Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. (...) First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

In the past decade, the perception of a bioterrorist threat has increased and created a demand on life scientists to consider the potential security implications of dual use research. This article examines a selection of proposed moral obligations for life scientists that have emerged to meet these concerns and the extent to which they can be considered reasonable. It also describes the underlying reasons for the concerns, how they are managed, and their implications for scientific values. Five criteria for what (...) constitutes preventable harm are suggested and a number of proposed obligations for life scientists are considered against these criteria, namely, the obligations to prevent bioterrorism; to engage in response activities; to consider negative implications of research; not to publish or share sensitive information; to oversee and limit access to dangerous material; and to report activities of concern. Although bioterrorism might be perceived as an imminent threat, the analysis illustrates that this is beyond the responsibility of life scientists either to prevent or to respond to. Among the more reasonable obligations are duties to consider potential negative implications of one's research, protect access to sensitive material, technology and knowledge, and report activities of concern. Responsibility, therefore, includes obligations concerned with preventing foreseeable and highly probable harm. A central conclusion is that several of the proposed obligations are reasonable, although not unconditionally. (shrink)

Most life science research entails dual-use complexity and may be misused for harmful purposes, e.g. biological weapons. The Precautionary Principle applies to special problems characterized by complexity in the relationship between human activities and their consequences. This article examines whether the principle, so far mainly used in environmental and public health issues, is applicable and suitable to the field of dual-use life science research. Four central elements of the principle are examined: threat, uncertainty, prescription and action. Although charges against the (...) principle exist – for example that it stifles scientific development, lacks practical applicability and is poorly defined and vague – the analysis concludes that a Precautionary Principle is applicable to the field. Certain factors such as credibility of the threat, availability of information, clear prescriptive demands on responsibility and directives on how to act, determine the suitability and success of a Precautionary Principle. Moreover, policy-makers and researchers share a responsibility for providing and seeking information about potential sources of harm. A central conclusion is that the principle is meaningful and useful if applied as a context-dependent moral principle and allowed flexibility in its practical use. The principle may then inspire awareness-raising and the establishment of practical routines which appropriately reflect the fact that life science research may be misused for harmful purposes. (shrink)

BackgroundInvoluntary treatment is a key issue in healthcare ethics. In this study, ethical issues relating to involuntary psychiatric treatment are investigated through interviews with Swedish psychiatrists.MethodsIn-depth interviews were conducted with eight Swedish psychiatrists, focusing on their experiences of and views on compulsory treatment. In relation to this, issues about patient autonomy were also discussed. The interviews were analysed using a descriptive qualitative approach.ResultsThe answers focus on two main aspects of compulsory treatment. Firstly, deliberations about when and why it was justifiable (...) to make a decision on involuntary treatment in a specific case. Here the cons and pros of ordering compulsory treatment were discussed, with particular emphasis on the consequences of providing treatment vs. refraining from ordering treatment. Secondly, a number of issues relating to background factors affecting decisions for or against involuntary treatment were also discussed. These included issues about the Swedish Mental Care Act, healthcare organisation and the care environment.ConclusionsInvoluntary treatment was generally seen as an unwanted exception to standard care. The respondents’ judgments about involuntary treatment were typically in line with Swedish law on the subject. However, it was also argued that the law leaves room for individual judgments when making decisions about involuntary treatment. Much of the reasoning focused on the consequences of ordering involuntary treatment, where risk of harm to the therapeutic alliance was weighed against the assumed good consequences of ensuring that patients received needed treatment. Cases concerning suicidal patients and psychotic patients who did not realise their need for care were typically held as paradigmatic examples of justified involuntary care. However, there was an ambivalence regarding the issue of suicide as it was also argued that risk of suicide in itself might not be sufficient for justified involuntary care. It was moreover argued that organisational factors sometimes led to decisions about compulsory treatment that could have been avoided, given a more patient-oriented healthcare organisation. (shrink)

Different ideas of the normative relevance of autonomy can give rise to profoundly different action-guiding principles in healthcare. If autonomy is seen as a value rather than as a right, it can be argued that patients’ decisions should sometimes be overruled in order to protect or promote their own autonomy. We refer to this as paternalism in the name of autonomy. In this paper, we discuss different elements of autonomy (decision-making capacity, efficiency, and authenticity) and arguments in favor of paternalism (...) for the sake of autonomy that have been proposed in the bioethical debate. We argue that if autonomy is valuable, then paternalism for the sake of autonomy may be justified. However, policies allowing paternalism in the name of autonomy may be self-defeating. (shrink)

The number of legal and nonlegal ethical regulations in the biomedical field has increased tremendously, leaving present-day practitioners and researchers in a virtual crossfire of legislations and guidelines. Judging by the production and by the way these regulations are motivated and presented, they are held to be of great importance to ethical practice. This view is shared by many commentators. For instance, Commons and Baldwin write that, within the nursing profession, patient care can be performed unethically or ethically depending on (...) the professional standards the nurses have set for themselves. They also hold that such standards are set when nurses become aware of the ethical codes available. As nurses are often not familiar with the codes, they do not all conform to them. Commons and Baldwin argue that nurses' ability to deal with ethical dilemmas is effectively secured with education on guidelines, creating a “barrier” between personal and professional values. (shrink)

In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different (...) set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good. (shrink)

Decision-making capacity is a key concept in contemporary healthcare ethics. Previous research has mainly focused on philosophical, conceptual issues or on evaluation of different tools for assessing patients’ capacity. The aim of the present study is to investigate how the concept and its normative role are understood in Swedish psychiatric care. Of special interest for present purposes are the relationships between decisional capacity and psychiatric disorders and between health law and practical ethics.

