Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, been received in a lukewarm (...) fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'. The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients. In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better. (shrink)

In a community that takes rights seriously, consent features pervasively in both moral and legal discourse as a justifying reason: stated simply, where there is consent, there can be no complaint. However, without a clear appreciation of the nature of a consent-based justification, its integrity, both in principle and in practice, is liable to be compromised. This book examines the role of consent as a procedural justification, discussing the prerequisites for an adequate consent -- in (...) particular, that an agent with the relevant capacity has made an unforced and informed choice, that the consent has been clearly signalled, and that the scope of the authorisation covers the act in question. It goes on to highlight both the Fallacy of Necessity (where there is no consent, there must be a wrong) and the Fallacy of Sufficiency (where there is consent, there cannot be a wrong). Finally, the extent to which the authority of law itself rests on consent is considered. If the familiarity of consent-based justification engenders confusion and contempt, the analysis in this book acts as a corrective, identifying a range of abusive or misguided practices that variously under-value or over-value consent, that fictionalise it or that are fixated by it, and that treat it too casually or too cautiously. In short, the analysis in Consent in the Law points the way towards recognising an important procedural justification for precisely what it is as well as giving it a more coherent application. (shrink)

Consent theory in sexual ethics, Jonathan Ichikawa argues, has a Euthyphro problem. -/- It is widely held that sexual violations are explicable in terms of nonconsensual sexual contact. But a notion of consent adequate to explain many moral judgments typical of sexual ethics — a notion that vindicates the idea that consent cannot be coerced, that it must be sober, that children cannot consent to sex with adults, etc. — cannot, Ichikawa argues, be articulated, motivated, or (...) explained in a way independently of moral judgments about sexual wrongs. Consequently, if there is as tight a connection between consent and sexual violation as many people think there is, there is good reason to suppose that that connection must ultimately explain consent in terms of sexual wronging, rather than vice versa. The paper highlights some costs and drawbacks to this horn of the Euthyphro dilemma in sexual ethics. One central upshot of the argument will be that mainstream accounts of sexual ethics fail in their explanatory ambitions. Consent cannot play its canonical explanatory role. (shrink)

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)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of (...) consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

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

Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an (...) Information and Decision Aid (IDA) that can support decision making and be used to guide the dialogue between researcher and potential participant. Our proposal requires limited changes to current processes or paperwork and would provide an easily accessible document for others that the potential participant might approach for advice. It could later be integrated with the Informed Consent Form to ensure all matters of concern to the individual participant have been addressed before consent is formally signed off. (shrink)

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

In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

How wrong is it to deceive someone into sex by lying, say, about one's profession? The answer is seriously wrong when the liar's actual profession would be a deal breaker for the victim of the deception: this deception vitiates the victim's sexual consent, and it is seriously wrong to have sex with someone while lacking his or her consent.

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)

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood. Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken. When investigating what information is needed for consent to be informed we might be trying to determine (...) what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the first type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons (...) for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

The acquisition of fully informed consent presents a central ethical problem for the procurement and storage of human tissue in biobanks. The tension lies between the apparent necessity of obtaining informed consent from potential research subjects and the projected future use of the tissue. Specifically, under the doctrine of informed consent medical researchers are required to inform their potential research subjects about the relevant risks and purposes of the proposed research (Declaration of Helsinki, 2008, “Section 24.” Accessed (...) November 1, 2009. http://www.wma.net/en/30publications/10policies/b3/index.html). However, because human tissue – when stored in biobanks – can be put to multifarious uses, the information that medical researchers are expected to divulge to their subjects is epistemologically inaccessible. Biobank researchers are thus thought to be unable to obtain informed consent from their subjects, making the practice ethically suspicious. We propose that such suspicions of ethical failure should be reconsidered by presenting two possible solutions. Firstly we argue that the epistemological difficulty might be partially solved by adopting the “waiver model” of informed consent. Secondly, we put forward an argument that individual consent can be supplemented by group ethical models. We thus conclude that while informed consent is problematic for biobank researchers, alternative ethical solutions are available. (shrink)

The process of seeking the consent of a patient to a medical procedure is, arguably, one of the most important skills a doctor, or indeed any clinician, should learn. In fact, the very idea that doctors may institute diagnostic or treatment processes of any sort without a patient's consent is utterly counter-intuitive to the modern practice of medicine. It was not always thus, and even now it can be reliably assumed that consent is still not sought and (...) gained appropriately in every clinical encounter. To say that it should be sought and gained in this manner elevates the value of consent to a high level. It can be instructive to ask oneself why such a value might be held to be the case. The answer to this question lies in the philosophical underpinning of clinical consent, which sits within a notion of personal autonomy, and respect for autonomous decision making. (shrink)

This paper argues, against the prevailing view, that consent to privacy policies that regular internet users usually give is largely unproblematic from the moral point of view. To substantiate this claim, we rely on the idea of the right not to know (RNTK), as developed by bioethicists. Defenders of the RNTK in bioethical literature on informed consent claim that patients generally have the right to refuse medically relevant information. In this article we extend the application of the RNTK (...) to online privacy. We then argue that if internet users can be thought of as exercising their RNTK before consenting to privacy policies, their consent ought to be considered free of the standard charges leveled against it by critics. (shrink)

