BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...) health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

In April 2020, close to the start of the first U.K. COVID-19 lockdown, the U.K. government announced the development of a COVID-19 contact tracing app, which was later trialled on the U.K. island, the Isle of Wight, in May/June 2020. United Kingdom surveys found general support for the development of such an app, which seemed strongly influenced by public trust. Institutions developing the app were called upon to fulfil the commitment to public trust by acting with trustworthiness. Such calls presuppose (...) that public trust associated with the app can emerge if the conditions for trustworthiness are met and that public trust is simplistic, i.e., linearly the sum of each member of the publics’ individual – U.K. government trust relationship. Drawing on a synthesis of the trust literature and fifteen interviews with members of the public trialling the app on the Isle of Wight, this paper aims to explore what trust mechanisms and relationships are at play when thinking about public trust in the context of the U.K. COVID-19 app. We argue that public trust is a complex social phenomenon and not linearly correlated with institutional trustworthiness. As such, attention needs to widen from calls for trustworthy infrastructures as a way to build public trust, to a deeper understanding of those doing the trusting; in particular, what or whom do people place their trust in when considering whether using the app and why. An understanding of this will help when trying to secure public trust during the implementation of necessary public health measures. (shrink)

BackgroundBiobanks provide an important foundation for genomic and personalised medicine. In order to enhance their scientific power and scope, they are increasingly becoming part of national or international networks. Public trust is essential in fostering public engagement, encouraging donation to, and facilitating public funding for biobanks. Globalisation and networking of biobanking may challenge this trust.MethodsWe report the results of an Australian study examining public attitudes to the networking and globalisation of biobanks. The study used quantitative and qualitative methods in conjunction (...) with bioethical analysis in order to determine factors that may contribute to, and threaten, trust.ResultsOur results indicate a generally high level of trust in biobanks and in medical research more broadly. Key factors that can reduce perceived trustworthiness of biobanks are commercialisation and involvement in global networking.ConclusionsWe conclude that robust ethical oversight and governance standards can both promote trust in global biobanking and ensure that this trust is warranted. (shrink)

In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.

In our recent paper ‘Trust and the Goldacre Review: Why TREs are not about trust’1 we argue that trusted research environments (TREs) reduce the need for trust in the use and sharing of health data, and that referring to these data storage systems as ‘trusted’ raises a number of concerns. Recent replies to our paper have raised several objections to this argument. In this reply, we seek to build on the arguments presented in our original paper, address some of the (...) misunderstanding of our position expressed in these replies, and sketch out where further research is needed. One of the central arguments of our original paper was that the language we use to describe data-sharing initiatives matters, because the way things like TREs are presented and framed makes a difference to what people can, and should, expect from them. However, there is a more basic and obvious problem with referring to these institutions as ‘trusted’: it begs the question about whether these institutions are, in fact, trusted. We cannot know in advance of these initiatives being implemented, established, and appropriate assessments completed, whether they are actually trusted. Further questions abound: whom might TREs eventually be trusted by? If some people end up trusting them, but not others, is it appropriate to call them ‘trusted’? At best, this is simply a case of wishful thinking (and a more accurate name would be ‘hopefully-TREs’). More problematically, this may be an instance of ‘trustworthiness-signalling’: an attempt to convince others to trust, without meeting the requirements for genuine trustworthiness. By calling TREs ‘trusted’, the implication seems to be that placing our trust in them is perfectly fine: they are the kinds of things that are trusted by others and can safely be trusted by us. But not only does simply calling something ‘trusted’ …. (shrink)