through the criminal law? Put simply, I shall argue that conceptual analysis will be of little help. Second, and with somewhat fewer professional credentials, I shall offer some thoughts about the substantive question (...) itself. Among other things, I will argue that it is a mistake to think that sexual crimes are about violence rather than sex and that we need to understand just why the violation of sexual autonomy is a serious wrong. I shall also argue that the principle that “no means no” does not tell us when “yes means yes,” and that it is the latter question that poses the most interesting theoretical difficulties about coercion, misrepresentation, and competence. In addition, I shall make some brief remarks concerning two questions about consent and sexual relations that lie beyond the criminal law: What “consent compromising behaviors” should be regarded as indecent, although not criminal? When should someone consent to sexual relations within an enduring relationship? (shrink)

Many first-time mothers (primiparous) within UK National Health Service (NHS) settings require an obstetric intervention to deliver their babies safely. While the antepartum period allows time for conversations about consent for planned interventions, such as elective caesarean section, current practice is that, in emergencies, consent is addressed in the moments before the intervention takes place. This paper explores whether there are limitations on the validity of consent offered in time-pressured and emotionally charged circumstances, specifically concerning emergency obstetric (...) interventions. Using the legal framework of the Mental Capacity Act,Montgomery v. Lanarkshire Health Board(2015) andMcCulloch v Forth Valley Health Board(2023), we argue that while women have the capacity to consent during labour, their autonomy is best supported by providing more information about instrumental delivery (ID) during the antepartum period. This conclusion is supported by some national guidelines, including those developed by the Royal College of Obstetricians and Gynaecologists, but not all. Further, we examine the extent to which these principles are upheld in modern-day practice. Data suggest there is relatively little antepartum information provision regarding ID within NHS settings, and that primiparous women do not report a thorough understanding of ID before labour. Based on these results, and bearing in mind the pressures under which NHS obstetric services currently operate, we recommend further research into patient and clinician perceptions of the consent process for ID. Pending these results, we discuss possible modes of information delivery in future practice. (shrink)

The reasons for judgment by the Supreme Court of Canada on the appeal in Mabior (2012 SCC 47) fail to address or resolve a number of significant questions. The reasons acknowledge the fundamental role of sexual consent in protecting sexual autonomy, equality, and human dignity, but do not use the law of consent as a tool to assist the Court in crafting a fresh approach to the issue on appeal. Instead the Court adopts the same general approach to (...) analysis of the elements of aggravated sexual assault committed by fraud it used in 1998 in Cuerrier. Fifteen years later, it should be possible to re-conceptualize the problem in a more straightforward manner that reflects Charter values, fundamental common law principles, recent developments in sexual assault law, and the limitations and uncertainties of current HIV treatment and diagnosis. -/- Ironically, the two pronged legal test ultimately proposed by the Court -- non-disclosure of HIV-positive status and a “realistic possibility of transmission,” is likely to give false confidence to individuals who adhere to a regime of anti-retroviral treatment, use good quality latex condoms, and routinely conceal their HIV-positive status from their sexual partners. Research shows that HIV viral loads fluctuate widely in response to a myriad of factors. An inevitable consequence of reliance on the Mabior test will be accused who are shocked to find themselves charged under s. 273, charges that would not apply had they disclosed their HIV-positive status to their sexual partner(s). There are further practical consequences. Non-disclosure will tend to increase the risk of transmission because non-HIV-positive sexual partner(s) will not fully appreciate the actual hazards of improper condom use. As a direct result, careless sexual practices will be more common. And finally, the decision will not contribute to reducing the social stigma that haunts the lives of those who are HIV-positive -- even those who are skilled at deceit. That stigma will not be reduced or eliminated by a ruling that can be seen as tacitly validating stigmatization and fear by appearing to permit infected individuals to pretend they are not HIV-positive when they know or suspect this to be false. Deceit harms the human dignity of the deceived and deceiver alike, and does nothing to build authentic social trust and cohesion. For all these reasons, the problem on appeal in Mabior requires a different approach. This article proposes one. (shrink)

