Engagement with genomic medicine and research has increased globally during the past few decades, including rapid developments in Sri Lanka. Genomic research is carried out in Sri Lanka on a variety of scales and with different aims and perspectives. However, there are concerns about participants' understanding of genomic research, including the validity of informed consent. This article reports a qualitative study aiming to explore the understanding, knowledge, and attitudes of the Sri Lankan public towards genomic medicine and to inform the (...) development of an effective and appropriate process for informed consent in that setting. Purposive sampling was employed. Participants were recruited from a sub-group of the public in Colombo, Sri Lanka who had either consented or refused to donate genetic material for a biobank. Data were collected using face-to-face semi-structured interviews. Interview data were transcribed verbatim and translated into English. Conventional content analysis was used. The analysis developed three key themes: a) ‘Scientific literacy’ describes an apparent lack of scientific knowledge that seems to affect a participant’s ability to understand the research, b) ‘Motivation’ describes narratives about why participants chose (not) to take part in the research, despite not understanding it, and c) ‘Trust’ describes how trust served to mitigate the apparent ethical deficit created by not being fully informed. In this article, we argue that informed trust is likely an acceptable basis for consent, particularly in settings where scientific literacy might be low. However, researchers must work to be worthy of that trust and ensure that misconceptions are actively addressed. (shrink)

The use of machine learning, or “artificial intelligence” (AI) in medicine is widespread and growing. In this paper, I focus on a specific proposed clinical application of AI: using models to predict incapacitated patients’ treatment preferences. Drawing on results from machine learning, I argue this proposal faces a special moral problem. Machine learning researchers owe us assurance on this front before experimental research can proceed. In my conclusion I connect this concern to broader issues in AI safety.

In this paper, we defend what we call the ‘Hybrid View’ of privacy. According to this view, an individual has privacy if, and only if, no one else forms an epistemically warranted belief about the individual’s personal matters, nor perceives them. We contrast the Hybrid View with what seems to be the most common view of what it means to access someone’s personal matters, namely the Belief-Based View. We offer a range of examples that demonstrate why the Hybrid View is (...) more plausible than the Belief-Based View. Finally, we show how the Hybrid View generates a more plausible fit between the concept of privacy, and the concept of a (morally objectionable) violation of privacy. (shrink)

In this paper, we defend what we call the ‘Hybrid View’ of privacy. According to this view, an individual has privacy if, and only if, no one else forms an epistemically warranted belief about the individual’s personal matters, nor perceives them. We contrast the Hybrid View with what seems to be the most common view of what it means to access someone’s personal matters, namely the Belief-Based View. We offer a range of examples that demonstrate why the Hybrid View is (...) more plausible than the Belief-Based View. Finally, we show how the Hybrid View generates a more plausible fit between the concept of privacy, and a (morally objectionable) violation of privacy. (shrink)

Obtaining human genetic samples is vital for many biobank research purposes, yet, the ethics of obtainment seems to many fraught with difficulties. One key issue is consent: it is by many considered ethically vital that consent must be fully informed (at least ideally speaking) in order to be legitimate. In this paper, we argue for a more liberal approach to consent: a donor need not know all the specifics of future uses of the sample. We argue that blanket consent is (...) ethically defensible, and that this is buttressed by considerations of (justified) trust-relations. Given robust institutional oversight, blanket consent is a permissible form of consent in the bio-banking context. (shrink)

This article will focus on the ethical issues of vaccine mandates and stake claim to the relatively extreme position that outright requirements for people to receive the vaccine are ethically correct at both the governmental and institutional levels. One novel strategy employed here will be to argue that deontological considerations pertaining to consent rights cut as much in favor of mandating vaccines as against them. The presumption seems to be that arguments from consent speak semi-definitively against forcing people to inject (...) something into their bodies, and so any argument in favor of mandates must produce different and overriding logical and ethical considerations. Our central claim will be that the same logic that might seem to prohibit vaccine mandates as violations of consent actually supports such mandates when viewed from the perspective of the potential bystander who might otherwise be exposed to COVID-19. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as (...) a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

