BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map (...) these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

Mobile applications are increasingly regarded as important tools for an integrated strategy of infection containment in post-lockdown societies around the globe. This paper discusses a number of questions that should be addressed when assessing the ethical challenges of mobile applications for digital contact-tracing of COVID-19: Which safeguards should be designed in the technology? Who should access data? What is a legitimate role for “Big Tech” companies in the development and implementation of these systems? How should cultural and behavioural issues be (...) accounted for in the design of these apps? Should use of these apps be compulsory? What does transparency and ethical oversight mean in this context? We demonstrate that responses to these questions are complex and contingent and argue that if digital contract-tracing is used, then it should be clear that this is on a trial basis and its use should be subject to independent monitoring and evaluation. (shrink)

In this paper we argue the need to reimagine research ethics frameworks to include notions of environmental sustainability. While there have long been calls for healthcareethics frameworks and decision-making to include aspects of sustainability, less attention has focused on howresearchethics frameworks could address this. To do this, we first describe the traditional approach to research ethics, which often relies on individualised notions of risk. We argue that we need to broaden this notion of individual risk to consider issues associated with (...) environmental sustainability. This is because research is associated with carbon emissions and other environmental impacts, both of which cause climate change health hazards. We introduce how bioethics frameworks have considered notions of environmental sustainability and draw on these to help develop a framework suitable for researchers. We provide a case study of data-driven health research to apply our framework. (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)

This paper examines the consequences of a culture of “personal ethics” when using new methodologies, such as the use of social media sites as a source of data for research. Using SM research as an example, this paper explores the practices of a number of actors and researchers within the “Ethics Ecosystem” which as a network governs ethically responsible research behaviour. In the case of SM research, the ethical use of this data is currently in dispute, as even though it (...) is seemingly publically available, concerns relating to privacy, vulnerability, potential harm and consent blur the lines of responsible ethical research behaviour. The findings point to the dominance of a personal, bottom-up, researcher-led, ‘ethical barometer’ for making decisions regarding the permissibility of using SM data. We show that the use of different barometers by different researchers can lead to wide disparities in ethical practice - disparities which are compounded by the lack of firm guidelines for responsible practice of SM research. This has widespread consequences on the development of shared norms and understandings at all levels, and by all actors within the Ethics Ecosystem, and risks inconsistencies in their approaches to ethical decision-making. This paper argues that this governance of ethical behaviour by individual researchers perpetuates a negative cycle of academic practice that is dependent on subjective judgements by researchers themselves, rather than governed by more formalised academic institutions such as the research ethics committee and funding council guidelines. (shrink)

Social scientists have drawn attention to the role of hype and optimistic visions of the future in providing momentum to biomedical innovation projects by encouraging innovation alliances. In this article, we show how less optimistic, uncertain, and modest visions of the future can also provide innovation projects with momentum. Scholars have highlighted the need for clinicians to carefully manage the expectations of their prospective patients. Using the example of a pioneering clinical team providing deep brain stimulation to children and young (...) people with movement disorders, we show how clinicians confront this requirement by drawing on their professional knowledge and clinical expertise to construct visions of the future with their prospective patients; visions which are personalized, modest, and tainted with uncertainty. We refer to this vision-constructing work as recalibration, and we argue that recalibration enables clinicians to manage the tension between the highly optimistic and hyped visions of the future that surround novel biomedical interventions, and the exigencies of delivering those interventions in a clinical setting. Drawing on work from science and technology studies, we suggest that recalibration enrolls patients in an innovation alliance by creating a shared understanding of how the “effectiveness” of an innovation shall be judged. (shrink)

The UK’s 100,000 Genomes Project has the aim of sequencing 100,000 genomes from UK National Health Service (NHS) patients while concomitantly transforming clinical care such that whole genome sequencing becomes routine clinical practice in the UK. Policymakers claim that the project will revolutionize NHS care. We wished to explore the 100,000 Genomes Project, and in particular, the extent to which policymaker claims have helped or hindered the work of those associated with Genomics England – the company established by the Department (...) of Health to deliver the project. We interviewed 20 individuals linked to, or working for Genomics England. Interviewees had double-edged views about the context within which they were working. On the one hand, policymakers’ expectations attached to the venture were considered vacuous “genohype”; on the other hand, they were considered the impetus needed for those trying to advance genomic research into clinical practice. Findings should be considered for future genomes projects. (shrink)

