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.

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)

Criminal offenders may be offered to participate in voluntary rehabilitation programs aiming at correcting undesirable behaviour, as a condition of early release. Behavioural treatment may include direct intervention into the central nervous system (CNS). This article discusses under which circumstances voluntary rehabilitation by CNS intervention is justified. It is argued that although the context of voluntary rehabilitation is a coercive circumstance, consent may still be effective, in the sense that it can meet formal criteria for informed consent. Further, (...) for a consent to be normatively valid (“take the wronging out of the act”) under a coercive circumstance, the subject to be treated must (1) have the sovereign authority to consent, and (2) the offer-giver must be in the right normative position to make the offer. While I argue that subjects do have the sovereign authority to consent to treatment, I also argue that inappropriate offers yield invalid consents. Considerations on inappropriate offers should therefore inform which kinds of CNS intervention-based rehabilitation schemes the state may propose as part of the criminal justice system. Yet as I conclude in this paper, while there are some intrinsic constraints on voluntary rehabilitation programs, the main constraints on voluntary rehabilitation are likely to be contingent overriders. However, CNS intervention is not ruled out as such in the context of voluntary rehabilitation. (shrink)

Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and (...) eventually mitigate it’. This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of ‘how to obtain and ascertain valid consent to participation in health-related research’ cannot always be fully answered by exclusive reference to pre-determined criteria/guidance provided by the guidelines and prior research’. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased. Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be – general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines’ nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts. (shrink)

Coercion is commonly said to invalidate consent, and that is always true if the source of the coercion is the physician. However, if it is a family member who coerces the patient to consent, the resultant consent may be quite valid and treatment should proceed.

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

It is widely assumed that the use of deception in research is always inconsistent with obtaining valid consent. In addition, guidelines and regulations permit research without valid consent only when it poses no greater than minimal risk. Current practice thus prohibits studies that use deception and pose greater than minimal risk, including studies that rely on deceptive methods to evaluate experimental treatments. To assess whether these prohibitions are justified, the present paper evaluates five arguments that might (...) be thought to support the assumption that deception is always inconsistent with valid consent. Analysis of these arguments reveals that deception is frequently, but not always, inconsistent with obtaining valid consent for research. This conclusion suggests that, in order to avoid unnecessarily blocking valuable research, current policies and practice should be revised to recognize the conditions under which the use of deception can be consistent with obtaining research participants’ valid consent. (shrink)

This article considers the claim that gender diverse minors and their families should not be able to consent to hormonal treatment for gender dysphoria. The claim refers particularly to hormonal treatment with so-called ‘blockers’, analogues that suspend temporarily pubertal development. We discuss particularly four reasons why consent may be deemed invalid in these cases: the decision is too complex; the decision-makers are too emotionally involved; the decision-makers are on a ‘conveyor belt’; the possibility of detransitioning. We examine each (...) of these reasons and we show that none of these stand up to scrutiny, and that some are based on a misunderstanding of the nature and purposes of this stage of treatment and of the circumstances in which it is usually prescribed. Moreover, accepting these claims at face value could have serious negative implications, not just for gender diverse youth, but for many other minors and families and in a much broader range of healthcare settings. (shrink)

Within medical ethics it is widely agreed both that it would be morally wrong to give a competent patient medical treatment without his consent, and that for his agreement to treatment to constitute valid consent it needs to meet certain criteria. In illustrating why these requirements are needed it is common to use treatments that involve a healthcare professional doing something to the patient's body—for example, performing surgery, giving an injection, or taking a blood sample or swab (...) (see, for example, Manson 2007, 299;... (shrink)

In this article I will argue first that if ignorance poses a problem for valid consent in medical contexts then framing effects do too, and second that the problem posed by framing effects can be solved by eliminating those effects. My position is thus a mean between two mistaken extremes. At one mistaken extreme, framing effects are so trivial that they never impinge on the moral force of consent. This is as mistaken as thinking that ignorance is (...) so trivial that it never impinges on the moral force of consent. At the other mistaken extreme, framing effects are so serious that their existence shows that consent has no independent moral force. This is as mistaken as the idea that ignorance is so serious that its existence shows that consent has no independent moral force. I will argue that, instead of endorsing either of these mistaken extreme views, we should instead endorse a moderate view according to which framing effects sometimes pose a serious challenge for the validity of consent, just as ignorance does, but one which we can solve by eliminating the effect, just as we can solve the problem of ignorance by eliminating it. (shrink)

