In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.
In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.
In her paper ‘Why Not Common Morality?’, Rosamond Rhodes argues that medical ethics cannot and should not be derived from common morality and that medical ethics should instead be conceptualised as professional ethics and the content left to the medical profession to develop and decide.1 I have considerable sympathy with the first claim and have myself argued along somewhat similar lines.2 I am, however, very sceptical about elements of the second claim and will briefly explain why. The first part of (...) Rhodes’s constructive argument is to show that practising medicine is not only a role, it is something more. Medicine is a profession and as such its members have to internalise and personally endorse a specific ethics. Rhodes is careful to state that more work is needed to complete the justification for this claim, but the arguments she does provide are strangely ahistorical. First, it is not that long ago that what we now conceive of as one profession was actually two very strictly separated professions, that is, university educated physicians and apprenticed surgeons. Can we really be certain that medicine is now one, unified profession1? Second the way butchers, bakers and candlestick makers are traduced is also oddly ahistorical. It is only fairly recently in many countries that anyone can butcher meat, bake bread or make candlesticks and legally sell the product to the public. Historically these trades have in Europe not been mere roles, but …. (shrink)
In an analysis of artificially intelligent systems for medical diagnostics and treatment planning we argue that patients should be able to exercise a right to withdraw from AI diagnostics and treatment planning for reasons related to the physician’s role in the patients’ formation of and acting on personal preferences and values, the bias and opacity problem of AI systems, and rational concerns about the future societal effects of introducing AI systems in the health care sector.
Increasingly, commissioners and providers of services for people with intellectual disabilities are turning to assistive technology and telecare as a potential solution to the problem of the increased demand for services, brought about by an expanding population of people with intellectual disabilities in the context of relatively static or diminishing resources. While there are numerous potential benefits of assistive technology and telecare, both for service providers and service users, there are also a number of ethical issues. The aim of this (...) paper is to raise these issues and to set them within the ethical framework proposed by Beauchamp and Childress. There is a need for a wider debate as a first step in the development of strategies to address the issues raised in the paper. (shrink)
Background: The knowledge of scientific dishonesty is scarce and heterogeneous. Therefore this study investigates the experiences with and the attitudes towards various forms of scientific dishonesty among PhD-students at the medical faculties of all Norwegian universities.MethodAnonymous questionnaire distributed to all post graduate students attending introductory PhD-courses at all medical faculties in Norway in 2010/2011. Descriptive statistics. Results: 189 of 262 questionnaires were returned (72.1%). 65% of the respondents had not, during the last year, heard or read about researchers who committed (...) scientific dishonesty. One respondent had experienced pressure to fabricate and to falsify data, and one had experienced pressure to plagiarize data. On average 60% of the respondents were uncertain whether their department had a written policy concerning scientific conduct. About 11% of the respondents had experienced unethical pressure concerning the order of authors during the last 12 months. 10% did not find it inappropriate to report experimental data without having conducted the experiment and 38% did not find it inappropriate to try a variety of different methods of analysis to find a statistically significant result. 13% agreed that it is acceptable to selectively omit contradictory results to expedite publication and 10% found it acceptable to falsify or fabricate data to expedite publication, if they were confident of their findings. 79% agreed that they would be willing to report misconduct to a responsible official. Conclusion: Although there is less scientific dishonesty reported in Norway than in other countries, dishonesty is not unknown to doctoral students. Some forms of scientific misconduct are considered to be acceptable by a significant minority. There was little awareness of relevant policies for scientific conduct, but a high level of willingness to report misconduct. (shrink)
The Principles of Biomedical Ethics by Tom L Beauchamp and James F Childress which is now in its fourth edition has had a great influence on the development of bioethics through its exposition of a theory based on the four principles: respect for autonomy; non-maleficence; beneficence, and justice (1). The theory is developed as a common-morality theory, and the present paper attempts to show how this approach, starting from American common-morality, leads to an underdevelopment of beneficence and justice, and that (...) the methods offered for specification and balancing of principles are inadequate. (shrink)
This paper argues that a precautionary approach to scientific progress of the sort advocated by Walter Glannon with respect to life-extending therapies involves both incoherence and irresolvable paradox. This paper demonstrates the incoherence of the precautionary approach in many circumstances and argues that with respect to life-extending therapies we have at present no persuasive reasons for a moratorium on such research.
