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)

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)

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)

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)

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)

This article illustrates the less-acknowledged social construction of the concept of ‘incompetency’ and draws attention to the moral concerns it raises in health care encounters in the south Indian city of Chennai. Based on data drawn from qualitative research, this study suggests that surgeons subjectively construct the idea of incompetency through their understanding of the perceived circumstantial characteristics of the patients and family members they serve. The findings indicate that surgeons often underestimate patients and family members’ capacity based on constructed (...) assessments, which leads to paternalistic practice. In this article, I illustrate how these assessments influence the surgeons’ practices and provide the moral and practical justifications for their actions. The constructed knowledge becomes a source for drawing normative justification for surgeons’ actions and, in conjunction with socially enforced power relationships, results in patients and family members to be on the receiving end of disrespectful attitudes. Based on the data analysis and by drawing on philosophical analysis, I emphasize the need to focus on ‘respect for persons,’ to rethink the framework of ‘capacity,’ and to practice respect in hospital settings. (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)

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)

Informed consent processes are a vital component of both human and veterinary medicine. Current practice encourages veterinarians to learn from insights in the human medical field about how best to achieve valid consent. However, drawing on published literature in veterinary and medical ethics, this paper identifies considerable differences between the purposes of veterinary and human medical consent. Crucially, it is argued that the legal status of animal patients as ‘property’ has implications for the ethical role of veterinary informed consent and (...) the protection of the animal ‘patient’. It is suggested that veterinary informed consent should be viewed as an ethical pivot point where the multiple responsibilities of a veterinary professional converge. In practice, balancing these responsibilities creates considerable ethical challenges. As an example, the paper discusses the renewed call for UK veterinarians to make animal welfare their first priority; we predict that this imperative may increasingly cause veterinary informed consent to become an ethical pressure point due to tensions caused by the often conflicting interests of animals, owners and the veterinary profession. In conclusion, the paper argues that whilst gaining informed consent can often be presented as a robust ethical justification in human medicine, the same cannot be said in veterinary medicine. If the veterinary profession wish to prioritise animal welfare, there is an urgent need to re-evaluate the nature of authority gained through owner informed consent and to consider whether animal patients might need to be better protected outside the consent process in certain circumstances. (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)

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK’s National Health Service. We explore two aspects of consent: first, (...) how healthcare professionals consider the act of ‘consenting’ patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients’ understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients’ decision-making. Rather, decision-making is socially contextualised – also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed. (shrink)

In this essay, I argue that the daily practice of expert nurses goes far toward enacting the kind of patient autonomy feminist bioethicists envision. Nursing theorists often utilize philosophical theories in their work, but bioethicists have not paid much attention to nursing theory and what it means to be an expert nurse. This is unfortunate because expert nurses do much in their daily practice to make the ideals for autonomy put forth by feminist bioethicists a reality. With this in mind, (...) I bring these two literatures together in what I hope is a fruitful dialogue. (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)

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)

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)

Medical tourism—the practice where patients travel internationally to privately access medical care—may limit patients’ regular physicians’ abilities to contribute to the informed decision-making process. We address this issue by examining ways in which Canadian family doctors’ typical involvement in patients’ informed decision-making is challenged when their patients engage in medical tourism.

Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more than minimal risk (...) with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent. (shrink)

Prenatal care and the practice of prenatal genetic testing are about to be changed fundamentally. Due to several ground-breaking technological developments prenatal screening and diagnosis (PND) will soon be offered earlier in gestation, with less procedure-related risks and for a profoundly enlarged variety of targets. In this paper it is argued that the existing normative framework for prenatal screening and diagnosis cannot answer adequately to these new developments. In concentrating on issues of informed consent and the reproductive autonomy of the (...) pregnant women the ethical debate misses problems related to the clinical pathway as a whole and to implicit normative attributions to clinical actions or the function of health care professionals. If, however, ethical debate would focus on the clinical context and on the ends of PND to a larger extent, it would be able to provide a more comprehensive analysis of the ethical challenges especially of the new technologies in order to be more adequately prepared for their implementation. (shrink)

A decade has passed since the mapping of the human genome—an event that paved the way for many new developments in biomedicine and related fields. In ethics, this milestone was accompanied by calls for changes in ruling ethical frameworks.

