Developments in medical big data analytics may bring societal benefits but are also challenging privacy and other ethical values. At the same time, an overly restrictive data protection regime can form a serious threat to valuable observational studies. Discussions about whether data privacy or data solidarity should be the foundational value of research policies, have remained unresolved. We add to this debate with an empirically informed ethical analysis. First, experiences with the implementation of the General Data Protection Regulation (GDPR) within (...) a European research consortium demonstrate a gap between the aims of the regulation and its effects in practice. Namely, strictly formalised data protection requirements may cause routinisation among researchers instead of substantive ethical reflection, and may crowd out trust between actors in the health data research ecosystem; while harmonisation across Europe and data sharing between countries is hampered by different interpretations of the law, which partly stem from different views about ethical values. Then, building on these observations, we use theory to argue that the concept of trust provides an escape from the privacy-solidarity debate. Lastly, the paper details three aspects of trust that can help to create a responsible research environment and to mitigate the encountered challenges: trust as multi-agent concept; trust as a rational and democratic value; and trust as method for priority setting. Mutual cooperation in research—among researchers and with data subjects—is grounded in trust, which should be more explicitly recognised in the governance of health data research. (shrink)

Zusammenfassung Die Forschungs- und Regulierungsebene bei datenintensiver Forschung in der Medizin liegen auseinander. Ein heterogenes Feld aus regulierenden Institutionen mit regional ungleichen Regelungen, sowohl hinsichtlich der Dichte als auch der Restriktivität von Regelungen, steht einer globalen Entwicklung der Technologien entgegen. Trotz oder gerade wegen mangelnder global-gültiger Regulierungen können auch unverbindliche oder nur bedingt verbindliche normative Vorgaben der Orientierung dienen. Doch wie soll eine solche normative Regulierung angesichts datenintensiver Forschung in der Medizin ausgestaltet werden und woran soll sie sich orientieren? Die (...) Frage, wie konkret und detailliert man eine solche Forschung regulieren sollte, lässt sich nur im Einzelfall für bestimmte Situationen und Institutionen beantworten. Ob dabei neue Normen oder Gewichtungen von Normen vorgenommen werden sollen, oder ob die Normen und deren Gewichtung weiterhin bestehen bleiben sollen, lässt sich nur mit Verweis auf starke normative Argumente beantworten. An zwingenden Argumenten für neue Normen angesichts der datenintensiven medizinischen Forschung mangelt es bisher. Dennoch ist eine Umsetzungsarbeit von Normen, egal ob neue oder alte, und deren Anwendung auf eine neue Methode oder Technologie allemal zu erbringen. Es bedarf daher – wie schon bisher – beider: sowohl etablierter und transparent kommunizierter Normen als auch des unabhängigen Urteils zur Anwendung dieser Normen. Angesichts der besonderen Eignung für diese Aufgabe sollten auch weiterhin Ethik-Kommissionen als prozedurale Instanz bei der Bewilligung von datenintensiver Forschung in der Medizin gefordert und befähigt werden, die als unabhängige Institution ein Urteil im Einzelfall anhand vorgegebener Normen fällen. Nichtsdestotrotz können sich die veränderten Praktiken datenintensiver Forschungsprojekte auch in neuen Anforderungen an Ethik-Kommissionen niederschlagen, denen mit Reformen der Arbeitsweise begegnet werden sollte. (shrink)

The article discusses the impact different concepts of solidarity can have on debates on models of consent for non-interventional research. It introduces three concepts of solidarity that have been referenced in bioethical debates: a purely descriptive concept, a concept that claims some derivative value for most but not all practices of solidarity, as well as a clearly normative concept where solidarity is tied to justice and taken to ground moral duties. It shows that regarding the rivalling models of study-specific consent, (...) tiered consent and broad consent, the first two concepts can be taken to favour tiered consent while only normative solidarity supports a model of broad consent—or an argument to allow non-interventional research without requiring consent at all. As normative solidarity is tied to considerations of justice, however, the argument appears less straightforward than one might expect: It presupposes that the research contributes to overcoming existing social injustices. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as (...) a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

Today there are multiple implantable medical devices on the market. The type of implants that interface the body’s tissues has been considered to have particular strong ethical implications. This article describes a development of a novel practice for ethical assessment and reflection within medical device research and development of non-CE marked medical devices, taking the perspective of both the ethicist and the researcher. The research case was an EU funded project where the aim was to develop and compare the efficiency (...) of invasive and non-invasive technological medical devices to create meaningful sensations as a novel therapy for phantom limb pain. An Independent Ethical Advisor with a regulatory and advisory role was assigned to the project, allowing us to investigate the projects deliberate incorporation of ethics. In the article we suggest and applied a novel framework based on action research for combining ethical assessment with building ethical reflection. The case analyse five different activities / elements: 1) the use of informed consent; 2) a survey amongst the research partners; 3) a workshop session; 4) observation of consortium meetings; and 5) an interview with a participating patient. (shrink)