This paper sets out an account of trust in AI as a relationship between clinicians, AI applications, and AI practitioners in which AI is given discretionary authority over medical questions by clinicians. Compared to other accounts in recent literature, this account more adequately explains the normative commitments created by practitioners when inviting clinicians’ trust in AI. To avoid committing to an account of trust in AI applications themselves, I sketch a reductive view on which discretionary authority is exercised by AI (...) practitioners through the vehicle of an AI application. I conclude with four critical questions based on the discretionary account to determine if trust in particular AI applications is sound, and a brief discussion of the possibility that the main roles of the physician could be replaced by AI. (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)

The practice around informed consent in clinical medicine is both inconsistent and inadequate. Indeed, in busy, contemporary health care settings, getting informed consent looks little like the formal process developed over the past sixty years and presented in medical textbooks, journal articles, and academic lectures. In this article, members of the Society of Teachers of Family Medicine (STFM) Collaborative on Ethics and Humanities review the conventional process of informed consent and its limitations, explore complementary and alternative approaches to doctor‐patient interactions, (...) and propose a new model of consent that integrates these approaches with each other and with clinical practice. The model assigns medical interventions to a consent continuum defined by the discrete categories of traditional informed consent, assent, and nondissent. Narrative descriptions and clinical exemplars are offered for each category. The authors invite colleagues from other disciplines and from the academic ethics community to provide feedback and commentary. (shrink)

The use of opaque, uninterpretable artificial intelligence systems in health care can be medically beneficial, but it is often viewed as potentially morally problematic on account of this opacity—because the systems are black boxes. Alex John London has recently argued that opacity is not generally problematic, given that many standard therapies are explanatorily opaque and that we can rely on statistical validation of the systems in deciding whether to implement them. But is statistical validation sufficient to justify implementation of these (...) AI systems in health care, or is it merely one of the necessary criteria? I argue that accountability, which holds an important role in preserving the patient‐physician trust that allows the institution of medicine to function, contributes further to an account of AI system justification. Hence, I endorse the vanishing accountability principle: accountability in medicine, in addition to statistical validation, must be preserved. AI systems that introduce problematic gaps in accountability should not be implemented. (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)

In _Pharmaceutical Freedom_ Professor Flanigan argues we ought to grant people self-medication rights for the same reasons we respect people’s right to give (or refuse to give) informed consent to treatment. Despite being the most comprehensive argument in favour of self-medication written to date, Flanigan’s _Pharmaceutical Freedom_ leaves a number of questions unanswered, making it unclear how the safe-guards Flanigan incorporates to protect people from harming themselves would work in practice. In this paper, I extend Professor Flanigan’s account by discussing (...) a hypothetical case to illustrate how these safe-guards could work together to protect people from harms caused by their own ignorance or incompetence. (shrink)

In her Pharmaceutical Freedom, Jessica Flanigan argues that antibiotics can be regulated consistent with her otherwise largely deregulatory view with respect to pharmaceuticals and recreational drugs. I contend in this essay that the reasons for justifying antibiotic regulation are reasons that can be offered to justify the regulation of many other drugs, both pharmaceutical and recreational. After laying out the specifics of Flanigan’s view, I suggest that it is amenable to the regulation of drugs like varenicline. Though such drugs can (...) legitimately improve the quality of a patient’s life by helping them quit smoking, they could be permissibly regulated if they expose others to impermissible risks. I then argue that recreational drugs like alcohol could be regulated using the same reasoning. In the penultimate section of this essay, I anticipate objections that one might have to my extension of arguments favoring antibiotic regulation to drugs correlated with aggression. Flanigan might find my extrapolation of her view as entirely plausible and accept that her view is relatively friendly to these regulations, or she might reconsider her antibiotic caveat if these regulations are overly paternalistic on her understanding. I conclude by briefly considering the benefits and drawbacks of adopting each view. (shrink)

Consider that an individual improves her capacities by neuroscientific means. It turns out that, besides altering her in the way(s) she intended, the enhancement also changes her personality in significant way(s) she did not foresee. Yet the person endorses her new self because the neuroenhancement she underwent changed her. Can the person’s approval of her new personality be autonomous? While questions of autonomy have already gathered a significant amount of attention in philosophical literature on human enhancement, the problem just described—henceforth (...) referred to as the question whether selfvalidating neuroenhancement can be autonomous—would not appear to have received due consideration. This article takes a step towards remedying the shortage. I start by explicating the main points of departure of its argument. In the subsequent sections of the article, I consider several possible reasons for deeming self-validating neuroenhancement incompatible with autonomy. On the basis of the consideration, I propose that self-validating neuroenhancement can be autonomous. (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)

