There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators (...) to guarantee that the subjects enrolled in their trials comprehend the risk/benefit information disclosed to them or even that they appreciate the difference between research and therapy. According to this critique, the significance of defects in informed consent, like therapeutic misconception or unrealistic optimism, has been greatly exaggerated. This article reevaluates informed consent in clinical research in light of this critique. It not only rebuts the main points the critics raise, but also shows that other points they raise can be accepted by a doctrine of informed consent that resembles the common view in maintaining that autonomous authorization is central to informed consent. (shrink)

Is it morally justifiable to force non-consenting pregnant women to submit to caesarean surgery to save their fetus in distress? Even though proponents and opponents largely agree on the interests at stake, such as the health and life of the fetus and the respect for bodily integrity and autonomy of pregnant women, they disagree on which moral weight to attach to these interests. This is why disagreements about the justifiability of forced caesareans tend to be pervasive and intractable. To sidestep (...) this deadlock, we will focus on conditions that give rise to the ‘caesarean dilemma’ in the first place, namely the conflict between inherent norms and values medical professionals are committed to by virtue of being a medical professional. Using the reflective equilibrium, we will test the opponents’ and proponents’ considered judgments about forced caesareans against the norms and values they—as medical professionals—are committed to and determine whether they are coherent. Subsequently we will identify the proponents’ incoherencies between the considered judgments and norms and values they are committed to and conclude that as long as these incoherencies are in place, forced caesareans are morally impermissible. (shrink)

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials .Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient (...) subjects based on this questionnaire.Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good , and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. (shrink)

Decisions regarding clinical procedures or research participation typically require the informed consent of individuals. When individuals are unable to give consent, the informed permission of a legally authorized representative or surrogate is required. Although many proposed procedures are aimed primarily at benefiting the individual, some are not. I argue that, particularly when individuals are asked to assume risks primarily or exclusively for the benefit of others, family members ought to be engaged in the informed consent process. Examples of procedures in (...) which individuals are asked to assume risks primarily or exclusively for the benefit of others include living organ donation and research participation. (shrink)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

In most, if not all, jurisdictions with active organ transplantation programs, there is a persistent desire to increase donation rates because the demand for transplantable organs exceeds the supply. China, in particular, faces an extraordinary gap between the number of organs donated by deceased donors and the number of people seeking one or more transplants. China might look to Western countries with higher donation rates to determine how best to introduce Western practices into the Chinese system. In attempting to increase (...) its organ donation rate, China must not only ensure that its organ donation system reflects different Chinese cultural values, but also that it avoids the ethical problems of the United States and of other Western systems. This article examines four such problems. They concern the family, obtaining permission for organ donation, the definition and diagnosis of “brain death,” and trust. Revisions to the Chinese system should involve a careful look to China and Chinese cultural resources rather than to Western models. (shrink)

Onora O’Neill hat 1984 den Zusammenhang zwischen grundsätzlichen Bedenken gegenüber dem ethischen Autonomiebegriff und der Kritik an der paternalistisch geprägten medizinethischen Praxis hergestellt, nicht die tatsächliche Einwilligung des konkreten Patienten zu berücksichtigen, sondern die angenommene, hypothetische Einwilligung, die ein idealisierter, völlig rationaler Patient geben würde. Im Anschluss an experimentalpsychologische Studien zur subliminalen Wahrnehmung, zu Volition und Handlungskontrolle erfahren kompatibilistische Theorien menschlicher Freiheit innerhalb der theoretischen Philosophie neue Popularität. Eine Handlung ist demnach frei, wenn sie das Resultat bestimmter Fähigkeiten einer Person (...) ist („Kompetenztheorie“). Der Artikel setzt sich mit zwei dieser Theorien, Henrik Walters Konzept „natürlicher Freiheit“ und Michael Pauens „Minimalkonzeption personaler Freiheit“ näher auseinander—und zwar vorderhand im Hinblick auf den Entwurf eines nichtidealisierten ethischen Autonomiekonzeptes. Als solches ist es an der aktualen bzw. faktischen Fähigkeit einer Person ausgerichtet, rekurrierend auf die spezifische Determiniertheit autonomer Entscheidungen und Handlungen sowie auf ein relativiertes Konzept menschlicher Vernunft. (shrink)

