In an earlier article in this journal I argued that the question of whether heroin addicts can give voluntary consent to take part in research which involves giving them a choice of free heroin does not – in contrast with a common assumption in the bioethics literature – depend exclusively on whether or not they possess the capacity to resist their desire for heroin. In some cases, circumstances and beliefs might undermine the voluntariness of the choices a person makes (...) even if they do possess a capacity for self-control. Based on what I took to be a plausible definition of voluntariness, I argued that the circumstances and beliefs typical of many vulnerable heroin addicts are such that we have good reasons to suspect they cannot give voluntary consent to take part in such research, even assuming their desire for heroin is not irresistible. In a recent article in this journal, Uusitalo and Broers object to this on the grounds that I misdescribe heroin addicts' options set, that the definition of voluntariness on which I rely is unrealistic and too demanding, and, more generally, that my view of heroin addiction is flawed. I think their arguments derive from a misunderstanding of the view I expressed in my article. In what follows I hope therefore to clarify my position. (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)

This paper argues, against the prevailing view, that consent to privacy policies that regular internet users usually give is largely unproblematic from the moral point of view. To substantiate this claim, we rely on the idea of the right not to know (RNTK), as developed by bioethicists. Defenders of the RNTK in bioethical literature on informed consent claim that patients generally have the right to refuse medically relevant information. In this article we extend the application of the (...) RNTK to online privacy. We then argue that if internet users can be thought of as exercising their RNTK before consenting to privacy policies, their consent ought to be considered free of the standard charges leveled against it by critics. (shrink)

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

Providing heroin to heroin addicts taking part in medical trials to assess the effectiveness of the drug as a treatment alternative, breaches ethical research standards, some ethicists maintain. Heroin addicts, they say, are unable to consent voluntarily to take part in these trials. Other ethicists disagree. In our view, both sides of the debate have an inadequate understanding of voluntariness. In this article we therefore offer a fuller conception, one which allows for a more flexible, case-to-case approach in which (...) some heroin addicts are considered capable of consenting voluntarily, others not. An advantage of this approach, it is argued, is that it provides a safety net to minimize the risk of inflicting harm on trial participants. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer (...) of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

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)

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform (...) patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

Informed consent is a central concept for empirical and theoretical research concerning pregnancy management decisions and is often taken to be one of the more fundamental goals of the profession of genetic counseling. Tellingly, this concept has been seen by disability communities as salutary, despite longstanding critiques made by disability activists, advocates, and scholars concerning practices involved in genetic counseling more generally. In this chapter, we show that the widespread faith in informed consent is misleading and (...) can be detrimental to the practice of genetic counseling as guided by concerns of justice and equity. We proceed in two steps. First, we explain how informed consent is flawed as a practical concept. Second, we show how the inadequacy of informed consent illuminates the animating core of disability critiques of genetic counseling: the issue of ableism. We argue that the problem of ableism cannot be solved with informed consent because it is not merely a problem of information, but also of epistemic schemas. We suggest that what we call critically informed consent is better suited to move genetic counseling from being aware of the problem of ableism to becoming actively anti-ableist. (shrink)

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

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential (...) clinical benefits for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (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)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical (...) studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Informed consent has become the most obvious instantiation of patient autonomy in contemporary medicine, though as a practice it does not encompass all spheres of medicine. While diagnostic radiological procedures carry some risk due to the use of radiation, there is no standardized practice of informed consent in the United States. The authors describe the ethical justification of informed consent, the legal background surrounding it, and a brief history of radiology and radiological protection. They (...) ultimately argue that informed consent should become a common practice in computed tomography given the risks involved due to radiation exposure, especially considering the overuse of this technology, since it respects patient autonomy. (shrink)

Florence Ashley has argued that requiring patients with gender dysphoria to undergo an assessment and referral from a mental health professional before undergoing hormone replacement therapy is unethical and may represent an unconscious hostility towards transgender people. We respond, first, by showing that Ashley has conflated the self-reporting of symptoms with self-diagnosis, and that this is not consistent with the standard model of informed consent to medical treatment. Second, we note that the model of informed consent (...) involved in cosmetic surgery resembles the model Ashley defends, and that psychological assessment and referral is recognised as an important aspect of such a model. Third, we suggest that the increased prevalence of psychiatric morbidity in the transgender population arguably supports the requirement of assessment and referral from a mental health professional prior to undergoing HRT. (shrink)

Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments, rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of (...) psychotherapy have a duty to ‘go open’ to patients about the role of common factors in therapy ; to not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ claim. While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works. (shrink)

In his article “Nudging and Informed Consent,” Shlomo Cohen (2013) argues, among other things, that 1) “to the extent that the nudge-influenced decision making is rational—in whatever sense,” there...

