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.
Rape and sexual assault are major problems. In the majority of rape and sexual assault cases consent is the central issue. Consent is, to borrow a phrase, the ‘moral magic’ that converts an impermissible act into a permissible one. In recent years, a handful of companies have tried to launch ‘consent apps’ which aim to educate young people about the nature of sexual consent and allow them to record signals of consent for future verification. Although (...) ostensibly aimed at addressing the problems of rape and sexual assault on university campuses, these apps have attracted a number of critics. In this paper, I subject the phenomenon of consent apps to philosophical scrutiny. I argue that the consent apps that have been launched to date are unhelpful because they fail to address the landscape of ethical and epistemic problems that would arise in the typical rape or sexual assault case: they produce distorted and decontextualised records of consent which may in turn exacerbate the other problems associated with rape and sexual assault. Furthermore, because of the tradeoffs involved, it is unlikely that app-based technologies could ever be created that would significantly address the problems of rape and sexual assault. (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)
The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely-related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed (...)consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. (shrink)
Lack of consent is valorized within popular culture to the point that sexual assault has become a spectator sport and creepshot entertainment on social media. Indeed, the valorization of nonconsensual sex has reached the extreme where sex with unconscious girls, especially accompanied by photographs as trophies, has become a goal of some boys and men.
Criminal offenders may be offered to participate in voluntary rehabilitation programs aiming at correcting undesirable behaviour, as a condition of early release. Behavioural treatment may include direct intervention into the central nervous system (CNS). This article discusses under which circumstances voluntary rehabilitation by CNS intervention is justified. It is argued that although the context of voluntary rehabilitation is a coercive circumstance, consent may still be effective, in the sense that it can meet formal criteria for informed consent. Further, (...) for a consent to be normatively valid (“take the wronging out of the act”) under a coercive circumstance, the subject to be treated must (1) have the sovereign authority to consent, and (2) the offer-giver must be in the right normative position to make the offer. While I argue that subjects do have the sovereign authority to consent to treatment, I also argue that inappropriate offers yield invalid consents. Considerations on inappropriate offers should therefore inform which kinds of CNS intervention-based rehabilitation schemes the state may propose as part of the criminal justice system. Yet as I conclude in this paper, while there are some intrinsic constraints on voluntary rehabilitation programs, the main constraints on voluntary rehabilitation are likely to be contingent overriders. However, CNS intervention is not ruled out as such in the context of voluntary rehabilitation. (shrink)
I distinguish between 'hard nudges' and 'soft nudges', arguing that it is possible to show that the latter can be compatible with informed consent - as Cohen has recently suggested; but that the real challenge is the compatibility of the former. Hard nudges are the more effective nudges because they work on less than conscious mechanisms such as those underlying our habits: whether those influences - which are often beyond the subject's awareness - can be reconciled with informed (...) class='Hi'>consent in health care is the more challenging question. I suggest two directions for possible answers: on the one hand, looking at the growing empirical literature on mindless judgement and behaviour; and on the other hand considering a more diversified conception of consent, which I sketch. (shrink)
The author examines two proposals to expand legal recognition of individual control over physical integrity. Protections for individual autonomy are discussed in relation to the right to die, euthanasia, medical treatment, and consensual and assaultive sexual behaviours. The author argues that at present, the legal doctrine of consent protects only those individual preferences which are seen to be congruent with dominant societal values; social preferences and convenience override all other individual choices. Under these conditions, more freedom to waive rights (...) of physical integrity can only place socially vulnerable persons at great risk of abuse. (shrink)
In 1993 the Law Lords upheld the original conviction of five men under the 1861 Offences Against the Person Act for participating in sado-masochistic practices. Although the five men were fully consenting adults, the Law Lords held that consent did not constitute a defence to acts of violence within a sado-masochistic context. This paper examines the judgements in this case and argues that sado-masochistic practices are no different from the known exceptions cited by the court to the idea that (...)consent is no defence to violence (sport, parental chastisement and surgery). It also argues that if we can make sense of rape as a non-consensual, violent act, expressed through sex, then we can make sense of sado-masochism as a consensual sexual act, expressed through violence. (shrink)
Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The (...) standard view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)