Social media data hold considerable potential for predicting health-related conditions. Recent studies suggest that machine-learning models may accurately predict depression and other mental health-related conditions based on Instagram photos and Tweets. In this article, it is argued that individuals should have a sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. The article (1) develops three basic arguments for a right to protection of personal data trading on the notions (...) of social control and stigmatization, (2) argues that a number of features of AI profiling make individuals more exposed to social control and stigmatization than other types of data processing (the exceptionalism of AI profiling), (3) considers a series of other reasons for and against protecting individuals against AI profiling based on publicly available data, and finally (4) argues that the EU General Data Protection Regulation does not ensure that individuals have a right not to be AI profiled based on publicly available data. (shrink)

Studies suggest that machine learning models may accurately predict depression and other mental health-related conditions based on social media data. I have recently argued that individuals should have sui generis right not to be subjected to AI profiling based on publicly available data without their explicit informed consent. In a comment, Holm claims that there are scenarios in which individuals have a reason to prefer attempts of social control exercised on the basis of accurate AI predictions and that the suggested (...) right burdens individuals unfairly by allowing for those individuals to consent to AI profiling. In this reply, I address both of these alleged problems and their underlying assumptions and show why they fail to provide any reasons not to introduce the suggested right. (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)

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)

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)

Clinical photography is an important tool for medical practice, training and research. While in the past clinical pictures were confined to the stringent controls of surgeries and hospitals technological advances have made possible to take pictures and share them through the internet with only a few clicks. Confronted with this possibility I explore if a case could be made for using clinical photography in tandem with social media. In order to do this I explore: if patient’s informed consent is required (...) for the publication of any clinical images that depicts her, irrespective of whether the patient can be identified from the image or not, if social media is an adequate place for clinical images to be displayed, and finally if there are special considerations that should be taken into account when publishing clinical images on social media. (shrink)

In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, (...) abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary “consent design toolkit” and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design. (shrink)

Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do not read the information provided as part of the consent process and they habitually provide or refuse their consent without adequate reflection. In principle, these practices call into question the validity of their consent. (...) In this paper we argue that although the ‘no read problem’ and the routinisation of consent may apply to research participants’ consent practices for studies on crowdsourcing platforms, this is not a serious problem. Furthermore, given that the informational requirements for informed consent in these contexts are minimal, we argue that these participants are, nevertheless, sufficiently informed to give valid consent. We conclude that research ethics committees and institutional review boards should only agonise over the precise details of the informed consent process and materials in those rare cases where appreciable risks to research participants need to be managed. (shrink)

In the debate surrounding the introduction of non-invasive prenatal testing in prenatal screening programmes, the concept of routinisation is often used to refer to concerns and potential negative consequences of the test. A literature analysis shows that routinisation has many different meanings, which can be distinguished in three major versions of the concept. Each of these versions comprises several inter-related fears and concerns regarding prenatal screening and particularly regarding NIPT in three areas: informed choice, freedom to choose and consequences for (...) people with a disability. Three of the strongest arguments raised under the flag of routinisation are assessed for their validity: the threat that NIPT poses to informed choice, the potential increase in uptake of first-trimester prenatal screening and its consequences for social pressure to participate in screening or terminate affected pregnancies, and the negative consequences for disabled people. These routinisation arguments lack empirical or normative ground. However, the results of this analysis do not imply that no attention should be paid to possible problems surrounding the introduction of NIPT. At least two problems remain and should be addressed: there should be an ongoing debate about the requirements of informed choice, particularly related to an expanded scope of prenatal screening. Also, reproductive autonomy can only be achieved when expecting parents’ options are variegated, real and valuable, so that they can continue to choose whether or not to screen or to terminate a pregnancy. (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)

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)

In this paper we argue that ‘informed’ consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and using insights from philosophy of (...) mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance‐theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants’ decision to consent. We do not prescribe a standard, formal approach to decision‐making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front‐line of genomic science. (shrink)

Wearable and mobile technology has advanced in leaps and bounds in the last decade with technological advances creating a role from enhancing healthy living to monitoring and treating disease. However, the discussion about the ethical use of such commercial technology in the community, especially in minors, is lacking behind. In this paper, we first summarize the major ethical concerns that arise from the usage of commercially available wearable technology in children, with a focus on smart watches, highlighting issues around the (...) consent process, mitigation of risk and potential confidentiality and privacy issues, as well as the potential for therapeutic misconceptions when used without medical advice. Then through a relevant thought experiment we move on to outline some further ethical concerns that are connected to the use of wearables by minors, to wit the issue of informed consent in the case of minors, forcing them to live in the spotlight, and compromising their right to an open future. We conclude with the view that mitigating potential pitfalls and enhancing the benefits of wearable technology especially for minors requires brave and comprehensive moral debates. (shrink)