There are a number of dispositionalist solutions to the free will problem based on freedom consisting in the agent's exercise of a power. But if a subject a is free when they exercise their power P, there is an objection to be overcome from the possibility of power implantation. A brainwasher, rather than directly manipulating a subject's movements, can instead implant in them a desire, to be understood as a disposition to act, and allow the subject to exercise such a (...) power. It seems that, according to the dispositionalist theory of freedom, such an agent would still count as acting freely. There is a strong non-consent intuition that a is not free in such a case because they did not consent to having the power P—the desire in question. Filling out this intuition is not straightforward. But it can be done in terms of the exercise of P being regulated by higher-order powers of self-reflection. Such regulation is what allows an agent to either take ownership of a power or to reject it. (shrink)

Th is chapter outlines the experiences of non-consented vaginal examinations that women have shared with Birthrights and the Association for Improvements in the Maternity Services (AIMS). It gives a flavour of the issues that arise in cases brought to our attention, the impact on women who have to live with these experiences, and the lack of opportunity for proper redress faced by women. This chapter uses case studies to illustrate the experiences which lead women to seek support from AIMS and (...) Birthrights. These are real case studies: real women. They are almost certainly the tip of the iceberg. As this chapter will show, one issue with vaginal examinations is that women oft en do not know that they can decline consent, and/or do not feel confident in doing so. Th ere are no statistics held on the number of women who experience non-consented vaginal examinations but, with a system that includes vaginal examinations within standard maternity care, Birthrights and AIMS are certain that many more cases exist than those which have come to our attention. (shrink)

Contre l’éternelle utopie, thème des conservateurs et des contrerévolutionnaires, postulant que le discours de l’utopie, identique à lui-même, revient toujours pour légitimer une société close, autoritaire et statique, négatrice de toute temporalité, et de la pluralité et de la singularité des individus, Miguel Abensour atteste de la persistance des utopies, recherche asymptotique, volontariste et sans cesse renouvelée d’en finir avec la domination, la servitude volontaire et l’exploitation, comme si chaque moment de lutte suscitait une nouvelle sommation utopique au non-consentement à (...) l’ordre des choses et à la recherche d’un tout autre social, sous l’impératif d’une conversion qui lie indistinctement philosophie, utopie et émancipation humaine. (shrink)

Carol Gould argues that democratic institutions can serve as mechanisms of informed consent or could at least facilitate creating regulations and other structures which facilitate informed consent in bioethics, medicine, and elsewhere. I am sceptical. I argue that democracies cannot serve as vehicles of consent, let alone informed consent. Further, the problems of democratic ignorance and irrationality created significant barriers to democratic deliberation helping to produce better regulations or conditions for informed consent. Democracy is not (...) a good surrogate for consent. (shrink)

ABSTRACTThe principle of informed refusal poses a specific problem when it is invoked by a pregnant woman who, in spite of having accepted her pregnancy, refuses the diagnostic and/or therapeutic measures that would ensure the well‐being of her endangered fetus. Guidelines issued by professional bodies in the developed world are conflicting: either they allow autonomy and informed consent to be overruled to the benefit of the fetus, or they recommend the full respect of these principles. A number of medical (...) ethicists advocate the overruling of alleged irrational or unreasonable refusal for the benefit of the fetus. The present essay supports the view of fetal rights to health and to life based on the principle that an ‘accepted’ fetus is a ‘third person’. In developing countries, however, the implementation of the latter principle is likely to be in conflict with a ‘communitarian’ perception of the individual – in this case, the pregnant woman. Within the scope of the limitations to the right to autonomy of J.S. Mill's ‘harm principle’, the South African Patients’ Charter makes provision for informed refusal. The fact that, in practice, it is not implemented illustrates the well‐known difficulty of applying Western bioethical principles in real life in the developing world. (shrink)