Respect for autonomy is typically considered a key reason for allowing physician assisted suicide and euthanasia. However, several recent papers have claimed this to be grounded in a misconception of the normative relevance of autonomy. It has been argued that autonomy is properly conceived of as a value, and that this makes assisted suicide as well as euthanasia wrong, since they destroy the autonomy of the patient. This paper evaluates this line of reasoning by investigating the conception of valuable autonomy. (...) Starting off from the current debate in end-of-life care, two different interpretations of how autonomy is valuable is discussed. According to one interpretation, autonomy is a personal prudential value, which may provide a reason why euthanasia and assisted suicide might be against a patient’s best interests. According to a second interpretation, inspired by Kantian ethics, being autonomous is unconditionally valuable, which may imply a duty to preserve autonomy. We argue that both lines of reasoning have limitations when it comes to situations relevant for end-of life care. It is concluded that neither way of reasoning can be used to show that assisted suicide or euthanasia always is impermissible. (shrink)

Our starting point in this article is the debate between John Harris and Iain Brassington on whether or not there is a duty to take part in scientific research. We consider the arguments that have been put forward based on fairness and a duty to rescue, and suggest an alternative justification grounded in a hypothetical agreement: that is, because effective healthcare cannot be taken for granted, but requires continuous medical research, and nobody knows what kind of healthcare they will need, (...) participating in research should be viewed from the perspective of a social contract, based on our mutual need for medical advances. (shrink)

The aim of the present study was to describe and explore the perception of ethical guidelines and their role in ethical competence-building among Swedish physicians and research nurses. Twelve informants were interviewed in depth. The results demonstrated that the informants had a critical attitude towards ethical guidelines and claimed to make little use of them in practical moral judgements. Ethical competence was seen primarily as character-building, related to virtues such as being empathic, honest and loyal to patients. Ethical competence was (...) assumed to be learned through good examples, role models and practical experience, while ethical guidelines were not perceived as valuable in this process. In order to improve the staff's familiarity with and the usability of ethical guidelines, the workplace needs to provide opportunities for ethical dialogues. In such discussions, argumentation can improve, virtues can be developed and guidelines can be usefully invoked. (shrink)

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)

Our claim in this paper is that not being identified as the data source might cause harm to a person or group. Therefore, in some cases the default of anonymisation should be replaced by a careful deliberation, together with research subjects, of how to handle the issues of identification and confidentiality. Our prime example in this article is community participatory research and similar endeavours on indigenous groups. The theme, content and aim of the research, and the question of how to (...) handle property rights and ownership of research results, as well as who should be in charge of the research process, including the process of creating anonymity, should all be answered, before anonymity is accepted. (shrink)

A wide variety of bioethical themes have recently been debated and researched in Sweden, including genetic screening, HPV vaccination strategies, end-of-life care, injustices and priority setting in healthcare, dual-use research, and the never-ending story of scientific fraud. Also, there are some new events related to Swedish biobanking that might be of general interest. Here we will concentrate on four themes: end-of-life care, dual-use research, scientific fraud, and biobanking.

The number of legal and nonlegal ethical regulations in the biomedical field has increased tremendously, leaving present-day practitioners and researchers in a virtual crossfire of legislations and guidelines. Judging by the production and by the way these regulations are motivated and presented, they are held to be of great importance to ethical practice. This view is shared by many commentators. For instance, Commons and Baldwin write that, within the nursing profession, patient care can be performed unethically or ethically depending on (...) the professional standards the nurses have set for themselves. They also hold that such standards are set when nurses become aware of the ethical codes available. As nurses are often not familiar with the codes, they do not all conform to them. Commons and Baldwin argue that nurses' ability to deal with ethical dilemmas is effectively secured with education on guidelines, creating a “barrier” between personal and professional values. (shrink)

In a previous paper in the Journal of Medical Ethics, the authors argued that the research ethical principle stating that the individual shall have priority over science, found in many guidelines, is utterly unclear and because of this should be explicated or otherwise deleted. In a recent commentary, Parker argued that this leaves us defending a position that would allow totalitarian regimes to pursue glory at the expense of its citizens. The present response addresses this and similar accusations.

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of ‘autonomy’ as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles – those of autonomy, integrity and authority – to (...) better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other – to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient-centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable. (shrink)

In this article, it is claimed that the protective provisions for adults with impaired decision-making capacity are misguided, insofar as they do not conclusively state whether research on this group should be permitted only as an exception, and as they arbitrarily allow for some groups to benefit from such research while others will not. Moreover, the presumed or former will of the subject is given insufficient weight, and the minimal risk standard does not make sense in this context. Because of (...) these problems, the present guidelines allow for the possibility of vulnerable people being exploited, something that is hidden behind a guise of solidarity. Instead we need to address the real issues at stake by rewriting the present statutes. It is suggested that new guidelines should be in some continuity with earlier efforts. However, in order to protect these subjects there is additional need for appointed representatives who monitor research and for legal obligations to compensate for any injuries suffered. Without these or similar measures we won't have an adequate system in place for the protection of non-benefiting persons who are unable to consent to research. (shrink)