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

Since the 1970s, sexual assault laws have evolved to include prohibitions of sexual acts with cognitively impaired individuals. The argument justifying this prohibition is typically as follows: A sex act that is forced (without the legally valid consent of) someone is sexual assault. Cognitively impaired individuals, because they lack certain intellectual abilities, cannot give legally valid consent. Therefore, cognitively impaired individuals cannot consent to sex. Therefore, sex acts with cognitively impaired individuals is sexual assault. The (...) prohibition of sex with such individuals is regarded by many as a significant advance. It certainly seems to be an improvement upon the days in which individuals could engage in sex with cognitively impaired adults with impunity regardless of the physical, emotional and psychological consequences such sex acts caused for those individuals. Yet, this legislation raises serious puzzles. For example, in the U.S., cognitively impaired individuals are routinely convicted for sexual assault with non-cognitively impaired minors. How should we think about the conviction of a cognitively impaired individual who has sex with an underage, non-cognitively impaired individual? Does this imply that cognitively impaired persons are capable of understanding the criminality of failing to obtain legal consent while being, nonetheless, incapable of giving such consent? Should the law address only those cases in which either both or neither of the individuals involved are cognitively impaired? If so, why? -/- In this paper, I claim that shifting the analysis to one based on harms (away from legal standards of consent) better captures our intuitions about sex acts involving cognitively impaired individuals. (Indeed, a review of case law reveals a focus within these cases on the harms experienced by the impaired individuals involved.) I close the paper by identifying the difficulties that plague any legislation concerning individuals with mental impairments. (shrink)

Children's autonomy includes, as far as possible, self-determination, bodily integrity and the right to influence outcomes. Limits to bodily integrity, which involves no touching without the child's consent or tacit agreement, are discussed. The clinical, legal and ethics literature tends to agree that children may give valid consent to major recommended treatment from around 12 years but may not refuse it until they are legal adults. Research shows that young children are more aware of their (...) bodily integrity and autonomy, of morality and decision making, than was assumed in the past. Adults therefore need to inform children and respect their initially instinctive efforts to protect their bodily integrity. Unlike assent, consent involves patients being adequately informed and being able to accept or refuse proposed treatment. Reasons are given for adults’ need to consult with children when determining their best interests. Beyond words, giving or withholding consent also involves emotions of fear, trust and courage, besides embodied reactions of cooperating with treatment or resisting it, in which young children actively engage. Some clinicians work with the informed cooperation of young children who need lifesaving treatment, and at times accept their refusal. Reasons for differences between mainstream experts’ views and clinical practices are considered. (shrink)

Certainly principles of criminal liability may be understood as rules or norms outlining orders or prohibitions and standing out among other norms with their weight, for legal culture, legal doctrine, etc. In such a classic approach they are norms defining basic rights and obligations in the applicable criminal law. However, is it the only possible and cognitively interesting meaning of the word “principle” in jurisprudence? From the semiotic point of view, they can occur in three forms: special-kind (...) norms, teleological directives, rules which constitute valid performance of conventional activities. In an extra-directival sense these principles may be understood as models-descriptions of shaping the system of criminal law. From a theoretical and practical point of view principles addressed to the legislator are extremely weighty—they can be called rules constructing the system of criminal liability. These all problems are discussed in the article. (shrink)

Introduction: Informed consent constitutes one of the most important legal, professional, and ethical principles of a surgical operation. Consent obtained from a patient is only valid when the patient has received enough information regarding the proposed treatment option. This study aims to determine how much the patients are informed before undergoing surgery, as well as the factors influencing it in hospitals affiliated with Tehran University of Medical Sciences. Method: This is a cross-sectional, descriptive–analytic study of (...) 300 patients undergoing surgery in 7 teaching hospitals affiliated with Tehran University of Medical Sciences. The patients were recruited through clustered sampling. Data were collected using a questionnaire completed by interview. Data were analyzed on SPSS software using descriptive and inferential statistics. Result: The mean score of data provision for patients was 27.09 out of 60, indicating the level of information provided as unacceptable. Among 12 questions dealing with data provision, patients had received an intermediate level of information about nature of the disease, type of surgery, benefits and importance of the surgery, and complications of rejecting the recommended therapy. On the contrary, they had not received enough information about the surgical procedure, type of anesthesia, potential complications of surgery, potential risks of surgery, other therapy options instead of surgery, length of hospital stay for surgery, postsurgical follow-up, and expenses of the surgery. In the majority (85%) of cases, the surgeon was reported to be the information provider. Among the variables studied, level of information received was directly related to the patient’s education level. Discussion: The findings of this study indicate that during the process of obtaining an informed consent for surgery, patients do not receive sufficient information, and it is necessary to provide the essential information in an understandable manner adjusted for the patient’s level of education. (shrink)