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)

What is privacy? What does privacy mean in relation to biobanking, in what way do the participants have an interest in privacy, (why) is there a right to privacy, and how should the privacy issue be regulated when it comes to biobank research? A relational view of privacy is argued for in this article, which takes as its basis a general discussion of several concepts of privacy and attempts at grounding privacy rights. In promoting and protecting the rights that participants (...) in biobank research might have to privacy, it is argued that their interests should be related to the specific context of the provision and reception of health care that participation in biobank research is connected with. Rather than just granting participants an exclusive right to or ownership of their health information, which must be waived in order to make biobank research possible, the privacy aspect of health information should be viewed in light of the moral rights and duties that accompany any involvement in a research based system of health services. (shrink)

More and more, we face AI-based products and services. Using these services often requires our explicit consent, e.g., by agreeing to the services’ Terms and Conditions clause. Current advances introduce the ability of AI to evolve and change its own modus operandi over time in such a way that we cannot know, at the moment of consent, what it is in the future to which we are now agreeing. Therefore, informed consent is impossible regarding certain kinds of AI. Call this (...) the problem of radical ignorance. Interestingly, radical ignorance exists in consent contexts other than AI, where it seems that individuals can provide informed consent. The article argues that radical ignorance can undermine informed consent in some contexts but not others because, under certain institutional, autonomy-protecting conditions, consent can be valid without being (perfectly) informed. By understanding these institutional conditions, we can formulate practical solutions to foster valid, albeit imperfectly informed consent across various decision contexts and within different institutions. (shrink)

Egg freezing can allow women to preserve their eggs to avoid age-related infertility. The UK's recent extension of elective egg freezing storage has been welcomed as a way of enhancing the reproductive choices of young women who wish to delay having children. In this paper, I explore the issue of enhancing women’s reproductive choices, questioning whether there is a more significant aspect overlooked in egg freezing. While increasing storage limits expands reproductive choices for some women, focus on this extension alone, (...) I argue, misses a fundamental issue with egg preservation that often remains ignored; the importance of effective information on egg freezing and the effect this has on women’s reproductive choices. Ultimately, I highlight the crucial role of balanced information in enhancing women’s choices regarding egg freezing and argue that focusing on extending and increasing provision may obscure this real opportunity to empower women and their authentic reproductive choices. (shrink)

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)

Advocates of the Person-Centered Healthcare (PCH) approach say that PCH is a response to a failure of caring for patients as persons. Nevertheless, there are many human subjects falling to fulfill the requirements of a traditional philosophical definition of personhood. Hence, if we take, PCH seriously, a greater clarification of the key terminology of PCH is urgently needed. It seems necessary, for instance, that the concept of the person should be extended in order to include those individuals with insipient or (...) immature levels of consciousness, as well as those who are severely and permanently mentally handicapped. In this article, we will depart from some well-known philosophical concepts of what it means to be a person and try to offer a broader and more inclusive meaning. We suggest that persons are human beings with a socially recognized biography, which implies to recognize as persons individuals with necessities, but also with narratives about their interests and claims, expressed sometimes by other people related to them. This is particularly the case of individuals that suffer from severe disorders of consciousness. For those, is not only care that matters; respect matters too. Caregivers should therefore not only sympathetically care for the well-being of these people; they should also be concerned to respect their interests and claims by interpreting them empathetically, in the light of their biographical story. Our conclusion is that, in order to be coherent, PCH must consider individuals with severe disorders of consciousness as persons and we think that our revised concept of personhood fits with this requirement. (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.

Informed consent is at the core of the clinical relationship. With the introduction of machine learning (ML) in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the (...) whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML. (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)

Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of informed consent. In this paper, (...) it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent. (shrink)

I explain the notion of contributory injustice, a kind of epistemic injustice, and argue that it occurs within psychiatric services, affecting those who hear voices. I argue that individual effort on the part of clinicians to avoid perpetrating this injustice is an insufficient response to the problem; mitigating the injustice will require open and meaningful dialogue between clinicians and service user organisations, as well as individuals. I suggest that clinicians must become familiar with and take seriously concepts and frameworks for (...) understanding mental distress developed in service user communities, such as Hearing Voices Network, and by individual service users. This is especially necessary when these concepts and frameworks explicitly conflict with medical or technical understandings of users’ experiences. I defend this proposal against three objections. (shrink)