How is the validity of our consent, and others’ moral permission to act on our consent affected by coercion? Everyone agrees that in cases of two-party coercion—when X coerces Y to do something with or for X—the consent of the coerced is invalid, and the coercer is not permitted to act upon the consent they receive. But coercers and the recipients of consent are not always identical. Sometimes a victim, Y, agrees to do something to, (...) with, or for Z because they are being coerced by X. Recently, several philosophers have argued that consent under third-party coercion can be fully valid. We argue that this view has troubling implications. We develop a novel view of consent in third-party coercion cases, which we call the partial validity account. The core idea is that, under severe coercion, Y’s consent is at most partially valid—it reduces the strength of, but does not completely dissolve, Z’s consent-sensitive duties. We argue that the partial validity account gets the right results in important cases and explains the moral factors at play better than alternative accounts. (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)

ABSTRACT The objective of this study was to determine the accuracy of a brief informed consent quiz to detect consent comprehension in individuals with cognitive impairment and to explore the degree to which cognitive domains and recent substance use, independently, predict comprehension. We performed a secondary analysis of two cross-sectional studies in individuals with substance use disorders. The ICQ total score was used as the index test and the Montreal Cognitive Assessment as reference standard in receiver operating characteristic (...) curves. Two independent multiple binary logistic regression models were performed using cognitive domains and days of recent substance use as predictors of ICQ outcome. We analyzed data from 215 and 251 participants, respectively. The ICQ showed moderate accuracy for major cognitive impairment and lower accuracy for mild impairment. Optimal cutoff score was set at 10 points or less for detecting comprehension difficulty. Lower scores in Short-Term Memory, Attention, Language, and Orientation increased the probability of failing the ICQ. A procedure including both the ICQ and cognitive screening measure could improve the accuracy of consent comprehension assessments. (shrink)

A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because they often have neither therapeutic nor diagnostic value, and because research participants may not realize this, which could compromise the validity of their consent to the procedure. In the first section of this paper, we describe the burdens, risks, and benefits associated with certain common invasive, nondiagnostic research procedures. We (...) next offer a series of arguments about the general properties of a valid consent for such procedures, and we close by examining what is currently known about consent quality for invasive research procedures when measured against the standards laid out in the second section. We conclude that there is little evidence to either confirm or dispel concerns about participants’ consent quality for protocols involving invasive, nondiagnostic research procedures. (shrink)

Participants in clinical studies are frequently unable to remember study information for the duration of their participation in the research. Along with a nine-member work group and a seven-member advisory group, we determined that six elements of consent are necessary to uphold the validity of consent over time: awareness of ongoing participation; understanding the right to withdraw; understanding that withdrawal will not influence other treatment options; knowledge of the general purpose of the research; knowledge of potential risks of (...) participation; and understanding of the differences between traditional, individualized clinical care and standardized treatment during research participation. Based on these important elements, we developed an Assessment of Sustained Informed Consent as a tool to periodically review a protocol’s essential elements with its participants. We hope this will be a useful means of confirming research participants’ continued knowledge of the critical elements of consent, and of identifying those subjects who need reminding. (shrink)

I argue that valid informed consent is ethically required for organ donation from individuals declared dead using neurological criteria. Current policies in the U.S. do not require this and, not surprisingly, current practices inhibit the possibility of informed consent. Relevant information is withheld, opportunities to ensure understanding and appreciation are extremely limited, and the ability to make and communicate a free and voluntary decision is hindered by incomplete disclosure and other practices. Current practices should be revised to (...) facilitate valid informed consent for organ donation. (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)

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more (...) on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved. (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)

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)

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)

There are two distinct ways for someone to place conditions on their morally valid consent. The first is to place conditions on the moral scope of their consent—whereby they waive some moral claim rights but not others. The second is to conditionally token consent—whereby the condition affects whether they waive any moral claim rights at all. Understanding this distinction helps make progress with debates about so-called “conditional consent” to sexual intercourse in English law, and with (...) understanding how individuals place conditions on their morally valid consent in other contexts. (shrink)

BackgroundThe conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in (...) conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research.AimsThis research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously.MethodsResearch participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants’ experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent.ResultsOver half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants. (shrink)