Research on human subjects aims to obtain knowledge of vital importance for human health and functioning. Neuroscientific research specifically is understood as oriented towards three goals: the maintenance of neurological health, the treatment of neurological diseases or syndromes, and the enhancement of neurological functioning. Most guidelines or regulations for pediatric research (whether in the U.S. or elsewhere) require that if a research intervention exposes subjects to more than minimal risk, a prospect of direct benefit is required—along with some other important (...) criteria. It is also required for any research project, that the methods and design will yield scientifically valid knowledge. This is typically met via placebo-controlled trials. This chapter presents an argument to the effect that more than minimal risk research on pediatric subjects cannot meet both ethical requirements. The basic idea is that either the subjects in the control or experimental arm will receive a prospect of direct benefit, but not both. This chapter also argues that the ethical weight or importance of this dilemma is very acute for neuroscientific research given the complexity of the brain’s functioning and the correlated difficulty of judging whether there is a “prospect” of direct benefit. The second half responds to this argument via a case study in neuroscientific research. The solution recapitulates a type of component analysis according to which different ethical principles apply to different activities of a research study. (shrink)

ABSTRACT The principle of informed refusal poses a specific problem when it is invoked by a pregnant woman who, in spite of having accepted her pregnancy, refuses the diagnostic and/or therapeutic measures that would ensure the well‐being of her endangered fetus. Guidelines issued by professional bodies in the developed world are conflicting: either they allow autonomy and informed consent to be overruled to the benefit of the fetus, or they recommend the full respect of these principles. A number of (...) medical ethicists advocate the overruling of alleged irrational or unreasonable refusal for the benefit of the fetus. The present essay supports the view of fetal rights to health and to life based on the principle that an ‘accepted’ fetus is a ‘third person’. In developing countries, however, the implementation of the latter principle is likely to be in conflict with a ‘communitarian’ perception of the individual – in this case, the pregnant woman. Within the scope of the limitations to the right to autonomy of J.S. Mill's ‘harm principle’, the South African Patients’ Charter makes provision for informed refusal. The fact that, in practice, it is not implemented illustrates the well‐known difficulty of applying Western bioethical principles in real life in the developing world. (shrink)

The pregnancy of a 12-year-old girl provides the basis for a consideration of approaches to a dilemma brought about by conflicting expectations. Here, medical opinion is to reject action implied by the lack of Gillick competence and by a ‘parental responsibility’ claim adopted by the girl’s mother. Construction of the dilemma and the subsequent process, which sought resolution, illustrates that the Gillick ruling, and other guidelines intended to be helpful, can prove to be less so.

Cancer screening programmes cause harm to individuals via overdiagnosis and overtreatment, even where they confer population-level benefit. Screening thus appears to violate the principle of non-maleficence, since it entails medically unnecessary harm to individuals. Can consent to screening programmes negate the moral significance of this harm? In therapeutic medical contexts, consent is used as a means of rendering medical harm morally permissible. However, in this paper, I argue that it is unclear that the model of consent used (...) within therapeutic medicine can be applied unproblematically to preventive medicine. Invitation to screening changes the pragmatic norms and expectations of the patient–doctor encounter such that two key principles of consent may be violated. First, the pragmatics of a medical invitation are such that patients may fail to be adequately informed, since patients appear to assume medical invitations are made with their best interests in mind, even where information to the contrary is outlined. Second, screening invitations may place pressure on patients; in the context of a medical encounter, to make an invitation to screening may constitute an inducement to accept. In order to be sure that a patient’s consent to a screening invitation is valid, we must make clear to patients that their decision to accept screening may be shaped not only by how information about screening is presented, but by the pragmatic form of the invitation itself. (shrink)

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)

There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the ‘therapeutic misconception’, but has ignored the ‘completion misconception’. This article argues that, other things being (...) equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if it is or should be anticipatable that there is a non-trivial possibility of non-completion and that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult. (shrink)