Digital phenotyping for mental health is an emerging trend which uses digital data, derived from mobile applications, wearable technologies and digital sensors, to measure, track and predict the mental health of an individual. Digital phenotyping for mental health is a growing, but as yet underexamined, field. As we will show, the rapid growth of digital phenotyping for mental health raises crucial questions about the values that underpin and are reinforced by this technology, as well as regarding to whom it may (...) become valuable. In this commentary, we explore these questions by focusing on the construction of value across two interrelated domains: user experience and epistemologies on the one hand, and issues of data and ownership on the other. In doing so, we demonstrate the need for a deeper ethical and epistemological engagement with the value assumptions that underpin the promise of digital phenotyping for mental health. (shrink)

Realising the societal gains from publicly funded health and medical research requires a model for a reflexive evaluation precedent for the societal impact of research. This research explores UK Research Excellence Framework evaluators’ values and opinions and assessing societal impact, prior to the assessment taking place. Specifically, we discuss the characteristics of two different impact assessment extremes – the “quality-focused” evaluation and “societal impact-focused” evaluation. We show the wide range of evaluator views about impact, and that these views could be (...) conceptually reflected in a range of different positions along a conceptual evaluation scale. We describe the characteristics of these extremes in detail, and discuss the different beliefs evaluators had which could influence where they positioned themselves along the scale. These decisions, we argue, when considered together, form a dominant definition of societal impact that influences the direction of its evaluation by the panel. (shrink)

In her paper, Galasso contends that transitioning precision medicine from its current emphasis on healthcare benefits, to a focus on precision public health, may help address the equity concerns th...

In this paper we contribute to “sociology in bioethics” and help clarify the range of ways sociological work can contribute to ethics scholarship. We do this using a case study of an innovative neurotechnology, functional magnetic resonance imaging, and its use to attempt to diagnose and communicate with severely brain-injured patients. We compare empirical data from interviews with relatives of patients who have a severe brain injury with perspectives from mainstream bioethics scholars. We use the notion of an “ethical landscape” (...) as an analogy for the different ethical positions subjects can take—whereby a person’s position relative to the landscape makes a difference to the way they experience and interact with it. We show that, in comparison to studying abstract ethics “from above” the ethical landscape, which involves universal generalizations and global judgements, studying ethics empirically “from the ground,” within the ethical landscape foregrounds a more plural and differentiated picture. We argue it is important not to treat empirical ethics as secondary to abstract ethics, to treat on-the-ground perspectives as useful only insofar as they can inform ethics from above. Rather, empirical perspectives can illuminate the plural vantage points in ethical judgments, highlight the “lived” nature of ethical reasoning, and point to all ethical vantage points as being significant. This is of epistemic importance to normative ethics, since researchers who pay attention to the various positions in and trajectories through the ethical landscape are unlikely to think about ethics in terms of abstract agency—as can happen with top-down ethics—or to elide agency with the agency of policymakers. Moreover, empirical perspectives may have transformative implications for people on the ground, especially where focus on the potential harms and benefits they face brings their experiences and interests to the forefront of ethical and policy discussion. (shrink)

Throughout the COVID-19 pandemic, the concept of solidarity has been invoked frequently. Much interest has centred around how citizens and communities support one another during times of uncertainty. Yet, empirical research which accounts and understands citizen’s views on pandemic solidarity, or their actual practices has remained limited. Drawing upon the analysis of data from 35 qualitative interviews, this article investigates how residents in England and Scotland enacted, understood, or criticised (the lack of) solidarity during the first national lockdown in the (...) United Kingdom in April 2020—at a time when media celebrated solidarity as being at an all-time high. It finds that although solidarity was practiced by some people, the perceived lack of solidarity was just as pronounced. We conclude that despite frequent mobilisations of solidarity by policy makers and other public actors, actual practices of solidarity are poorly understood—despite the importance of solidarity for public health and policy. (shrink)

BackgroundThe health sector aims to improve health outcomes and access to healthcare. At the same time, the sector relies on unsustainable environmental practices that are increasingly recognised to be catastrophic threats to human health and health inequities. As such, a moral imperative exists for the sector to address these practices. While strides are currently underway to mitigate the environmental impacts of healthcare, less is known about how health researchers are addressing these issues, if at all.MethodsThis paper uses an interview methodology (...) to explore the attitudes of UK health researchers using data-intensive methodologies about the adverse environmental impacts of their practices, and how they view the importance of these considerations within wider health goals.ResultsInterviews with 26 researchers showed that participants wanted to address the environmental and related health harms associated with their research and they reflected on how they could do so in alignment with their own research goals. However, when tensions emerged, their own research was prioritised. This was related to their own desires as researchers and driven by the broader socio-political context of their research endeavours.ConclusionTo help mitigate the environmental and health harms associated with data-intensive health research, the socio-political context of research culture must be addressed. (shrink)

