Ethicists widely accept the notion that scientists have moral responsibilities to benefit society at large. The dissemination of scientific information to the public and its political representatives is central to many of the ways in which scientists serve society. Unfortunately, the task of providing information can often give rise to moral quandaries when scientific experts participate in politically charged debates over issues that are fraught with uncertainty. This paper develops a theoretical framework for an “ethics of expertise” (EOE) based on (...) the notion that scientists have responsibilities to provide information in a way that promotes autonomous decision-making on the part of the public and its representatives. Moreover, insofar as the principle of informed consent has developed in biomedical ethics as a way for physicians to promote autonomous decision-making on the part of their patients, this paper suggests that the informed-consent concept may suggest a set of criteria and guidelines that can help scientists to fulfill their similar ethical responsibilities to the public. In order to illustrate how the resulting EOE could provide practical guidance for scientific experts, the paper examines a case study involving the dissemination of information about the low-dose biological effects of toxic chemicals and carcinogens. (shrink)

We describe the growth of interest in the ethics of research with human participants based on articles abstracted in Psychological Abstracts and PsycLZT. Interest was low and variable until 1974, after which there was a marked increase in the number of articles published. We explain this emergence of ethical interest in terms of the social climate of concern for human rights in the 1960s and 1970s, the 1973 revision of the American Psychological Association's ethical principles, and the development of federal (...) regulation of research with human participants. (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)

This article defines the nature of paternalistic interventions in psychotherapy and discusses reasons why the client's right to consent to treatment is important. We describe a reasoning process developed by Culver and Gert (1982) that can be used to determine when paternalistic actions are and are not ethically justifiable in mental health practice. We demonstrate how this procedure may be applied to psychotherapy by using a number of case illustrations.

In den westlichen Industrienationen gilt das Prinzip der informierten Einwilligung als das Zentralelement medizinischer Forschungsethik. In anderen, stärker die Relationalität als die Individualität von Personen betonenden Kulturen hingegen werden medizinische Entscheidungen traditionell eher durch die Gemeinschaft bzw. ihr Oberhaupt getroffen. Um verschiedenen kulturellen Normen gerecht zu werden, wird international tätigen Forschungsteams häufig empfohlen, den Community Consent und den Informed Consent einzuholen. Ausschlaggebend soll dabei letztlich der Informed Consent des Individuums sein. Es soll die Teilnahme auch dann verweigern können, wenn die (...) Gemeinschaft bzw. ihr Repräsentant dem Vorhaben zugestimmt hat. Der Beitrag diskutiert, ob eine solche Kopplung von Community Consent und Informed Consent tatsächlich geeignet ist, den Ansprüchen beider Prinzipien gerecht zu werden. Es wird argumentiert, dass die Kopplung von Community Consent und Informed Consent ethisch problematisch ist, wenn der Gemeinschaft hierbei ein Vetorecht eingeräumt wird, das geeignet ist, die Realisation konträrer individueller Interessen und damit das Selbstbestimmungsrecht der Betroffenen zu unterlaufen. Um zu gewährleisten, dass in interkulturellen Forschungszusammenhängen sowohl der individuellen als auch der relationalen Autonomie von Personen angemessener Raum gewährt wird, wäre es empfehlenswert, den Informed Consent ausdrücklich mit einer Community Consultation zu koppeln. Hier käme die Entscheidung gegen, aber auch für eine Studienteilnahme in letzter Instanz klar dem Individuum zu, während die Vorzüge einer Einbeziehung der Gemeinschaft in den Entscheidungsfindungsprozess anerkannt und genutzt werden könnten. (shrink)