This paper discusses the issue of overriding the right of individual consent to participation in cluster randomised trials (CRTs). We focus on CRTs testing the efficacy of non-pharmaceutical interventions. As an example, we consider school closures during the COVID-19 pandemic. In Norway, a CRT was promoted as necessary for providing the best evidence to inform pandemic management policy. However, the proposal was rejected by the Norwegian Research Ethics Committee since it would violate the requirement for individual informed consent. (...) This sparked debate about whether ethics stand in the way of evidence-based health policy, since the Norwegian Research Ethics law’s strict requirements for individual consent make it practically impossible to carry out CRTs of public health interventions. We argue that, in the case of the school closure trial, the suggested CRT would not have eliminated an epistemic gap and thus would not have justified the violation of consent rights. First, we focus on the methodological challenges to estimating quantifiable effects of school closures in the specific case of an airborne infectious disease. Second, in line with Evidential Pluralism, we highlight the value of alternative lines of evidence for informing school closure policy in a pandemic. In general, we propose that a trial requiring the waiver of participants’ consent rights must be highly likely to eliminate an epistemic gap. We elaborate on the practical aspects of this criterion and discuss the potential advantages of adding it to the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. (shrink)

Part of the standard protection of decisionally incapacitated research subjects is a prohibition against enrolling them unless surrogate decision makers authorize it. A common view is that surrogates primarily ought to make their decisions based on what the decisionally incapacitated subject would have wanted regarding research participation. However, empirical studies indicate that surrogate predictions about such preferences are not very accurate. The focus of this article is the significance of surrogate accuracy in the context of research that is not expected (...) to benefit the research subject. We identify three morally relevant asymmetries between being enrolled and not being enrolled in such non-beneficial research, and conclude that when there is a non-negligible probability that surrogates’ predictions are wrong, it will generally be better to err on the side of not authorizing enrollment. (shrink)

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults.Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments (...) selected for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties.Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making.Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)

The reasons for judgment by the Supreme Court of Canada on the appeal in Mabior (2012 SCC 47) fail to address or resolve a number of significant questions. The reasons acknowledge the fundamental role of sexual consent in protecting sexual autonomy, equality, and human dignity, but do not use the law of consent as a tool to assist the Court in crafting a fresh approach to the issue on appeal. Instead the Court adopts the same general approach to (...) analysis of the elements of aggravated sexual assault committed by fraud it used in 1998 in Cuerrier. Fifteen years later, it should be possible to re-conceptualize the problem in a more straightforward manner that reflects Charter values, fundamental common law principles, recent developments in sexual assault law, and the limitations and uncertainties of current HIV treatment and diagnosis. -/- Ironically, the two pronged legal test ultimately proposed by the Court -- non-disclosure of HIV-positive status and a “realistic possibility of transmission,” is likely to give false confidence to individuals who adhere to a regime of anti-retroviral treatment, use good quality latex condoms, and routinely conceal their HIV-positive status from their sexual partners. Research shows that HIV viral loads fluctuate widely in response to a myriad of factors. An inevitable consequence of reliance on the Mabior test will be accused who are shocked to find themselves charged under s. 273, charges that would not apply had they disclosed their HIV-positive status to their sexual partner(s). There are further practical consequences. Non-disclosure will tend to increase the risk of transmission because non-HIV-positive sexual partner(s) will not fully appreciate the actual hazards of improper condom use. As a direct result, careless sexual practices will be more common. And finally, the decision will not contribute to reducing the social stigma that haunts the lives of those who are HIV-positive -- even those who are skilled at deceit. That stigma will not be reduced or eliminated by a ruling that can be seen as tacitly validating stigmatization and fear by appearing to permit infected individuals to pretend they are not HIV-positive when they know or suspect this to be false. Deceit harms the human dignity of the deceived and deceiver alike, and does nothing to build authentic social trust and cohesion. For all these reasons, the problem on appeal in Mabior requires a different approach. This article proposes one. (shrink)