In this paper we explore shifts in how the law and ethics allow European law enforcement officers to use forensic genetic technologies. We do so by reviewing three technologies, ‘traditional’ (STR-based) forensic DNA profiling, forensic DNA phenotyping and the searching of genetic genealogy databases. In particular, we discuss changes in how ethical boundaries have been placed around what is seen as an appropriate use of genetic technologies in European criminal justice systems. While the ‘type’ of DNA that law enforcement officers (...) are permitted to analyse offers a useful ethical reference point, for newer forensic genomic technologies, ethical scrutiny, we argue, would also look at the specific purpose or use of the technology. (shrink)

Forensic DNA phenotyping (FDP) is an emerging technology that seeks to make probabilistic inferences regarding a person’s observable characteristics (“phenotype”) from DNA. The aim is to aid criminal investigations by helping to identify unknown suspected perpetrators, or to help with non-criminal missing persons cases. Here we provide results from the analysis of 36 interviews with those who have a professional stake in FDP, including forensic scientists, police officers, lawyers, government agencies and social scientists. Located in eight EU countries, these individuals (...) were asked for their views on the benefits and problems associated with the prospective use of FDP. While all interviewees distinguished between those phenotypic tests perceived to either raise ethical, social or political concerns from those tests viewed as less ethically and socially problematic, there was wide variation regarding the criteria they used to make this distinction. We discuss the implications of this in terms of responsible technology development. (shrink)

In their article, de Groot et al respond to a call to bring investigative genetic genealogy i to the bioethical debate.1 They explore the extent to which the ethical approach used in the medical clinical genetics context can be helpful for conceptualising the ethical issues associated with IGG. They conclude that such an individual-based model, which revolves around notions of consent and privacy, has significant limitations in the IGG context. The authors call for a broader balancing of the benefits and (...) risks of IGG, and the need for collective democratic engagement. de Groot et al ’s paper is a welcome addition to the literature—not only because it is an interesting and important analysis in its own right, but also because it foregrounds the importance of bringing forensic genetic debate to the bioethical audience. While forensic genetics has become increasingly widespread in the criminal justice system, bioethicists have often shied away from engaging with the ethical issues these practices raise.ii Perhaps this relates to the narrowing of bioethics debate over the past half a century to focus primarily on health-related issues,iii or to the techno-legal normative separation of DNA analysis in these two sectors, or perhaps both. Either way, as our desire for an ever-increasing collection and analysis of genetic data continues—and as we have seen in the IGG context—the lines between health, forensics and recreational associated DNA analysis and use are set to become …. (shrink)

The UK Chief Medical Officer’s 2016 Annual Report, Generation Genome, focused on a vision to fully integrate genomics into all aspects of the UK’s National Health Service. This process of integration, which has now already begun, raises a wide range of social and ethical concerns, many of which were discussed in the final Chapter of the report. This paper explores how the UK’s 100,000 Genomes Project —the catalyst for Generation Genome, and for bringing genomics into the NHS—is negotiating these ethical (...) concerns. The UK’s 100 kGP, promoted and delivered by Genomics England Limited, is an innovative venture aiming to sequence 100,000 genomes from NHS patients who have a rare disease, cancer, or an infectious disease. GEL has emphasised the importance of ethical governance and decision-making. However, some sociological critique argues that biomedical/technological organisations presenting themselves as ‘ethical’ entities do not necessarily reflect a space within which moral thinking occurs. Rather, the ‘ethical work’ conducted by organisations is more strategic, relating to the politics of the organisation and the need to build public confidence. We set out to explore whether GEL’s ethical framework was reflective of this critique, and what this tells us more broadly about how genomics is being integrated into the NHS in response to the ethical and social concerns raised in Generation Genome. We do this by drawing on a series of 20 interviews with individuals associated with or working at GEL. (shrink)

Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional (...) stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service. (shrink)

Over the past decade, umbilical cord blood (UCB) has routinely been used as a source of haematopoietic stem cells for allogeneic stem cell transplants in the treatment of a range of malignant and non-malignant conditions affecting children and adults. UCB banks are a necessary part of the UCB transplant program, but their establishment has raised a number of important scientific, ethical and political issues. This paper examines the scientific and clinical evidence that has provided the basis for the establishment of (...) UCB banks. We also discuss the major ethical issues that UCB banks raise, including ownership of cord blood, processes for obtaining consent for its collection and storage, and confidentiality. Finally, we review other concerns about commercial non-altruistic banking, including concerns about social justice, equity of access and equity of care. (shrink)