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)

Healthcare services should be provided according to contemporary ethical norms that require patients’ active engagement in all the relevant processes. However, authoritarian attitudes and behaviors in healthcare, one of which is paternalism, put patients in a passive role. But, as Avedis Donabedian emphasizes, patients are co-producers of care, reformers of healthcare, informants, and definers and evaluators of quality. Overlooking these significant functions and merely focusing on physicians’ benevolence due to their medical knowledge and skills in the production of healthcare services (...) would leave the fate of patients in the hands of clinicians and impose physicians’ hegemony on patients and their choices. Nevertheless, the concept of co-production is a practical and effective mechanism to redefine the language used in healthcare by recognizing patients as co-producers and equal partners. The application of co-production in healthcare would improve the therapeutic relationship, decrease ethical violations, and promote the patient’s dignity. (shrink)

The necessity of consent is widely justified on the basis of the principle of respect for autonomy. Also, it is widely believed that shared decision making (SDM) is the practical device to seek patients’ consent for medical treatment. In this essay, I argue that SDM, while necessary, is insufficient for consent; because, in the paradigm of evidence-based medicine, SDM is contingent upon other practices to identify appropriate treatments that form the subjects of SDM. Indeed, case law emphasises normative decision-making practices (...) that precede SDM. Furthermore, case law supplies a nuanced understanding of SDM, which includes not only exchange of information but also attention to human vulnerability that persists despite formal retention of decision-making capacity. In addition, the law marks out a space in which people with capacity are absolutely entitled to self-determination. Thus, a four-step framework of decision making can be induced from legal doctrine. This legal framework corresponds to a construct of respect for autonomy that draws upon feminist theory. Feminist scholars have objected to the focus on individuals in traditional theories of autonomy; instead, they insist that people have to be considered in the context of their social influences and relationships. Feminists separate out four ideas of autonomy, and these ideas can be used to construct a four-layered model of respect for autonomy, in which each layer corresponds sequentially to a step in the legal framework of decision making. This model of respect for autonomy provides both conceptual clarity and theoretically robust justification for doctors’ various obligations in decision-making practices for consent. (shrink)

Disclosure in clinical practice is aimed at promoting patient autonomy, usually culminating in patient choice (e.g., to consent to an operation or not, or between different medications). In medical ethics, there is an implicit background assumption that knowing more about (X) automatically translates to greater, or more genuine, autonomy with respect to one's choices involving (X). I challenge this assumption by arguing that in rare cases, withholding information can promote a patient's autonomy (understood as the capacity for rational choice in (...) alignment with one's values and goals). (shrink)

This paper analysed the nature of autonomy, in particular respect for autonomy in medical ethics/bioethics in Japan. We have undertaken a literature survey in Japanese and English and begin with the historical background and explanation of the Japanese wordJiritsu (autonomy). We go on to identify patterns of meaning that researchers use in medical ethics / bioethics discussions in Japan, namely, Beauchamp and Childress’s individual autonomy, relational autonomy, and O’Neill’s principled autonomy as the three major ways that autonomy is understood. We (...) examine papers discussing these interpretations. We propose using the term ‘a form of autonomy’ first used by Edmund Pellegrino in 1992 and examine the nature of ‘a form of autonomy.’ We finally conclude that the crux of what Pellegrino calls ‘something close to autonomy,’ or ‘a form of autonomy' might best be understood as the minimization of physician paternalism and the maximization of respect for patient preference. Simultaneously, we introduce a family-facilitated approach to informed consent and respond to criticism by Laura Sullivan. Finally, we discuss cross-cultural approaches and global bioethics. Furthermore, we use the term ‘Bioethics across the Globe’ instead of ‘Global Bioethics’, calling for international scholars to write works to provide an in-depth understanding of each country. We conclude that deep understanding of others is pivotal for dialogue to be of value. We hope this article will deepen the reader’s understanding of Japan and will contribute to the progress of bioethics worldwide. (shrink)

