A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in (...) the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework. (shrink)

In recent years, several studies have advocated the need to expand the concept of patient autonomy beyond the capacity to deliberate and make decisions regarding a specific medical intervention or treatment (decision-making or decisional autonomy). Arguing along the same lines, this paper proposes a multidimensional concept of patient autonomy (decisional, executive, functional, informative and narrative) and argues that determining the specific aspect of autonomy affected is the first step towards protecting or promoting (and respecting) patient autonomy. These different manifestations of (...) autonomy are not mutually dependent; there may be patients who have problems in one dimension, while at the same time being fully autonomous in others. Nevertheless, a close interaction has been observed between the various dimensions and indeed, a phenomenological analysis shows that damage to or a reduction in one aspect of people’s capacity for self-government generally affects other aspects of their autonomy, which in turn disrupts their identity and the way in which they see themselves and are seen by others. In this paper, I shall examine some of these interactions and show how they may lie at the heart of the problem of poor treatment adherence (where adherence is defined as being the extent to which a patient’s behavior over time coincides with the recommendations made by and agreed with their health professional). One example given is that of psoriasis, a chronic skin disease with a very poor adherence record. In Spain, it is calculated that 85% of patients diagnosed with mild to moderate psoriasis fail to comply properly with their treatment, and figures from other parts of the world are similar. Although there are many possible causes for non-adherence among psoriasis patients, assessing their decisional, executive and narrative capacities and taking appropriate action based on the results may help increase adherence rates. (shrink)

In der gegenwärtigen Diskussion um Patientenverfügungen dominieren die Fragen nach deren Reichweite und Verbindlichkeit. Diese bilden, ebenso wie die Kontroverse um diese beiden Themen, die professionsspezifische Sichtweise von Ärzten und Juristen ab. Aus Patientenperspektive jedoch, so die Ergebnisse einer Studie mit 272 Tumorpatienten, stellt sich die Situation anders dar: Hier fungieren Patientenverfügungen vielmehr als Türöffner für eine intensivere Kommunikation mit Ärzten, aber auch mit Angehörigen und mit sich selbst. Die Frage nach der Verbindlichkeit spielt demgegenüber nur eine nachgeordnete Rolle.

ZusammenfassungIn der gegenwärtigen Diskussion um Patientenverfügungen dominieren die Fragen nach deren Reichweite und Verbindlichkeit. Diese bilden, ebenso wie die Kontroverse um diese beiden Themen, die professionsspezifische Sichtweise von Ärzten und Juristen ab. Aus Patientenperspektive jedoch, so die Ergebnisse einer Studie mit 272 Tumorpatienten, stellt sich die Situation anders dar: Hier fungieren Patientenverfügungen vielmehr als Türöffner für eine intensivere Kommunikation mit Ärzten, aber auch mit Angehörigen und mit sich selbst. Die Frage nach der Verbindlichkeit spielt demgegenüber nur eine nachgeordnete Rolle.

ZusammenfassungIn der gegenwärtigen Diskussion um Patientenverfügungen dominieren die Fragen nach deren Reichweite und Verbindlichkeit. Diese bilden, ebenso wie die Kontroverse um diese beiden Themen, die professionsspezifische Sichtweise von Ärzten und Juristen ab. Aus Patientenperspektive jedoch, so die Ergebnisse einer Studie mit 272 Tumorpatienten, stellt sich die Situation anders dar: Hier fungieren Patientenverfügungen vielmehr als Türöffner für eine intensivere Kommunikation mit Ärzten, aber auch mit Angehörigen und mit sich selbst. Die Frage nach der Verbindlichkeit spielt demgegenüber nur eine nachgeordnete Rolle.

Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...) clinical trials are means to ends, and thus their moral status depends both on how well they perform as means to reach desired ends and on which ends they are meant to achieve. Building upon this normative framework in the next two sections we analyze the specific ethical issues raised by non-inferiority trials. By making it clear that clinical trials are just epistemic tools – i.e. means to certain ends – it is possible not only to clarify the conceptual debate over a fundamental issue in clinical research, but also to identify which ethically relevant considerations ought to be addressed in setting up a non-inferiority trial. (shrink)

The use of tanning beds has been identified as being among the most significant causes of melanoma and non-melanoma skin cancer. Accordingly, the activity is properly seen as one that involves profound harm to self. The article examines paternalistic reasons for restricting sunbed usage. We argue that both so-called soft and hard paternalistic arguments support prohibiting the use of sunbeds. We make the following three arguments: an argument from oppressive patterns of socialization suggesting that the autonomous nature of the conduct (...) in question is questionable; an argument from so-called evaluative delusions in which individuals attach incorrect weights to some of their values; a strictly hard paternalistic argument appealing to the harm in itself pertaining to the use of sunbeds. (shrink)

Large-scale whole genome sequencing (WGS) studies promise to revolutionize cancer research by identifying targets for therapy and by discovering molecular biomarkers to aid early diagnosis, to better determine prognosis and to improve treatment response prediction. Such projects raise a number of ethical, legal, and social (ELS) issues that should be considered. In this study, we set out to discover how these issues are being handled across different jurisdictions.

The spectacular progress in assisted reproduction technology that has been witnessed for the past thirty years resulted in emerging new ethical dilemmas as well as the revision of some perennial ones. The paper aims at a feminist approach to oocyte and spare embryo donation for research. First, referring to different concepts of autonomy and informed consent, we discuss whether the decision to donate oocyte/embryo can truly be an autonomous choice of a female patient. Secondly, we argue the commonly adopted language (...) of gift is misleading and that calling for altruism could put female patients at risk of exploitation. Finally, we point out that the presence of gender stereotypes in the procreative area casts doubt whether even a more robust notion of informed consent manages to overcome this risk. (shrink)

Background: Informed consent involves patients being informed, in detail, of information relating to diagnosis, treatment, care and prognosis that relates to him or her. It also involves the patient explicitly demonstrating an understanding of the information and a decision to accept or decline the intervention. Nurses in particular experience problems regarding informed consent. Research question and design: This descriptive study was designed to determine nurse knowledge and practices regarding their roles and responsibilities for informed consent in Turkey. The research was (...) performed using 92 nurses who work at the surgical clinics. Data collection form was prepared by the researchers with assistance from the literature, and the data were evaluated by the SPSS 12.0 data analysis program. Ethical consideration: This study was approved by the Medicine and Health Sciences Research and Ethics Committee of the university. Written consent was received from the nurses. Findings: Among the nurses who participated in this study, 39.1% indicated that they were responsible for obtaining informed consent. It was also found that 90.2% of the nurses informed patients before providing nursing interventions and 32.6% of the nurses obtained consent from patients, and 90.0% of the nurses who indicated that they obtain patient consent only obtain verbal consent. Among all of the nurses, 21.7% agreed that informed consent needs to be obtained in order to protect the medical staff legally. Discussion: It is argued that a lack of official procedures at hospitals regarding informed consent and insufficient information being provided to healthcare providers has caused problems regarding informed consent. Conclusion: The nurses in this study lacked information regarding their role in obtaining informed consent from patients and they often performed incomplete and/or incorrect practices within the framework of their required role. It is believed that an increased level of education along with the creation of official policies and procedures would contribute towards solving these problems. (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)

The Japanese Ministry of Health and Welfare has implemented a policy of paying physicians to explain the nature of the patient's medical condition and the treatment plan. We describe the precepts of this policy and examine ethical dimensions of this development. We question whether this policy will be sufficient to ensure patients will have the opportunity to become informed participants in medical decision making. The policy also raises a broader philosophical question as to whether informed consent is a fundamental ethical (...) requirement of all doctor-patient encounters or an option that can be exercised by physicians for financial gain. The impact of this policy in Japan merits continued observation from abroad. (shrink)

Patients belonging to ethnic, racial, and religious minorities have been all but excluded from the legal academy's on-going conversation about informed consent. This article repairs that egregious omission. It begins by observing the narrowing of ethical justifications that underlie our informed consent law, tracing the ethical literature from the ancients to modern formulations of autonomy-centered models. Next, this article reviews the vast body of empirical data available in social science literature, that demonstrates how distinct from the autonomy model the broad (...) range of values and priorities held by patients from racial, ethnic, and religious minority groups is. The conclusion that informed consent's focus on the western notion of autonomy affirmatively harms minority patients is inescapable. The article concludes by offering a fiduciary model of informed consent law that could improve the quality of health care for more than 100 million minority patients, potentially at risk under current law while also regulating the informed consent procedure and practice in a way that will bring balance and justice to all American patients and providers. (shrink)

The aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. (...) We also propose that a broader definition of manipulation of information should be adopted (than that already existing in the literature) since informational manipulation can affect not only a person’s beliefs but also their desires in decision-making. We conclude that manipulation of information can either be used to protect the potential subject and facilitate the informed consent process or be used to exploit and merely use a person for scientific goals. (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)

Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values (...) underlying informed consent. Methods: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute’s requirements for consent, and the researchers’ strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Results: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors’ accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. Conclusions: We argue that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out. (shrink)

Patients are more likely to make an informed choice to accept a screening test if it is arranged as part of a routine hospital visit rather than if it requires a separate visit. As the rate of informed choice is influenced both by the information provided and the manner in which ….

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the (...) circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals? perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

According to a number of influential views in penal theory, 1 one of the primary goals of the criminal justice system is to rehabilitate offenders. Rehabilitativemeasures are commonly included as a part of a criminal sentence. For example, in some jurisdictions judges may order violent offenders to attend anger management classes or to undergo cognitive behavioural therapy as a part of their sentences. In a limited number of cases, neurointerventions — interventions that exert a direct biological effect on the brain (...) — have been used as aids to rehabilitation, typically being imposed as part of criminal sentences, separate treatment orders, or conditions of parole. Examples of such interventions include medications intended to attenuate addictive desires in substance-abusing offenders and agents intended to suppress libido in sex offenders.This chapter reviews some of the ethical issues raised by the use of neurointerventions as aids to rehabilitation. (shrink)

Obtaining informed consent from patients is a moral and legal duty and, thus, a key legitimation for medical treatment. The pivotal prerequisite for valid informed consent is decision-making capacity of the patient. Related to the question of whether and when consent should be morally and legally valid, there has been a long-lasting philosophical debate about freedom of will and the connection of freedom and responsibility. The scholarly discussion on decision-making capacity and its clinical evaluation does not sufficiently take into account (...) this fundamental debate. It is contended that the notion of free will must be reflected when evaluating decision-making capacity. Namely, it should be included as a part of the appreciation-criterion for decision-making capacity. The argumentation is mainly drawn on the compatibilism of Harry Frankfurt. A solution is proposed which at the same time takes the notion of free will seriously and enriches the traditional understanding of decision-making capacity, strengthening its justificatory force while remaining clinically applicable. (shrink)

In a recent paper, Levy, Gadd, Kerridge, and Komesaroff attempt to defend the ethicality of homeopathy by attacking the utilitarian ethical framework as a basis for medical ethics and by introducing a distinction between evidence-based medicine and modern science. This paper demonstrates that their argumentation is not only insufficient to achieve that goal but also incorrect. Utilitarianism is not required to show that homeopathic practice is unethical; indeed, any normative basis of medical ethics will make it unethical, as a defence (...) of homeopathic practice requires the rejection of modern natural sciences, which are an integral part of medical ethics systems. This paper also points out that evidence-based medicine lies at the very core of modern science. Particular arguments made by Levy et al. within the principlist medical ethics normative system are also shown to be wrong. (shrink)

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal (...) implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a ‘collective’ TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism. (shrink)

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. (...) In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the objects of study. (shrink)

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. (...) In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the objects of study. (shrink)

In recent years, increasing pressures have been brought to bear upon nurses and others more closely to inform, involve and support the rights of parents or guardians when crucial ‘life and death’ ethical decisions are made on behalf of their seriously ill child. Such decisions can be very painful for all involved, and may easily become deadlocked when there is an apparent clash of moral ideals or values between the medical team and the parents or guardians. This article examines a (...) growing number of such cases in New Zealand and analyses the moral parameters, processes, outcomes and ethical responses that must be considered when life and death ethical decisions involving children are made. The article concludes with a recommendation that nurses should be recognized as perhaps the most suitable of all health care personnel when careful mediation is needed to produce an acceptable moral outcome in difficult ethical situations. (shrink)