Modern health data practices come with many practical uncertainties. In this paper, I argue that data subjects’ trust in the institutions and organizations that control their data, and their ability to know their own moral obligations in relation to their data, are undermined by significant uncertainties regarding the what, how, and who of mass data collection and analysis. I conclude by considering how proposals for managing situations of high uncertainty might be applied to this problem. These emphasize increasing organizational flexibility, (...) knowledge, and capacity, and reducing hazard. (shrink)

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta-consent framework, participants can choose the type (...) of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process. (shrink)

With the hope of somehow contributing to the ongoing discussion on the topic, this paper is loosely based on the debate that emerged from Rob Sparrow's article “Should human beings have sex? Sexual dimorphism and human enhancement”. Building on some of his arguments, my claim is that we should not refer to gender when discussing not-yet-born agents. More broadly still, my intention is to provide a further analysis of the intersection of the concepts of gender and autonomy. I will begin (...) by briefly highlighting Sparrow's article and critiques, with special emphasis on the poststructuralist attack. In doing so, I will consider the differences between structuralism and poststructuralism in relation to this debate. Subsequently, I will draw a parallel between Judith Butler's notion of the performativity of gender, sex and Ronald Dworkin's distinction between zoe and bios. The next move will then be to re-divert attention to the crucial role that health plays in the discussion, suggesting that one of the substantial differences between human enhancers and non-enhancers is the ranking that health has in their corresponding scale of values. Setting the bar for how an organism functions “normally” will be the last step necessary to create the basis for my main claim: building on Butler's description of the singular agent in relation to others, I will suggest Jürgen Habermas and Onora O'Neill as credible and valuable expansions of a position willing to reconcile individual and relational autonomy, supporting this final claim with the words of Immanuel Kant. If we aim to use genetic engineering and preimplantation genetic diagnosis to prevent unhealthy children from being born – as I shall state we should – we can use this notion of normality in a way that will be accepted also by those who are historically critical of such a way of conceptualising a human being, only if we understand the parallel need for society to shift to a more inclusive and shared definition of autonomy. (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)

The current informed consent mechanism is based mainly on the rationale of individualism, particularly for its emphasis on autonomy and self-determination. However, in biobanking and genetic research, research findings may pose a risk of harm to the collective, quite aside from a particular individual. Under this circumstance, individual consent needs to be supplemented by other mechanisms, such as group consent obtained from the relevant group or community. In Taiwan, the inclusion of Taiwanese aborigines in biobanking and genetic research challenges the (...) conventional wisdom of individual consent-taking, which overlooks the significance of collective involvement in decision-making. This paper discusses the rationale of the group consent requirement in Taiwan, which seeks to include Taiwanese aborigines’ perspectives, and the related measures that have been pronounced to implement group consultation. It is further argued that consent procedures should not be transactional in being primarily focused on types of information that is to be communicated. Rather, it should be a process that ensures comprehension, empowerment and trust. (shrink)

Mindfulness exercises are presented as being compatible with almost any spiritual, religious or philosophical beliefs. In this paper, we argue that they in fact involve imagining and conceptualising rather striking and controversial claims about the self, and the self’s relationship to thoughts and feelings. For this reason, practising mindfulness exercises is likely to be in tension with many people’s core beliefs and values, a tension that should be treated as a downside of therapeutic interventions involving mindfulness exercises, not unlike a (...) side effect. Clients ought to be informed of these metaphysical aspects of the exercises, and mental health providers ought to take them into account in assessing which course of treatment to recommend. Given these concerns, the casual way in which mindfulness exercises are presently distributed by mental health providers to the general public is inappropriate. (shrink)

The adoption of web-based telecare services has raised multifarious ethical concerns, but a traditional principle-based approach provides limited insight into how these concerns might be addressed and what, if anything, makes them problematic. We take an alternative approach, diagnosing some of the main concerns as arising from a core phenomenon of shifting trust relations that come about when the physician plays a less central role in the delivery of care, and new actors and entities are introduced. Correspondingly, we propose an (...) applied ethics of trust based on the idea that patients should be provided with good reasons to trust telecare services, which we call sound trust. On the basis of this approach, we propose several concrete strategies for safeguarding sound trust in telecare. (shrink)