ZusammenfassungOnora O’Neill hat 1984 den Zusammenhang zwischen grundsätzlichen Bedenken gegenüber dem ethischen Autonomiebegriff und der Kritik an der paternalistisch geprägten medizinethischen Praxis hergestellt, nicht die tatsächliche Einwilligung des konkreten Patienten zu berücksichtigen, sondern die angenommene, hypothetische Einwilligung, die ein idealisierter, völlig rationaler Patient geben würde. Im Anschluss an experimentalpsychologische Studien zur subliminalen Wahrnehmung, zu Volition und Handlungskontrolle erfahren kompatibilistische Theorien menschlicher Freiheit innerhalb der theoretischen Philosophie neue Popularität. Eine Handlung ist demnach frei, wenn sie das Resultat bestimmter Fähigkeiten einer Person (...) ist. Der Artikel setzt sich mit zwei dieser Theorien, Henrik Walters Konzept „natürlicher Freiheit“ und Michael Pauens „Minimalkonzeption personaler Freiheit“ näher auseinander—und zwar vorderhand im Hinblick auf den Entwurf eines nichtidealisierten ethischen Autonomiekonzeptes. Als solches ist es an der aktualen bzw. faktischen Fähigkeit einer Person ausgerichtet, rekurrierend auf die spezifische Determiniertheit autonomer Entscheidungen und Handlungen sowie auf ein relativiertes Konzept menschlicher Vernunft. (shrink)

Nudging is a tool of libertarian paternalism. It involves making use of certain psychological tendencies in order to help people make better decisions without restricting their freedom. However, some have argued that nudging is objectionable because it interferes with, or undermines, the rational decision-making of the nudged agents. Opinions differ on why this is objectionable, but the underlying concerns appear to begin with nudging’s threat to rational decision-making. Those who discuss this issue do not make it clear to what this (...) threat to rationality amounts. In this paper I evaluate what effect nudging has on our decision-making and I argue that it does not typically interfere with our rationality in a problematic way. Perhaps nudging is objectionable for other reasons, but we should not argue that nudging is objectionable based on concerns about rational decision-making. (shrink)

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and (...) procedures that develop, test, and oversee any novel technology. This supports recommendations to coordinate efforts through an interagency Working Group and a Secretary-level Advisory Committee to provide flexibility and sensitivity to emerging issues of concern. (shrink)

Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration foreground procedures for minimizing risk for human subjects and require (...) local IRBs to engage in some sort of risk-benefit analysis in decisions to approve or deny proposed research. Existing ethical review and oversight practices are based on the presumption that risk can be clearly identified within the planned activities of the protocol, that metrics can reasonably accurately predict potential hazards, and that mitigation measures can be taken to deal with unintended, harmful, or catastrophic events. (shrink)

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad (...) consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material. (shrink)

In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors’ motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of (...) autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research. (shrink)

Providing patients with information is fundamental to respecting autonomy. However, there may be circumstances when information may be withheld to prevent serious harm to the patient, a concept referred to as therapeutic privilege. This paper provides an analysis of the ethical, legal and professional considerations which impact on a decision to withhold information that, in normal circumstances, would be given to the patient. It considers the status of the therapeutic privilege in English case law and concludes that, while reference is (...) made to circumstances when information (primarily in relation to risk disclosure) may be withheld, further clarification is required on the status of therapeutic privilege. I suggest there has been shift in English law relating to the standard of information disclosure towards one set by the test of the reasonable, prudent patient. It is this shift that necessitates the existence of a therapeutic privilege which enables doctors to withhold information that would usually be given to the patient in order to prevent serious harm. I then explore the professional guidance in relation to information disclosure and how this relates to the legal position. There are strong ethical arguments in favour of disclosure of information to patients. In light of these, further clarification is required to identify and define the grounds on which this exception exists, the information that could lawfully be withheld and how this exception extends to rest of the health care team, particularly nurses. As such, explicit ethical and legal scrutiny of therapeutic privilege is needed in order to consider how this concept might be articulated, constrained and regulated. (shrink)