In the debates regarding the ethics of human organoid biobanking, the locus of donor autonomy has been identified in processes of consent. The problem is that, by focusing on consent, biobanking processes preclude adequate engagement with donor autonomy because they are unable to adequately recognise or respond to factors that determine authentic choice. This is particularly problematic in biobanking contexts associated with organoid research or the clinical application of organoids because, given the probability of unforeseen and varying purposes for which (...) a donor’s organoids could be employed and given the different ways in which a donor can relate to her biospecimens, a donor can value her organoids differently in different contexts and her reasons for autonomously permitting use of her cells and tissues in one case may not support an autonomous decision in another. In response, this paper has three aims: firstly, to make the case for why organoid biobanks ought to respect donor autonomy conceived as authentic choice; secondly, to explore the autonomy-respecting limits of established and widely prevalent models of biobank consent; and thirdly, to propose certain conditions that organoid biobanks ought to support or facilitate in order to respect donor autonomy. (shrink)

In recent times, informed consent has been adopted worldwide as a cornerstone to ensure autonomy during HIV testing. However, there are still ongoing debates on whether the edifice on which informed consent requirements are grounded, that is, personal autonomy, is philosophically, morally, and practically sound, especially in countries where HIV is an epidemic and/or may have a different ontological perspective or lived reality. This study explores the views of participants from Zambia. In-depth and focus group discussions were conducted at various (...) locations in Lusaka and Chongwe, Zambia. Participants came from various demographics, including people living with HIV, healthcare professionals and workers, policymakers, pregnant women, churchgoers, teachers, rural-based persons, and police officers. Data were manually analysed by conducting inductive and deductive thematic analyses. Results show that participants were not in favour of HIV policies that promote personal autonomy at the expense of pursuit of the common good. Participants viewed interdependence, not autonomy, as an essential characteristic of being human. The participants’ views have a realistic potential to provide a contextual and appropriate ethical, respectful, and realistic foundation for HIV testing policies. (shrink)

In this paper, we discuss several problems with current Big data practices which, we claim, seriously erode the role of informed consent as it pertains to the use of personal information. To illustrate these problems, we consider how the notion of informed consent has been understood and operationalised in the ethical regulation of biomedical research (and medical practices, more broadly) and compare this with current Big data practices. We do so by first discussing three types of problems that can impede (...) informed consent with respect to Big data use. First, we discuss the transparency (or explanation) problem. Second, we discuss the re-repurposed data problem. Third, we discuss the meaningful alternatives problem. In the final section of the paper, we suggest some solutions to these problems. In particular, we propose that the use of personal data for commercial and administrative objectives could be subject to a ‘soft governance’ ethical regulation, akin to the way that all projects involving human participants (e.g., social science projects, human medical data and tissue use) are regulated in Australia through the Human Research Ethics Committees (HRECs). We also consider alternatives to the standard consent forms, and privacy policies, that could make use of some of the latest research focussed on the usability of pictorial legal contracts. (shrink)

It is commonly claimed that when X coerces Y into consenting to Z φ-ing, Y’s consent is invalid, and Z is only permitted to φ if this reduces harm or increases optionality for Y. This article demonstrates that Y’s consent in such cases is valid if Y is choosing between options that include all those Z has a duty to offer Y and no autonomy-reducing options Z has a duty to not offer Y. When these conditions are met, Z acts (...) permissibly in φ-ing even if φ-ing does not reduce harm for Y or increase Y’s optionality. (shrink)

Transparency is now a fundamental principle for data processing under the General Data Protection Regulation. We explore what this requirement entails for artificial intelligence and automated decision-making systems. We address the topic of transparency in artificial intelligence by integrating legal, social, and ethical aspects. We first investigate the ratio legis of the transparency requirement in the General Data Protection Regulation and its ethical underpinnings, showing its focus on the provision of information and explanation. We then discuss the pitfalls with respect (...) to this requirement by focusing on the significance of contextual and performative factors in the implementation of transparency. We show that human–computer interaction and human-robot interaction literature do not provide clear results with respect to the benefits of transparency for users of artificial intelligence technologies due to the impact of a wide range of contextual factors, including performative aspects. We conclude by integrating the information- and explanation-based approach to transparency with the critical contextual approach, proposing that transparency as required by the General Data Protection Regulation in itself may be insufficient to achieve the positive goals associated with transparency. Instead, we propose to understand transparency relationally, where information provision is conceptualized as communication between technology providers and users, and where assessments of trustworthiness based on contextual factors mediate the value of transparency communications. This relational concept of transparency points to future research directions for the study of transparency in artificial intelligence systems and should be taken into account in policymaking. (shrink)