Norman Daniels' and James Sabin's theory of “accountability for reasonableness” is a much discussed account of due process for decision-making on health care priority setting. Central to the theory is the acceptance that people may justifiably disagree on what reasons it is relevant to consider when priorities are made, but that there is a core set of reasons, that all centre on fairness, on which there will be no disagreement. A4R is designed as an institutional decision process which will ensure (...) that only those reasons which everybody will agree are relevant and appropriate form part of decision-making. The argument which we will put forward in this paper questions whether it is a simple matter to delineate the core set of reasons and claims that it is a potential problem in A4R that it does not provide an indication of the exact content of this process.The paper first briefly outlines the content of A4R. It is argued that disagreement on what services should be high priorities cannot be resolved solely with a reference to “due process.” In order to retain consistency over time, decision-makers are required to agree and articulate what reasons qualify as relevant and how conflicting reasons are to be balanced in the course of the process.The second and main part of the paper then considers how the reason of “solidarity” can be handled within the A4R framework, and it is shown that deciding whether solidarity should be admitted to the core set of allowable reasons is not a simple matter. (shrink)
The question of when we have justification for overriding ordinary, everyday decisions of persons with dementia is considered. It is argued that no single criterion for competent decision-making is able to distinguish reliably between decisions we can legitimately override and decisions we cannot legitimately override.
The question of if, and under what conditions transsexuals should be allowed to participate in sports in their acquired sex is becoming increasingly relevant partly because the number of transsexuals is increasing partly because many countries now provide mechanisms for achieving legal recognition as belonging to the new acquired sex. This paper develops (1) an analysis of the justification for maintaining sex segregation in some sports and (2) an account of the rights of transsexuals to be recognised in their new (...) sex. On the basis of these two analyses it critically evaluates two set of rules for the participation of transsexuals in elite sports: the UK guidelines issued in pursuance of the Gender Recognition Act 2004 and the International Olympic Committee's guidelines. It is argued that these guidelines are conflicting and that a modified set of criteria is more justifiable. (shrink)
Two protechnology arguments, the “hopeful principle” and the “automatic escalator”, often used in bioethics, are identified and critically analysed in this paper. It is shown that the hopeful principle is closely related to the problematic precautionary principle, and the automatic escalator argument has close affinities to the often criticised empirical slippery slope argument. The hopeful principle is shown to be really hopeless as an argument, and automatic escalator arguments often lead nowhere when critically analysed. These arguments should therefore only be (...) used with great caution. (shrink)
The ongoing legal and bioethics debates on consent requirements for collecting, storing, and utilizing human biological material for purposes of basic and applied research—that is, genomic research biobanking—have already managed to pass through three ostensibly dissimilar stages.
This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence (...) that the extent of the routinisation of informed consent is dependent on the character of the information exchanged, and we uncover a range of causes of routinisation. Finally, the article discusses possible ways of countering the problem of routinisation of informed consent. (shrink)
How are we individually and as a society to handle new and emerging technologies? This challenging question underlies much of the bioethical debates of modern times. To address this question we need suitable conceptions of the new technology and ways of identifying its proper management and regulation. To establish conceptions and to find ways to handle emerging technologies we tend to use analogies extensively. The aim of this article is to investigate the role that analogies play or may play in (...) the processes of understanding and managing new technology. More precisely we aim to unveil the role of analogies as analytical devices in exploring the "being" of the new technology as well the normative function of analogies in conceptualizing the characteristics and applications of new technology. Umbilical cord blood biobanking will be used as a case to investigate these roles and functions. (shrink)
Theorists analyzing the concept of disease on the basis of the notion of dysfunction consider disease to be dysfunction requiring. More specifically, dysfunction-requiring theories of disease claim that for an individual to be diseased certain biological facts about it must be the case. Disease is not wholly a matter of evaluative attitudes. In this paper, I consider the dysfunction-requiring component of Wakefield’s hybrid account of disease in light of the artifactual organisms envisioned by current research in synthetic biology. In particular, (...) I argue that the possibility of artifactual organisms and the case of oncomice and other bred or genetically modified strains of organism constitute a significant objection to Wakefield’s etiological account of the dysfunction requirement. I then develop a new alternative understanding of the dysfunction requirement that builds on the organizational theory of function. I conclude that my suggestion is superior to Wakefield’s theory because it (a) can accommodate both artifactual and naturally evolved organisms, (b) avoids the possibility of there being a conflict between what an organismic part is supposed to do and the health of the organism, and (c) provides a nonarbitrary and practical way of determining whether dysfunction occurs. (shrink)
In this paper I examine the prospects for a rights-based approach to the morality of pure risk-imposition. In particular, I discuss a practical challenge to proponents of the thesis that we have a right against being imposed a risk of harm. According to an influential criticism, a right against risk-imposition will rule out all ordinary activities. The paper examines two strategies that rights theorists may follow in response to this “Paralysis Problem”. The first strategy introduces a threshold for when a (...) risk-imposition is a rights violation. The second strategy drops the claim that rights are absolute and maintains that all rights infringements generate compensation duties. It is argued that both strategies face significant practical problems of their own and that the Paralysis Problem seems fatal for a right against risk-imposition in the absence of an adequate account of the morally relevant threshold risk. (shrink)
Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The (...) main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)
New medical technologies provide us with new possibilities in health care and health care research. Depending on their degree of novelty, they may as well present us with a whole range of unforeseen normative challenges. Partly, this is due to a lack of appropriate norms to perceive and handle new technologies. This article investigates our ways of establishing such norms. We argue that in this respect analogies have at least two normative functions: they inform both our understanding and our conduct. (...) Furthermore, as these functions are intertwined and can blur moral debates, a functional investigation of analogies can be a fruitful part of ethical analysis. We argue that although analogies can be conservative; because they bring old concepts to bear upon new ones, there are at least three ways in which they can be creative. First, understandings of new technologies are quite different from the analogies that established them, and come to be analogies themselves. That is, the concepts may turn out to be quite different from the analogies that established them. Second, analogies transpose similarities from one area into another, where they previously had no bearing. Third, analogies tend to have a figurative function, bringing in something new and different from the content of the analogies. We use research-biobanking as a practical example in our investigations. (shrink)
In a recent article in the Journal of Medical Ethics, Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy that misconstrues how biobank research is (...) actually conducted and a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice. (shrink)
In this paper, I discuss the aetiological account of biological interests, developed by Varner, in the context of artefactual organisms envisioned by current research in synthetic biology. In “Sections 2–5”, I present Varner's theory and criticise it for being incapable of ascribing non-derivative interests to artefactual organisms due to their lack of a history of natural selection. In “Sections 6–7”, I develop a new alternative to Varner's account, building on the organisational theory of biological teleology and function. I argue that (...) the organisational account of biological interest is superior to Varner's aetiological account because it can accommodate both artefactual and naturally evolved organisms, provides a non-arbitrary and practical way of determining biological interests, supports the claim that organisms have interests in a sense in which artefacts do not, and avoids the possibility of there being a conflict between what an organismic part is supposed to do and what is in the interest of the organism. (shrink)
Background There has been debate on whether a global or unified field of bioethics exists. If bioethics is a unified global field, or at the very least a closely shared way of thinking, then we should expect bioethicists to behave the same way in their academic activities anywhere in the world. This paper investigates whether there is a 'global bioethics' in the sense of a unified academic community. Methods To address this question, we study the web-linking patterns of bioethics institutions, (...) the citation patterns of bioethics papers and the buying patterns of bioethics books. Results All three analyses indicate that there are geographical and institutional differences in the academic behavior of bioethicists and bioethics institutions. Conclusion These exploratory studies support the position that there is no unified global field of bioethics. This is a problem if the only reason is parochialism. But these regional differences are probably of less concern if one notices that bioethics comes in many not always mutually understandable dialects. (shrink)
When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject one (...) ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child. (shrink)
The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of specific consent, broad consent, blanket consent (...) or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years. Most users indicate 1) that they find the choices they are asked to make easy to understand, 2) that the application is easy to use, and 3) that this kind of choice should be offered to people. It is possible to collect meta consent preferences in the general, adult population using a smartphone app. (shrink)
One of the ways in which public health officials control outbreaks of epidemic disease is by attempting to control the situations in which the infectious agent can spread. This may include isolation of infected persons, quarantine of persons who may be infected and detention of persons who are present in or have entered premises where infected persons are being treated. Most who have analysed such measures think that the restrictions in liberty they entail and the detriments in welfare they impose (...) can be justified and this paper proceeds from the assumption that detention measures are justifiable in some circumstances. Such measures are often implemented without any compensation being given to the persons who are detained. This raises the question: What do we owe to those whose liberty is justifiably restricted (e.g. through isolation, quarantine or detention) as a public health measure during a public health emergency? More specifically, do we owe them compensation for any losses they experience? The paper falls in four main sections. The first section provides examples of the current regulatory state of affairs from the US, Canada and WHO. The second section lays out the liberal, welfarist and pragmatic arguments for providing compensation. The third section discusses the arguments against compensation and the fourth and final section provides the conclusion. It is argued that the arguments for providing compensation clearly outweigh the counterarguments and that the default public policy therefore should be that compensation is provided. (shrink)