Hospize verstehen sich als Orte einer ganzheitlichen Sterbebegleitung, welche nicht allein die Behandlung körperlicher und psychischer Symptome, sondern auch die soziale und spirituelle Betreuung der Sterbenden beinhaltet. Eine zentrale Bedeutung innerhalb dieser umfassenden Begleitung am Lebensende hat die Idee der Selbstbestimmung. Dem Hospizgast soll ermöglicht werden, im Sinne einer größtmöglichen Autonomie über die eigenen Belange bis zuletzt selbst entscheiden zu können. Diese zentrale Zielsetzung der Hospizarbeit wurde in der Literatur bisher überwiegend in theoretisch-programmatischer Weise thematisiert, es liegen jedoch kaum Untersuchungen (...) zu der Frage vor, wie die Idee der „Selbstbestimmung bis zuletzt“ im Alltag der Hospize praktisch umgesetzt wird. Über die besonderen Umstände der Pflege in stationären Hospizen hinaus ist der hier zugrunde gelegte Begriff von Autonomie auch von grundsätzlichem medizinethischen Interesse. Das ganzheitlich-palliative Konzept von Behandlung und Pflege, welches bereits im Hospiz als Institution fest verankert ist, legt nahe, dass die Idee der Selbstbestimmung in diesem Umfeld anders konzeptualisiert wird als im Bereich der „klassischen“, zumeist kurativ orientierten Medizin. Die qualitative Interviewstudie mit haupt- und ehrenamtlichen Mitarbeiterinnen und Mitarbeitern konnte zeigen, dass in stationären Hospizen ein Konzept von Selbstbestimmung vertreten wird, welches über rein medizinische Entscheidungen weit hinausgeht. Zugleich konnte aber auch herausgearbeitet werden, wo nach Ansicht der Mitarbeiterinnen und Mitarbeiter mögliche Grenzen der Selbstbestimmung des Gastes im Hospiz liegen. (shrink)

Gerben Meynen (2019) invites us to consider the potential ethical implications of what he refers to as “thought apprehension” technology for psychiatric practice, that is, technologies that involve recording brain activity, and using this to infer what people are thinking (or intending, desiring, feeling, etc.). His article is wide-ranging, covering several different ethical principles, various situations psychiatrists might encounter in therapeutic, legal and correctional contexts, and a range of potential incarnations of this technology, some more speculative than others. Although Meynen’s (...) article raises some highly relevant potential implications of some “thought apprehension”-based neurotechnologies, which are certainly worthy of further exploration, I suggest that Meynen’s analysis is beset by two problems. First, some of the technologies that form the focus of his discussion are too speculative, and second, due to the many issues under consideration, some problems are not adequately characterized, relevant ethical principles are misidentified, and valuable literature is not sufficiently engaged with. Consideration of these weaknesses might allow us to better see how to conduct a fruitful analysis of speculative neurotechnologies. (shrink)

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)

The realm of non-rational influence, which includes nudging, is home to many other morally interesting phenomena. In this paper, I introduce the term bumping, to discuss the category of unintentional non-rational influence. Bumping happens constantly, wherever people make choices in environments where they are affected by other people. For instance, doctors will often bump their patients as patients make choices about what treatments to pursue. In some cases, these bumps will systematically tend to make patients’ decisions worse. Put another way: (...) doctors will sometimes harm their patients by bumping them in systematic (although still unintentional) ways. I use the case of medical overuse, the provision of medical services where the likely harm outweighs the likely benefit to the patient, as a touchstone for arguing that doctors who systematically bump their patients towards harm can be blameworthy for their unwitting influence. (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)

Misconceived Consent: Miguel has stage IV lung cancer. He has nearly exhausted his treatment options when his oncologist, Dr. Llewellyn, tells him about an experimental vaccine trial that may boost his immune response to kill cancer cells. Dr. Llewellyn provides Miguel with a consent form that explains why the study is being conducted, what procedures he will undergo, what the various risks and benefits are, alternative sources of treatment, and so forth. She even sits down with him, carefully talks through (...) the most important points, and gives him time to ask questions. Though it is a Phase 1 study and the chance that he will benefit is very low, Miguel happily agrees to take part. A week later, after the first experimental injection, she asks him if he is worried about the risks. “Risks?” he asks. “I’m sure this is safe—you’re a doctor, after all!”. (shrink)

Discussions of patient-centred care and patient autonomy in bioethics have tended to focus on the decision-making context and the process of obtaining informed consent, leaving open the question of how patients ought to be counselled in the daily maintenance of their health and management of chronic disease. Patient activation is an increasingly prominent counselling approach and measurement tool that aims to improve patients’ confidence and skills in managing their own health conditions. The strategy, which has received little conceptual or ethical (...) analysis, raises important questions about how clinicians ought to foster confidence and a sense of control in their patients without exposing them to blame, stigma and other harms. In this paper, we describe patient activation, discuss its relationship to personal responsibility, autonomy and health disparities, and make recommendations regarding its use and measurement. (shrink)

ABSTRACTThis paper introduces the category of ‘non-deceptive manipulation that causes false beliefs’, analyzes how it narrows the traditional scope of ‘deception’, and draws moral implications.