When does a woman give valid consent to sexual relations? When does her consent render it morally or legally permissible for a man to have sexual relations with her? Why is sexual consent generally regarded as an issue about female consent? And what is the moral significance of consent? These are some of the questions discussed in this important book, which will appeal to a wide readership in philosophy, law, and the social sciences. Alan (...) Wertheimer develops a theory of consent to sexual relations that applies to both law and morality in the light of the psychology of sexual relations, the psychology of perpetrators, and the psychology of the victims. He considers a wide variety of difficult cases such as coercion, fraud, retardation, and intoxication. We can all agree that 'no' means 'no'. This book suggests that the difficult question is whether 'yes' means 'yes'. (shrink)

The past decade has witnessed escalating legal and ethical challenges to the diagnosis of death by neurologic criteria. The legal tactic of demanding consent for the apnea test, if successful, can halt the DNC. However, US law is currently unsettled and inconsistent in this matter. Consent has been required in several trial cases in Montana and Kansas but not in Virginia and Nevada. In this paper, we analyze and evaluate the legal and ethical bases for (...) requiring consent before apnea testing and defend such a requirement by appealing to ethical and legal principles of informed consent and battery and the right to refuse medical treatment. We conclude by considering and rebutting two major objections to a consent requirement for apnea testing: a justice-based objection to allocate scarce resources fairly and a social utility objection that halting the diagnosis of brain death will reduce the number of organ donors. (shrink)

It is argued that accepting that there are human rights, or that there are categorically binding requirements of any kind on action, logically requires accepting the PGC (Principle of Generic Consistency) as the supreme criterion of practical reasonableness.Consequently, all legal systems that recognise human rights (hence, the English legal system), all who view law as a matter of obligation, and all who consider that there are categorically binding requirements on action, must take the PGC to be a necessary (...) criterion of legal validity. Conventions on human rights must, as conventions on human rights, be interpreted to conform with the PGC. (shrink)

The principle of bivalence is the assertion that every statement is either true or else false. Its legal analog, however, must be formulated relative to particular legal systems and in terms of validity rather than truth. It asserts that every statement of law that can be formulated in the vocabulary of a given legal system is valid or else invalid in that system. A line of New York cases is traced, beginning with Thomas v. Winchester . (...) This case, which involved a poison mislabeled as a medicine, established an exception to the rule that a manufacturer or supplier is never liable for negligence to a remote purchaser. The court made an exception because a poison is an “imminently dangerous” thing. How far may this exception be applied to other fact‐situations? Some subsequent cases are examined, and it is considered whether there is no correct answer in these instances and, more dramatically, whether more than one correct answer is tenable. In either event the legal analog of bivalence would seem to fail. (shrink)

Adolescent pregnancy results from the complex interaction between various internal and external vulnerabilities. These vulnerabilities persist after the infant's birth when the adolescent becomes a parent. Adolescent parents are unfairly stereotyped as unmotivated and incompetent. Some legislations prohibit adolescents from giving consent on the grounds of incompetency. Despite being different, “competency” is frequently used interchangeably with “capacity”; thus, incompetent individuals are often mistaken to lack capacity. Consequently, legally incompetent adolescents who became parents are frequently disregarded during their infant's decision-making (...) process. This article discusses the distinction between the competence and capacity of adolescent parents, the various vulnerabilities that contribute to an adolescent's incompetency, and advocates respect for the adolescent's capacity in making decisions for her infant. We propose a workflow for obtaining informed consent for infants born to adolescents ethically guided by the respect for individuals principle while staying within the country's legal framework. (shrink)

The recent #metoo movement has turned public attention to the problem of sex under conditions of power inequality. Is consent impaired, when you have plenty to lose (e.g. a great professional opportunity) from saying “no” to a sexual advance? And even if consent is valid, is this a morally acceptable situation, especially if one party is aware that their position of relative power will influence the other’s decision to have sex? Such situations bring to the fore not (...) only the issues of coerced sex and quid pro quo harassment (asking for sex in exchange for benefits), but the much more controversial question of whether sex between unequal but otherwise competent consenting adult partners is in principle OK—and whether institutions such as companies, universities, or the state itself should be in the business of regulating such relations. In what follows, I will outline the central concept of power asymmetry and its ethical relevance (section 2). I will then distinguish two main views about the ethics of sexual interaction under conditions of power asymmetry: a Kantian view, which categorically condemns such interactions, and a Millian view, which justifies at least some such interactions (section 3). I then briefly consider three contexts, which raise difficult questions about sex between unequals: the workplace, the university (section 4), and voluntary prostitution (section 5). Section 6 provides a short conclusion. (shrink)