The emergence of controlled, Maastricht Category III, non-heart-beating organ donation programs has the potential to greatly increase the supply of donor solid organs by increasing the number of potential donors. Category III donation involves unconscious and dying intensive care patients whose organs become available for transplant after life-sustaining treatments are withdrawn, usually on grounds of futility. The shortfall in organs from heart-beating organ donation following brain death has prompted a surge of interest in NHBD. In a recent editorial, the British (...) Medical Journal described NHBD as representing “a challenge which the medical profession has to take up.”. (shrink)

Objective To document the legal guardian-related barriers to consent procurement, and their stated reasons for non-participation in a paediatric critical care research study.Study design A multicentre, prospective, cohort study.Participants Legal guardians of children who participated in a multicentre study on adrenal insufficiency in paediatric critical illness. Data were collected on all consent encounters in the main study.Methods Screening data, reasons for consent not being obtained, paediatric risk of mortality scores and age were collected on all 1707 patients (...) eligible for participation in the Adrenal Insufficiency Study.Results The main barriers to approaching legal guardians for consent were lack of availability of the legal guardians and language barriers . Legal guardians of 917 patients were approached with an overall consent rate of 42% . 81% of the 528 legal guardians who declined consent provided an unsolicited reason for refusal. The three most commonly stated reasons were: being overwhelmed , not wanting anything else done to their child and not wanting an additional medication . In addition, 14.2% cited research-related concerns as the reason for their non-participation.Conclusions Barriers to consent procurement in a non-therapeutic paediatric critical care study appear to occur at many levels with lack of availability of legal guardians, and legal guardians feeling overwhelmed, being the most commonly recorded reasons. Further research into the impact of these findings on the validity and generalisability of the results of such studies is necessary prior to the development and study of future consent models. (shrink)

Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non-invasive prenatal testing (NIPT) in first-trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent (...) compared to informed choice, and for a focus on value-consistent choices and personalized informational preferences. We argue for a three-step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical-technical information and are asked to make a decision about screening; (3) during post-test counselling, women are supported in decision-making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre-test) counselling, where techniques for expanding genome analysis and burdensome test-outcomes challenge counselling of patients. (shrink)

Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non‐invasive prenatal testing (NIPT) in first‐trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent (...) compared to informed choice, and for a focus on value‐consistent choices and personalized informational preferences. We argue for a three‐step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical‐technical information and are asked to make a decision about screening; (3) during post‐test counselling, women are supported in decision‐making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre‐test) counselling, where techniques for expanding genome analysis and burdensome test‐outcomes challenge counselling of patients. (shrink)

The quality of the consent obtained from 41 volunteer subjects in eight experiments is evaluated. Five subjects (all physicians) gave informed consent; 22 subjects gave partially informed consent; and 14 subjects merely gave consent. It is argued that 'informed' consent is obtainable only from medically trained people, and that lip service to this concept in laymen should cease. The concept of medical competence should instead be introduced and a personal medical referee appointed to adjudicate on (...) behalf of the volunteer. (shrink)

A large body of literature supports the notion that the language used in informed consent forms is not comprehensible to most research participants. Creating comprehensible informed consent forms for international research presents a further challenge because they are generally written first in English and then translated into the local language. The Kenya Medical Research National Ethical Review Committee determines readability of English consent forms before translation; however, it is neither their policy nor practice to determine whether the (...) forms, once translated into Kiswahili, are of comparable readability to the English forms. Thus, the aim of this study is to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili. (shrink)

Background and rationale Several factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries. Methods This was a single-centre study conducted over 4 months in which a questionnaire was administered to 102 healthy participants and 16 patient participants who had earlier taken part in non-therapeutic studies at our centre. Descriptive statistics and univariate analysis were used to analyse data. Results The most common motivation (...) among healthy participants was financial reward (65%) followed by altruism, free medical check up, curiosity and personal health benefit. Patient participants, however, most commonly said they consented to take part in the trial as they were ‘invited to participate by the treating physician’ (88%). In comparison with the patient participants, healthy participants were more likely to be satisfied with the financial reward (p=0.02), and recommend participation in studies to friends or relatives (p=0.0013). Conclusions The most common motivating factor to participate in non-therapeutic studies appears to be different for healthy participants (financial reward) and patient participants (invitation to participate by the physician). Participants also felt that adequate information and care was given to them during the trial, and that they would participate in future clinical studies, and would also recommend such studies to their friends. (shrink)