A widespread and influential characterization of synthetic biology emphasizes that synthetic biology is the application of engineering principles to living systems. Furthermore, there is a strong tendency to express the engineering approach to organisms in terms of what seems to be an ontological claim: organisms are machines. In the paper I investigate the ontological and heuristic significance of the machine analogy in synthetic biology. I argue that the use of the machine analogy and the aim of producing rationally designed organisms (...) does not necessarily imply a commitment to mechanical biology. The ideal of applying engineering principles to biology is best understood as expressing recognition of the machine-unlikeness of natural organisms and the limits of human cognition. The paper suggests an interpretation of the identification of organisms with machines in synthetic biology according to which it expresses a strategy for representing, understanding, and constructing living systems that are more machine-like than natural organisms. (shrink)
Moore and Donnelly argue in the paper ‘The job of “ethics committees”’ that research ethics committees should be renamed and that their job should be specified as “review of proposals for consistency with the duly established and applicable code” only.1 They raise a large number of issues, but in this comment I briefly want to suggest that two of their arguments are fundamentally flawed. The first flawed argument is the argument related to the separation of powers. Moore and Donnelly proceed (...) from the premise that it is pro tanto better to have an institutional arrangement that separates code-making powers and decisional powers, and then proceed to argue that this separation is not feasible for what they call ‘ethics consistency review’ because “no matter who established any prespecified review standards, the review decision maker must be empowered at review to revise those standards when this would make for an ethical improvement. This is because any understanding of ethics-consistency standards themselves and of their implications for any case is fallible and improvable in …. (shrink)
Several authors have argued that contractualism faces a dilemma when it comes to justifying risks generated by socially valuable activities. At the heart of the matter is the question of whether contractualists should adopt an ex post or an ex ante perspective when assessing whether an action or policy is justifiable to each person. In this paper I argue for the modest conclusion that ex post contractualism is a live option notwithstanding recent criticisms raised by proponents of the ex ante (...) perspective. I then consider how an ex post contractualist can best respond to the problem that it seems to prohibit a range of intuitively permissible and socially valuable activities. (shrink)
Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and (...) Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. (shrink)
In discussions about the legalisation of active, voluntary euthanasia it is sometimes claimed that what should happen in a liberal society is that the two sides in the debate “agree to disagree”. This paper explores what is entailed by agreeing to disagree and shows that this is considerably more complicated than what is usually believed to be the case. Agreeing to disagree is philosophically problematic and will often lead to an unstable compromise.
On one conception of "best interest" there can only be one course of action in a given situation that is in a person's best interest. In this paper we will first consider what theories of "best interest" and rational decision-making that can lead to this conclusion and explore some of the less commonly appreciated implications of these theories. We will then move on to consider what ethical theories that are compatible with such a view and explore their implications. In the (...) second part of the paper we will explore a range of possible criticisms of these views. And in the third part we will criticise the view that a court is always or even often in a good position to decide what the patient's best interest is. In the fourth and final part we will put forward a reconstructive proposal aimed at saving whatever is sound in the "best interest" conception. (shrink)
This paper analyses the British Human Fertilisation and Embryology Authority's 2002 public consultation on sex selection, a consultation that was mainly concerned with sex selection for non-medical reasons. Based on a close reading of the consultation document and questionnaire it is argued that the consultation is biased towards certain outcomes and can most plausibly be construed as an attempt not to investigate but to influence public opinion.
Non-compliance is a label often used about patients who do not follow therapeutic advice. This paper analyses the notion of compliance, and tries to show that this notion is inextricably bound to a paternalistic conception of the doctor-patient relationship. It is proposed that we should perhaps not talk so much about the non-compliant patient, but instead shift the focus towards the non-compliant doctor.
OBJECTIVES: To study the ethical reasoning of nurses and physicians, and to assess whether or not modified focus groups are a valuable tool for this purpose. DESIGN: Discussion of cases in modified focus groups, each consisting of three physicians and three nurses. The discussion was taped and analysed by content analysis. SETTING: Five departments of internal medicine at Danish hospitals. SAMPLE: Seven discussion groups. MAIN MEASUREMENTS: Ethical content of statements, style of statements, time used by each participant. RESULTS: Danish physicians (...) and nurses do not differ in the kind of ethical reasoning they use, but physicians use more of the discussion time than nurses, they use a more assertive style of argumentation, and the solutions chosen are usually first put forward by physicians. CONCLUSION: The results and informal comparisons with similar data from long qualitative interviews indicate that groups of this kind are a useful tool for gathering data on ethical reasoning. (shrink)
This paper considers the argument that if the ban on doping in sports was abolished it would be possible to have doping under medical control, i.e. open doping, prescribed by doctors with collection of reliable information about effects and side-effects. A game-theoretic argument is developed showing that this positive scenario is very unlikely to be instantiated given reasonable assumptions about the motivation of sportspersons and sports doctors. It is furthermore shown that the standard arguments against the current ban on doping (...) also entail that if doping was made legal any requirements that it should be open doping could not be justified. (shrink)