Philosophy, political philosophy and legal philosophy are all concerned with issues of justice and the validity of law (also known as the force of law ). These two problem areas are discussed against the background of the intersection of traditional theories of natural law and legal positivism, mediated by the contribution of the historical school. In addition the influence of the two neo-Kantian schools of thought (Baden and Marburg) required attention, particularly because certain elements in the thought of (...) Derrida, Dooyeweerd and Habermas are (implicitly) influenced by these schools. Derrida positions the problem of justice within the context of distinguishing universality and singularity (what is unique) and he alludes to the difficulty of bridging the gap between the two. It turned out that modern nominalism had an important effect on all three of the mentioned thinkers, in spite of their willingness to recognize “extra-mental” forms of universality. The problem of legal validity (the “force of law”) appears to be an instance of the interconnectedness between different aspects of reality, namely the jural and the physical . In order to account for this coherence Dooyeweerd developed a theory in which both the uniqueness and coherence between different aspects are explained in terms of inter-modal analogies. On this basis the difference between law and justice is specified by distinguishing between constitutive legal principles and the regulatively deepened (disclosed) principles of legal morality (such as f ault, equity, bona fides and so on). It will be shown that the idea of positivization , shared by thinkers coming from different backgrounds, is an important ingredient of an understanding of the nature of legal validity . Explaining it will require a focus on the nature of state law, of the power of the state, and of the legal competence entailed in the office of government. (shrink)

The article analyses the legal regulation of electronic marketing in the European context. The historical and teleological perspective on past and present regulations of electronic marketing is provided. Emphasis is given on the ability of the legal rules to preserve the balance of private and entrepreneurial interests, and the desirable principles of the regulation of the socially beneficial electronic marketing. The paper concludes that the harmonization of legal regulation of electronic marketing at the European Union level (...) is limited, which causes numerous negative consequences, such as jurisdiction shopping. Some countries (e.g. Finland) follow opt-out regimes for at least some types of electronic marketing, while other countries (including Lithuania) prohibit most forms of electronic marketing without the prior consent of the customer (opt-in). Thus, further regulation and harmonization of the electronic marketing law is suggested at the regional (the EU) and national level, along with more self-regulation and a balanced approach towards future regulation. (shrink)

In Criminalizing Sex, Stuart Green wisely eschews any attempt to fully analyse the problem of ‘sex-by-deception’ in a single chapter, instead offering a ‘basic framework’ for determining whether an expansion of the law of ‘rape by deceit’ might be justified. In this article, I offer a revision to that framework. Green begins from an account of rape centred on the right to (negative) sexual autonomy and seeks to reject an expansionist account under which any deceptions and mistakes could vitiate (...) class='Hi'>consent to sexual activity. Sharing these starting points, I argue, pace Green, that variations in the harmfulness and wrongfulness of different deceptions cannot ground content-based restrictions on consent-vitiating deceptions. I argue that whilst different kinds of deceptive practices might wrong V to a greater or lesser extent, these variations lead to content-neutral, form-based restrictions on consent-vitiating deceptions. Moreover, whilst variations in the harms of D’s conduct are unlikely to ground a coherent set of content-sensitive restrictions on consent-vitiating deceptions, the harms of criminalisation differ depending on the content of the deception in question and this might lead to content-based restrictions on liability. However, an analysis of the variable costs of criminalisation is not obviously connected to the moral concept of consent-validity. Accordingly, whilst I suspect that both form and content-based restrictions on consent-vitiating deceptions are warranted in this area, the justification for the latter is unlikely to lie within an analysis of consent-validity itself, or the varied harmfulness and wrongfulness of D’s own conduct. (shrink)