The prohibition on using others ‘merely as means’ is one of the best-known and most influential elements of Immanuel Kant’s moral theory. But it is widely regarded as impossible to specify with precision the conditions under which this prohibition is violated. On the basis of a re-examination of Kant’s texts, the article develops a novel account of the conditions for using someone ‘merely as a means’. It is argued that this account has not only strong textual support but also significant (...) philosophical advantages over alternative conceptions. (shrink)

According to the doctrine of informed consent medical procedures are morally permissible when a patient has consented to the treatment. Problematically it is possible for a patient to consent to or refuse treatment which consequently leads to a decline in her best interests. Standardly, such conflicts are resolved by prioritising the doctrine of informed consent above the requirement that the medical practitioner acts in accordance with the duty of care. This means that patient free choice is respected regardless as to (...) whether her choice leads to a decline in her best interests, since to disrespect patient choice would be an instance of ‘unwarranted’ paternalism. This thesis defends the claim that in cases where patient consent comes into conflict with her best interests, paternalistic interference is in fact justified. The ambition of the thesis is thus twofold: in the first place I argue that the doctrine of informed consent cannot be used as an ethical guarantor for medical decision making. Secondly I will conclude that hard paternalism is justified in medical practice, thereby calling for a reversal of the prioritisation of informed consent procedures over the medical practitioner’s duty of care. (shrink)

In this paper I will use sex by deception as a case study for highlighting some of the most tricky concepts around sexuality and moral psychology, including rape, consensual sex, sexual rights, sexual autonomy, sexual individuality, and disrespectful sex. I begin with a discussion of morally wrong sex as rooted in the breach of five sexual liberty rights that are derived from our fundamental human liberty rights: sexual self-possession, sexual autonomy, sexual individuality, sexual dignity and sexual privacy. I then argue (...) (against the standard interpretation) that experimental findings in moral psychology show that the principle of respect for persons—a principle that grounds our human liberty rights—drives our intuitive moral judgments. In light of this discussion, I examine a puzzle about sex by deception—a puzzle which at first may seem to compel us to define 'rape' strictly in terms of force rather than sexual autonomy. I proceed by presenting an argument against the view that, as a rule, sex by deception undermines consent—a position held by prominent thinkers such as Philippe Patry (2001), Onora O’Neill (2003), Rubenfeld (2012), Tom Dougherty (2013a, 2013b), Joyce M. Short (2013), and Danielle Bromwich and Joseph Millum (2013, 2018). As we will see, sex following deception to increase your chances does not always constitute rape. Lying about your age, education, job, family background, marital status, or interest in a relationship, for example, does not make your sex partner incapable of consenting, which is to say that sex by deception need not be rape. I even go so far as to say that sex with another person that is facilitated by withholding information about having a venereal disease shouldn't be classified as rape. Although sex by deception doesn't compromise consent, it nonetheless violates the principle of respect for persons, not by vitiating sexual autonomy and compromising consent, but by failing to respect other sexual rights, such as our rights to sexual dignity, individuality, and privacy. (shrink)

Many argue that consumers possess a “right to know” when products contain ingredients derived from genetically modified organisms, on the grounds that it would protect consumer autonomy. In this paper, I critically evaluate that claim. I begin by providing a version of the “consumer autonomy” argument, showing that its success relies on ambiguities in the notion of autonomy. I then distinguish four approaches to autonomy and articulate the circumstances under which they would support active disclosure of a product property. I (...) argue that none of these conceptions would support active disclosure of the presence of ingredients derived from genetically modified organisms. (shrink)