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)

According to a number of influential views in penal theory, 1 one of the primary goals of the criminal justice system is to rehabilitate offenders. Rehabilitativemeasures are commonly included as a part of a criminal sentence. For example, in some jurisdictions judges may order violent offenders to attend anger management classes or to undergo cognitive behavioural therapy as a part of their sentences. In a limited number of cases, neurointerventions — interventions that exert a direct biological effect on the brain (...) — have been used as aids to rehabilitation, typically being imposed as part of criminal sentences, separate treatment orders, or conditions of parole. Examples of such interventions include medications intended to attenuate addictive desires in substance-abusing offenders and agents intended to suppress libido in sex offenders.This chapter reviews some of the ethical issues raised by the use of neurointerventions as aids to rehabilitation. (shrink)

Ethics should guide the design of electronic health records (EHR), and recognized principles of bioethics can play an important role. This approach was adopted recently by a team of informaticists designing and testing a system where patients exert granular control over who views their personal health information. While this method of building ethics in from the start of the design process has significant benefits, questions remain about how useful the application of bioethics principles can be in this process, especially when (...) principles conflict. For instance, while the ethical principle of respect for autonomy supports a robust system of granular control, the principles of beneficence and non-maleficence counsel restraint due to the danger of patients being harmed by restrictions on provider access to data. Conflict between principles has long been recognized by ethicists and has even motivated attacks on approaches that state and apply principles. In this paper we show how using ethical principles can help in the design of EHRs by first, explaining how ethical principles can and should be used generally, and then by, discuss how attention to details in specific cases can show that the tension between principles is not as bad as it initially appeared. We conclude by suggesting further ways in which the application of these (and other) principles can add value to the ongoing discussion of patient involvement in their health care. This is a new approach to linking principles to informatics design that we expect will stimulate further interest. (shrink)

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem (...) from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)

Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to (...) broaden the focus of discussion beyond individual choice and individuals’ moral interests. The uptake of those concepts in precision medicine is to be welcomed. However, as data and medical information from research participants in precision medicine cohorts will be collected on an individual basis, translating a participatory approach in this emerging area may prove cumbersome. Therefore, drawing on Joseph Raz’s perfectionism, we propose a principle of respect for autonomous agents that, we reckon, can address many of the concerns driving recent scholarship on partnership and public participation, while avoiding some of the limitations these concept have in the context of precision medicine. Our approach offers a normative clarification to how becoming partners in precision is compatible with retaining autonomy.Realigning the value of autonomy with ideals of direct engagement, we show, can provide adequate normative orientation to precision medicine; it can do justice to the idea of moral pluralism by stressing the value of moral self-determination: and, finally, it can reconcile the notion of autonomy with other more communitarian values such as participation and solidarity. (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)

Techniques from behavioral economics—nudges—may help physicians increase pediatric vaccine compliance, but critics have objected that nudges can undermine autonomy. Since autonomy is a centrally important value in healthcare decision-making contexts, it counts against pediatric vaccination nudges if they undermine parental autonomy. Advocates for healthcare nudges have resisted the charge that nudges undermine autonomy, and the recent bioethics literature illustrates the current intractability of this debate. This article rejects a principle to which parties on both sides of this debate sometimes seem (...) committed: that nudges are morally permissible only if they are consistent with autonomy. Instead, I argue that, at least in the case of pediatric vaccination, some autonomy-undermining nudges may be morally justified. This is because parental autonomy in pediatric decision-making is not as morally valuable as the autonomy of adult patients, and because the interests of both the vaccinated child and other members of the community can sometimes be weighty enough to justify autonomy-infringing pediatric vaccination nudges. This article concludes with a set of worries about the effect of pediatric vaccination nudges on parent-physician relationships, and it calls on the American Academy of Pediatrics to draw on scientific and bioethics research to develop guidelines for the use of nudges in pediatric practice and, in particular, for the use of pediatric vaccination nudges. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...) third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (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 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)

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in (...) large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights, Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”. (shrink)

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)

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)