Patient and citizen participation is now regarded as central to the promotion of sustainable health and health care. Involvement efforts create and encounter many diverse ethical challenges that have the potential to enhance or undermine their success. This article examines different expressions of patient and citizen participation and the support health ethics offers. It is contended that despite its prominence and the link between patient empowerment and autonomy, traditional bioethics is insufficient to guide participation efforts. In addition, the turn to (...) a “social paradigm” of ethics in examinations of biotechnologies and public health does not provide an account of values that is commensurable with the pervasive autonomy paradigm. This exacerbates rather than eases tensions for patients and citizens endeavoring to engage with health. Citizen and patient participation must have a significant influence on the way we do health ethics if its potential is to be fulfilled. (shrink)

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

Three main claims are made in this paper. First, it is argued that Onora O’Neill has uncovered a serious problem in the way medical ethicists have thought about both respect for autonomy and informed consent. Medical ethicists have tended to think that autonomous choices are intrinsically worthy of respect, and that informed consent procedures are the best way to respect the autonomous choices of individuals. However, O’Neill convincingly argues that we should abandon both these thoughts. Second, it is argued that (...) O’Neill’s proposed solution to this problem is inadequate. O’Neill’s approach requires that a more modest view of the purpose of informed consent procedures be adopted. In her view, the purpose of informed consent procedures is simply to avoid deception and coercion, and the ethical justification for informed consent derives from a different ethical principle, which she calls principled autonomy. It is argued that contrary to what O’Neill claims, the wrongness of coercion cannot be derived from principled autonomy, and so its credentials as a justification for informed consent procedures is weak. Third, it is argued that we do better to rethink autonomy and informed consent in terms of respecting persons as ends in themselves, and a characteristically liberal commitment to allowing individuals to make certain categories of decisions for themselves. Respect for autonomy is in trouble. In recent work in this journal1 and elsewhere,2 O’Neill has forcefully argued that respect for autonomy, as it has come to be used in medical ethics, is philosophically indefensible. If her arguments are sound, then, contrary to the standard view, respect for autonomy cannot be the source of the ethical requirement to seek informed consent before treating a patient or enrolling a participant in a trial. So her critique goes to the heart of contemporary medical ethics: if O’Neill is right, medical ethicists have systematically misunderstood two of the most fundamental concepts they deal with—respect for autonomy and informed consent. This paper has four sections. Section 1 distinguishes between three different ways of talking about respect for autonomy, and looks in more detail at the one that has come to be central to bioethical writing on informed consent—namely, the idea that we should respect autonomous choices. Section 2 argues, following O’Neill, that it is implausible to think that the purpose of informed consent requirements is to respect autonomous choices. Section 3 argues that O’Neill’s proposed reworking of autonomy and informed consent is inadequate. O’Neill’s approach requires us to adopt a more modest view of the purpose of informed consent procedures. In her view, the purpose of informed consent procedures is simply to avoid deception and coercion, and the ethical justification for informed consent derives from a different ethical principle, which she calls principled autonomy. I argue that contrary to what O’Neill claims, we cannot derive the wrongness of coercion from principled autonomy, and so its credentials as a justification for informed consent procedures is weak. Section 4 argues that we do better to rethink autonomy and informed consent in terms of respecting persons as ends in themselves, and a characteristically liberal commitment to allowing individuals to make certain categories of decisions for themselves. (shrink)

