BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford (...) and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures. (shrink)

The aim of the article is to intervene in debates about the digital and, in particular, framings that imagine the digital in terms of epochal shifts or as redefining life. Instead, drawing on recent developments in digital methods, we explore the lively, productive and performative qualities of the digital by attending to the specificities of digital devices and how they interact, and sometimes compete, with older devices and their capacity to mobilize and materialize social and other relations. In doing so, (...) our aim is to explore the implications of digital devices and data for reassembling social science methods or what we call the social science apparatuses that assemble digital devices and data to ‘know’ the social and other relations. Building on recent work at CRESC on the social life of methods, we recommend a genealogical approach that is alive to the ways in which digital devices are simultaneously shaped by social worlds, and can in turn become agents that shape those worlds. This calls for attending to the specificities of digital devices themselves, how they are varied and composed of diverse socio-technical arrangements, and are enrolled in the creation of new knowledge spaces, institutions and actors. Rather than exploring what large-scale changes can be revealed and understood through the digital, we argue for explorations of how digital devices themselves are materially implicated in the production and performance of contemporary sociality. To that end we offer the following nine propositions about the implications of digital data and devices and argue that these demand rethinking the theoretical assumptions of social science methods: transactional actors; heterogeneity; visualization; continuous time; whole populations; granularity; expertise; mobile and mobilizing; and non-coherence. (shrink)

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which (...) other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific (...) consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given. (shrink)

England and Wales are moving toward a model of ‘opt out’ for use of personal confidential data in health research. Existing research does not make clear how acceptable this move is to the public. While people are typically supportive of health research, when asked to describe the ideal level of control there is a marked lack of consensus over the preferred model of consent. This study sought to investigate a relatively unexplored difference between the consent model that people prefer and (...) that which they are willing to accept. It also sought to explore any reasons for such acceptance. (shrink)

In 2009, with the enactment of the Lisbon Treaty, the Charter of Fundamental Rights of the European Union entered into force. Under Article 8 of the Charter, for the first time, a stand-alone fundamental right to data protection was declared. The creation of this right, standing as a distinct right to the right to privacy, is undoubtedly significant, and it is unique to the European legal order, being absent from other international human rights instruments. This commentary examines the parameters of (...) this new right to data protection, asking what are the principles underpinning the right. It argues that the right reflects some key values inherent in the European legal order, namely: privacy, transparency, autonomy and nondiscrimination. It also analyses some of the challenges in implementing this right in an era of ubiquitous veillance practices and Big Data. (shrink)