Approximately 6000 men die every year from ruptured abdominal aortic aneurysm in England and Wales. Randomised clinical trials and a large pilot study have shown that ultrasound screening of men aged 65 years can prevent about half of these deaths. However, there is a significant perioperative morbidity and mortality from interventions to repair the detected aneurysm. This paper explores the ethical issues of screening men for abdominal aortic aneurysm. It is concluded that a population screening programme for abdominal aortic aneurysm (...) offers a clear balance of good over harm. It is therefore ethically justified, as long as men are given adequate information at every stage of the process. Each man has the right to be properly informed, regardless of whether he accepts the invitation to be screened and, if an aneurysm is detected, whether or not he accepts treatment. (shrink)

Background:There are no universally agreed rules of healthcare ethics. Ethical decisions and standards tend to be linked to professional codes of practice when dealing with complex issues.Objectives:This paper aims to explore the ethical complexities on who should decide to give infants born on the borderline of viability lifesaving treatment, parents or the healthcare professionals.Method:The paper is a discussion using the principles of ethics, professional codes of practice from the UK, Nursing Midwifery Council and UK legal case law and statute. Healthcare (...) professionals' experiences that influence parental decision are also considered.Findings & Discussion:There are considerable barriers to an effective discussion taking place in an environment where clinical decisions have to be made quickly once the baby is born. This is compounded by the need and respect for parental autonomy and the difficulties they face when making a best interest's decision knowing that this could cause more harm than good for their infant child and balancing any decision they make with quality of life.Conclusion:On deciding whether to give lifesaving treatment born at the borderline of viability, it should be a joint decision between the parents and the neonatal team. (shrink)

I argue against various versions of the ‘attitude’ view of consent and of the ‘action’ view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic context, absence of dissent is sufficient for consent: what is crucial is having access to dissent. In the latter part of the paper I illustrate my view of consent (...) by applying it to the case of consenting to being an organ donor. (shrink)

BackgroundAccess to research volunteers may be hampered by low numbers of cases and few eligible participants for rare diseases in clinical settings.MethodsWe recruited volunteers and obtained informed consent by mail from narcolepsy cases in a case-control study, and here in we report feasibility, response rate, timeliness and cost. We invited index cases into the study by mail through their care-giving physicians then mailed study information and consent forms to cases that indicated interest in the study.ResultsOf the 33 index cases invited, (...) 15 expressed interest in the study, and of those, 14 returned their signed informed consents by mail. The median number of days from invitation to consent return was 39, interquartile range = 45, and the cost per consent obtained from the recruited subjects was $ 23.61.ConclusionIn this setting, postal recruitment for biomedical research on rare conditions is feasible and time and cost effective. (shrink)

I argue that valid informed consent is ethically required for organ donation from individuals declared dead using neurological criteria. Current policies in the U.S. do not require this and, not surprisingly, current practices inhibit the possibility of informed consent. Relevant information is withheld, opportunities to ensure understanding and appreciation are extremely limited, and the ability to make and communicate a free and voluntary decision is hindered by incomplete disclosure and other practices. Current practices should be revised to facilitate valid informed (...) consent for organ donation. (shrink)

South Africa has made great progress in the development of HIV/AIDS testing, treatment and prevention campaigns. Yet, it is clear that prevention and treatment campaigns alone are not enough to bring this epidemic under control.

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 participant9s consent to research (...) participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan9s 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)

Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient consent ought to be (...) obtained before any piece of research is conducted. The Data Protection Act, furthermore, requires informed consent to be given before any use of identifiable personal data is made for any purpose. Moreover, ensuring that the informed consent of participants is gained is common practice on most research ethics committees. I argue, in this paper, that applying the principle of ‘informed consent’ too mechanistically in the research ethics context risks undermining the very principle it is designed to support – the principle of autonomy. This issue has been much discussed in medical ethics but not so much, so far, in the research ethics context. It will be argued that a more discerning and a less rigid and mechanistic approach, applied by research ethics committees, may help ensure that ethical issues are properly considered. (shrink)

Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.