In ‘Psychotherapy, Placebos and Informed Consent’, I argued that the minimal standard for informed consent in psychotherapy requires that ‘patients understand that there is currently no consensus about the mechanisms of change in psychotherapy, and that the therapy on offer…is based on disputed theoretical foundations’, and that the dissemination of this information is compatible with the delivery of many theory-specific forms of psychotherapy (including cognitive behavioural therapy [CBT]). I also argued that the minimal requirements for (...) class='Hi'>informed consent do not include information about the role of therapeutic common factors in healing (e.g., expectancy effects and therapist effects); practitioners may discuss the common factors with patients, but they are not part of the ‘core set’ of information necessary to obtain informed consent. In a recent reply, Charlotte Blease criticises these two arguments by claiming they are not supported by empirical findings about the therapeutic common factors. Blease’s response is based on serious misunderstandings of both CBT and what the common factor findings actually find. Nevertheless, addressing the reasons for these misunderstandings is instructive and gives us an opportunity to clarify what, exactly, needs to be explained to patients in order to obtain informed consent for psychotherapy. (shrink)

In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality (...) and quantity of the evidence for the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues. (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)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in (...) biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do not read the information provided as part of the consent process and they habitually provide or refuse their consent without adequate reflection. In principle, these practices call into question the validity (...) of their consent. In this paper we argue that although the ‘no read problem’ and the routinisation of consent may apply to research participants’ consent practices for studies on crowdsourcing platforms, this is not a serious problem. Furthermore, given that the informational requirements for informed consent in these contexts are minimal, we argue that these participants are, nevertheless, sufficiently informed to give valid consent. We conclude that research ethics committees and institutional review boards should only agonise over the precise details of the informed consent process and materials in those rare cases where appreciable risks to research participants need to be managed. (shrink)

The field of bioethics is replete with applications of moral theories such as utilitarianism and Kantianism. For a given dilemma, even if it is not clear how one of these western philosophical principles of right (and wrong) action would resolve it, one can identify many of the considerations that each would conclude is relevant. The field is, in contrast, largely unaware of an African account of what all right (and wrong) actions have in common and of the sorts of factors (...) that for it are germane to developing a sound response to a given bioethical problem. My aim is to help rectify this deficiency by first spelling out a moral theory grounded in the mores of many sub-Saharan peoples, and then applying it to some major bioethical issues, namely, the point of medical treatment, free and informed consent, standards of care and animal experimentation. For each of these four issues, I compare and contrast the implications of the African moral theory with utilitarianism and Kantianism, my overall purposes being to highlight respects in which the African moral theory is distinct and to demonstrate that the field should take it at least as seriously as it does the Western theories. (shrink)

It is sometimes argued that autonomous decision-making requires that the decision-maker’s desires are authentic, i.e., “genuine,” “truly her own,” “not out of character,” or similar. In this article, it is argued that a method to reliably determine the authenticity (or inauthenticity) of a desire cannot be developed. A taxonomy of characteristics displayed by different theories of authenticity is introduced and applied to evaluate such theories categorically, in contrast to the prior approach of treating them individually. The conclusion is drawn that, (...) in practice, the authenticity of desires cannot be reliably determined. It is suggested that authenticity should therefore not be employed in informed consent practices in healthcare. (shrink)

Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy (...) research conducted or authorized by government. We argue that investigators need not secure participants' informed consent when conducting government policy experiments if: the government institution conducting or authorizing the experiment possesses a right to rule over the spheres of policy targeted by the research; and data collection does not involve the violation of participants' autonomy rights. (shrink)

Analytic Philosophy, Volume 62, Issue 1, Page 33-56, March 2021.