Vaccine hesitancy is a growing threat to public health. The reasons are complex but linked inextricably to a lack of trust in vaccines, expertise and traditional sources of authority. Efforts to increase immunization uptake in children in many countries that have seen a fall in vaccination rates are two-fold: addressing hesitancy by improving healthcare professional-parent exchange and information provision in the clinic; and, secondly, public health strategies that can override parental concerns and values with coercive measures such as mandatory and (...) presumptive vaccination. It is argued that such conflicting, parallel approaches seriously risk undermining trust that is crucial for sustaining herd immunity. Although public health strategies can be ethically justified in limiting freedoms, a parent-centered approach seldom acknowledges how it is impacted by contemporaneous coercive measures. In addition, the clinical encounter is not well suited to helping parents consider the public dimensions of vaccination, despite these being important for trust formation and informed decision-making. Efforts to address vaccine hesitancy require more consistent engagement of parental and citizen views. Along with evidence-based information, debates need to be informed by ethical support that equips parents and professionals to respond to the private and public dimensions of vaccination in a more even-handed, transparent manner. Efforts to address vaccine hesitancy need to avoid simple reliance on either parental values or coercive public policies. To do this effectively requires increasing citizen engagement on vaccination to help inform a parent-centered approach and legitimize public policy measures. In addition, cultivating a more ethically consistent strategy means moving beyond the current silos of health ethics - clinical and public health ethics. (shrink)

The paper begins with a brief analysis of the concepts of environmental justice and environmental racism and classism. The authors argue that pollution- and environment-related decision-making is prima facie wrong whenever it results in inequitable treatment of individuals on the basis of race or socio-economic status. The essay next surveys the history of the doctrine of free informed consent and argues that the consent of those affected is necessary for ensuring the fairness of decision-making for siting hazardous facilities. The paper (...) also points out that equal opportunity to environmental protection and free informed consent are important rights. Finally, it presents a case study on the proposed uranium enrichment facility near Homer, Louisiana and argues that siting the plant would violate norms of distributive equity and free informed consent. It concludes that siting the facility is a case of environmental injustice and likely an example of environmental racism or classism. (shrink)

The notion of respect for autonomy dominates bioethical discussion, though what qualifies precisely as autonomous action is notoriously elusive. In recent decades, the notion of autonomy in medical contexts has often been defined in opposition to the notion of autonomy favoured by theoretical philosophers. Where many contemporary theoretical accounts of autonomy place emphasis on a condition of “authenticity”, the special relation a desire must have to the self, bioethicists often regard such a focus as irrelevant to the concerns of medical (...) ethics, and too stringent for use in practical contexts. I argue, however, that the very condition of authenticity that forms a focus in theoretical philosophy is also essential to autonomy and competence in medical ethics. After tracing the contours of contemporary authenticity-based theories of autonomy, I consider and respond to objections against the incorporation of a notion of authenticity into accounts of autonomy designed for use in medical contexts. By looking at the typical problems that arise when making judgments concerning autonomy or competence in a medical setting, I reveal the need for a condition of authenticity—as a means of protecting choices, particularly high-stakes choices, from being restricted or overridden on the basis of intersubjective disagreement. I then turn to the treatment of false and contestable beliefs, arguing that it is only through reference to authenticity that we can make important distinctions in this domain. Finally, I consider a potential problem with my proposed approach; its ability to deal with anorexic and depressive desires. (shrink)

Physicians make some medical decisions without disclosure to their patients. Nondisclosure is possible because these are silent decisions to refrain from screening, diagnostic or therapeutic interventions. Nondisclosure is ethically permissible when the usual presumption that the patient should be involved in decisions is defeated by considerations of clinical utility or patient emotional and physical well-being. Some silent decisions - not all - are ethically justified by this standard. Justified silent decisions are typically dependent on the physician's professional judgment, experience and (...) knowledge, and are not likely to be changed by patient preferences. We condemn the inappropriate exclusion of the patient from the decision-making process. However, if a test or treatment is unlikely to yield a net benefit, disclosure and discussion are at times unnecessary. Appropriate silent decisions are ethically justified by such considerations as patient benefit or economy of time. (shrink)

Gerben Meynen (2019) invites us to consider the potential ethical implications of what he refers to as “thought apprehension” technology for psychiatric practice, that is, technologies that involve recording brain activity, and using this to infer what people are thinking (or intending, desiring, feeling, etc.). His article is wide-ranging, covering several different ethical principles, various situations psychiatrists might encounter in therapeutic, legal and correctional contexts, and a range of potential incarnations of this technology, some more speculative than others. Although Meynen’s (...) article raises some highly relevant potential implications of some “thought apprehension”-based neurotechnologies, which are certainly worthy of further exploration, I suggest that Meynen’s analysis is beset by two problems. First, some of the technologies that form the focus of his discussion are too speculative, and second, due to the many issues under consideration, some problems are not adequately characterized, relevant ethical principles are misidentified, and valuable literature is not sufficiently engaged with. Consideration of these weaknesses might allow us to better see how to conduct a fruitful analysis of speculative neurotechnologies. (shrink)