This article offers a critique of Ronald Dworkin’s article “A New Philosophy for International Law”, (Philos Public Aff 41: 1–30, 2013). It begins by showing that Dworkin’s moralised theory of law is built on two highly questionable background assumptions. On the one hand, a descriptively implausible characterisation of a positivist-voluntarist view of international law as the reigning “orthodoxy”. On the other hand, the methodologically questionable assumption that a theory of international law must discharge the dual function of explaining the validity (...) of international law in a manner that underwrites its presumptive legitimacy. In its core part, the article then offers a sustained criticism of Dworkin’s moralised account of the validity and legitimacy of international law. Various problems are identified with the “principle of salience” that Dworkin offers in place of consent as a ground for international law. A key concern is the difficulties that stem from Dworkin’s willingness to proceed on the “fantasy” assumption that his theory needs to get off the ground, i.e. that there is an international court with compulsory jurisdiction and reliable mechanisms for enforcing its judgements. Finally, the article concludes with some thoughts on how Dworkin’s “fantasy-based” approach led him to over-estimate the degree to which international law can be a vehicle for the global spread of liberal democratic values. More minimalist ambitions for international legal order, along the lines suggested by John Rawls inThe Law of Peoples, seem more realistic. (shrink)

Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of (...) informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care. (shrink)

ABSTRACT Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information provided. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand (...) and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk. (shrink)

Cancer screening programmes cause harm to individuals via overdiagnosis and overtreatment, even where they confer population-level benefit. Screening thus appears to violate the principle of non-maleficence, since it entails medically unnecessary harm to individuals. Can consent to screening programmes negate the moral significance of this harm? In therapeutic medical contexts, consent is used as a means of rendering medical harm morally permissible. However, in this paper, I argue that it is unclear that the model of consent used (...) within therapeutic medicine can be applied unproblematically to preventive medicine. Invitation to screening changes the pragmatic norms and expectations of the patient–doctor encounter such that two key principles of consent may be violated. First, the pragmatics of a medical invitation are such that patients may fail to be adequately informed, since patients appear to assume medical invitations are made with their best interests in mind, even where information to the contrary is outlined. Second, screening invitations may place pressure on patients; in the context of a medical encounter, to make an invitation to screening may constitute an inducement to accept. In order to be sure that a patient’s consent to a screening invitation is valid, we must make clear to patients that their decision to accept screening may be shaped not only by how information about screening is presented, but by the pragmatic form of the invitation itself. (shrink)

In The Concept of Law, H. L. A. Hart propounds three central theses about the nature of law: a standard of behavior is a law in a society S if and only if that standard has been promulgated in accordance with the procedures specified in S's rule of recognition ; there are no necessary substantive moral constraints on the content of law ; and judges have discretion in hard cases to base their decisions on extralegal standards; thus, judges decide hard (...) cases by creating new law and not by applying existing law . ;Despite the apparent simplicity of Hart's positivism, it has been the subject of fierce controversy. In "The Model of Rules I," Ronald Dworkin argues that judges are bound in hard cases to consider legal principles that derive their authority from, as Dworkin puts it, "a sense of appropriateness developed in the profession and the public over time." Thus, he concludes that two of Hart's theses are false. First, since the authority of such principles does not depend on their having been promulgated in accordance with the requirements of the rule of recognition, Hart's Pedigree Thesis is false. Second, since judges are always bound by these principles in hard cases, Hart's Discretion Thesis is false. ;In my dissertation, I consider a number of attempts to defend Hart's positivism from Dworkin's criticisms. I show that Hart would reject each of these attempts as involving an unacceptable modification of his version of the Pedigree Thesis. Additionally, I argue that, contra Dworkin, the authority of legal principles derives from their having been declared by judges in the course of deciding hard cases. Accordingly, I conclude that the validity of legal principles is consistent with Hart's version of the Pedigree and Discretion Theses. (shrink)

In this paper, I answer the following question: suppose that two individuals, C and D, have been in a long-term committed relationship, and D now has dementia, while C is competent; if D agrees to have sex with C, is it permissible for C to have sex with D? Ultimately, I defend the view that, under certain conditions, D can give valid consent to sex with C, rendering sex between them permissible. Specifically, I argue there is compelling reason (...) to endorse the following thesis: -/- Prior Consent Thesis: D, when competent, can give valid prior consent to sex with her competent partner (C) that will take place after she has dementia, assuming that D is the same person as she was when she gave prior consent, meaning that, if D, when competent, gave prior consent to sex with C, then C may permissibly have sex with D. In section I, I explain both the background and the existing literature on this issue. In section II, I outline relevant stipulations about the kinds of cases I will be examining. In section III, I defend the Prior Consent Thesis. And, in section IV, I address objections to the Prior Consent Thesis. (shrink)