Protecting the privacy of individually-identifiable health data is a dominant health policy objective in the new millennium. Technological, economic, and health-related reasons substantiate the development of a national electronic health information infrastructure. Through this emerging infrastructure, billions of pieces of health data of varying sensitivities are exchanged annually to provide health care services and service transactions, conduct health research, and promote the public’s health. These multi-purpose, rapid exchanges of electronic health data, far removed from the typical disclosure of health information (...) through the doctor/patient relationship of yesteryear, contribute to heightened individual concerns about identifiable health data. Responding to American fears and perceptions of actual and potential privacy abuses, policymakers have recently developed new, modern privacy protections through legislative and regulatory laws, as well as ethical and industry codes.Modern health information privacy protections are reflected in federal regulations developed by the federal Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996. (shrink)

Protecting the privacy of individually-identifiable health data is a dominant health policy objective in the new millennium. Technological, economic, and health-related reasons substantiate the development of a national electronic health information infrastructure. Through this emerging infrastructure, billions of pieces of health data of varying sensitivities are exchanged annually to provide health care services and service transactions, conduct health research, and promote the public’s health. These multi-purpose, rapid exchanges of electronic health data, far removed from the typical disclosure of health information (...) through the doctor/patient relationship of yesteryear, contribute to heightened individual concerns about identifiable health data. Responding to American fears and perceptions of actual and potential privacy abuses, policymakers have recently developed new, modern privacy protections through legislative and regulatory laws, as well as ethical and industry codes.Modern health information privacy protections are reflected in federal regulations developed by the federal Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996. (shrink)

Individual autonomy is a concept highly appreciated in modern Western societies. Its significance is reflected by the central importance and broad use of the model of informed consent in all fields of medicine. In predictive genetic testing, individual autonomy gains particular importance, for what is in focus here is not so much a concrete medical treatment but rather options for taking preventive measures and the influence that the test results have on long-term lifestyle and preferences. Based on an analysis of (...) autonomy-related issues in predictive genetic diagnosis and genetic screening programmes, this contribution stresses the central relevance of a broad notion of autonomy for the discussion of ethical issues raised in connection with predictive genetic testing and genetic screening programmes. Only against the background of such a broad notion of autonomy, which stresses not only free and informed decision-making but also the relevance of long-term prospects for leading a self-determined life in familial and social contexts, can the manifold autonomy-related issues linked to predictive genetic testing be given adequate consideration. (shrink)

Research into human ageing is a growing field of research with two central foci: geriatric medicine works to reduce the incidence and severity of age-related diseases and disabilities by devising adequate therapeutic and preventive strategies. A second focus, this time in the emerging field of biogerontology, is to bring about a general retardation of the ageing process and by this increase the average and maximum human lifespan. This contribution looks into the second focus, i.e. the possibility of age retardation which, (...) for the time being, is merely hypothetical. After outlining research strategies studying age retardation in animal experiments, it will ask how extending human life by technological interventions might play out on the individual, familial and social level. The central concern here will be autonomy-linked issues, seeing that in debates concerning the ethical implications of age-retarding techniques the argument from autonomy is one of the main arguments in favour of the prolongation of human life. In particular, this contribution will assess whether the argument from autonomy does, in fact, unequivocally support the recourse to age-retarding techniques. (shrink)