The liberal view that valid consent is sufficient for a sex act to be morally legitimate is challenged by three major philosophies of sex: the Catholic view of sex as ordained for procreation and properly confined to marriage, the romantic view of sex as bound up with love, and the radical feminist analysis of sex in our society as part and parcel of the domination of women by men. I take a critical look at all three, focusing on (...) Mary Geach''s recent statement of the procreation view, Roger Scruton''s theory of sexual desire as naturally evolving into intimacy and love, and several radical feminist discussions of sex in sexist society which argue that the notion of consent is unhelpful and, indeed, irrelevant. I argue that none of these lines of argument is convincing, and that consent remains the touchstone of morally permissible sex – although, dmittedly, it may not be very helpful in discussing ideals of human sexuality. (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)

In this essay, I discuss why consent is invalidated by duress that involves attaching penalties to someone's refusal to give consent. At the heart of my explanation is the Complaint Principle. This principle specifies that consent is defeasibly invalid when the consent results from someone conditionally imposing a penalty on the consent‐giver's refusal to give the consent, such that the consent‐giver has a legitimate complaint against this imposition focused on how it is affects (...) their incentives for consenting. The Complaint Principle says that this consent is defeasibly invalid to make room for the Authorization Principle, which allows sincere authorizations to constitute valid consent, even when these are issued by an agent acting under duress. The Authorization Principle has application only in cases of third‐party duress because when the consent‐receiver is the source of the duress, the consent‐giver is not sincerely authorizing the action. (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)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential (...) participant's consent to research participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan's argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (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)

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)

Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...

In the wake of scandals about the unauthorised retention of organs following postmortem examination, the issue of valid consent has returned to the forefront. Emphasis is put on obtaining explicit authorisation from the patient or family prior to any medical intervention, including those involving the dead. Although the controversies in the UK arose from the retention of human material for education or research rather than therapy, concern has been expressed that public mistrust could also adversely affect organ donation (...) for transplantation. At the same time, however, the British Medical Association continues to call for a shift to a system of presumed consent for organ transplantation. This apparent inconsistency can be justified because valid distinctions exist between the reasons requiring explicit consent for retention and the acceptability of presumed consent for transplantation. This paper argues for introducing a system of presumed consent for organ donation, given the overwhelming expressions of public support for transplantation. Ongoing legislative review in the UK provides an ideal chance to alter the default position to one where potential donors can simply acquiesce or opt out of donation. Combined with consultation with their relatives, this could be a much better method of realising individuals’ wishes. It would also achieve a better balance between the duties owed to the deceased and those owed to people awaiting a transplant. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The (...) standard view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question (...) of under what conditions consent is valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)

In this essay, I discuss why consent is invalidated by duress that involves attaching penalties to someone's refusal to give consent. At the heart of my explanation is the Complaint Principle. This principle specifies that consent is defeasibly invalid when the consent results from someone conditionally imposing a penalty on the consent‐giver's refusal to give the consent, such that the consent‐giver has a legitimate complaint against this imposition focused on how it is affects (...) their incentives for consenting. The Complaint Principle says that this consent is defeasibly invalid to make room for the Authorization Principle, which allows sincere authorizations to constitute valid consent, even when these are issued by an agent acting under duress. The Authorization Principle has application only in cases of third‐party duress because when the consent‐receiver is the source of the duress, the consent‐giver is not sincerely authorizing the action. (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)

Consent that is voluntary, informed and given by a competent person sometimes transforms a wrong into a right act. How does consent that meets these requirements change the moral property of an act, namely that of being a wronging of a person? This is the question this paper will deal with. Some authors argue that valid consent changes the moral property of an act by changing the reasons which speak against the act. This account of the (...) normative force of consent will be critically examined and rejected. An alternative model will then be put forward and defended according to which consent changes the moral property of an act if and only if the wrong‐making property of the act is that it is not consented to. The upshot will be that consent does not eliminate the wrong‐making property if the unconsented act is wrong for other reasons than not being consented to. (shrink)

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

Clinicians cannot obtain valid consent to treatment because they cannot guess which treatment option will serve a particular patient's best interests. These guesses could be made more accurately if patients were paired with providers who share their deep values.

The notion of “consent” is frequently referred to as “informed consent” to emphasise the informational component of a valid consent. This article considers aspects of that informational component. One misuse of the language of informed consent is highlighted. Attention is then directed to some features of the situation in which consent would not have been offered had certain information been disclosed. It is argued that whether or not such consent is treated as sufficiently (...) informed must, from a moral point of view, take account of four conditions. When these are applied to the operation of consent in relation to criminal responsibility for HIV transmission, the approach in some recent cases is shown to be morally questionable. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The (...) standard view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

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