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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Research from behavioural sciences shows that people reach decisions in a much less rational and well-considered way than was often assumed. The doctrine of informed consent, which is an important ethical principle and legal requirement in medical practice, is being challenged by these insights into decision-making and real-world choice behaviour. This article discusses the implications of recent insights of research on decision-making behaviour for the informed consent doctrine. It concludes that there is a significant tension between the often non-rational choice (...) behaviour and the traditional theory of informed consent. Responsible ways of dealing with or solving these problems are considered. To this end, patient decisions aids are discussed as suitable interventions to support autonomous decision-making. However, current PDAs demand certain improvements in order to protect and promote autonomous decision-making. Based on a conception of autonomy, we will argue which type of improvements are needed. (shrink)

Objectives: Efficient procedures for obtaining informed (proxy) consent may contribute to high influenza vaccination rates in nursing homes. Yet are such procedures justified? This study’s objective was to gain insight in informed consent policies in Dutch nursing homes; to assess how these may affect influenza vaccination rates and to answer the question whether deviating from standard informed consent procedures could be morally justified. Design: A survey among nursing home physicians. Setting & Participants: We sent a questionnaire to all (356) nursing (...) homes in the Netherlands, to be completed by one of the physicians. Results: We received 245 completed questionnaires. As 21 institutions appeared to be closed or merged into other institutions, the response was 73.1% (245/335). Of all respondents 81.9% reported a vaccination rate above 80%. Almost 50% reported a vaccination rate above 90%. Most respondents considered herd immunity to be an important consideration for institutional policy. Freedom of choice for residents was considered important by almost all. Nevertheless, 106 out of 245 respondents follow a tacit consent procedure, according to which vaccination will be administered unless the resident or her proxy refuses. These institutions show significantly higher vaccination rates (p < 0.03). Conclusions: In our discussion we focus on the question whether tacit consent procedures can be morally justifiable. Such procedures assume that vaccination is good for residents either as individuals or as a group. Even though this assumption may be true for most residents, there are good reasons for preferring express consent procedures. (shrink)

The concept of informed consent for medical treatment has been well established as a necessary element in ensuring compliance with patients' right to self determination and respect of individual au...

It has been suggested that, in addition to individual level decision-making, informed consent procedures could be used in collective decision-making too. One of the main criticisms directed at this suggestion concerns decision-making power. It is maintained that consent is a veto power concept and that, as such, it is not appropriate for collective decision-making. This paper examines this objection to collective informed consent. It argues that veto power informed consent can have some uses in the collective level and that when (...) it is not appropriate the decision power a concerned party ought to have in connection with an arrangement should be made relative to the interest she has at stake in it. It concludes that the objection examined does not undermine collective informed consent. (shrink)

The moral status of business bluffing is a controversial issue. On the one hand, bluffing would seem to be relevantly similar to lying and deception. Because of this, business bluffing can be taken to be an activity that is at least prima facie morally condemnable. On the other hand, it has often been claimed that in business bluffing is part of the game and that therefore there is nothing morally questionable in business bluffing. In a recent issue of this journal, (...) Fritz Allhoff puts forward a novel defence of business bluffing. In this article, I will examine Allhoff’s arguments for the moral acceptability of business bluffing and argue that they are implausible. (shrink)

Newborn screening consists of taking a few drops of blood from a baby's heel in the first week of life and testing it for a list of disorders. In the United States and most countries in Europe, newborn screening programs began in the 1960s and 1970s with screening for phenylketonuria (PKU), a rare metabolic disease that causes severe and irreversible mental retardation unless treated before problems arise. As knowledge about rare diseases expanded and new screening technologies were introduced—such as the (...) tandem mass spectrometer and high‐performance liquid chromatography—the same blood sample could be used to test for a whole list of disorders. In general, screening programs in most countries have tended to expand, but in different countries they have expanded in different ways. Regulation also varies. In some states, screening is mandatory, whereas in others—Wyoming and Maryland—parents are asked for their informed consent. Germany and France have adopted an explicit informed consent procedure, whereas other European countries have a more informal “opt‐out” procedure that does not require signing an informed consent form. Whether newborn screening requires informed consent is an ongoing issue in bioethics. In this article, we will focus on the tension between informed consent and the problem of compliance in newborn screening. Asking for informed consent—allowing parents to opt out—is often thought to pose a threat to compliance. Building on the work of Onora O'Neill on informed consent and trust, however, as well as on work she coauthored with Neil Manson, we will argue that informed consent procedures may actually help maintain trust in newborn screening and may therefore support compliance. (shrink)

Informed consent needs to be practised within a culture of openness if it is to enhance public trust in medical procedures around death. Openness should entail patients not just receiving information from doctors, but also having the right to see certain medical procedures. This article proposes in particular that it would be desirable for the public to be allowed to attend an autopsy of a person they do not know. Evidence from the UK, where members of the public may go (...) backstage to witness the process of cremation, the other technical process in which dead bodies are violently but legitimately assaulted, suggests benefits from a policy of openness. When a family consents to cremation in Britain, their consent is only minimally informed, but the system has nothing to hide, and trust is high. This suggests that the opportunity for lay people also to witness certain medical procedures might do more to restore public trust in medical procedures around death than a narrow interpretation of informed consent in which information is controlled by the profession. (shrink)