The traditional view according to which we adults tacitly consent to a state’s lawful actions just by living within its borders—the residence theory—is now widely rejected by political philosophers. According to the critics, this theory fails because consent must be (i) intentional, (ii) informed, and (iii) voluntary, whereas one’s continued residence within a state is typically none of these things. Few people intend to remain within the state in which they find themselves, and few realize that by remaining (...) they are consenting to the state’s lawful actions. In addition, the various obstacles standing in the way of us leaving the state render our remaining involuntary. Thus, the critics conclude, few if any people can be considered to have consented through their residence. I argue that these objections fail and that the residence theory remains a viable option, at least for those who are not committed incompatibilists. (shrink)

Coercion by the recipient of consent renders that consent invalid. But what about when the coercive force comes from a third party, not from the person to whom consent would be proffered? In this paper I analyze how threats from a third party affect consent. I argue that, as with other cases of coercion, we should distinguish threats that render consent invalid from threats whose force is too weak to invalidate consent and threats that (...) are legitimate. Illegitimate controlling third party threats render consent invalid just as they do in two party cases. However, knowing that the consent is invalid is not sufficient to tell the recipient of consent what she may or should do. I argue that when presented with a token of consent from someone whom she thinks is experiencing an illegitimate controlling threat, the recipient may act on that token if and only if doing so represents a reasonable joint decision for her and the victim of coercion. The appropriate action for someone faced with third party coercion therefore depends on the other options open to her and those open to the victim of coercion. (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)

Informed consent is reviewed as it applies to psychiatric patients. Although new legislation, such as the Mental Health Act 1983, provides a useful safeguard for the protection of the civil rights of patients, it could actually reduce their humane care unless applied with sensitivity for the nature of their unique difficulties. In order to guard against this possibility, we suggest that legal requirements should be considered in light of the ethical principles which underlie them. Three principles are considered: those (...) of autonomy (freedom); beneficence (paternalism); and the fiduciary principle (partnership). Psychotherapy is offered as a model for informed consent, which might be generalised to other clinical situations. (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)

Philosophy and Phenomenological Research, EarlyView. Despite the acknowledgement of the moral significance of consent there is still much work to be done in determining which specific sexual encounters count as unproblematically consensual. This paper focuses on the impact of deception. It takes up the specific case of deception about one's self. It may seem obvious that one ought not to lie to a sexual partner about who one is, but determining which features of oneself are most relevant, as well (...) as the lies which it follows would be impermissible to tell, is complicated. It is argued here that deception about one's morally valenced character traits, those we think of as virtues and vices, are particularly problematic. This is true regardless of whether knowing the truth about those traits would have made a difference to one's partner's consent. Attention is then drawn to a range of types of lies that one ought not to tell. (shrink)

In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem (...) to informed consent. The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. (...) The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Unconsented pelvic exams under anesthesia are assaults cloaked in defense of healthcare education. Preemptive linguistic qualifiers “presumed” or “implied” attempt to justify such violations with flippancy toward their oxymoronic implications: to suggest a priori that consent can be assumed undermines its otherwise standalone social, ethical, and medico-legal reverence. In this paper I conceptualize “medical sexual assault” and argue that presumed consent for intimate exams exemplifies its definition. By bluntly describing pelvic exams as “penetration,” this work aims to reify (...) the intimate reality of the clinical label “pelvic exam” and to call attention to cisheteronormative and androcentric assumptions involved in its practice. Additionally, this scholarship seeks to create a foundation toward broader work in conceptualizing clinical rape culture. Given recent national survey data indicating a surprising frequency of unconsented intimate exams, detailed language as to their problematics is necessary for ongoing legal and ethical efforts. Explicit consent for intimate exams must be the standard of care for conscious and unconscious patients. (shrink)

There is currently intense debate about the significance of user consent to data practices. Consent is often taken to legitimate virtually any data practice, no matter how invasive. Many scholars argue, however, that user consent is typically so defective as to be ‘meaningless’ and that user privacy should thus be protected by substantive legislation that does not rely (or does not rely heavily) on consent. I argue that both views rest on serious mistakes about the validity (...) conditions for consent. User consent is sufficiently impoverished that it does not guarantee legitimacy but is not so impoverished as to be ‘meaningless’; it can legitimate data practices that are independently reasonable but not those that are exploitative. Since many valuable data practices must be consented to if they are to be legitimate (or so I argue), our privacy legislation should continue emphasizing the importance of user consent, even if auxiliary protections are also desirable. (shrink)

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

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the (...) moral values essential to valid consent – autonomy, voluntariness, non-manipulation, and non-exploitation – and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. (shrink)

I argue against various versions of the ‘attitude’ view of consent and of the ‘action’ view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic context, absence of dissent is sufficient for consent: what is crucial is having access to dissent. In the latter part of the paper I (...) illustrate my view of consent by applying it to the case of consenting to being an organ donor. (shrink)