Health checks or health screenings identify disease in people without a specific medical indication. So far, the perspective of health check users has remained underexposed in discussions about the ethics and regulation of health checks. In 2017, we conducted a qualitative study with lay people from the Netherlands. We asked what participants consider characteristics of good and bad health checks, and whether they saw a role for the Dutch government. Participants consider a good predictive value the most important characteristic of (...) a good health check. Information before, during and after the test, knowledgeable and reliable providers, tests for treatable disease, respect for privacy, no unnecessary health risks and accessibility are also mentioned as criteria for good health checks. Participants make many assumptions about health check offers. They assume health checks provide certainty about the presence or absence of disease, that health checks offer opportunities for health benefits and that the privacy of health check data is guaranteed. In their choice for provider and test they tend to rely more on heuristics than information. Participants trust physicians to put the interest of potential health check users first and expect the Dutch government to intervene if providers other than physicians failed to do so by offering tests with a low predictive value, or tests that may harm people, or by infringing the privacy of users. Assumptions of participants are not always justified, but they may influence the choice to participate. This is problematic because choices for checks with a low predictive value that do not provide health benefits may create uncertainty and may cause harm to health; an outcome diametrically opposite to the one intended. Also, this may impair the relationship of trust with physicians and the Dutch government. To further and protect autonomous choice and to maintain trust, we recommend the following measures to timely adjust false expectations: advertisements that give an accurate impression of health check offers, and the installation of a quality mark. (shrink)

Childfree females encounter greater obstacles in obtaining voluntary sterilizations than childfree males. This paper discusses what might explain this and it proposes that female patients encounter particular credibility deficits that undermine their ability to grant informed consent. In particular, the paper explores Miranda Fricker’s recent suggestion that members of structurally disadvantaged groups encounter a particular sort of injustice that harms them in their capacity as knowers: they sustain testimonial injustice. The task of the paper is to investigate whether and in (...) what sense this holds. (shrink)

In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. (...) To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply. (shrink)

In recent years, direct brain interventions have shown increased success in manipulating neurobiological processes often associated with moral reasoning and decision-making. As current DBIs are refined, and new technologies are developed, the state will have an interest in administering DBIs to criminal offenders for rehabilitative purposes. However, it is generally assumed that the state is not justified in directly intruding in an offender’s brain without valid consent. Thomas Douglas challenges this view. The state already forces criminal offenders to go to (...) jail without their consent. This represents a serious interference with an offender’s rights. If criminal offenders are already morally liable to incarceration, why is the state not also entitled to administer DBIs without consent for the purposes of rehabilitation? Douglas argument focuses on the right to ‘bodily integrity’. He argues that there is no compelling reason to believe that bodily rights that protect an offender from non-consensual DBIs are stronger than rights that protect an offender from incarceration. This paper will extend Douglas’ analysis. It will consider the more fundamental right to ‘mental integrity’. The right to mental integrity defends an inner sphere of liberty. It protects critical capacities necessary for the exercise of autonomous human agency—without which a vast majority of moral rights could not exist. Thus, the right to mental integrity is ultimately more important for a moral assessment of DBIs. The right strongly suggests that both presently, and in the future, there may be many cases in which the state is not entitled to administer DBIs to criminal offenders without valid consent. (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)

Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition and measurement of the therapeutic misconception is a subject of continuing debate. Our qualitative pilot study of persons enrolled in a phase I trial of gene transfer for Parkinson disease suggests potential avenues for both measuring and preventing the therapeutic misconception. Building on earlier literature on the topic, we developed and (...) tested an interview guide that focuses on how the subjects decided to participate, emphasizing the integration of subjects’ various statements that are relevant to assessing the therapeutic misconception, rather than evaluating them as isolated statements. The results indicate that a subject’s understanding of the purpose of research is best explored in juxtaposition to the subject’s motivation for participating. (shrink)

In biomedical ethics the principle of autonomy is closely connected with the moral and legal claim to informed consent. After World War II and the dramatic misuse of medicine in Nazi Germany, informed consent regulations were expected to help avoid similar misuse in the future, to help overcome the traditional medical paternalism, and to advance the liberty rights of patients and human subjects of research. With the rise of the new field of bioethics in the 1970s, the traditional beneficence-based model (...) of medical ethics shifted in the direction of an individual autonomy model. (shrink)

