Correction: Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study.

[This corrects the article DOI: 10.1371/journal.pone.0285807.].

Ethical challenges of using remote monitoring technologies for clinical research: A case study of the role of local research ethics committees in the RADAR-AD study.

INTRODUCTION: Clinical research with remote monitoring technologies (RMTs) has multiple advantages over standard paper-pencil tests, but also raises several ethical concerns. While several studies have addressed the issue of governance of big data in clinical research from the legal or ethical perspectives, the viewpoint of local research ethics committee (REC) members is underrepresented in the current literature. The aim of this study is therefore to find which specific ethical challenges are raised by RECs in the context of a large European study on remote monitoring in all syndromic stages of Alzheimer's disease, and what gaps remain. METHODS: Documents describing the REC review process at 10 sites in 9 European countries from the project Remote Assessment of Disease and Relapse-Alzheimer's Disease (RADAR-AD) were collected and translated. Main themes emerging in the documents were identified using a qualitative analysis approach. RESULTS: Four main themes emerged after analysis: data management, participant's wellbeing, methodological issues, and the issue of defining the regulatory category of RMTs. Review processes differed across sites: process duration varied from 71 to 423 days, some RECs did not raise any issues, whereas others raised up to 35 concerns, and the approval of a data protection officer was needed in half of the sites. DISCUSSION: The differences in the ethics review process of the same study protocol across different local settings suggest that a multi-site study would benefit from a harmonization in research ethics governance processes. More specifically, some best practices could be included in ethical reviews across institutional and national contexts, such as the opinion of an institutional data protection officer, patient advisory board reviews of the protocol and plans for how ethical reflection is embedded within the study.

Solidarity during the COVID-19 pandemic: evidence from a nine-country interview study in Europe.

Calls for solidarity have been an ubiquitous feature in the response to the COVID-19 pandemic. However, we know little about how people have thought of and practised solidarity in their everyday lives since the beginning of the pandemic. What role does solidarity play in people's lives, how does it relate to COVID-19 public health measures and how has it changed in different phases of the pandemic? Situated within the medical humanities at the intersection of philosophy, bioethics, social sciences and policy studies, this article explores how the practice-based understanding of solidarity formulated by Prainsack and Buyx helps shed light on these questions. Drawing on 643 qualitative interviews carried out in two phases (April-May 2020 and October 2020) in nine European countries (Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, German-speaking Switzerland and the UK), the data show that interpersonal acts of solidarity are important, but that they are not sustainable without consistent support at the institutional level. As the pandemic progressed, respondents expressed a longing for more institutionalised forms of solidarity. We argue that the medical humanities have much to gain from directing their attention to individual health issues, and to collective experiences of health or illness. The analysis of experiences through a collective lens such as solidarity offers unique insights to understandings of the individual and the collective. We propose three essential advances for research in the medical humanities that can help uncover collective experiences of disease and health crises: (1) an empirical and practice-oriented approach alongside more normative approaches; (2) the confidence to make recommendations for practice and policymaking and (3) the pursuit of cross-national and multidisciplinary research collaborations.

The impact of artificial intelligence on the person-centred, doctor-patient relationship: some problems and solutions.

Artificial intelligence (AI) is often cited as a possible solution to current issues faced by healthcare systems. This includes the freeing up of time for doctors and facilitating person-centred doctor-patient relationships. However, given the novelty of artificial intelligence tools, there is very little concrete evidence on their impact on the doctor-patient relationship or on how to ensure that they are implemented in a way which is beneficial for person-centred care.Given the importance of empathy and compassion in the practice of person-centred care, we conducted a literature review to explore how AI impacts these two values. Besides empathy and compassion, shared decision-making, and trust relationships emerged as key values in the reviewed papers. We identified two concrete ways which can help ensure that the use of AI tools have a positive impact on person-centred doctor-patient relationships. These are (1) using AI tools in an assistive role and (2) adapting medical education. The study suggests that we need to take intentional steps in order to ensure that the deployment of AI tools in healthcare has a positive impact on person-centred doctor-patient relationships. We argue that the proposed solutions are contingent upon clarifying the values underlying future healthcare systems.

Systems thinking and efficiency under emissions constraints: Addressing rebound effects in digital innovation and policy.