ZusammenfassungDie Bestimmung der Einwilligungsfähigkeit von Patienten beinhaltet weitreichende ethische und rechtliche Implikationen. Ausreichende Klärung des Begriffs ist daher unerlässlich. Solche Bemühungen gelten vorwiegend der Definition von Kriterien hinsichtlich relevanter mentaler Fähigkeiten. Grundlegendere Aspekte werden kaum explizit besprochen, so die Frage, ob Einwilligungsfähigkeit eher eine inhärente Fähigkeit oder ein ethisches Urteil bezeichnet. Zentral bei dieser Unterscheidung ist der Stellenwert ethischer Überlegungen die Zulässigkeit fürsorglicher Bevormundung betreffend. Geht man von einer inhärenten Fähigkeit aus, schließen solche Überlegungen an die Beurteilung von Einwilligungsfähigkeit an. (...) Im Fall eines Urteils sind diese konstitutiv für das Verständnis und die Bestimmung von Einwilligungsfähigkeit. Obwohl Einwilligungsfähigkeit idealerweise als inhärente Fähigkeit gedacht wird, weist die tatsächliche Herangehensweise eher in die Richtung, sie als ethisches Urteil zu verstehen. Diese verschiedenen Tendenzen sind für konzeptuelle Kontroversen hinsichtlich des Stellenwerts risiko-relativer Beurteilungen verantwortlich. Des Weiteren muss sich die Bestimmung von Einwilligungsfähigkeit – konzipiert man sie als ethisches Urteil – nicht rigide an einer bestimmten Definition des Begriffs der Autonomiefähigkeit orientieren und vermag so mit dessen definitorischen Unklarheiten besser umzugehen. (shrink)

In debate over the ethics of deceptive experiments in American psy chology, commentators often provide an inaccurate history of these experiments. This happens especially where writers portray experi mental deception as a necessary accompaniment to human experiments, rather than a conscious choice based on values attached to persons and scientific inquiry. Compounding the error, commentators typically give a misleading portrayal of psychologists' attitudes and procedures. Commentators frequently cite Stanley Milgram's work in the 1960s as a harbinger of changed attitudes towards (...) deception, and suggest that today's psychologists abide by more enlightened ethical practices. It is difficult to find evidence to support this portrayal. (shrink)

About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially (...) standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process. (shrink)

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research (...) on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right. (shrink)

Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants.

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

ZusammenfassungDas juristische Konzept der Einwilligung nach Aufklärung ist im Respekt vor dem Selbstbestimmungsrecht begründet. Es entwickelte sich seit Ende des 19. Jahrhunderts, gewann mit der rapiden Ausweitung der klinischen Forschung seit Mitte des 20. Jahrhunderts mittels der Deklaration von Helsinki und seit 1972 in den USA als Konzept des informed consent erhebliche Bedeutung in der klinischen Forschung, nachfolgend auch in der klinischen Praxis. Die psychiatrische Forschung stieß bald auf das grundlegende ethische Problem, dass psychische Krankheiten die Einwilligungsfähigkeit und damit die (...) Voraussetzung jeder Forschungsteilnahme beeinträchtigen oder gar zerstören können. Versuche der Lösung dieses ethischen und juristischen Problems in den letzten 30 Jahren – von frühen, durch das Konzept angestoßenen Fragen über die Entwicklung von Verfahren zur Feststellung der Einwilligungsfähigkeit bis zu aktuellen Vorschlägen für Forschungs- bzw. Probandenverfügungen und Forschungsvollmachten – werden im Kontext ihrer gesellschaftlichen Resonanz wie auch der eigenen Erfahrung skizziert. Die Übersicht soll die zunehmende Differenzierung des Konzepts verdeutlichen; sie folgt der Auseinandersetzung mit Problemen, die sich aus der Umsetzung und Wirksamkeit des Konzepts in der Forschungspraxis ergaben, um das Selbstbestimmungsrecht der Probanden zu bewahren. Als Schlussfolgerung ergibt sich 1. Das juristische Konzept der Einwilligung nach Aufklärung wurde erst durch die Entwicklung klinischer Kriterien zur Erfassung der Einwilligungsfähigkeit praktikabel; im Forschungskontext ist die Feststellung der Einwilligungsfähigkeit unverzichtbar, da von ihr die Gültigkeit der Einwilligung abhängt. 2. Zu erkennen ist ein langsamer Wandel von der Erfüllung einer juristisch begründeten Pflicht des forschenden Psychiaters, den potentiellen Forschungsteilnehmer nach Aufklärung um seine Einwilligung zu bitten, hin zu einer stärkeren Patientenorientierung; sie anerkennt das Selbstbestimmungsrecht und bemüht sich, im Prozess der Aufklärung die Fähigkeit des Patienten zu optimieren, sich zu einer Forschungsteilnahme selbstbestimmt entscheiden zu können. Dabei wird die Einwilligungsfähigkeit anhand klinischer Kriterien bestimmbar. 3. Es wird bezweifelt, dass die jüngsten legislativen Bemühungen geeignet sind, die Selbstbestimmung bei Forschung ohne potentiellen individuellen Nutzen mit nicht-einwilligungsfähigen Probanden zu sichern; denn es ist fraglich, ob die vorverlegte, dann aber prinzipiell nur unspezifisch mögliche Aufklärung und die auf einen später spezifisch aufgeklärten Vertreter verlagerte Entscheidung praktisch ausreichend realisiert werden können; ethisch enthält diese kontroverse Einschränkung der Selbstbestimmung zumindest das Risiko, das Verhältnis zwischen Individualwohl und Gemeinwohl zu Ungunsten des Individuums zu verschieben. Dadurch wäre dann auch das mit der Respektierung des Selbstbestimmungsrechtes begründete Konzept der Einwilligung nach Aufklärung infrage gestellt. (shrink)