This paper explores how transformative experience generates decision-making problems of particular seriousness in medical settings. Potentially transformative experiences are especially likely to be encountered in medicine, and the associated decisions are confronted jointly by patients and clinicians in the context of an imbalance of power and expertise. However in such scenarios the principle of informed consent, which plays a central role in guiding clinicians, is unequal to the task. We detail how the principle’s assumptions about autonomy, rationality and (...) information handle transformative experiences poorly, appealing to several difficult cases for medical decision-making to illustrate the resulting problem, and we consider how the existing literature on complications with consent fails to offer a resolution. We argue that recognition of the problem has a role to play in achieving a more effective response to transformative decisions. In Sect. 1 we introduce several representative cases of challenging patient decision-making that clinicians might face. In Sect. 2 we detail how transformative experience has been analysed in the recent literature, before outlining in Sect. 3 the theoretical basis of the principle of informed consent, which plays a central role in how clinicians are expected to support decision-making. In Sect. 4, having laid the groundwork for a clear description, we return to the cases given in Sect. 1 to confirm how their transformative nature presents a problem: either clinicians treat the decisions faced by these patients as ‘normal’, encouraging them to focus on information provision that patients may be unable to act on, or they treat them as transformative, in which case they lack the resources to recognise whether they are helping patients make (subjectively) good decisions. In Sect. 5 we argue that the existing literature does not offer any escape from this problem. We close in Sect. 6 by noting the significant impact that appreciating the problem of transformative experience could have on supporting transformative decisions in medicine and briefly suggesting how we might aim to develop new approaches to dealing with these. (shrink)

This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self‐determination. The environmental release of such animals has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political‐economic‐legal problems that would arise with the environmental release of such (...) organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected. (shrink)

Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical (...) codes become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically. (shrink)

Anomaly in English law between age of children's permitted consent to treatment and much lower age of criminal responsibility.

Subjective rights enjoy limited import in Kelsenian theory for whereas the concept of duty underlies every legal norm, that of rights is merely possible and only emerges when the imposition of the sanction attached to the breach of the duty is made dependent upon a subject's will to bring legal action. The presence of secondary norms establishing certain duties of medical professionals on informed consent displays the existence of correlative reflex rights of patients. Yet, together with secondary norms, (...) Western legal systems typically institute norms of competence enabling patients to take legal action when those duties correlative to their reflex right to informed consent have been infringed. Thus, informed consent constitutes a set of subjective legal positions of patients and medical professionals. Despite its excessive formalism and questionable neutrality, the Kelsenian approach permits to define and clearly distinguish patients' genuine rights from mere aspirations devoid of legal basis. (shrink)

El consentimiento informado del paciente se inserta en el ámbito de su autonomía decisoria. Aunque presenta un sustrato corporal, este aparece combinado con elementos de índole moral que presuponen una noción concreta de persona como libre y autónoma. Tanto de las definiciones doctrinales como del material normativo se desprende que se trata de una posición jurídica subjetiva del paciente, alternativamente calificada como una “pretensión” o “derecho subjetivo en sentido estricto”, en términos hohfeldianos; un “derecho negativo de defensa”, o una “inmunidad”. (...) En España, el Tribunal Constitucional ha vinculado el consentimiento informado del paciente al derecho fundamental a la integridad física y moral (15 CE), lo cual permite plantear el análisis en clave iusfundamental. Con todo, se advierten dudas e incompatibilidades entre la explicación habitual del consentimiento informado, su fundamento constitucional y su regulación jurídica. El objetivo del presente libro consiste en proporcionar una definición integral del consentimiento informado como derecho subjetivo del paciente y como manifestación de un derecho fundamental, a partir de una óptica poliédrica que aporta certeza en la práctica asistencial y jurídica. // The patient's right to informed consent is inserted within the scope of his decisional autonomy. Although it has a bodily background, it is combined with features of moral nature, which presupposes a concrete notion of the person as free and autonomous. Both, doctrinal approaches and normative legal material show that it is a subjective legal position of the patient, being alternatively qualified as a Hohfeldian “claim” or a “subjective right in a strict sense”; a "negative right" or an "immunity." The Spanish Constitutional Court has linked the informed consent of the patient to the fundamental right to physical and moral integrity (15 CE), which allows us to propose a fundamental rights-based analysis. Nonetheless, doubts and inconsistencies are perceived between the customary explanation of informed consent, its constitutional foundation and its legal regulation. The aim of this book is to provide a comprehensive definition of informed consent as subjective right of the patient and expression of a fundamental right, from a multi-fold perspective that provides certainty in both legal and health care practice. (shrink)