Innovations and efficiencies in digital technology have lately been depicted as paramount in the green transition to enable the reduction of greenhouse gas emissions, both in the information and communication technology (ICT) sector and the wider economy. This, however, fails to adequately account for rebound effects that can offset emission savings and, in the worst case, increase emissions. In this perspective, we draw on a transdisciplinary workshop with 19 experts from carbon accounting, digital sustainability research, ethics, sociology, public policy, and sustainable business to expose the challenges of addressing rebound effects in digital innovation processes and associated policy. We utilize a responsible innovation approach to uncover potential ways forward for incorporating rebound effects in these domains, concluding that addressing ICT-related rebound effects ultimately requires a shift from an ICT efficiency-centered perspective to a "systems thinking" model, which aims to understand efficiency as one solution among others that requires constraints on emissions for ICT environmental savings to be realized.

Understanding Pandemic Solidarity: Mutual Support During the First COVID-19 Lockdown in the United Kingdom.

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.

Democratic research: Setting up a research commons for a qualitative, comparative, longitudinal interview study during the COVID-19 pandemic.

The sudden and dramatic advent of the COVID-19 pandemic led to urgent demands for timely, relevant, yet rigorous research. This paper discusses the origin, design, and execution of the SolPan research commons, a large-scale, international, comparative, qualitative research project that sought to respond to the need for knowledge among researchers and policymakers in times of crisis. The form of organization as a research commons is characterized by an underlying solidaristic attitude of its members and its intrinsic organizational features in which research data and knowledge in the study is shared and jointly owned. As such, the project is peer-governed, rooted in (idealist) social values of academia, and aims at providing tools and benefits for its members. In this paper, we discuss challenges and solutions for qualitative studies that seek to operate as research commons.

Normative positions towards COVID-19 contact-tracing apps: findings from a large-scale qualitative study in nine European countries.

Mobile applications for digital contact tracing have been developed and introduced around the world in response to the COVID-19 pandemic. Proposed as a tool to support 'traditional' forms of contact-tracing carried out to monitor contagion, these apps have triggered an intense debate with respect to their legal and ethical permissibility, social desirability and general feasibility. Based on a large-scale study including qualitative data from 349 interviews conducted in nine European countries (Austria, Belgium, France, Germany, Ireland, Italy, the Netherlands, German-speaking Switzerland, the United Kingdom), this paper shows that the binary framing often found in surveys and polls, which contrasts privacy concerns with the usefulness of these interventions for public health, does not capture the depth, breadth, and nuances of people's positions towards COVID-19 contact-tracing apps. The paper provides a detailed account of how people arrive at certain normative positions by analysing the argumentative patterns, tropes and (moral) repertoires underpinning people's perspectives on digital contact-tracing. Specifically, we identified a spectrum comprising five normative positions towards the use of COVID-19 contact-tracing apps: opposition, scepticism of feasibility, pondered deliberation, resignation, and support. We describe these stances and analyse the diversity of assumptions and values that underlie the normative orientations of our interviewees. We conclude by arguing that policy attempts to develop and implement these and other digital responses to the pandemic should move beyond the reiteration of binary framings, and instead cater to the variety of values, concerns and expectations that citizens voice in discussions about these types of public health interventions.

Remote monitoring technologies in Alzheimer's disease: design of the RADAR-AD study.