The ethics of biobanking is one of the most controversial issues in current bioethics and public health debates. For some, biobanks offer the possibility of unprecedented advances which will revolutionise research and improve the health of future generations. For others they are worrying repositories of personal information and tissue which will be used without sufficient respect for those from whom they came. Wherever one stands on this spectrum, from an ethics perspective biobanks are revolutionary. Traditional ethical safeguards of informed consent (...) and confidentiality, for example, simply don’t work for the governance of biobanks and as a result new ethical structures are required. Thus it is not too great a claim to say that biobanks require a rethinking of our ethical assumptions and frameworks which we have applied generally to other issues in ethics. This paper maps the key challenges and controversies of biobanking ethics; it considers; informed consent (its problems in biobanking and possibilities of participants’ withdrawal), broad consent, the problems of confidentiality, ownership, property and comercialisation issues, feedback to participants and the ethics of re-contact. (shrink)

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)

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)

In this paper, I examine the rhetoric employed by court judgements, with a particular emphasis on the narrative construct of the ‘passive patient’. This construction advances and reinforces paternalistic values, which have scant regard for the patients’ preferences, values, or choices within the legal context. Further, I critique the rhetoric employed and argue that the use of this rhetoric is the basis for a precedent that limits the understanding and respect of patients. Through this paper, I present the contemporary use (...) of the ‘passive patient’ construct in the context of the Indian legal system and describe how such constructions have become a source of normative justification for legal reasoning that jeopardizes the patient’s agency. I argue for the primacy of ‘respect for persons’ within Indian law and the need to treat each patient as a person who has agency, preferences, and values during clinical interactions. I conclude by suggesting that laws that adopt narratives that acknowledging the significance of patient engagement and the relevance of effective communication during clinical encounters would help cultivate a culture of patient-centred care, by moving beyond the rhetoric of ‘passive patient’ and the ‘health/choice’ dichotomy. (shrink)

I denne artikel undersøges kroniske patienters beslutninger om forsøgsdeltagelse og betydningen af deltagerinformation. På baggrund af et års feltarbejde på fire danske forskningsklinikker argumenterer jeg for, at de observerede patienter opererer efter andre logikker, når de tager beslutninger om at deltage i kliniske forsøg, end hvad der antages i den gældende forskningsetiske regulering. Feltarbejdet fulgte et klinisk lægemiddelforsøg og inkluderede observationer af forsøgskonsultationer; interviews med investigatorer, projektsygeplejersker, forsøgsdeltagere og virksomhedsrepræsentanter; samt en mindre spørgeskemaundersøgelse blandt de danske forsøgsdeltagere. Resultaterne indikerer, at (...) for en gruppe af erfarne forsøgsdeltagere handler beslutningerne om forsøgsdeltagelse ikke om forsøget i sig selv, men om at opretholde en nær relation til forskningspersonalet. Disse patienter orienterer sig ikke efter deltagerinformation, men i forhold til tillidsrelationer. De agerer ikke som autonome individer, men oplever, at de er afhængige af sundhedssystemet. De udtrykker altruistiske motiver, men håber samtidig, at forsøgsdeltagelse vil give dem bedre helbredskontrol. For dem er forsøgsdeltagelse blevet en måde at leve med kronisk sygdom. Mulige implikationer af denne situation diskuteres, idet det understreges, at tillidsfulde relationer er en forudsætning både for god behandling og god forskning, men at de tætte relationer samtidig kan bevirke, at patienter bliver mindre kritiske, i forhold til hvilke forsøg de accepterer at deltage i, og at en bevidsthed om forsøgsrelaterede risici fortrænges fra forsøgssituationen.Nøgleord: informeret samtykke, deltagerinformation, deltagermotivation, kliniske forsøg, kronisk sygdom, DanmarkEnglish summary: Informed consent in clinical trials: technicalities, trust and intimate relationshipsThis article explores decisions about clinical trial participation in a group of patients with chronic conditions, focusing especially on motivation for trial participation and trial information. Based on ethnographic research in four Danish hospitals in conjunction with a clinical drug trial, I argue that these patients’ decisions follow logics other than those anticipated in research ethics regulations. I build on observations, interviews with physician-investigators, project nurses, patient-participants and trial sponsors, and a survey of the participants. The results indicate that for a group of experienced trial participants, trial information plays a very limited role because their decisions do not concern the trial per se but the sustainment of a close relationship with the research staff. They do not act as autonomous individuals weighing pros and cons based on the written information they receive. Rather, they feel dependent on the healthcare system and navigate in trust relations. For them, trial participation has become a way of living with chronic disease. I discuss implications of this situation underlining that trustful relationships constitute a precondition for high quality chronic care and research, yet the social dynamics may also lead patients to pay less attention to risks associated with trial participation. (shrink)