Health care providers are expected both to relieve pain and to provide anticipatory guidance regarding how much a procedure is going to hurt. Fulfilling those expectations is complicated by the cognitive modulation of pain perception. Warning people to expect pain or setting expectations for pain relief not only influences their subjective experience, but it also alters how nociceptive stimuli are processed throughout the sensory and discriminative pathways in the brain. In light of this, I reconsider the characterization of placebo analgesia (...) as pharmacologically inert and the use of it as deceptive. I show that placebo analgesia exploits the same physical mechanisms as proven analgesics and argue that it should be utilized to relieve pain. Additionally, I describe factors to help identify situations in which clinicians have the obligation to disclose the potential for pain coupled with ways of mitigating the risk of high-intensity pain by setting positive expectations. (shrink)

Medical ethicists conventionally assume that the requirement to employ informed consent procedures is grounded in autonomy. It seems intuitively plausible that providing information to an agent promotes his autonomy by better allowing him to steer his life. However, James Taylor questions this view, arguing that any notion of autonomy that grounds a requirement to inform agents turns out to be unrealistic and self-defeating. Taylor thus contends that we are mistaken about the real theoretical grounds for informed (...) class='Hi'>consent procedures. Through analysing Taylor's arguments and showing that they do not stand up to scrutiny, it is possible to defend the view that autonomy is a plausible theoretical basis for informed consent, and to enhance our understanding of the relationship between autonomy and informed consent. (shrink)

Human development is meant to be transformational in that it aims to improve people's lives by enhancing their capabilities. But who does it target: people as they are or the people they will become? This paper argues that the human development approach relies on an understanding of personal identity as dynamic rather than as static collections of preferences, and that this distinguishes human development from conventional approaches to development. Nevertheless, this dynamic understanding of personal identity is presently poorly conceptualized and (...) this has implications for development practice. We identify a danger of paternalism and propose institutionalizing two procedural principles as side constraints on development policies and projects: the principle of free prior informed consent and the principle of democratic development. -/- . (shrink)

In this article we explore the underpinnings of what we view as a recent "backlash" in English law, a judicial reaction against considering children's and young people's expressions of their own feelings about treatment as their "true" wishes. We use this case law as a springboard to conceptual discussion, rooted in (a) empirical psychological work on child development and (b) three key philosophical ideas: rationality, autonomy and identity. Using these three concepts, we explore different understandings of our central theme, true (...) wishes. These different conceptual interpretations, we argue, help to elucidate important clinical questions in the area of children's informed consent to treatment. For example, how much should a child's own wishes count in making medical decisions? Does it make a difference if the child or young person is undergoing psychiatric treatment?—if in some sense her wishes are abnormal, not "true" expressions of what she really wants? If the child's wishes do not count, why not? If they do matter but count for less, how much less? We conclude by advocating functional tests of a young person's true wishes, applicable on a case-by-case basis, rather than a black-and-white distinction between "incompetent" children and "competent" adults. (shrink)

In “Informed Consent: What Must be Disclosed and What Must be Understood?”, we reject a dogma at the heart of research ethics. We demonstrate that the constitutive claim...

Vaccination against various diseases has been widely practised for more than a century and on a more limited scale its use in a variety of forms stretches back far longer. During earlier eras disease spread more slowly along shipping lanes on water and traditional transport routes on land. Today, in an era of air transport, contagion spreads far more rapidly. Travelling far more rapidly (indeed instantaneously) is the spread of misinformation that hinders vaccination which can, in the instance of Covid-19, (...) reduce disease impacts, including rates of severe illness and death. This paper explores the ethical issue of informed consent in the context of the contest between personal choice and the greater public welfare. It also makes reference to a number of low, middle and high income countries where vaccine hesitance, and to a lesser extent refusal, has been fed by misinformation on a scale not previously observed but made possible by the proliferation of modern technology. This campaign of ignorance has further undermined trust in governmental health bodies and their attempts to implement quarantine and other measures such as vaccination that had already been damaged by early variations and vacillation in governmental approaches around the globe due in part to a reluctance by some governments to take actions that would have economic repercussions but also by the necessary evolution of their approaches as more became known about the disease and its variants. The paper examines the historical background and the current situation and finds that more must be done to restore or increase trust levels between citizens and governmental authorities, including the dissemination of high quality accurate information in a form relevant to readers/viewers. While potential side-effects of vaccines must be disclosed to ensure informed consent, their incidence should also be clearly communicated (e.g., in vaccine information statements) so that clients/patients are aware that a risk is 1 in 100 or 1in 1000 or 1 in 2 million etc. Governments are urged to learn from their experience and better prepare for inevitable future pandemics to minimise vaccine hesitancy and refusal and maximise its acceptance where evidence is overwhelming as to the benefit to the community. Informed consent is part of the context of efforts to use vaccination to contain or eradicate any disease. Nevertheless, while better information for clients/patients/consumers may reduce vaccine hesitancy/refusal, it is unlikely that it would but eliminate the need for mandating vaccination in some circumstances for the benefit of the broader community, although strict quarantine of those reluctant to accept it is an alternative but one not generally accepted by those reluctant to be vaccinated. The information war is one that needs to be won to increase the voluntary uptake of vaccination in the context of voluntary informed consent. (shrink)