Ideas about freedom and related concepts like autonomy and self-determination play a prominent role in the moral debate about human enhancement interventions. However, there is not a single understanding of freedom available, and arguments referring to freedom are simultaneously used to argue both for and against enhancement interventions. This gives rise to misunderstandings and polemical arguments. The paper attempts to disentangle the different distinguishable concepts, classifies them and shows how they relate to one another in order to allow for a (...) more structured and clearer debate. It concludes in identifying the individual underpinnings and the social conditions of choice and decision-making as particularly salient dimensions of freedom in the ethical debate about human enhancement. (shrink)

There is an ongoing debate about the “ontology” of consent. Some argue that it is a mental act, some that it is a “hybrid” of a mental act plus behaviour that signifies that act; others argue that consent is a performative, akin to promising or commanding. Here it is argued that all these views are mistaken—though some more so than others. We begin with the question whether a normatively efficacious act of consent can be completed in the mind alone. Standard (...) objections to this “mentalist” account of consent can be rebutted. Here we identify a much deeper problem for mentalism. Normatively transformative acts of consent change others’ reasons for acting in a distinctive—“robust”—way. Robust reason-changing involves acts aimed at fulfilling a distinctive kind of reflexive and recognition-directed intention. Such acts cannot be coherently performed in the mind alone. Consent is not a mental act, but nor is it the signification of such an act. Acts of consent cannot be “completed” in the mind, and it is a mistake to view consent behaviour as making known a completed act of consent. The robust reason-changing account of consent developed here shares something with the performative theory, but is not saddled with a label whose home is philosophy of language. Certain kinds of performative utterance may change reasons robustly, but not all robust reason-changing involves or requires acts of speech, and consent can be effected by a wide range of behavioural acts. (shrink)

There are ethical guidelines that form the foundation of the traditional doctor–patient relationship in medicine. Health care providers are under special obligations to their patients. These include obligations to disclose information, to propose alternative treatments that allow patients to make decisions based on their own values, and to have special concern for patients’ best interests. Furthermore, patients know that these obligations exist and so come to their physicians with a significant level of trust. In this sense, therapeutic medicine significantly differs (...) from straightforward business practices such as the buying and selling of houses, cars, cell phones, etc. However, we argue that this relationship differs when medicine is used for enhancement rather than therapy. When patients seek enhancements they are not as vulnerable as when they are ill. And in an enhancement setting, physicians have little role outside of medical risks to discuss motivation and alternatives. Therefore, we conclude that a more reasonable alternative may be for doctors and patients to use ethical norms associated more with straightforward business practices, specifically sales. We believe that full disclosure of this different set of norms will benefit both physicians and patients. (shrink)

Medical practitioners are duty-bound to tell their patients the truth about their medical conditions, along with the risks and benefits of proposed treatments. Some patients, however, would rather not receive medical information. A recent response to this tension has been to argue that that the disclosure of medical information is not optional. As such, patients do not have permission to refuse medical information. In this paper I argue that, depending on the context, the disclosure of medical information can undermine the (...) patient’s ability to exercise her autonomy or have therapeutically detrimental effects. In the light of these insights I go on to develop a context-sensitive approach to medical disclosure. The advantage of this account is that it addresses concerns on both sides of the debate; whilst it acknowledges that patients do not have an exercisable ‘right not to know,’ it allows that in some cases medical information ought to be withheld. (shrink)

In medical practice, the doctrine of informed consent is generally understood to have priority over the medical practitioner’s duty of care to her patient. A common consequentialist argument for the prioritisation of informed consent above the duty of care involves the claim that respect for a patient’s free choice is the best way of protecting that patient’s best interests; since the patient has a special expertise over her values and preferences regarding non-medical goods she is ideally placed to make a (...) decision that will protect her interests. In this paper I argue against two consequentialist justifications for a blanket prioritisation of informed consent over the duty of care by considering cases in which patients have imperfect access to their overall best interests. Furthermore, I argue that there are cases where the mere presentation of choice under the doctrine of informed consent is detrimental to patient best interests. I end the paper by considering more nuanced approaches to resolving the conflict between informed consent and the duty of care and consider the option of permitting patients to waive informed consent. (shrink)