Informed consent is central to modern research ethics. Informed consent procedures have mainly been justified in terms of respect for autonomy, the core idea being that it should be every competent individual’s right to decide for herself whether or not to participate in scientific studies. A number of conditions are normally raised with regard to morally valid informed consent. These include that potential research subjects get adequate information, understand those aspects that are relevant to them, and, based on that information, (...) make a voluntary decision whether or not to participate. These conditions are meant to guarantee that participation is genuinely the individual’s own choice and is coherent with his or her authentic interests. (shrink)

This paper deals with ethical issues of particular relevance to longitudinal research involving children. First some general problems concerning information and lack of understanding are discussed. Thereafter focus is shifted to issues concerning information and consent procedures in studies that include young children growing up to become autonomous persons while the project still runs. Some of the questions raised are: When is it right to include children in longitudinal studies? Is an approval from the child needed? How should information to (...) children be handled? A general point stressed is that autonomy considerations underline the importance of adjusting the information given to meet demands. A “presumption of competence” may be needed in research involving children, in order to pay their views sufficient attention. (shrink)

In this article, we report the findings from a qualitative study that explored how relatives of terminally ill, alert and competent intensive care patients perceived their involvement in the end-of-life decision-making process. Eleven family members of six deceased patients were interviewed. Our findings reveal that relatives narrate about a strong intertwinement with the patient. They experienced the patients’ personal individuality as a fragile achievement. Therefore, they viewed their presence as crucial with their primary role to support and protect the patient, (...) thereby safeguarding his values and interests. However, their inclusion in decision making varied from active participation in the decision-making process to acceptance of the physicians’ decision or just receiving information. We conclude that models of informed shared decision making should be utilised and optimised in intensive care, where nurses and physicians work with both the patient and his or her family and regard the family as partners in the process. (shrink)

The American Journal of Bioethics, Volume 12, Issue 4, Page 47-48, April 2012.

This paper defends an ‘opt-out’ scheme for organ procurement, by distinguishing this system from ‘presumed consent’ (which the author regards as an erroneous justification of it). It, first, stresses the moral importance of increasing the supply of organs and argues that making donation easier need not conflict with altruism. It then goes on to explore one way that donation can be increased, namely by adopting an opt-out system, in which cadaveric organs are used unless the deceased (or their family) registered (...) an objection. Such policies are often labelled ‘presumed consent’, but it is argued that critics are right to be sceptical of this idea—consent is shown to be an action, rather than a mental attitude, and thus not something that can be presumed. Either someone has consented or they have not, whatever their attitude to the use of their organs. Thankfully, an opt-out scheme need not rest on the presumption of consent. Actual consent can be given implicitly, by one's actions, so it is argued that the failure to register an objection (given certain background conditions) should itself be taken as sign of consent. Therefore, it is permissible to use the organs of someone who did not opt out, because they have—by their silence—actually consented. (shrink)

Over the past decades, mood enhancement effects of various drugs and neuromodulation technologies have been proclaimed. If one day highly effective methods for significantly altering and elevating one’s mood are available, it is conceivable that the demand for them will be considerable. One urgent concern will then be what role physicians should play in providing such services. The concern can be extended from literature on controversial demands for aesthetic surgery. According to Margaret Little, physicians should be aware that certain aesthetic (...) enhancement requests reflect immoral social norms and ideals. By granting such requests, she argues, doctors render themselves complicit to a collective ‘evil’. In this paper, we wish to question the extent to which physicians, psychiatrists and/or neurosurgeons should play a role as ‘moral gatekeepers’ in dealing with suspect demands and norms underlying potential desires to alter one’s mood or character. We investigate and discuss the nature and limits of physician responsibilities in reference to various hypothetical and intuitively problematic mood enhancement requests. (shrink)