The first objective of this article is to demonstrate that ethics committee members can learn a great deal from a forensic analysis of two classic psychology studies: Zimbardo’s Stanford Prison Study and Milgram’s Obedience Study. Rather than using hindsight to retrospectively eradicate the harm in these studies, the article uses a prospective minimization of harm technique. Milgram attempted to be ethical by trying to protect his subjects through debriefing and a follow-up survey. He could have done more, however, by carrying (...) out what ethics committees routinely insist on today for those researching sensitive topics. The establishment of counselling supports to identify harm to participants would have minimized additional harm. Were these in place, or in Zimbardo’s case had the Stanford Ethics Committee properly identified Zimbardo’s conflict of interest – he was both a principal investigator and the prison warden – how much harm could have been minimized? The second aim is to examine how some qualitative authors routinely demonize these classic studies. It might appear that there are too few cases of unethical qualitative research to justify such an examination; however, this article identifies a number of recent examples of ethically dubious qualitative research. This would suggest that qualitative research should examine its own ethics before poaching from psychology. (shrink)

A competent patient has the right to refuse treatment necessary to sustain life. However, for many end-of-life decisions, we lack direct access to the wishes of a competent patient. Some treatment decisions near the end of life involve patients with severely diminished mental capacity, some involve patients who are unable to communicate, and some involve patients who are simply unable or unwilling to participate in decisionmaking due to the nature or severity of their illness.

In recent years, there has been a considerable increase in the degree of philosophical attention devoted to the question of the morality of offering financial compensation in an attempt to increase the medical supply of human body parts and products, such as plasma. This paper will argue not only that donor compensation is ethically acceptable, but that plasma donors should not be prohibited from being offered compensation if they are to give their informed consent to donate. Regulatory regimes that prohibit (...) donor compensation thus unethically prevent the typical donor from being able to give her informed consent to donate. (shrink)

Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators is that the work of REBs often results in the marginalisation of Indigenous approaches to knowledge construction and dissemination, especially in relation to the vexed issue of informed consent. Based on analysis of the results of research (...) with Indigenous researchers and research participants, this paper argues that institutionalised REBs’ preference for ‘universal’ and ‘individualised’ approaches for determining ethical research conduct marginalises Indigenous approaches to ethical research conduct. The paper concludes by calling for a decolonisation of REB processes through recognition of the validity of communal processes for attaining the informed conse... (shrink)

Despite intense academic debate in the recent past over the use of ‘sham surgery’ control groups in research, there has been a recent resurgence in their use in the field of neurodegenerative disease. Yet the primacy of ethical arguments in favour of sham surgery controls is not yet established. Preliminary empirical research shows an asymmetry between the views of neurosurgical researchers and patients on the subject, while different ethical guidelines and regulations support conflicting interpretations. Research ethics committees faced with a (...) proposal involving sham surgery should be aware of its ethical complexities. An overview of recent and current placebo-controlled surgical trials in the field of Parkinson's Disease is provided here, followed by an analysis of the key ethical issues which such trials raise. (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.

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training (...) and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (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)

In contemporary liberal ethics patient autonomy is often interpreted as the right to self-determination: when it comes to treatment decisions, the patient is given the right to give or withhold informed consent. This paper joins in the philosophical and ethical criticism of the liberal interpretation as it does not regard patient autonomy as a right, rule or principle, but rather as a practice. Patient autonomy, or so I will argue, is realised in the concrete activities of day-to-day health care, in (...) the material and technological context of care, in arrangements of health care institutions, in the physical training of people with disabilities, as well as in the concrete activities of care-giving. This move from conversations in the consultation room to other sites and situations in the practice of care takes seriously the empirical reality of medical care and intends to show that patient autonomy is practically realised in a much richer and more creative way than most ethical theory seems to assume. (shrink)

Health checks identify disease in individuals without a medical indication. More and more checks are offered by more providers on more risk factors and diseases, so we may speak of an omnipresence of health checks. Current ethical evaluation of health checks considers checks on an individual basis only. However, omnipresent checks have effects over and above the effects of individual health checks. They might give the impression that health is entirely manageable by individual actions and strengthen the norm of individual (...) responsibility for health to the point where people hold themselves and others responsible for health outcomes they cannot reasonably be held accountable for. This process of so-called ‘over-responsibilization’ may result in increased feelings of guilt over health, decreased health solidarity and unfairly distributed health outcomes. Moreover, effects on privacy and peace of mind may be observed. Taking into account all possible harms and benefits of health checks in their ethical evaluation requires evaluation of health checks on an individual basis as well as on the level of all checks. Therefore, we urge the amendment of existing ethical evaluation to include the effects of an omnipresence of health checks. We make a first attempt at the formulation of amended criteria. (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, 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)