A central goal in regulating direct-to-consumer advertising of prescription pharmaceuticals is to ensure that explicit drug claims are truthful. Yet imagery can also alter viewer attitudes, and the degree to which this occurs in DTCA is uncertain. Addressing this data gap, we provide evidence that positive feelings produced by images can promote favourable beliefs about pharmaceuticals. We had participants view a fictitious anti-influenza drug paired with unrelated images that elicited either positive, neutral or negative feelings. Participants who viewed positive images (...) rated the influenza drug as significantly more effective, safe, and beneficial than did participants who viewed negative images. This effect, known as evaluative conditioning, is well described in experimental social psychology but has not previously been shown with pharmaceuticals. We discuss how evaluative conditioning in DTCA may compromise viewer autonomy, and canvass possible regulatory responses. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, (...) talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

In a recent paper, Levy, Gadd, Kerridge, and Komesaroff attempt to defend the ethicality of homeopathy by attacking the utilitarian ethical framework as a basis for medical ethics and by introducing a distinction between evidence-based medicine and modern science. This paper demonstrates that their argumentation is not only insufficient to achieve that goal but also incorrect. Utilitarianism is not required to show that homeopathic practice is unethical; indeed, any normative basis of medical ethics will make it unethical, as a defence (...) of homeopathic practice requires the rejection of modern natural sciences, which are an integral part of medical ethics systems. This paper also points out that evidence-based medicine lies at the very core of modern science. Particular arguments made by Levy et al. within the principlist medical ethics normative system are also shown to be wrong. (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)

Recently the World Health Organization has highlighted the need to strengthen mental health systems following emergencies, including natural and manmade disasters. Mental health services need to be informed by culturally attuned evidence that is developed through research. Therefore, there is an urgent need to establish rigorous ethical research practice to underpin the evidence-base for mental health services delivered during and following emergencies.

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...) the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

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

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (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)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant9s consent to research (...) participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan9s argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)

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

A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details the (...) curriculum topics developed that incorporate ethical principles, particularly for group protections/benefits within the field practices of environmental/engineering researchers. (shrink)

“Neurodiversity” is associated with the struggle for the civil rights of all those diagnosed with neurological or neurodevelopmental disorders. Two basic approaches in the struggle for what might be described as “neuro-equality” are taken up in the literature: There is a challenge to current nosology that pathologizes all of the phenotypes associated with neurological or neurodevelopmental disorders ); there is a challenge to those extant social institutions that either expressly or inadvertently model a social hierarchy where the interests or needs (...) of individuals are ranked relative to what is regarded as properly functioning cognitive capacities. In this paper, we explore some of the reasons justifying which make it an important tool for achieving greater neuro-equality, while still recognizing its limitations for achieving this goal. Particularly, we explore how an appeal to functionality and neurological diversity can support a re-seeing of at least certain forms of ASD. (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)

Empirical evidence suggests that some health professionals believe consent procedures for the emerging technology of non-invasive prenatal diagnosis (NIPD) should become less rigorous than those currently used for invasive prenatal testing. In this paper, we consider the importance of informed consent and informed choice procedures for protecting autonomy in those prenatal tests which will give rise to a definitive result. We consider whether there is anything special about NIPD that could sanction a change to consent procedures for prenatal diagnosis or (...) otherwise render informed decision-making less important. We accept the claim that the absence of risk of miscarriage to some extent lessens the gravity of the decision to test compared with invasive methods of testing. However, we also claim that the definitive nature of the information received, and the fact that the information can lead to decisions of great significance, makes NIPD an important choice. This choice should only be made by means of a rigorous and appropriately supported decision-making process (assuming that this is what the pregnant woman wants). We conclude that, on balance, consent procedures for NIPD should mirror those for invasive testing, albeit without the need to emphasise procedure-related risk. (shrink)

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

Brain Computer Interface (BCI) technology offers potential for human augmentation in areas ranging from communication to home automation, leisure and gaming. This paper addresses ethical challenges associated with the wider scale deployment of BCI as an assistive technology by documenting issues associated with the development of non-invasive BCI technology. Laboratory testing is normally carried out with volunteers but further testing with subjects, who may be in vulnerable groups is often needed to improve system operation. BCI development is technically complex, sometimes (...) requiring lengthy recording sessions to achieve the necessary personalisation of the paradigms, and this can present ethical challenges that vary depending on the subject group. The paper contributes to the on-going ethical discussion surrounding the deployment BCI outside the specialist laboratory and suggests some tentative guidelines for BCI research teams, appropriate to those deploying the technology, derived from experience on a multisite project. Any tension between deployment and technical progress must be managed by a formal process within a multidisciplinary consortium. (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)