This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has (...) challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (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)

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)

Zusammenfassung Die informierte Einwilligung von Teilnehmer:innen gilt in vielen Fällen als Voraussetzung auch für die rein datenbasierte medizinische Forschung. In diesem Kontext wird ein Modell der breiten Einwilligung (_Broad Consent_) diskutiert. In Deutschland hat die Medizininformatik-Initiative einen konkreten Vorschlag für deutsche Kliniken ausgearbeitet, der eine Gültigkeit der Einwilligung für einen Zeitraum von 30 Jahren vorsieht. Der vorliegende Artikel diskutiert vor diesem Hintergrund die Frage, wie der Anspruch der Informiertheit in dieser zeitlichen Perspektive einzuordnen ist. Die Praxis der Einwilligung wird dabei (...) so verstanden, dass sie auf die Verwirklichung von Wohlergehen, persönlicher Souveränität und Vertrauen ausgerichtet ist. Eine anzunehmende Informationsasymmetrie zwischen Forschungsteilnehmenden, Forschenden, und datenspeichernden Institutionen wird dabei als spezifisches Kontextmerkmal herausgestellt. Um dieser Informationsasymmetrie in angemessener Weise zu begegnen, so die These, ist eine kontinuierliche Weitergabe von verständlich aufbereiteten Informationen an Forschungsteilnehmende notwendig, um die Wahrnehmung persönlicher Souveränität zu ermöglichen. (shrink)

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 aperfectduty 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 aperfectduty 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 animperfectduty, and reveals a number of strong reasons for insisting that participation in health records research is based on informed consent. (shrink)