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 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.
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.
BackgroundHealth data holds great potential for improved treatments. Big data research and machine learning models have been shown to hold great promise for improved diagnostics and treatment planning. The potential is tied, however, to the availability of personal health data. In recent years, it has been argued that data from health records should be available for health research, and that individuals have a duty to make the data available for such research. A central point of debate is whether such secondary (...) use of health data requires informed consent.Main bodyIn response to recent writings this paper argues that a requirement of informed consent for health record research must be upheld. It does so by exploring different contrasting notions of the duty of easy rescue and arguing that none of them entail a perfect duty to participate in health record research. In part because the costs of participation cannot be limited to 1) the threat of privacy breaches, but includes 2) the risk of reduced trust and 3) suboptimal treatment, 4) stigmatization and 5) medicalisation, 6) further stratification of solidarity and 7) increased inequality in access to treatment and medicine. And finally, it defends the requirement of informed consent by arguing that the mere possibility of consent bias provides a rather weak reason for making research participation mandatory, and that there are strong, independent reasons for making.ConclusionArguments from the duty of easy rescue in combination with claims about little risk of harm and potential consent bias fail to establish not only a perfect duty to participate in health record research, but also that participation in such research should be mandatory. On the contrary, an analysis of these arguments indicates that the duty to participate in research is most adequately construed as an imperfect duty, and reveals a number of strong reasons for insisting that participation in health records research is based on informed consent. (shrink)
In this response to Neil Manson’s latest intervention in our debate about the best consent model for biobank research we show, contra Manson that the ‘expiry problem’ that affects broad consent models because of changes over time in methods, purposes, types of data used and governance structures is a real and significant problem. We further show that our preferred implementation of meta consent as a national consent platform solves this problem and is not subject to the cost and burden objections (...) that Manson raises. (shrink)
This paper deals with the historical and philosophical background of the introduction of the notion of branching time in philosophical logic as it is revealed in the hitherto unpublished mail-correspondence between Saul Kripke and A.N. Prior in the late 1950s. The paper reveals that the idea was first suggested by Saul Kripke in a letter to A.N. Prior, dated September 3, 1958, and it is shown how the elaboration of the idea in the course of the correspondence was intimately intervowen (...) with considerations of how to represent indeterminism and of the adequacy of tensed logic in light of special relativity. The correspondence underpins the point that Prior's later development of branching time may be understood as a crucial part of his attempt at the formulating a conceptual framework integrating basic human notions of time and free choice. (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)
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)
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)
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)
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)
Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by (...) facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests. (shrink)
This article reinvigorates a key question in publication ethics: Is there research that it is permissible to conduct but that ought not to be published? The article raises the question in relation to two recent medical studies. It is argued that the publication of these studies may cause significant harm to individuals, that editors of medical journals have a moral responsibility for such harm, that denial of publication is inadequate as an instrument to fulfil this moral responsibility and that internationally (...) acknowledged publication ethics codes should incorporate this aspect of editors’ moral responsibility. (shrink)
In his recent article ‘Nudging, Informed Consent and Bullshit’, William Simkulet1 convincingly argues that certain types of nudging satisfy Frankfurt’s criteria of bullshit. As a prelude to this argument, Simkulet considers whether recommendations and framing are types of nudging and whether they satisfy the requirement of adequate disclosure essential for a valid informed consent. He defines nudging as the systematic attempt at altering behaviour by non-rational means, and describes adequate disclosure as providing the patient with true information that enables an (...) understanding of treatment options and their risks and benefits. Simkulet argues that recommendations and framing are types of rational persuasion in that they potentially enhance patients’ understanding of treatment options and their risks and benefits. Therefore, not only do they not qualify as nudging, but they may be required in order to secure adequate disclosure. In this brief comment, I focus on Simkulet’s considerations of framing and show that framing may be nudging and that it may violate the requirements of informed consent. The framing of medical information may influence patients’ preferences for treatment. It has been shown that framing information about a risky medical intervention in chance of survival rather than risk of death increases patients’ preferences for the intervention.2 3 In his exploration of framing, Simkulet contends that the fact that people respond differently to …. (shrink)
The idea that it is acceptable to ‘nudge’ people to opt for the ‘healthy choice’ is gaining currency in health care policy circles. This article investigates whether researchers evaluating Abdominal Aortic Aneurysm Screening Programmes attempt to influence decision makers in ways that are similar to popular ‘nudging’ techniques. Comparing two papers on the health economics of AAASP both published in the BMJ within the last 3 years, it is shown that the values chosen for the health economics modelling are not (...) representative of the literature and consistently favour the conclusions of the articles. It is argued that this and other features of these articles may be justified within a Libertarian Paternalist framework as ‘nudging’ like ways of influencing decision makers, but also that these ways of influencing decision makers raise significant ethical issues in the context of democratic decision making. (shrink)
Many ICT services require that users explicitly consent to conditions of use and policies for the protection of personal information. This consent may become ‘routinised’. We define the concept of routinisation and investigate to what extent routinisation occurs as well as the factors influencing routinisation in a survey study of internet use. We show that routinisation is common and that it is influenced by factors including gender, age, educational level and average daily internet use. We further explore the reasons users (...) provide for not reading conditions and policies and show that they can be grouped in meaningful ways that may delineate different types of routinsation. (shrink)
Late 2009, the Microsoft Corporation terminated its sales, distribution and upgrading of Microsoft Office Accounting. This article presents an ethical analysis of the way in which Microsoft Corporation effected its decision to withdraw the product with special emphasis on how consumer expectations were formed, maintained and handled throughout the lifecycle of the accounting software in question. The analysis proceeds from initial reflections on and arguments for the ethical significance of consumer expectations – an area which has until recently only received (...) little attention in moral analysis. (shrink)
The focus of this paper is an analysis and discussion of what kind of empirical evidence bodies that advise on or set public policy in the area of reproduction and reproductive technologies are looking for when developing new advice or policy, but the analysis has implications for other areas of ‘bioethics policy making’ as well. The paper outlines some important differences between policy making and philosophical analysis, provides an account of ‘policy relevance’ and discusses ways in which evidence may be (...) misused in policy making. The scope of the paper is, for the most part restricted to considerations of empirical evidence of a social scientific nature. (shrink)
Clinical information about patients is increasingly being stored in electronic form and has therefore become more easily shareable. Data are collected as part of clinical care but have multiple other potential uses in relation to health system planning, audit and research. The use of clinical information for these secondary uses is controversial, and the ability to safeguard personal and sensitive data under current practices is contested. In this study, we investigate the attitudes of a representative sample of the Danish population (...) towards transfer of clinical data from their general practice for secondary use. We specifically study: patients’ trust in different types of healthcare professionals, their interest in being asked about secondary use of data and their willingness to dispense from a requirement of informed consent based on their trust in healthcare professionals. We find that adult Danes are positive towards research that use patient data, and they generally trust general practitioners, hospitals and researchers to treat their data confidentially. Nevertheless, they feel that they have a right to control the use of their data, only 7.3% disagreeing, and that the data belong to them, only 14.0% disagreeing. Answers to further questions about the relation between trust, information and consent show that although trust modifies the wish for information and consent, there is still a strong view that the patient should control the use of data. We find no differences between those who have frequent contact with the healthcare system and those who do not. (shrink)