Bioethicists have for quite some time discussed the right to know and the right not to know personal health information, such as genetic information acquired in health care and incidental health-related findings in research. Several international ethical guidelines explicitly defend these rights.My own interest in these matters stems from my participation in ethics-related research tied to a longitudinal screening study on Type I diabetes involving young children. A few of the participating parents did not want to be informed if the (...) study revealed their child had a high risk of developing diabetes. This response was troublesome, not least since the information would concern the child's and not the parents’ health. Our inclination was that there cannot be a right not to know that should be granted without qualifications. Furthermore, other contextual factors, e.g., that parents experienced pressure to participate and felt concern about some of the personal data handled in the study, gave reason to question whether autonomous decisions were made regarding participation. The autonomy of their expressed desire not to know was therefore questionable. (shrink)

Recent developments in neuroscience have inspired proposals to perform deep brain stimulation on psychopathic detainees. We contend that these proposals cannot meet important ethical requirements that hold for both medical research and therapy. After providing a rough overview of key aspects of psychopathy and the prospects of tackling this condition via deep brain stimulation, we proceed to an ethical assessment of such measures, referring closely to the distinctive features of psychopathic personality, particularly the absence of subjective suffering and a lack (...) of moral motivation. Scrutiny of these factors reveals that two essential bioethical criteria, individual medical benefit and voluntary informed consent, cannot be met in performing neurosurgical experiments or treatments on psychopathic inmates. (shrink)

: In this essay, I consider the question of whether women have an obligation to confront men who sexually harass them. A reluctance to be guilty of blaming the victims of harassment, coupled with other normative considerations that tell in favor of the unfairness of this sort of obligation, might make us think that women never have an obligation to confront their harassers. But I argue that women do have this obligation, and it is not overridden by many of the (...) considerations that can override other obligations to confront wrongdoers. (shrink)

In this essay, I consider the question of whether women have an obligation to confront men who sexually harass them. A reluctance to be guilty of blaming the victims of harassment, coupled with other normative considerations that tell in favor of the unfairness of this sort of obligation, might make us think that women never have an obligation to confront their harassers. But 1 argue that women do have this obligation, and it is not overridden by many of the considerations (...) that can override other obligations to confront wrongdoers. (shrink)