Deception of subjects is used frequently in the social sciences. Examples are provided. The ethics of experimental deception are discussed, in particular various maneuvers to solve the problem. The results have implications for the use of deception in the biomedical sciences.

Vaccination against various diseases has been widely practised for more than a century and on a more limited scale its use in a variety of forms stretches back far longer. During earlier eras disease spread more slowly along shipping lanes on water and traditional transport routes on land. Today, in an era of air transport, contagion spreads far more rapidly. Travelling far more rapidly (indeed instantaneously) is the spread of misinformation that hinders vaccination which can, in the instance of Covid-19, (...) reduce disease impacts, including rates of severe illness and death. This paper explores the ethical issue of informed consent in the context of the contest between personal choice and the greater public welfare. It also makes reference to a number of low, middle and high income countries where vaccine hesitance, and to a lesser extent refusal, has been fed by misinformation on a scale not previously observed but made possible by the proliferation of modern technology. This campaign of ignorance has further undermined trust in governmental health bodies and their attempts to implement quarantine and other measures such as vaccination that had already been damaged by early variations and vacillation in governmental approaches around the globe due in part to a reluctance by some governments to take actions that would have economic repercussions but also by the necessary evolution of their approaches as more became known about the disease and its variants. The paper examines the historical background and the current situation and finds that more must be done to restore or increase trust levels between citizens and governmental authorities, including the dissemination of high quality accurate information in a form relevant to readers/viewers. While potential side-effects of vaccines must be disclosed to ensure informed consent, their incidence should also be clearly communicated (e.g., in vaccine information statements) so that clients/patients are aware that a risk is 1 in 100 or 1in 1000 or 1 in 2 million etc. Governments are urged to learn from their experience and better prepare for inevitable future pandemics to minimise vaccine hesitancy and refusal and maximise its acceptance where evidence is overwhelming as to the benefit to the community. Informed consent is part of the context of efforts to use vaccination to contain or eradicate any disease. Nevertheless, while better information for clients/patients/consumers may reduce vaccine hesitancy/refusal, it is unlikely that it would but eliminate the need for mandating vaccination in some circumstances for the benefit of the broader community, although strict quarantine of those reluctant to accept it is an alternative but one not generally accepted by those reluctant to be vaccinated. The information war is one that needs to be won to increase the voluntary uptake of vaccination in the context of voluntary informed consent. (shrink)

Armed conflict in Darfur, west Sudan since 2003 has led to the influx of about 100 international humanitarian UN and non-governmental organizations to help the affected population. Many of their humanitarian i...

Contrary to intuitions that human beings are free to think and act with “buck-stopping” freedom, philosophers since Holbach and Hume have argued that universal causation makes free will nonsensical. Contemporary neuroscience has strengthened their case and begun to reveal subtle and counterintuitive mechanisms in the processes of conscious agency. Although some fear that determinism undermines moral responsibility, the opposite is true: free will, if it existed, would undermine coherent systems of justice. Moreover, deterministic views of human choice clarify the conditions (...) in which we ought to protect people from themselves, for example when they cannot give informed consent to medical procedures. Some of the most unresolved questions in this domain are just now emerging; they include robot ethics and the responsibilities of groups. We propose a philosophical and scientific research program to apply complex systems science to these problems. (shrink)