While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because they differ (...) so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized. (shrink)
Does addiction to heroin undermine the voluntariness of heroin addicts' consent to take part in research which involves giving them free and legal heroin? This question has been raised in connection with research into the effectiveness of heroin prescription as a way of treating dependent heroin users. Participants in such research are required to give their informed consent to take part. Louis C. Charland has argued that we should not presume that heroin addicts are competent to do this (...) since heroin addiction by nature involves a loss of ability to resist the desire for heroin. In this article, I argue that Charland is right that we should not presume that heroin addicts are competent to consent, but not for the reason he thinks. In fact, as Charland's critics correctly point out, there is plenty of evidence showing that heroin addicts can resist their desire for heroin. These critics are wrong, however, to conclude from this that we should presume that heroin addicts are competent to give their voluntary consent. There are, I shall argue, other conditions associated with heroin addiction that might constrain heroin addicts' choice in ways likely to undermine the voluntariness of their consent. In order to see this, we need to move beyond the focus on the addicts' desires for heroin and instead consider the wider social and psychological circumstances of heroin addiction, as well as the effects these circumstances may have on the addicts' beliefs about the nature of their options. (shrink)
BackgroundThe potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' (...) on the ground and the challenges of community consultation.MethodsThe findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach.ResultsField workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research.ConclusionsCommunity engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field workers conducting informed consent faced complex issues and their understanding, attitudes and communication skills were key influences on ethical practice. Community consultation was a challenging concept to put into practice, illustrating the complexity of assessing information needs and levels of deliberation that are appropriate to a given study. (shrink)
Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this (...) concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (shrink)
Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite (...) its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers. (shrink)
I argue against various versions of the ‘attitude’ view of consent and of the ‘action’ view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic context, absence of dissent is sufficient for consent: what is crucial is having access to dissent. In the latter part of the paper I (...) illustrate my view of consent by applying it to the case of consenting to being an organ donor. (shrink)
It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit (...) assessment and informed consent. (shrink)
Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
Empirical evidence suggests that some health professionals believe consent procedures for the emerging technology of non-invasive prenatal diagnosis (NIPD) should become less rigorous than those currently used for invasive prenatal testing. In this paper, we consider the importance of informed consent and informed choice procedures for protecting autonomy in those prenatal tests which will give rise to a definitive result. We consider whether there is anything special about NIPD that could sanction a change to consent procedures for (...) prenatal diagnosis or otherwise render informed decision-making less important. We accept the claim that the absence of risk of miscarriage to some extent lessens the gravity of the decision to test compared with invasive methods of testing. However, we also claim that the definitive nature of the information received, and the fact that the information can lead to decisions of great significance, makes NIPD an important choice. This choice should only be made by means of a rigorous and appropriately supported decision-making process (assuming that this is what the pregnant woman wants). We conclude that, on balance, consent procedures for NIPD should mirror those for invasive testing, albeit without the need to emphasise procedure-related risk. (shrink)
Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. (...) Methods We sought to use mabaraza , traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research. (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)
For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If (...) the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill’s conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill’s conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy. (shrink)
Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is (...) argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified. (shrink)
The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical (...) ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent. This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis. (shrink)
Biobanks for long-term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides (...) the research participants with some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes. (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.
Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman.The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. (...) In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review.Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms.Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. (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.