In this essay, I consider the question of whether women have an obligation to confront men who sexually harass them. A reluctance to be guilty of blaming the victims of harassment, coupled with other normative considerations that tell in favor of the unfairness of this sort of obligation, might make us think that women never have an obligation to confront their harassers. But 1 argue that women do have this obligation, and it is not overridden by many of the considerations (...) that can override other obligations to confront wrongdoers. (shrink)

Objective To determine whether presenting delivery room management options as defaults influences decisions to resuscitate extremely premature infants. Materials and methods Adult volunteers recruited from the world wide web were randomised to receive either resuscitation or comfort care as the delivery room management default option for a hypothetical delivery of a 23-week gestation infant. Participants were required to check a box to opt out of the default. The primary outcome measure was the proportion of respondents electing resuscitation. Data were analysed (...) using χ2 tests and multivariate logistic regression. Results Participants who were told the delivery room management default option was resuscitation were more likely to opt for resuscitation (OR 6.54 95% CI 3.85 to 11.11, p<0.001). This effect persisted on multivariate regression analysis (OR 7.00, 95% CI 3.97 to 12.36, p<0.001). Female gender, being married or in a committed relationship, being highly religious, experiences with prematurity, and favouring sanctity of life were significantly associated with decisions to resuscitate. Discussion Presenting delivery room options for extremely premature infants as defaults exert a significant effect on decision makers. The information structure of the choice task may act as a subtle form of manipulation. Further, this effect may operate in ways that a decision maker is not aware of and this raises questions of patient autonomy. Conclusion Presenting delivery room options for extremely premature infants as defaults may compromise autonomous decision-making. (shrink)

Objectives: The aim of this paper is to examine the way in which nurses manage patients who refuse nursing care procedures.Design: This paper reports on a qualitative study which was undertaken to explore the way in which nurses obtain consent prior to nursing care procedures. Focus groups were carried out to obtain background data concerning how consent is obtained. Critical incidents were collected through in depth interviews as a means of focusing on specific incidents in clinical practice.Setting: Two teaching hospitals (...) in England.Participants: Purposive sample of qualified nurses.Results: When a patient refuses nursing care, nurses respond by giving information until the patient finally accedes to the procedure. Nurses will go to great lengths to achieve patients’ agreement to the procedure, but the extent to which the agreement remains voluntary cannot be ascertained by the data collected in this study. If the patient does not eventually agree to a procedure, there is evidence that nurses will administer the care in the absence of consent.Conclusions: Nurses are concerned to obtain the patient’s consent prior to the administration of nursing care but if this cannot be achieved do not regard obtaining consent as an absolute requirement. Consent is preferred, but not considered essential. Nurses have some understanding of the principles of informed consent but do not apply them to everyday clinical nursing practice. (shrink)

This article addresses how health professionals should monitor and safeguard their patients’ ability to participate in making clinical decisions and making subsequent decisions regarding the implementation of their treatment plan. Patient participation in clinical decision-making is essential, e.g. in self-care, where patients are responsible for most ongoing care. We argue that one common, fact-oriented patient education strategy may in practice easily tend to take a destructive form that we call error trawling. Illustrating with empirical findings from a video study of (...) consultations between clinicians and adolescent patients with diabetes, we argue on independent grounds that this strategy not only risks to overlook significant weaknesses in patient decision competence, but also to undermine patient capacity for decision-making and implementing care. In effect, this strategy for clinically monitoring and addressing the problem of fragile decision-making capacity brings hazards in need of address. We clo... (shrink)