James Sterba uses the Pauline Principle to argue that the occurrence of significant, horrendous evils is logically incompatible with the existence of a good God. The Pauline Principle states that (as a rule) one must never do evil so that good may come from it, and according to Sterba, this principle implies that God may not permit significant evils even if that permission would be necessary to secure other, greater goods. By contrast, I argue that the occurrence of significant evils (...) is logically compatible with the existence of a good God because victims of significant evils may themselves reasonably consent to their suffering. In particular, I argue that they may be able to accept their suffering if it turns out that there was no way for God to secure relevant greater goods (or prevent other, greater evils) except by way of allowing their suffering, and God also provides them with other compensating, heavenly comforts. After using this consent-based argument to address Sterba’s logical problem from evil, I briefly consider how this argument may also help address a related evidential problem from evil, which suggests that while it is possible that victims of significant evils would consent to their suffering, it is unlikely that they would do so. While I do not provide a definitive solution to this evidential problem of evil, I highlight one important example of a trade-off that God may need to make that would—along with the provision of compensating, heavenly comforts—potentially persuade victims of significant evils to consent to their suffering. Specifically, I argue that there may be a necessary trade-off that God needs to make between permitting significant evils (on the one hand) and protecting a certain, morally significant form of free will (on the other hand). (shrink)

On many science-related policy questions, the public is unable to make informed decisions, because of its inability to make use of knowledge obtained by scientists. Philip Kitcher and James Fishkin have both suggested therefore that on certain science-related issues, public policy should not be decided on by actual democratic vote, but should instead conform to the public’s counterfactual informed democratic decision. Indeed, this suggestion underlies Kitcher’s specification of an ideal of a well-ordered science. This article argues that this (...) suggestion misconstrues the normative significance of CIDDs. At most, CIDDs might have epistemic significance, but no authority or legitimizing force. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some (...) studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

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

*As mentioned in Peter Coy's NYT essay "When Being Good Is Just a Matter of Being Lucky" (2023) -/- ----- -/- How is the problem of free will related to the problem of moral luck? In this essay, I answer that question and outline a new solution to the paradox of moral luck, the source-paradox solution. This solution both explains why the paradox arises and why moral luck does not exist. To make my case, I highlight a few key connections (...) between the paradox of moral luck and two related problems, namely the problem of free will and determinism and the paradox of self-creation. Piecing together intuitions, arguments, and insights from recent work on each of these three problems, I argue that the type of control necessary for moral responsibility can only be had by someone who is a genuine source of his own actions, but the relevant notion of sourcehood admits no coherent characterization. If our commonsense view of moral responsibility is incoherent, it is unsurprising that our commitment to the existence of morally responsible agents commits us to some paradoxical things—e.g. to both the existence and impossibility of moral luck. For more information about this article, please write to gmail account: kristin.mickelson.42. (shrink)

As it was shown in the Part I of this work, the driving of our life is determined by series of YES/NO - type elemental decision, which is actually the information unit (Bit), so we operate actually in an informational mode. The informational analysis and modeling of consciousness reveals seven informational systems, reflected at the conscious level by the cognitive informational centers suggestively called Iknow (Ik - memory), Iwant (Iw - decision center), Iove (Il-emotions), Iam (Ia-body status), Icreate (Ic-informational genetic (...) transmitter and educator), Icreated (I-cd genetic generator inherited from the parents) and Ibelieve, (Ib - connection to the informational field of the universe). As the mind can operate in a bipolar mode, we dispose of two alternatives to use our free will: in a positive (YES) or negative (NO) mode. Such modes can be applied as a function of the personal criteria, especially that inhered from the family, which are the fundamental ones, but also from that acquired during the life. The persistence to operate in a positive or a negative mode is fundamental for the designing of our personal trajectory and therefore for our destiny. The destiny and the role of our free will in deciding the course of our own life are analyzed therefore with respect to our YES/NO attitude, which is an integrated informational output composed by the contribution of all cognition centers, showing that when this is favorable to the life rules, it is avoided its deterioration determined by a permanently negative attitude and thinking mode. It is shown that our intervention should be directed both to the operating mode but also to the decision criteria, when it is ascertained that they do not correspond to the reality, allowing a favorable adaptation. As parents and therefore as forming and educator of the next generation, an activity specific for the center Ic, it is necessary to observe, discover and encourage the talents and predispositions of their Children, to put them on a privileged way of the destiny, because they will benefit of an advanced informational “budget” with respect to their generation and a certain sort of preparation. The comparative analysis between personal operating mode and the reality for adaptation necessities should guide permanently the selected trajectory way, to include new criteria, to change the older, or to reprogramming the operation mode, with the participation of all centers. The stereotype thinking chains triggered by repetitive negative thoughts acts on the informational system as stressing agents, leading to chronic, sometime serious disorders. Such thinking operation forms should be therefore detected and substituted or eliminated without delay, according to some recommended suggestions. Furthermore, it is shown that a specific self-control of the thoughts as positive or negative information and of the lifestyle, helps the health maintenance and the life prolongation under high qualitative. (shrink)