Without trust there is no credible human health research (HHR). This article accepts this truism and addresses a crucial question that arises: how can trust continually be promoted in an ever-changing and uncertain HHR environment? The article analyses long-standing mechanisms that are designed to elicit trust—such as consent, anonymization, and transparency—and argues that these are best understood as trust represented by proxies of trustworthiness, i.e., regulatory attempts to convey the trustworthiness of the HHR system and/or its actors. Often, such proxies (...) are assumed to operate as markers that trust exists or, at least, has not been lost. But, since trust can neither be “built” nor “secured,” this is a precarious assumption. Worryingly, there is no existing theoretical account of how to understand and evaluate these proxies of trustworthiness as part of a trusted HHR ecosystem. To remedy this, the paper argues for a radical reimagining of trust and trustworthiness as performative acts that ought to be understood in relation to each other and by reference to the common values at stake. It is shown that proxies of trustworthiness are the operational tools used to perform trustworthiness. It advocates for a values-based approach to understanding the relationship between trust and trustworthiness. This establishes a strong basis for an evaluative framework for proxies of trustworthiness, i.e., to determine how to perform trustworthiness well. Five common proxies in HHR are scrutinized from a values perspective. The contribution is to provide a far-reaching normative and practical framework by which existing and future proxies of trustworthiness can be identified, assessed, maintained, or replaced in rapidly changing HHR regulatory ecosystems where trust itself is crucial to the success of the entire HHR enterprise. (shrink)

Six people were interviewed about the possibility of becoming posthumous body donors. Interview transcripts were analyzed using interpretative phenomenological analysis. Individual-level analysis suggested a common interest in Personhood Concerns and a common commitment to Enlightenment Values. Investigations of these possible themes across participants resulted in identification of two sample-level themes, each with two subthemes: Autonomy, with subthemes of agency and consent, and Rationality, with subthemes of knowledge/epistemology and materialism/ontology. This paper concentrates on the former. Consent for posthumous body donation was (...) felt to sometimes fall short of adequately identifying donors’ preferences about what happened after consent was given, even with respect to actions for which consent established permission. In turn, paucity of information about donors’ preferences limited others’ ability to act as proxy agents to facilitate donors’ posthumous autonomy. Thus, while consent may curtail violations of people’s autonomy by authorizing actions for which permission has been established, it may fall short of facilitating their autonomy in ways that might be possible with greater knowledge of those people’s desires. Alternative methods of establishing consent are explored that might better-determine people’s desires and thereby improve others’ ability to act as proxy agents for them to facilitate their subsequent (even posthumous) autonomy. (shrink)

The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...) autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account. (shrink)

BackgroundIn this article, we address questions regarding how people consider what they do or do not consent to and the reasons why. This article presents the findings of a citizen forum study conducted by the University of Geneva in partnership with the Geneva University Hospitals to explore the opinions and concerns of members of the public regarding predictive oncology, genetic sequencing, and cancer. MethodsThis paper presents the results of a citizen forum that included 73 participants. A research tool titled "the (...) mechanics of consent" was designed for this study. This tool is a table encouraging participants to reflect on social and research actors, types of data, and desired levels of control while sharing different types of data with different actors. Participants’ discussion that led to the completion of each table were audio-recorded, transcribed, and analyzed using thematic analysis.ResultsThe results are a compilation of responses from the mechanics of consent tool divided into two sections; the first presents quantitative results of collective responses regarding attitudes to consent to donate their data. The second section present qualitative findings emerged from the discussion amongst participants.DiscussionChoice and control of personal data is crucial for the public to be able to decide who and how to trust. Key information to be disclosed to potential research participants shall include information about potential risks and benefits; who will be accessing and using their data; as well as assurances that their choice will be respected. Furthermore, researchers ought to make sure they are trustworthy, by acting in a competent, reliable, and honest manner. Governance systems ought to be better equipped to address ethical issues raise by the growing presence of non-traditional research actors, consent of exchanges of data via digital devices and online activity such as social media and fairness of data trading. Finally, informed consent is one of the various elements that contribute to conducting ethical research. More needs to be done to strengthen governance and ensure adequate protection of research participants, particularly to address issues related to predictive health analytics. (shrink)

The use of decision-making capacity assessments in clinical medicine is an underdeveloped yet quickly growing practice. Despite the ethical and clinical importance of these assessments as a means of protecting patient autonomy, clinicians, philosophers, and ethicists have identified a number of practical and theoretical hurdles which remain unresolved. One ethically important yet largely unaddressed issue is whether, and to what extent physicians ought to inform and obtain consent from patients prior to initiating a capacity assessment. In what follows, I address (...) the following question: Must, or should, physicians obtain consent for capacity assessments? I argue that physicians have an ethical obligation to obtain express patient consent for capacity assessments, and in doing so, I challenge the predominant view which requires physicians to merely inform patients without obtaining consent. I then identify an underlying philosophical paradox that complicates the clinician's duty to obtain consent: in short, consent is needed for an assessment of one's ability to consent. Finally, I recommend a practical solution to this paradox of consent for capacity assessments by proposing a model of double consent from both the patient and health care representative. (shrink)