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

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)

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

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

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

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

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)

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

This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect of beneficial outcome to the (...) individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation. (shrink)

People have understandable concerns over what happens to their bodies, both during their life and after they die. Consent to organ donation is often perceived as an altruistic decision made by individuals prior to their death so that others can benefit from use of their organs once they have died. More recently, live organ donation has also been possible, where an individual chooses to donate an organ or body tissue that will not result in their death (such as a (...) kidney). Although these live organ donations can be purely altruistic, they are usually done to benefit a close family member. An additional complicating factor with both kinds of donation is whether forms of extended decision-making can be used as a means of consent. This is where instructions are issued through some form of advance directive giving specific written instructions as to donation or by appointing a proxy surrogate decision-maker to determine such issues. In the case of deceased donation, there is a question as to whether an advance directive can override the wishes of family members. In the case of live organ donation, there is a largely untested concern as to whether advance directives or surrogates can provide acceptable consent to donation when an individual, though still alive, has lost the capacity to consent for themselves. In this paper, I will focus predominantly on the second of these issues concerning live organ donation and the challenges this poses for donors who have lost capacity to consent. I argue that the limitations on advance directives and surrogate decision-making mean that they can only give us an indication of preference and cannot serve as an authoritative consent where there is any dispute over donation. Instead, in turns out that family members have a significant and usually determinate role to play in these decisions. Although I am focusing on organ donation, the implications for this potentially extend to the use of other tissues and even gametes, which could be used for reproductive purposes. (shrink)

The fifth text-revised iteration of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) defines paraphilia as “any intense and persistent sexual interest other than sexual interest in genital stimulation or preparatory fondling with phenotypically normal, physically mature, consenting human partners”. Paraphilic disorders specifically denote a paraphilia that is “currently causing distress or impairment to the individual or a paraphilia whose satisfaction has entailed personal harm, or risk of harm, to others”. A diagnosis of paraphilic disorder either demands the personal (...) distress and/or impairment of function that is caused by the atypical sexual urges and fantasies to be present, or the status of non-consent of the other person that these sexual fantasies and urges are directed towards when acted upon by the patient. This paper discusses how consent not only becomes the standard for permissible and legal sexual activity with other persons, but also, when the diagnostic criteria are taken at face-value, for sexual pathology in the DSM-5-TR when the patient acts on their sexual urges. After a close investigation of various possible interpretations of the element of non-consensuality in the diagnostic criteria for paraphilic disorders, this paper concludes that the DSM-5-TR does not offer a clarifying explanation on how mental health professionals should under-stand its approach to diagnosing paraphilic disorders, leaving us with an ambiguous, unclear and unsettled conceptualisation of what it would mean to fulfil its diagnostic criteria. (shrink)

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings (...) We adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)

That consent could wholly explain – either descriptively or normatively – the legitimacy of the structure of political community and it’s most important and influential institutions and practices is deeply implausible. There are two general sorts of considerations adduced against such a proposition. First, history simply refutes it: force is an essential feature of the founding of any political society, and arguably, for its continued existence, and power relations, in all their complexity, are imperfectly tracked by consent. Moreover, (...) there are deep questions about what people are actually consenting to, given the plurality and changing nature of political collectivities over time. Second, in modern societies (perhaps in just any complex human society) our conduct is shaped and governed in so many ways so as to influence not only the options we have, but also the interests, desires and capabilities constitutive of our ability to act in relation to them in the first place. This undermines any easy connection between the presence of consent and my being free. A familiar conundrum for consent as a standard of legitimacy is that if it means literally that individual consent is required for non-arbitrariness in public decision-making, then public decision-making – indeed almost any form of collective action –becomes almost impossible. If only tacit or implicit consent is required, then we can find it everywhere, and thus nowhere, and the standard is empty. (shrink)