This paper describes a model of legal reasoning and a logic for reasoning with rules, principles and goals that is especially suited to this model of legal reasoning. The paper consists of three parts. The first part describes a model of legal reasoning based on a two-layered view of the law. The first layer consists of principles and goals that express fundamental ideas of a legal system. The second layer contains legal rules which (...) in a sense summarise the outcome of the interaction of the principles and goals for a number of case types. Both principles, goals and rules can be used in legal arguments, but their logical roles are different. One characteristic of the model of legal reasoning described in the first part of the paper is that it takes these logical differences into account. Another characteristic is that it pays serious attention to the phenomena of reasoning about the validity and acceptance of rules, respectively principles and goals, and about the application of legal rules, and the implications of these arguments for the use of rules, principles and goals in deriving legal conclusions for concrete cases.The second part of the paper first describes a logic (Reason-Based Logic) that is especially suited to deal with legal arguments as described in terms of the previously discussed model. The facilities of the logic are illustrated by means of examples that correspond to the several aspects of the model. (shrink)

U.K. regulation of sexual identity within a marriage context has traditionally been linked to biological sex. In response to the European Court of Human Rights decisions in Goodwin and I.,2 and in order to address the question of whether a transsexual person can be treated as a “real” member of their adoptive sex, the U.K. has recently passed the Gender Recognition Act 2004. While the Act appears to signal a move away from biology and towards a conception of sexual identity (...) based on gender rather than sex, questions of sexual identity remain rooted in medico-legal assessments of the individual transsexual body/mind. In contrast, because transsexual people in some parts of Canada have been able to marry in their post-operative sex since 1990, contemporary debates on the sexual identity of transsexual people in British Columbia and Ontario do not focus on the validity of marriage, and more frequently centre upon the provision of goods and services, in human rights contexts where sex is said to matter. Currently in Canada this is prompting questions of what it means to be a woman in society, how the law should interpret sex and gender, and how, if at all, the parameters of sexual identity should be established in law. This article seeks to compare recent U.K. legal conceptualisations of transsexuality with Canadian law in this area. As human rights discourse begins to grow in the U.K., the question remains as to whether or not gender will become an adequate substitute for sex. (shrink)

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now (...) the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice. (shrink)

Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give (...) class='Hi'>valid informed consent.Design: 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

Appropriate language use is essential to ensure inclusion of diverse populations in research. We aimed to identify possible language-related barriers regarding the informed consent process and propose interventions to improve clarity and understanding of pregnant and breastfeeding women participating in research. A cross-sectional qualitative study employing focus group discussions (FGD) was conducted in Uganda from August 2023 to September 2023, involving a diverse group of stakeholders from the community, including community members, research participants, and Community Advisory Board members. 19 (...) FGD comprised adult participants representing at least six different mother tongues (Luganda, Acholi, Runyankole, Runyoro, Lugbara and English). An inductive thematic approach was utilized for data analysis using NVivo version 12 software to identify language factors that influence informed consent. A series of community validation workshops ensured concurrence. At the individual level, language barriers, and low levels of literacy contributed to poor comprehension, thus hindering ability to achieve genuine informed consent. At the health facility level, participants reported that there was use of inappropriate, unclear language including inaccurate translations, with poor and complicated grammar in some consent forms. Participants reported that complex medical terminologies are difficult to translate to local languages. Community members highlighted that social/cultural norms in language use affected cultural perceptions of informed consent. To enhance understanding for individuals without education in science, participants suggested simplification of terminologies and avoidance of complex medical jargon. Researchers should identify participants’ preferred languages and communicate in those languages whenever possible. If researchers are not fluent, trained interpreters should be identified. Informed consent documents must be translated into local languages to ensure participants comprehend the study’s purpose, procedures, risks, and benefits. Involving community members during development and translation of these documents can provide valuable insights into local dialects and culturally specific concepts, ensuring that study tools like surveys and consent forms are accurate and respectful. Language barriers influence the informed consent process within communities in Uganda. These can potentially be resolved at individual, health system and community levels. Consideration of locally understandable terms in community-facing study documentation is likely to enhance understanding and could improve research participation, although further studies are needed to assess these. The use of appropriate language ensures that informed consent is genuine in keeping with principles of Good Clinical Practice, and developing a research communication strategy should be part of inclusive research design. (shrink)