Several attempts have been made to transfer the concept of informed consent from medical and research ethics to dealing with affected groups in other areas such as engineering, land use planning, and business management. It is argued that these attempts are unsuccessful since the concept of informed consent is inadequate for situations in which groups of affected persons are dealt with collectively (rather than individually, as in clinical medicine). There are several reasons for this. The affected groups from which informed (...) consent is sought cannot be identified with sufficient precision. Informed consent is associated with individual veto power, but it does not appear realistic to give veto power to all individuals who are affected for instance by an engineering project. Most importantly, the concept of informed consent puts focus on the public’s acceptance of ready-made proposals rather than on its participation in the decision-making process as a whole, which includes the development of alternatives for the decision. Therefore, the concept of informed consent is not applicable to a company’s relations with groups and collectives. It may, however, be applicable to a company’s relations with individual persons such as customers and employees. (shrink)

ABSTRACTTeam physicians have a complicated job that involves potentially conflicting obligations to multiple entities. Though responsible for the medical care of the athletes as individuals, they also have obligations to the team that employs them which can include returning athletes to play who are at heightened risk of re-injury. The fact that the athletes and owners have some overlapping interests only complicates this issue. Further, there are strong financial incentives to do what is necessary to obtain and keep a position (...) as a team physician. This article examines dual loyalty and conflict of interest in sports medicine, and argues that there is not now a widely accepted or adequate solution to either. Moving toward a solution will require fairly serious changes in the role of the team physician.Abbreviations: FIMS International Federation of Sports Medicine; NFL National Football League; MVP Most Valuable Player; RGIII Robert Griffin, III. (shrink)

Our decision-making is often subject to framing effects: alternative but equally informative descriptions of the same options elicit different choices. When a decision-maker is vulnerable to framing, she may consent under one description of the act, which suggests that she has waived her right, yet be disposed to dissent under an equally informative description of the act, which suggests that she has not waived her right. I argue that in such a case the decision-maker’s consent is simply irrelevant to the (...) permissibility of proceeding. I then consider two alternative views. According to the first, people susceptible to framing are able to give valid consent so long as they are sufficiently informed. This suggestion, I argue, maintains an overly narrow focus on mere quantity of information to the exclusion of other choice-affecting factors. A second response, which appeals to hypothetical consent, is likewise of little use in resolving the moral problem posed by framing effects. I conclude that if susceptibility to framing undermines the validity of consent, we may have good reason to reconsider whether consent has the rights-waiving function commonly attributed to it. (shrink)

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

It is often claimed that managed care organizations involve physicians in conflicts of interest by creating financial incentives for physicians to refrain from ordering treatments or making referrals. Such incentives, the argument goes, force the physician to balance the patient's health interests against the MCO's interests and the physician's own financial interest. I assume, for the sake of argument, that such arrangements at least provide reason to believe that physicians in MCOs are involved in conflicts of interest. Two approaches have (...) evolved for dealing with these conflicts. On one approach, MCOs disclose the financial arrangements under which their physicians work so that patients can consent to the managed care plan and thereby to the plan's limitations. The chief proponent of this approach is Mark Hall, whose recent book Making Medical Spending Decisions applies prior consent to a variety of decisions regarding medical financing and allocation. The other approach is simply to forbid conflicts of interest through regulations. (shrink)

It is often claimed that managed care organizations involve physicians in conflicts of interest by creating financial incentives for physicians to refrain from ordering treatments or making referrals. Such incentives, the argument goes, force the physician to balance the patient's health interests against the MCO's interests and the physician's own financial interest. I assume, for the sake of argument, that such arrangements at least provide reason to believe that physicians in MCOs are involved in conflicts of interest. Two approaches have (...) evolved for dealing with these conflicts. On one approach, MCOs disclose the financial arrangements under which their physicians work so that patients can consent to the managed care plan and thereby to the plan's limitations. The chief proponent of this approach is Mark Hall, whose recent book Making Medical Spending Decisions applies prior consent to a variety of decisions regarding medical financing and allocation. The other approach is simply to forbid conflicts of interest through regulations. (shrink)