BackgroundThis essay provides an ethical and conceptual argument for the use of informed consent prior to the diagnosis of brain death. It is meant to enable the family to make critical end-of-life decisions, particularly withdrawal of life support system and organ donation, before brain death is diagnosed, as opposed to the current practice of making such decisions after the diagnosis of death. The recent tragic case of a 13-year-old brain-dead patient in California who was maintained on a ventilator for (...) over 2 years illustrates how such a consent would have made a crucial difference.MethodsConceptual, philosophical, and ethical analysis.ResultsI first consider a conceptual justification for the use of consent for certain non-beneficial and unwanted medical diagnoses. I suggest that the diagnosis of brain death falls into this category for some patients. Because the diagnostic process of brain death lacks the transparency of traditional death determination, has a unique epistemic structure and a complex risk-benefit profile which differs markedly from case to case, and presents conflicts of interest for physicians and society, I argue that pre-diagnostic counseling and informed consent should be part of the diagnostic process. This approach can be termed as “allow cardiac death”, whose parallel logic with “allow natural death” is discussed. I also discuss potential negative impacts on organ donation and health care cost from this proposal and offer possible mitigation. I show that the pre-diagnostic counseling can improve the possibility for well-thought-out decisions regarding organ donation and terminating life-support system in cases of hopeless prognosis. This approach differs conceptually from the pluralism of the definition of death, such as those in New Jersey and Japan, and it upholds the Uniform Determination of Death Act.ConclusionsMy intention is not to provide an instant panacea for the ongoing impasse of the brain death debate, but to point to a novel conceptual ground for a more pragmatic, and more patient- and family-centered approach. By enabling the family to consent to or decline the diagnostic process of brain death, but not to choose the definition of death, it upholds the current legal definition of death. (shrink)

Consented autopsy is almost non-existent in the Middle-East where established social and cultural beliefs regarding the procedure might discourage family members from requesting a consented autopsy. Evidence suggests that new information is obtained from consented autopsies. It would not be in the best interest of medicine if social and cultural misconceptions succeed in erasing the existence of consented autopsies entirely.

The two most commonly discussed and implemented rationales for acquiring organs for transplantation give consent a central role. I argue that such centrality is a mistake. The reason is that practices of consent serve only to respect patients as autonomous beings. The primary issue in acquiring organs for transplantation, however, is how it is appropriate to treat a newly non-autonomous being. Once autonomy and consent are dislodged from their central position, considerations of utility and fairness take a (...) more prominent position. On the basis of these values, a strongly suggestive moral case is presented for routinely harvesting organs for transplantation. (shrink)

According to the Behavioral View of consent, consent must be expressed in behavior in order to release someone from a duty. By contrast, the Mental View of consent is that normatively efficacious consent is entirely mental. In previous work, I defended a version of the Behavioral View, according to which normatively efficacious ‘consent always requires public behavior, and this behavior must take the form of communication in the case of high-stakes consent’. In this essay, (...) I respond to two arguments by proponents of the Mental View. First, Larry Alexander, Heidi Hurd and Peter Westen have argued that my view has mistaken implications concerning the culpability of different actors. I counter that my version of the view does not have these implications, as it leaves us free to draw moral and legal distinctions between different offences involving non-consensual behavior. Second, Larry Alexander and Kimberly Ferzan have argued for an analogy between consent and abandonment: on the grounds that the normative power to abandon resides in one’s will, Alexander and Ferzan concludes consent does too. I counter that abandonment requires behavior, and call into question the assumption that the ethics of property have much to teach us about the ethics of sexual consent. (shrink)