Euthanasia and assisted suicide have proved to be very contentious topics in medical ethics. Some ethicists are particularly concerned that allowing physicians to carry out these procedures will undermine their professional obligations and threaten the very goals of medicine. However, I maintain that the fundamental goals of medicine not only do not preclude the practice of euthanasia and assisted suicide by physicians, but can in fact be seen to support these practices in some instances. I look at two influential views (...) of the goals of medicine, one based on the broad guiding principles of autonomy, beneficence and nonmaleficence, and the other focusing on several more concrete aims, concluding that both approaches can be seen to support euthanasia and assisted suicide. I then turn to the popular concern that allowing physicians to carry out euthanasia and assisted suicide will lead to widespread abuse. I argue that the possibility for abuse can be minimised if we make the patient's autonomous consent an essential requirement of the practice. (shrink)

This is the fourth in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which are traditionally thought to make (...) consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary. (shrink)

Libertarian paternalism's notion of “nudging” refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging (...) for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy. (shrink)

Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.

In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem to informed consent. (...) The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

In their recent article, Erbay et al considered whether a seriously injured patient should be able to refuse treatment if the refusal was based on a (mis)interpretation of religious doctrine. They argued that in such a case ‘what is important…is whether the teaching or philosophy used as a reference point has been in fact correctly perceived’ (p 653). If it has not been, they asserted that this eroded the patient's capacity to make an autonomous decision and that therefore, in such (...) cases, it is the role of the healthcare professional (HCP) to ‘assist patients to think more clearly and rationally’ (p 653). There are, however, a number of problems with the reasons why Erbay et al suggest we should help patients to rationalise their decisions and how HCPs should go about this. In this article, the author explores some of their main arguments regarding consent and rationality (particularly in relation to religious beliefs), as well as Erbay et al's normative claim that HCPs have an obligation to promote autonomy by helping patients to come to a ‘rational’ decision. Ultimately, the author agrees that the (temporary) solution to the dilemma presented in this scenario (which was to insert an intravenous cannula into the patient in order to allow an infusion of fluids in the event that he changed his mind) seemed both pragmatic and ethically permissible. However, it is suggested that the arguments which underpin this conclusion in Erbay et al's article are largely unsound. (shrink)

BackgroundThe role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.MethodsWe conducted seven (...) day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.ResultsBroad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.ConclusionBecause no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. (shrink)

BackgroundAs the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.DiscussionParents want to do their best for their children, and socially and legally their role is to care for (...) and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.SummaryDiscussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties. (shrink)

With the growing focus on prevention in medicine, studies of how to describe risk have become increasing important. Recently, some researchers have argued against giving patients “comparative risk information,” such as data about whether their baseline risk of developing a particular disease is above or below average. The concern is that giving patients this information will interfere with their consideration of more relevant data, such as the specific chance of getting the disease (the “personal risk”), the risk reduction the treatment (...) provides, and any possible side effects. I explore this view and the theories of rationality that ground it, and I argue instead that comparative risk information can play a positive role in decision-making. The criticism of disclosing this sort of information to patients, I conclude, rests on a mistakenly narrow account of the goals of prevention and the nature of rational choice in medicine. (shrink)

With the waves of reform occurring in mental health legislation in England and other jurisdictions, mental capacity is set to become a key medico-legal concept. The concept is central to the law of informed consent and is closely aligned to the philosophical concept of autonomy. It is also closely related to mental disorder. This paper explores the interdisciplinary terrain where mental capacity is located. Our aim is to identify core dilemmas and to suggest pathways for future interdisciplinary research. The terrain (...) can be separated into three types of discussion: philosophical, legal and psychiatric. Each discussion approaches mental capacity and judgmental autonomy from a different perspective yet each discussion struggles over two key dilemmas: whether mental capacity and autonomy is/should be a moral or a psychological notion and whether rationality is the key constitutive factor. We suggest that further theoretical work will have to be interdisciplinary and that this work offers an opportunity for the law to enrich its interpretation of mental capacity, for psychiatry to clarify the normative elements latent in its concepts and for philosophy to advance understanding of autonomy through the study of decisional dysfunction. The new pressures on medical and legal practice to be more explicit about mental capacity make this work a priority. (shrink)