What I propose in this article is application of existing dispute resolution practices that take place outside the courtroom to the negotiating that takes place between health providers and families when they try to reach agreement about the limits of medical care that arguably is futile. Specifically, I focus on a bargaining paradigm that is associated with divorce proceedings, and suggest how this paradigm is at work in the conflict about futile treatment. At issue are not the well-publicized aspects of (...) high profile cases, but the rather unpublicized bargaining that goes no further than the clinical setting.Physicians and families who disagree about the futility of medical treatments frequently engage in give-and-take exchanges about whether to start disputed treatments, about what period of time might comprise a reasonable trial period if a treatment is to be administered, and about when and how to transfer a patient to another facility if the dispute cannot be resolved. (shrink)

What I propose in this article is application of existing dispute resolution practices that take place outside the courtroom to the negotiating that takes place between health providers and families when they try to reach agreement about the limits of medical care that arguably is futile. Specifically, I focus on a bargaining paradigm that is associated with divorce proceedings, and suggest how this paradigm is at work in the conflict about futile treatment. At issue are not the well-publicized aspects of (...) high profile cases, but the rather unpublicized bargaining that goes no further than the clinical setting.Physicians and families who disagree about the futility of medical treatments frequently engage in give-and-take exchanges about whether to start disputed treatments, about what period of time might comprise a reasonable trial period if a treatment is to be administered, and about when and how to transfer a patient to another facility if the dispute cannot be resolved. (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.

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted (...) to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests. (shrink)

The study reports on the results of an empirical investigation of the education and recruitment processes used in HIV vaccine trials conducted in South Africa. Interviews were conducted with 21 key informants involved in HIV vaccine research in South Africa and three focus groups of community advisory board members. Data analysis identified seven major themes on the relationship between education and recruitment: the process of recruitment, the combined dual role of educators and recruiters, conflicts perceived by field staff, pressure to (...) achieve recruitment targets, problems in achieving comprehension, accountability and education as capacity building. The results raise ethical concerns about the adequacy of current informed consent processes in these settings. The study findings bear directly on current debates about issues of exploitation and the scope of moral responsibilities of researchers and funding agencies to assure that HIV clinical prevention research is conducted ethically. (shrink)

While their strength, electrical, optical, or magnetic properties are expected to contribute a trillion dollars in global commerce before 2015, nanomaterials also appear to pose threats to human health and safety. Nanotoxicology is the study of these threats. Do nanomaterial benefits exceed their risks? Should all nanomaterials be regulated? Currently nanotoxicologists cannot help answer these questions because too little is known about nanomaterials, because their properties differ from those of bulk materials having the same chemical composition, and because they differ (...) so widely in their applications. Instead, this paper answers a preliminary ethical question: What nanotech policies are likely to contribute to society’s ability to give or withhold free informed consent to the potential risks associated with production and use of nanomaterials? This paper argues that at least four current policies appear to jeopardize the risk-disclosure condition that is required for informed consent. These are the funding problem, the conflict-of-interest problem, the labeling problem, and the extrapolation problem. Apart from future decisions on how to ethically make, use, and regulate nanomaterials, this paper argues that, at a minimum, these four policies must be modified. Government must spend greater monies on nanotoxicology; ensure independent nanotoxicology research; label consumer products containing nanomaterials; and avoid assuming that nanotoxicological properties are based merely on mass and chemical composition. Otherwise free informed consent to these new technologies and materials may be jeopardized. (shrink)

One way to do socially relevant investigations of science is through conceptual analysis of scientific terms used in special-interest science (SIS). SIS is science having welfare-related consequences and funded by special interests, e.g., tobacco companies, in order to establish predetermined conclusions. For instance, because the chemical industry seeks deregulation of toxic emissions and avoiding costly cleanups, it funds SIS that supports the concept of "hormesis" (according to which low doses of toxins/carcinogens have beneficial effects). Analyzing the hormesis concept of its (...) main defender, chemical-industry-funded Edward Calabrese, the paper shows Calabrese and others fail to distinguish three different hormesis concepts, H, HG, and HD. H requires toxin-induced, short-term beneficial effects for only one biological endpoint, while HG requires toxin-induced, net-beneficial effects for all endpoints/responses/subjects/ages/conditions. HD requires using the risk-assessment/regulatory default rule that all low-dose toxic exposures are net-beneficial, thus allowable. Clarifying these concepts, the paper argues for five main claims. (1) Claims positing H are trivially true but irrelevant to regulations. (2) Claims positing HG are relevant to regulation but scientifically false. (3) Claims positing HD are relevant to regulation but ethically/scientifically questionable. (4) Although no hormesis concept (H, HG, or HD) has both scientific validity and regulatory relevance, Calabrese and others obscure this fact through repeated equivocation, begging the question, and data-tri mm ing. Consequently (5) their errors provide some undeserved rhetorical plausibility for deregulating low-dose toxins. (shrink)