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)

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)

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)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (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.

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)

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.

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: providing transparency; allowing control and authorization; promoting concordance with participants' values; and protecting and promoting welfare interests. Three other functions are systemic or policy focused: promoting trust; satisfying regulatory requirements; and promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

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)

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)

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

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)

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)

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 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.

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)

BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of (...) Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures. (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)

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)

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)

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)

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 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 received view in medical contexts is that informed consent is both necessary and sufficient for patient autonomy. This paper argues that informed consent is not sufficient for patient autonomy, at least when autonomy is understood as a "relational" concept. Relational conceptions of autonomy, which have become prominent in the contemporary literature, draw on themes in the thought of Charles Taylor. I first identify four themes in Taylor's work that together constitute a picture of human agency corresponding to (...) the notion of agency implicit in relational accounts of autonomy. Drawing on these themes, I sketch two arguments against the position that informed consent secures autonomy. The first is that informed consent is an "opportunity" concept whereas autonomy is an "exercise" concept; the second is that informed consent requires merely weak evaluation and not strong evaluation. On Taylor's analysis of agency, strong evaluation is required for agency and for autonomy. (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.

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)

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

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.

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

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)

Over the past few decades, Indigenous communities have successfully campaigned for greater inclusion in decision-making processes that directly affect their lands and livelihoods. As a result, two important participatory rights for Indigenous peoples have now been widely recognized: the right to consultation and the right to free, prior and informed consent (FPIC). Although these participatory rights are meant to empower the speech of these communities—to give them a proper say in the decisions that most affect them—we argue that the (...) way these rights have been implemented and interpreted sometimes has the opposite effect, of denying them a say or ‘silencing’ them. In support of this conclusion we draw on feminist speech act theory to identify practices of locutionary, illocutionary, and perlocutionary group silencing that arise in the context of consultation with Indigenous communities. (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)

Unrealistic therapeutic beliefs are very common—the majority of patient-subjects enrol in phase 1 trials seeking and expecting significant medical benefit, even though the likelihood of such benefit has historically proven very low. The high prevalence of therapeutic misestimation and unrealistic optimism in particular has stimulated debate about whether unrealistic therapeutic beliefs in early-phase clinical trials preclude adequate informed consent. We seek here to help resolve this controversy by showing that a crucial determination of when such therapeutic beliefs are ethically (...) problematic turns on whether they are causally linked and instrumental to the motivation to participate in the trial. Thus, in practice, it is ethically incumbent on researchers to determine which understanding and beliefs lead to the participant’s primary motivation for enrolling, not to simply assess understanding, beliefs and motivations independently. We further contend that assessing patient-subjects’ appreciation as a component of informed consent—it is already an established component of decision-making capacity assessments—can help elucidate the link between understanding-beliefs and motivation; appreciation refers to an individual’s understanding of the personal significance of both the medical facts and the experience of trial participation. Therefore, we recommend that: in addition to the usual question, ‘Why do you want to participate in this trial?’, all potential participants should be asked the question: ‘What are you giving up by participating in this trial?’ and researchers should consider the settings in which it may be possible and practical to obtain ‘two-point consent’. (shrink)

Consider three cases: -/- Turn: A trolley is about to kill five innocent strangers. You can turn the trolley onto me, saving the five and killing me. -/- Hurl: A trolley is about to kill five innocent strangers. You can hurl me at the trolley, saving the five and paralyzing me. -/- TurnHurl: A trolley is about to kill five innocent strangers. You can turn the trolley onto me, saving the five and killing me. You can instead hurl me at (...) the trolley, saving the five and paralyzing me. -/- Most find the following four claims intuitively plausible: -/- (1) It is permissible to turn the trolley onto me in Turn. (2) It is impermissible to hurl me at the trolley in Hurl. (3) It is impermissible to turn the trolley onto me in TurnHurl. (4) It is permissible to hurl me at the trolley in TurnHurl. -/- But how does turning go from permissible to impermissible, and hurling from impermissible to permissible, when both alternatives are available? I argue that such “secondary permissibility” claims are explained by contrastive consent. Even if I do not consent to being harmed, it is likely I’ll consent to being hurled at the trolley rather than being turned onto. (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)