To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response (...) from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (shrink)
This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to justify the exposure (...) of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. The assent therefore did not provide a valid justification for requesting a blood sample from these children. This study indicates that most children younger than 9 years of age cannot be expected to consent or assent to clinical research in a meaningful way. The current age of 7 years for initiating assent (in addition to parental consent) is possibly not appropriate and should be reconsidered. (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)
In this ground-breaking article submitted for publication in mid-1986, Lucinda Vandervort creates a radically new and comprehensive theory of sexual consent as the unequivocal affirmative communication of voluntary agreement. She argues that consent is a social act of communication with normative effects. To consent is to waive a personal legal right to bodily integrity and relieve another person of a correlative legal duty. If the criminal law is to protect the individual’s right of sexual self-determination and physical (...) autonomy, rather than simply to regulate the type and degree of force that may be used to obtain compliance from a victim, the point of reference must be the individual complainant, as a person who makes choices, not social norms or objective tests based on the ordinary person. To determine whether consent is voluntary, attention must be directed to the presence or absence of factors that had a coercive impact on the individual complainant, a specific person with a collection of social, cultural, and psychological experiences, needs, fears, values, and priorities. Individuals have the right to exercise self-determination in accordance with their own values and perceptions, not those of a mythical victim. Accordingly, Vandervort argues that the prosecution may show either refusal, the absence of affirmative voluntary agreement (including passivity or the absence of consent due to unconsciousness), or circumstances that invalidate any apparent consent. Any of these prove the absence of consent for the purposes of establishing the actus reus of sexual assault. -/- The definition of consent as the affirmative communication of voluntary agreement is also shown to have a variety of implications for the interpretation and application of the law of sexual assault and the handling of evidentiary issues at trial in sexual assault cases. Key among these is the pivotal significance of the legal definition of consent as a tool to bar availability of the defence of “mistaken belief in consent.” Vandervort argues that in many cases the defence of “mistaken belief in consent” is based on ignorance of the law of consent, mistake about the legal definition of consent, or a failure to appreciate the legal significance of facts that are well-known, and not on a mistaken belief in an erroneous set of facts. The broad proposition asserted here is that a statutory criminal law is enforceable only if all defences based directly or indirectly on belief in the validity of extra-legal norms that authorize infringement of rights protected by the criminal law are barred. This proposition and the characterization of some mistakes about consent as legal, not factual, are also shown to be useful to exclude rape-myths and stereotypical assumptions---the stuff of which “social” definitions of consent have long been constructed---from the decision-making process at trial. -/- . (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)
Consent's capacity to legitimise actions and claims is limited by conditions such as coercion, which render consent ineffective. A better understanding of the limits to consent's capacity to legitimise can shed light on a variety of applied debates, in political philosophy, bioethics, economics and law. I show that traditional paternalist explanations for limits to consent's capacity to legitimise cannot explain the central intuition that consent is often rendered ineffective when brought about by a rights violation (...) or threatened rights violation. I argue that this intuition is an expression of the same principles of corrective justice that underlie norms of compensation and rectification. I show how these principles can explain and clarify core intuitions about conditions which render consent ineffective, including those concerned with the consenting agent's option set, his mental competence, and available information. (shrink)
It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's (...)consent to research participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan's argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)
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)
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)
The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre-test information and achieving autonomous decision-making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized (...) by the International Association of Bioethics, these challenges were presented for three different areas in which these so-called ‘new genetics’ technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set-up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set-up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct-to-consumer applications of the new genetics. (shrink)
I begin my analysis of consent by agreeing with Professor Hurd that consent functions as a “moral transformative” by altering the obligations and permissions that determine the Tightness of others' actions. I further agree with her that consent is intimately related to the capacity for autonomous action; one who cannot alter others' obligations through consent is not fully autonomous. I cannot improve on her elaboration of these points.
Machine generated contents note: 1. Introduction: why focus on informed consent?; 2. Deciding who decides: capacity and consent; 3. Putting the informed into 'informed consent': information and decision-making; 4. Freedom of expression: the voluntary nature of consent; 5. A patient's prerogative? The continuing nature of consent; 6. Concluding words about consent; Index.
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.
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)
Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated (...) in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (shrink)
Some political philosophers have judged that it is absurd to think that there can be unintentional consent. In this paper, I present an example of unintentional consent, which I refer to as the adapted boardroom example. I consider reasons for denying that this is an example of unintentional consent, but find that these reasons are unconvincing.
Over the past several decades the ‘affective revolution’ in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. (...) More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification. (shrink)
The liberal view that valid consent is sufficient for a sex act to be morally legitimate is challenged by three major philosophies of sex: the Catholic view of sex as ordained for procreation and properly confined to marriage, the romantic view of sex as bound up with love, and the radical feminist analysis of sex in our society as part and parcel of the domination of women by men. I take a critical look at all three, focusing on Mary (...) Geach''s recent statement of the procreation view, Roger Scruton''s theory of sexual desire as naturally evolving into intimacy and love, and several radical feminist discussions of sex in sexist society which argue that the notion of consent is unhelpful and, indeed, irrelevant. I argue that none of these lines of argument is convincing, and that consent remains the touchstone of morally permissible sex – although, dmittedly, it may not be very helpful in discussing ideals of human sexuality. (shrink)
Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent (...) by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p vs. 8[4,9], p vs. 5[2,7], p Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. (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)
The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings. Parental informed consent process in a rural setting of northern Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing informed consent process.