BackgroundThe EU’s 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children’s rights.MethodThis study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 (...) pupils (mean age 13.1 years) of a secondary school in northern Germany.ResultsA majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents’ decision-making process.ConclusionBearing in mind adolescents’ generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample. (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)

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)

Background: Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study. Methods: The study used a rapid assessment incorporating multiple qualitative (...) methods including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information. Results: MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research.Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation. Conclusions: It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections.Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important. (shrink)

Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study.

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.

A popular introduction to common consent arguments for belief in God.

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)

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.

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)

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)

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

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)

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 order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent (...) needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (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)

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)

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)

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)

Objectives: To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15–45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge.Methods: 60 semistructured interviews and 12 focus groups were conducted to explore subjects’ perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge (...) that not all trial capsules are the same. The subjects’ fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling.Results: Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers’ characteristics were not associated with subjects’ knowledge.Conclusions: Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education. (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)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions (...) for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (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)

Implantable brain–computer interface technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy (...) and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants. (shrink)

Kant’s Formula of Humanity can be analyzed into two parts. One is an injunction to treat humanity always as an end. The other is a prohibition on using humanity as a mere means. The second is often referred to as the FH prohibition or the mere means prohibition. It has become popular to interpret this prohibition in terms of consent. The idea is that, if X uses Y's humanity as a means and Y does not consent to it, (...) then X uses Y's humanity as a mere means. There is then debate about the kind of consent that is relevant: possible, actual, or rational. In this paper, I argue against this interpretation. Section one sets up the consent account. Section two attacks possible and actual consent accounts on doctrinal grounds. Section three extends this doctrinal attack to rational consent accounts. Section four circles back to the original motivation for the consent interpretation. I argue that the consent account rests on a misinterpretation, and I conclude with a quick sketch of an alternative interpretation of the FH prohibition. (shrink)

This chapter contains sections titled: The Moral Foundation The Legal Requirement for Consent in Therapeutic Settings The Exceptions References.

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)

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)

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)

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)

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)

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)

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)

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)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions (...) for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

Must we obtain a patient’s consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient’s prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. (...) In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important (...) changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

Given the widening gap between the number of individuals on transplant waiting lists and the availability of donated organs, as well as the recent plateau in donations based on neurological criteria, there has been a growing interest in expanding donation after circulatory determination of death. While the prevalence of this form of organ donation continues to increase, many thorny ethical issues remain, often creating moral distress in both clinicians and families. In this article, we address one of these issues, namely, (...) the challenges surrounding patient and surrogate informed consent for donation after circulatory determination of death. First we discuss several general concerns regarding consent related to this form of organ donation, and then we address additional issues that are unique to three different patient categories: adult patients with medical decision-making capacity or potential capacity, adult patients who lack capacity, and pediatric patients. (shrink)

Why is consent revocable? In other words, why must we respect someone's present dissent at the expense of her past consent? This essay argues against act-based explanations and in favor of a rule-based explanation. A rule prioritizing present consent will serve our interests the best, in light of our interests in having flexibility over our consent and in minimizing the possibility of error in people's judgments about whether we consent.

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.

Feminist legal scholarship has questioned the usefulness of non-consent as a criterion for rape. Under conditions of generalized sexual oppression, consent may not be an adequate for absence of coercion. I defend this argument and propose that rape law reform can be usefully informed by state protection of workers in the capitalist labor market, where it is assumed that the parties occupy an unequal bargaining position.

The practice around informed consent in clinical medicine is both inconsistent and inadequate. Indeed, in busy, contemporary health care settings, getting informed consent looks little like the formal process developed over the past sixty years and presented in medical textbooks, journal articles, and academic lectures. In this article, members of the Society of Teachers of Family Medicine (STFM) Collaborative on Ethics and Humanities review the conventional process of informed consent and its limitations, explore complementary and alternative approaches (...) to doctor‐patient interactions, and propose a new model of consent that integrates these approaches with each other and with clinical practice. The model assigns medical interventions to a consent continuum defined by the discrete categories of traditional informed consent, assent, and nondissent. Narrative descriptions and clinical exemplars are offered for each category. The authors invite colleagues from other disciplines and from the academic ethics community to provide feedback and commentary. (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.

In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say “no.” I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that are (...) known to the patient prior to treatment. Yet, for many patients, knowledge of the price is relevant to whether they would give consent. If informed consent requires that patients know all information about their treatment that is relevant to their decision, then consent to a medical intervention in the absence of the price is not informed consent. (shrink)

In his recent book Democratic Authority, David Estlund defends a strikingly new and interesting account of political authority, one that makes use of a distinctive kind of hypothetical consent that he calls ‘normative consent’: a person can come to have a duty to obey another when it is the case that, were she given the chance to consent to the duty, she would have a duty to consent to it. If successful, Estlund’s account promises to provide (...) what has arguably so far remained elusive: the basis for the authority of suitably democratic laws. In this paper, I argue that, despite its promise, the account Estlund develops is, in a crucial respect, incoherent: the principle of normative consent that he offers relies on a claim about a hypothetical situation, but the hypothetical situation at issue is one that, according to the principle itself, is morally impossible. (shrink)

Several attempts have been made to transfer the concept of informed consent from medical and research ethics to dealing with affected groups in other areas such as engineering, land use planning, and business management. It is argued that these attempts are unsuccessful since the concept of informed consent is inadequate for situations in which groups of affected persons are dealt with collectively (rather than individually, as in clinical medicine). There are several reasons for this. The affected groups from (...) which informed consent is sought cannot be identified with sufficient precision. Informed consent is associated with individual veto power, but it does not appear realistic to give veto power to all individuals who are affected for instance by an engineering project. Most importantly, the concept of informed consent puts focus on the public’s acceptance of ready-made proposals rather than on its participation in the decision-making process as a whole, which includes the development of alternatives for the decision. Therefore, the concept of informed consent is not applicable to a company’s relations with groups and collectives. It may, however, be applicable to a company’s relations with individual persons such as customers and employees. (shrink)