Modern military organizations are paternalistic organizations. They typically recognize a duty of care toward military personnel and are willing to ignore or violate the consent of military personnel in order to uphold that duty of care. In this paper, we consider the case for paternalism in the military and distinguish it from the case for paternalism in medicine. We argue that one can consistently reject paternalism in medicine but uphold paternalism in the military. We consider two well-known arguments for (...) the conclusion that military organizations should not be entitled to use experimental drugs on troops without first obtaining the informed consent of those troops. We argue that both of these are unsuccessful, in the absence of an argument for the rejection of paternalism in the military altogether. The case for military paternalism is widely accepted. However, we consider three ways in which it could be challenged. (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)

Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully (...) talks through the most important points, and gives him time to ask questions. Though it is a Phase 1 study and the chance that he will benefit is very low, Miguel happily agrees to take part. A week later, after the first experimental injection, she asks him if he is worried about the risks. “Risks?” he asks. “I’m sure this is safe—you’re a doctor, after all!”. (shrink)

Tom Dougherty has recently defended the claim that all deception that is consequential for sex is seriously wrong. This discussion piece argues that deception does not have to seriously undermine consent and that when sexual deception is seriously wrong, that may not only be to do with its relation to consent. In doing so, it defends distinguishing between the seriousness of deceptions, whether these are sexual or in other areas of life, and so defends what Dougherty calls the (...) lenient view. (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)

(2013). Informed Consent, Big Data, and the Oxymoron of Research That Is Not Research. The American Journal of Bioethics: Vol. 13, No. 4, pp. 40-42. doi: 10.1080/15265161.2013.768864.

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria (...) for broad consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material. (shrink)

Hypothetical contracts have been said to be not worth the paper they are not written on. This paper defends hypothetical consent theories of justice, such as Rawls's, against the view that they lack justificatory power. I argue that while hypothetical consent cannot generate political obligation, it can generate political legitimacy.

Researchers have explored questions concerning public participation and consent in geoengineering governance. Yet, the notion of consent has received little attention from researchers, and it is rarely discussed explicitly, despite being prescribed as a normative requirement for geoengineering research and being used in rejecting some geoengineering options. As it is noted in the leading geoengineering governance principles, i.e. the Oxford Principles, there are different conceptions of consent; the idea of consent ought to be unpacked more carefully (...) if, and when, we invoke it in the discussion. This article offers a theoretical reflection on different conceptions of consent and their place in geoengineering governance. More specifically, I discuss three models of consent, i.e. explicit consent, implied consent and hypothetical consent, and assess their applicability to geoengineering governance. Although there are different models of consent, much discussion of geoengineering governance has committed only to explicit consent. I note that such a commitment springs from a specific ideal political order. Accordingly, we should be wary of any naïve commitment to it so long as the political order we hope for remains open to debate. Finally, I illustrate two approaches to introduce consent into a geoengineering governance framework. (shrink)

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.

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

I argue that a policy of presumed consent for cadaveric organ procurement, which assumes that people do want to donate their organs for transplantation after their death, would be a moral improvement over the current American system, which assumes that people do not want to donate their organs. I address what I take to be the most important objection to presumed consent. The objection is that if we implement presumed consent we will end up removing organs from (...) the bodies of people who did not want their organs removed, and that this situation is morally unacceptable because it violates the principle of respect for autonomy that underlies our concept of informed consent. I argue that while removing organs from the bodies of people who did not want them removed is unfortunate, it is morally no worse that not removing organs from the bodies of people who did want them removed, and that a policy of presumed consent will produce fewer of these unfortunate results than the current system. (shrink)

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)

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)

According to an often repeated definition, economics is the science of individual choices and their consequences. The emphasis on choice is often used – implicitly or explicitly – to mark a contrast between markets and the state: While the price mechanism in well-functioning markets preserves freedom of choice and still efficiently coordinates individual actions, the state has to rely to some degree on coercion to coordinate individual actions. Since coercion should not be used arbitrarily, coordination by the state needs to (...) be legitimized by the consent of its citizens. The emphasis in economic theory on freedom of choice in the market sphere suggests that legitimization in the market sphere is “automatic” and that markets can thus avoid the typical legitimization problem of the state. In this paper, I shall question the alleged dichotomy between legitimization in the market and in the state. I shall argue that it is the result of a conflation of choice and consent in economics and show how an independent concept of consent makes the need for legitimization of market transactions visible. Footnotes1 For helpful comments and suggestions I am most grateful to Marc Fleurbaey, Alain Marciano, Herlinde Pauer-Studer, Thomas Pogge, Hans Bernhard Schmid, to seminar or conference participants in Aix-Marseille, Tutzing, Paris, and Amsterdam, and to two anonymous referees. (shrink)