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

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)

This paper discusses the role of consent in decision making generally and its role in end of life decisions in particular. It outlines a conception of autonomy which explains and justifies the role of consent in decision making and criticises some misapplications of the idea of consent, particular the role of fictitious or “proxy” consents.Where the inevitable outcome of a decision must be that a human individual will die and where that individual is a person who can (...) consent, then that decision is ethical if and only if the individual consents. In very rare and extreme cases such a decision will be ethical in the absence of consent where it would be massively cruel not to end life in order to prevent suffering which is in no other way preventable.Where, however, the human individual is not a person, as is the case with abortion, the death of infants like Mary , or in the very rare and extreme cases of those who have ceased to be persons like Tony Bland, such decisions are governed by the ethics of ending the lives of non-persons. (shrink)

Since its advent in the 20th century, informed consent has become a cornerstone of ethical healthcare, and obtaining it a core obligation in medical contexts. In my dissertation, I aim to examine the theoretical underpinnings of informed consent and identify what values it is taken to protect. I will suggest that the fundamental motivation behind informed consent rests in something I’ll call bodily self-sovereignty, which I argue involves a coupling of two groups of values: autonomy and non-domination (...) on the one hand, and self-ownership and personal integrity on the other. I will then go on to consider two 'case studies' I take to shed light on what is at stake in securing informed consent - consent in psychiatrically ill populations, and consent to interventions that involve the modification of the genetic germline. (shrink)

Children and young people under 18 years old should no longer be regarded as incompetent to give or withhold consent in decisions involving their health care, Recent research suggests a functional test of cognitive and emotional maturity, rather than a strict age cut-off point. However, it is often difficult to implement these recommendations in practice, not least because the law is, if anything, increasingly 'hard-line' about children's autonomy.

This paper formulates a response to standard accounts of Kantian sexual morality, by first clarifying why sex should be understood as a case of using a person as a thing, rather than merely as a means. The author argues that Kant’s remedy to this problem is not sexual consent, but a model of setting and sharing sexual ends. Kant’s account of sexual morality, read in this way, is a critical framework for contemporary moves to think beyond consent, and (...) to grapple with concerns about sexual violation and “bad sex” that have gained uptake in the wake of the MeToo movement. The author defends an account of sex as a process of setting and sharing sexual ends in a Kantian key, which provides us with resources for thinking about the robust ongoing project of making our sexual selves in nonideal conditions, as well as for identifying the wrongs of both “bad” sex and sexual harassment. In doing so, they offer a critical middle ground between contemporary accounts of sexual morality that center questions of individual agency or autonomy, and those that foreground the intersubjective nature of sex. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; (...) and third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons (...) at University teaching Hospitals in a low resource setting. (shrink)

Broad consent – the act of gaining one consent for multiple potential future research projects – sits at the core of much current genomic research practice. Since the 25th May 2018, the General Data Protection Regulation (GDPR) has applied as valid law concerning genomic research in the EU and now occupies a dominant position in the legal landscape. Yet, the position of the GDPR concerning broad consent has recently been cause for concern in the genomic research community. (...) Whilst the text of the GDPR apparently supports the practice, recent jurisprudence contains language which is decidedly less positive. This article takes an in-depth look at the situation concerning broad consent under the GDPR and – despite the understandable concern flowing from recent jurisprudence – offers a positive outlook. This positive outlook is argued from three perspectives, each of which is significant in defining the current, and ongoing, legitimacy and utility of broad consent under the GDPR: the principled, the legal technical, and the practical. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some (...) studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

According to one influential view, requirements to elicit consent for medical interventions and other interactions gain their rationale from the respect we owe to each other as autonomous, or self-governing, rational agents. Yet the popular presumption that consent has a central role to play in legitimate intervention extends beyond the domain of cases where autonomous agency is present to cases where far from fully autonomous agents make choices that, as likely as not, are going to be against their (...) own best interest. The question how we should understand the rationale for eliciting consent in this range of ‘non-ideal’ cases is comparatively ill understood. In this paper, I explore the prospects of accounting for consent requirements in such ‘non-ideal’ cases by appealing to a set of agency-based interests; including an interest in playing a meaningful part in joint decisions affecting ourselves and others. (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)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it (...) with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

From Hippocrates to paternalism to autonomy : the new hegemony -- From autonomy to consent -- Consent, autonomy, and the law -- Autonomy at the end of life -- Autonomy and pregnancy -- Autonomy and genetic information -- Autonomy and organ transplantation -- Autonomy, consent, and the law.

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to (...) limited abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

The 2008 housing and financial crisis brought to light many ethically questionable lending and borrowing practices. As we learn more about what caused this crisis, it has become apparent that we need to think more carefully about the conditions under which can loans be ethically offered and accepted, but also about when it might be morally permissible to default on debts. I critique two distinct philosophical approaches to assessing the ethics of debt, arguing that bothapproaches are too simplistic because they (...) focus only on individual borrowers and lenders. As a result, neither approach can adequately grasp the moral implications of the social and economic failures that frame actual dilemmas of debt facing many individuals today. (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)