Accounts of the value of patient choice in contemporary medical ethics typically focus on the act of choosing. Being the one to choose, it is argued, can be valuable either because it enables one to bring about desired outcomes, or because it is a way of enacting one’s autonomy. This paper argues that all such accounts miss something important. In some circumstances, it is having the opportunity to choose, not the act of choosing, that is valuable. That is because in (...) many situations whether one has, or is denied, that opportunity conveys how one is seen. In particular, it conveys whether or not one is seen as an equal and competent member of society. Adequately recognising this fact has implications for what healthcare professionals should do, ones that require a move away from the current focus on autonomy. The paper draws out these implications by focusing on patients who may struggle to be recognised as competent and equal members of society, and whose autonomy may thus itself sometimes be in question. (shrink)

Although recent trends in politics and media make it appear that conspiracy theories are on the rise, in fact they have always been present, probably because they are sustained by natural dispositions of the human brain. This is also the case with medical conspiracy theories. This article reviews some of the most notorious health-related conspiracy theories. It then approaches the reasons why people believe these theories, using concepts from cognitive science. On the basis of that knowledge, the article makes normative (...) proposals for public health officials and health workers as a whole, to deal with conspiracy theories, in order to preserve some of the fundamental principles of medical ethics. (shrink)

Women are over-represented within alternative medicine, both as consumers and as service providers. In this paper, I show that the appeal of alternative medicine to women relates to the neglect of women’s health needs within scientific medicine. This is concerning because alternative medicine is severely limited in its therapeutic effects; therefore, those who choose alternative therapies are liable to experience inadequate healthcare. I argue that while many patients seek greater autonomy in alternative medicine, the absence of an evidence base and (...) plausible mechanisms of action leaves patients unable to realize meaningful autonomy. This seems morally troubling, especially given that the neglect of women’s needs within scientific medicine seems to contribute to preferences for alternative medicine. I conclude that the liberatory credentials of alternative medicine should be questioned and make recommendations to render scientific medicine better able to meet the needs of typical alternative medicine consumers. (shrink)

Gamification is the use of elements and techniques from video game design in non-game contexts. Amid the rapid growth of this practice, normative questions have been under-explored. The primary goal of this article is to develop a normatively sophisticated and descriptively rich account for appropriately addressing major ethical considerations associated with gamification. The framework suggests that practitioners and designers should be precautious about, primarily, but not limited to, whether or not their use of gamification practices: takes unfair advantage of workers (...) ; infringes any involved workers’ or customers’ autonomy ; intentionally or unintentionally harms workers and other involved parties; or has a negative effect on the moral character of involved parties. (shrink)

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge (...) the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice. (shrink)

Mill’s harm principle is commonly supposed to rest on a distinction between self-regarding conduct, which is not liable to interference, and other-regarding conduct, which is. As critics have noted, this distinction is difficult to draw. Furthermore, some of Mill’s own applications of the principle, such as his forbidding of slavery contracts, do not appear to fit with it. This article proposes that the self-regarding/other-regarding distinction is not in fact fundamental to Mill’s harm principle. The sphere of protected liberty includes not (...) only self-regarding conduct, but also actions that affect only consenting others. On the other hand, the occasional permissibility of interfering with self-regarding conduct can plausibly be explained by reference to the agent’s consent. Thus, the more important distinction appears to be that between consensual and non-consensual harm, rather than that between the self-regarding and non-self-regarding action. That is, interference can be justified in order to prevent non-consensual harms, but not to prevent consensual harms. It is argued that the harm principle, thus reformulated, both captures Mill’s intentions and is a substantively plausible position. (shrink)

How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An (...) ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society. (shrink)

Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching (...) Hospitals in a low resource setting. (shrink)