Although tissue plasminogen activator (tPA) is the only medication approved by the United States Food and Drug Administration (FDA) for acute ischemic stroke, there is no consensus about the need for informed consent for its use. As a result, hospitals throughout the U.S. have varying requirements regarding obtaining informed consent from patients for the use of tPA, ranging from no requirement for informed consent to a requirement for verbal or written informed consent. We conducted a study (...) to (1) determine current beliefs about obtaining patients’ informed consent for tPA among a large group of stroke clinicians and (2) identify the ethical, clinical, and organizational factors that influence tPA consent practices. Semi-structured interviews were conducted by trained and experienced investigators and research staff to identify key barriers to implementing acute stroke services. Part of the interview explored current beliefs and practices around informed consent for tPA.This was a multicenter study that included 38 Veterans Health Administration (VHA) hospital locations. Participants were 68 stroke team clinicians, serving primarily on the neurology (35 percent) or emergency medicine (41 percent) service. We conducted thematic analysis based on principles of grounded theory to identify codes about consent for tPA. We used interpretive convergence to ensure consistency among the individual investigators’ codes and to ensure that all of the investigators agreed on coding and themes.We found that 38 percent of the stroke clinicians did not believe any form of consent was necessary for tPA, 47 percent thought that some form of consent was necessary, and 15 percent were unsure. Clinicians who believed tPA required informed consent were divided on whether consent should be written (40 percent) or verbal (60 percent). We identified three factors describing clinicians’ attitudes about consent: (1) legal and policy factors, (2) ethical factors, and (3) medical factors.The lack of consensus regarding consent for tPA creates the potential for delays in treatment, uneasiness among clinicians, and legal liability. The identified factors provide a potential framework to guide discussions about developing a standard of care for acquiring the informed consent of patients for the administration of tPA. (shrink)

The large-scale change of Czech society since 1989 has involved the democratic transformation of the health system. To empower the patient was one important goal of the healthcare reform launched immediately after the Velvet Revolution. The process has been enhanced by the accession of the Czech Republic to the European Union and the adoption of important European conventions regulating the area. The concept of informed consent and a culture of negotiation are being inserted into a traditionally paternalistic culture. Our (...) article describes the current situation on the issue of the communication of information on state of health and treatment, and on the question of the participation of the patient in decisions on treatment. We present empirical results of a public opinion survey on this issue. The results show a still prevailing submissive attitude towards the physicians, despite the fact that the concept of informed consent has become more and more publicly familiar . The impact of age, education and sex on answers to the questionnaire was analysed. Men, younger and more educated respondents were more likely to show the autonomous attitude, whereas women, older and less educated people tended to show the traditional submissive attitude. Further, our article raises the question of the cultural and historical background within which the current ethically and legally binding norms are interpreted. The question is how far cultural modifications are tolerable in the practical implementation of universal ethical constructs. (shrink)

This article examines Lamb, Gable & de Ruyter's critique of consent as the standard by which one can determine if a sexual encounter is ethical in their ‘Mutuality in sexual relationships: a standard of ethical sex?’. Their examination of this issue is to be welcomed for a number of reasons, including growing criticism of ‘consent’ as the gold standard in medical and social science research ethics. The focus of this article is specifically on school sex education (principally, for (...) 11–16-year-olds). Contrary to Lamb et al., I argue that it is difficult to maintain that ‘The standard of mutuality should be taught in all schools and the government should indeed demand or support this, even with checks to see if children have learned this standard, at least in attitudes about sexual behavior’ for three reasons. First, while there are good arguments in favour of school children being introduced to the ideal of mutuality, it seems too high a bar to require children to ‘have learned’—a phrase that can be taken to mean to ‘have come to accept’ rather than merely to ‘understand’—this; consent is a more appropriate requirement and is itself a sufficiently rich term that it merits analysis by students, aided by their teachers. Second, my judgement as a sex educator is that sex education is more effective when students are given the opportunity to explore what is good and what is right, rather than simply being told. Third, if we have to adopt a single principle, there is much to be said for ‘respect for others’ to trump both ‘consent’ and ‘mutuality’. (shrink)

This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion (...) about the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies. (shrink)