BackgroundThe assessment of patients’ decision-making capacity is ubiquitous in contemporary healthcare. This paper examines the ethics of undisclosed probing of capacity by psychiatrists. The discussion will refer to the law in England and Wales, though the highlighted issues are likely to be relevant in similar jurisdictions.Main textDecision-making capacity is a private attribute, and patients may not necessarily be aware that one of their personal abilities is being explored. Routine exploration of capacity has not historically been a part of psychiatric examination, (...) but it is now difficult to avoid during psychiatric interview.Ethical practice and shared decision-making require patients to be aware that their decision-making may be evaluated by the doctor at some point, and the potential implications of an objective professional conclusion of incapacity. Case law directs that patients should be informed about any assessment of their decision-making ability, though the extent to which this has translated into practice is unclear. However, explanation about the assessment may cause a patient to react negatively, which may impede therapeutic engagement and constitute an ethical dilemma. It is argued that in the absence of systemic measures, professionals should retain the discretion to decide whether a particular patient should be informed about the impending probe into their decision-making ability, or not. In the latter instance, concealment of information about the assessment or its purpose should be subject to the caveats and safeguards associated with any recourse to therapeutic exception.ConclusionThe necessity to mandatorily inform patients about assessment of their capacity introduces a novel ethical dilemma for psychiatrists. The negotiation of this dilemma should not be the prerogative of the clinician, and requires systemic initiatives to ensure universal awareness of patients about the possibility of their capacity being assessed during their journeys through healthcare systems. (shrink)

Do privacy rights restrict what is permissible to infer about others based on statistical evidence? This paper replies affirmatively by defending the following symmetry: there is not necessarily a morally relevant difference between directly appropriating people’s private information—say, by using an X-ray device on their private safes—and using predictive technologies to infer the same content, at least in cases where the evidence has a roughly similar probative value. This conclusion is of theoretical interest because a comprehensive justification of the thought (...) that statistical inferences can violate privacy rights is lacking in the current literature. Secondly, the conclusion is of practical interest due to the need for moral assessment of emerging predictive algorithms. (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the (...) informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

Digital farming technologies promise to help farmers make well-informed decisions that improve the quality and quantity of their production, with less labour and less impact on the environment. This future, however, can only become a reality if farmers are willing to share their data with agribusinesses that develop digital technologies. To foster trust in data sharing, in Europe the EU Code of Conduct for agricultural data sharing by contractual agreement was launched in 2018 which encourages transparency about data use. This (...) article looks at the EU Code through the lens of literature on trust and contract agreements. We agree with the makers of the EU Code that a contract can make an important contribution to trust relationships as it is needed to mitigate the detrimental effects of power relationships between experts and non-experts. Building on Onora O’Neills perspective to trust, however, we argued that a contract can only be successful in fostering trust when information is comprehended by the more vulnerable party in this relationship who has to sign the contract, the more powerful partner takes responsibility to provide that information, and information is tailored to the information needs of the party signing the contract, even when data are re-used over a longer period. In addition, we think that differences between trust relationships and relationships of accountability, give reason to add to informed consent other more substantive ethical components in a more encompassing code of conduct. (shrink)

The author reviews various conceptions of autonomy to show that humans are actually not autonomous, strictly speaking. He argues for a need to rethink the personal autonomy approaches to HIV testing in sub-Saharan Africa (SSA) countries. HIV/AIDS has remained a leading cause of disease burden in SSA. It is important to bring this disease burden under control, especially given the availability of current effective antiretroviral regimens in low- and middle-income countries. In most SSA countries the ethic or value of personal (...) autonomy or self-determination is promoted as primary in HIV testing decision-making. SSA policymakers have an ontological and moral duty to adopt HIV testing policies that reflect human and medical realities, relationships, local contexts, and respect human rights for both individuals and others who are affected by HIV in society. Without rethinking the value of autonomy in HIV testing decision-making, the article cautions that attainment of the Sustainable Development Goal (SDG) 3 and the UNAIDS fast-track strategy that explicitly call to end the epidemic by 2030 will not be feasible for SSA. (shrink)

Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents, healthcare professionals and policy decision makers in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information (...) attainment. Decision-making comprised: parent decision authority; voluntariness; parent engagement with decision-making; and the process of enacting choice. Information ascertainment comprised: professional responsibilities ; parent responsibilities; and the need for discussion and understanding prior to a decision. Our findings indicate that consent-related terms are variously understood, with substantive implications for practice. We suggest that consent procedures should be explained descriptively, regardless of approach, so there are clear indications of what is expected of parents and healthcare professionals. Support systems are required both to meet the educational needs of parents and families and to support healthcare professionals in delivering information in a manner in keeping with parent needs. (shrink)