Aulisio and Arora argue that the moral significance of value imposition explains the moral distinction between traditional conscientious objection and non-traditional conscientious objection. The former objects to directly performing actions, whereas the latter objects to indirectly assisting actions on the grounds that indirectly assisting makes the actor morally complicit. Examples of non-traditional conscientious objection include objections to the duty to refer. Typically, we expect physicians who object to a practice to refer, but the non-traditional conscientious objector physician refuses to refer. (...) Aulisio and Arora argue that physicians have a duty to refer because refusing to do so violates the patient’s values. While we agree with Aulisio and Arora’s conclusions, we argue value imposition cannot adequately explain the moral difference between traditional conscientious objection and non-traditional conscientious objection. Treating autonomy as the freedom to live in accordance with one’s values, as Aulisio and Arora do, is a departure from traditional liberal conceptions of autonomy and consequently fails to explain the moral difference between the two kinds of objection. We outline how a traditional liberal understanding of autonomy would help in this regard, and we make two additional arguments—one that maintains that non-traditional conscientious objection undermines society’s autonomy, and another that maintains that it undermines the physician-patient relationship—to establish why physicians have a duty to refer. (shrink)

This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a mistake. Instead, (...) advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health. (shrink)

What does autonomy mean from a moral point of view? Throughout Western history, autonomy has had no less than four different meanings. The first is political: the capacity of old cities and modern states to give themselves their own laws. The second is metaphysical, and was introduced by Kant in the second half of the 18th century. In this meaning, autonomy is understood as an intrinsic characteristic of all rational beings. Opposed to this is the legal meaning, in which actions (...) are called autonomous when performed with due information and competency and without coercion. This last meaning, the most frequently used in bioethics, is primarily legal instead of moral. Is there a proper moral meaning of the word autonomy? If so, this would be a fourth meaning. Acts can only be called moral when they are postconventional (using the terminology coined by Lawrence Kohlberg), inner-directed (as expressed by David Riesman), and responsible (according to Hannah Arendt). Such acts are autonomous in this new, fourth, and to my mind, the only one proper, moral meaning. The goal of ethics cannot be other than forming human beings capable of making autonomous and responsible decisions, and doing so because they think this is their duty and not because of any other nonmoral motivation, like comfort, convenience, or satisfaction. The goal of ethics is to promote postconventional and mature human beings. This was what Socrates tried to do with the young people of Athens. And it is also the objective of every course of ethics and of any process of training. (shrink)

Incentives are typically conceived as a form of trade, and so voluntariness appears to be the only ethical concern. As a consequence, incentives are often considered ethically superior to regulations because they are voluntary rather than coercive. But incentives can also be viewed as one way to get others to do what they otherwise would not; that is, as a form of power. When incentives are viewed in this light, many ethical questions arise in addition to voluntariness: What are the (...) responsibilities of the powerful in using incentives? Can incentives be manipulative or exploitative, even if people are free to refuse them? Like all other forms of power, incentives can be abused. This paper develops criteria for distinguishing their legitimate from their illegitimate uses, viz. legitimacy of purpose, voluntariness, and effect on character. The criteria are then applied to three cases: plea bargaining, recruiting medical research subjects, and motivating children to learn. Thinking of incentives in terms of.. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to (...) a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

The advent of population-specific genomic research has prompted calls for invention of informed consent protocols that would treat entire social groups as research subjects as well as endow such groups with authority as agents of consent. Critics of such an unconventional ethical norm of group consent fear the rhetorical effects of approaching social groups with offers to participate in dialogues about informed consent. Addressing a specific population as the collective subject of genomic research, on this logic, adds currency to the (...) potentially dangerous public opinion that such a group is bound by genetic ties. The paper considers the problem of group and individual identity within the rhetorical dynamics of the discourse and politics of consent. (shrink)

Autonomy is essential in the exercise of responsibility and the recognized capacity of the user in new health rights. The objective here is to analyze the influence of the empowerment of autonomy arising from new health rights, in the self-responsibility of professionals and users in the face of public health problems. It is necessary to achieve the self-care of users by promoting those values thanks to both the commitment of professionals and by "empowering" patients, with higher levels of health education (...) and an ethic of citizenship in the use of public resources. (shrink)