Twenty-five long-term care nurses in eight nursing homes in central Kentucky were inter viewed concerning ways in which they might assist elderly residents to preserve and enhance their personal autonomy. Data from the interviews were analysed using grounded theory methodology. Seven specific categories of assisting were discovered and described: personalizing, informing, persuading, shaping instrumental circumstances, considering, mentioning opportunities, and assessing causes of an impaired capacity for decision-making. The ethical implications of these categories of assisting for clinical prac tice are examined. (...) Although nurses recognized the importance of resident autonomy, the majority of them failed consistently to employ the categories of assistance to foster resi dent self-determination and most of them held an inadequate understanding of the con cepts of consent and decisional capacity. To assure confidentiality, pseudonyms are used in the following cases and discussions for all names of nurses, residents and facilities. (shrink)

In accordance with a recent statement released by the World Health Organization, the Canadian province of Ontario is moving to ban payment for plasma donation. This is partially based on contentions that remuneration for blood and blood products undermines autonomy and personal dignity. This paper is dedicated to evaluating this claim. I suggest that traditional autonomy-based arguments against commodification of human body parts and substances are less compelling in the context of plasma donation in Canada, but that there is another (...) autonomy-based objection to paid plasma donation that has not received sufficient attention. Namely, the stigma that surrounds exchanging plasma for payment makes it difficult to make an autonomous decision to engage in this activity. I suggest that this problem can be overcome in one of two ways; by banning payment for plasma, or by reducing the stigma surrounding this practice. I provide an indication of how we might work to achieve the latter, contending that this possibility should be taken seriously, due to the difficulties in achieving a sufficient supply of plasma without remuneration. (shrink)

Despite US policy documents which recommend that in areas of environmental risk, interaction between scientific experts and the public move beyond the so-called “Decide, Announce, and Defend model,” many current public involvement policies still do not guarantee meaningful public participation. In response to this problem, various attempts have been made to define what counts as sufficient or meaningful participation and free informed consent from those affected. Though defining “meaningfulness” is a complex task, this paper explores one under-examined dimension that concerns (...) the relationship between consent and the idea that citizens should be sufficiently informed: epistemic capacity. This paper will look at some of the work on meaningful participation and consent, give a definition of epistemic capacity, and argue that only a community with sufficient epistemic capacity can have the understanding and competence to give informed enough consent and thus participate meaningfully. (shrink)

The Standard View in research ethics maintains that, under certain conditions, investigators may deceive subjects and may enroll subjects without their consent. In contrast, it is always impermissible to coerce subjects to enroll, even when the same conditions are satisfied. This view raises a question that, as far as we are aware, has received no attention in the literature. Why is it always impermissible to undermine the validity of subjects’ consent through coercion, but it can be permissible to undermine the (...) validity of subjects’ consent through deception, and it can be permissible to enroll subjects without any consent at all? The present analysis suggests that the answer traces to the conditions on the appropriate treatment of subjects. This conclusion suggests that some requirements for human subjects research, and for valid consent more generally, trace not to the protection of subjects per se but to the proper behavior of agents. (shrink)

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces (...) a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable. (shrink)

The notion of autonomy commonly employed in medical ethics literature and practices is inadequate on three fronts: it fails to properly identify nonautonomous actions and choices, it gives a false account of which features of actions and choices makes them autonomous or nonautonomous, and it provides no grounds for the moral requirement to respect autonomy. In this paper I offer a more adequate framework for how to think about autonomy, but this framework does not lend itself to the kinds of (...) practical application assumed in medical ethics. A general problem then arises: the notion of autonomy used in medical ethics is conceptually inadequate, but conceptually adequate notions of autonomy do not have the practical applications that are the central concern of medical ethics. Thus, a revision both of the view of autonomy and the practice of “respect for autonomy” are in order. (shrink)