BACKGROUND: Functional decline in Alzheimer's disease (AD) is typically measured using single-time point subjective rating scales, which rely on direct observation or (caregiver) recall. Remote monitoring technologies (RMTs), such as smartphone applications, wearables, and home-based sensors, can change these periodic subjective assessments to more frequent, or even continuous, objective monitoring. The aim of the RADAR-AD study is to assess the accuracy and validity of RMTs in measuring functional decline in a real-world environment across preclinical-to-moderate stages of AD compared to standard clinical rating scales. METHODS: This study includes three tiers. For the main study, we will include participants (n = 220) with preclinical AD, prodromal AD, mild-to-moderate AD, and healthy controls, classified by MMSE and CDR score, from clinical sites equally distributed over 13 European countries. Participants will undergo extensive neuropsychological testing and physical examination. The RMT assessments, performed over an 8-week period, include walk tests, financial management tasks, an augmented reality game, two activity trackers, and two smartphone applications installed on the participants' phone. In the first sub-study, fixed sensors will be installed in the homes of a representative sub-sample of 40 participants. In the second sub-study, 10 participants will stay in a smart home for 1 week. The primary outcome of this study is the difference in functional domain profiles assessed using RMTs between the four study groups. The four participant groups will be compared for each RMT outcome measure separately. Each RMT outcome will be compared to a standard clinical test which measures the same functional or cognitive domain. Finally, multivariate prediction models will be developed. Data collection and privacy are important aspects of the project, which will be managed using the RADAR-base data platform running on specifically designed biomedical research computing infrastructure. RESULTS: First results are expected to be disseminated in 2022. CONCLUSION: Our study is well placed to evaluate the clinical utility of RMT assessments. Leveraging modern-day technology may deliver new and improved methods for accurately monitoring functional decline in all stages of AD. It is greatly anticipated that these methods could lead to objective and real-life functional endpoints with increased sensitivity to pharmacological agent signal detection.

Digital/computational phenotyping: What are the differences in the science and the ethics?

The concept of 'digital phenotyping' was originally developed by researchers in the mental health field, but it has travelled to other disciplines and areas. This commentary draws upon our experiences of working in two scientific projects that are based at the University of Oxford's Big Data Institute - The RADAR-AD project and The Minerva Initiative - which are developing algorithmic phenotyping technologies. We describe and analyse the concepts of digital biomarkers and computational phenotyping that underlie these projects, explain how they are linked to other research in digital phenotyping and compare and contrast some of their epistemological and ethical implications. In particular, we argue that the phenotyping paradigm in both projects is grounded on an assumption of 'objectivity' that is articulated in different ways depending on the role that is given to the computational/digital tools. Using the concept of 'affordance', we show how specific functionalities relate to potential uses and social implications of these technologies and argue that it is important to distinguish among them as the concept of digital phenotyping is increasingly being used with a variety of meanings.

How does the use of digital consulting change the meaning of being a patient and/or a health professional? Lessons from the Long-term Conditions Young People Networked Communication study.

BACKGROUND: While studies have examined the impact of digital communication technology on healthcare, there is little exploration of how new models of digital care change the roles and identities of the health professional and patient. The purpose of the current study is to generate multidisciplinary reflections and questions around the use of digital consulting and the way it changes the meaning of being a patient and/or a health professional. METHOD: We used a large pre-existing qualitative dataset from the Long-term Conditions Young People Networked Communication (LYNC) study which involved interviews with healthcare professionals and a group of 16-24 years patients with long-term physical and mental health conditions. We conducted a three-stage mixed methods analysis. First, using a small sample of interview data from the LYNC study, we identified three key themes to explore in the data and relevant academic literature. Second, in small groups we conducted secondary analysis of samples of patient and health professional LYNC interview data. Third, we ran a series of rapid evidence reviews. FINDINGS: We identified three key themes: workload/flow, impact of increased access to healthcare and vulnerabilities. Both health professionals and patients were 'on duty' in their role more often. Increased access to healthcare introduced more responsibilities to both patients and health professionals. Traditional concepts in medical ethics, confidentiality, empathy, empowerment/power, efficiency and mutual responsibilities are reframed in the context of digital consulting. CONCLUSIONS: Our collaboration identified conflicts and constraints in the construction of digital patients and digital clinicians. There is evidence that digital technologies change the nature of a medical consultation and with it the identities and the roles of clinicians and patients which, in turn, calls for a redefinition of traditional concepts of medical ethics. Overall, digital consulting has the potential to significantly reduce costs while maintaining or improving patient care and clinical outcomes. Timely study of digital engagement in the National Health Service is a matter of critical importance.

COVID-19 and Contact Tracing Apps: Ethical Challenges for a Social Experiment on a Global Scale.

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.

Big Data, Big Waste? A Reflection on the Environmental Sustainability of Big Data Initiatives.

This paper addresses a problem that has so far been neglected by scholars investigating the ethics of Big Data and policy makers: that is the ethical implications of Big Data initiatives' environmental impact. Building on literature in environmental studies, cultural studies and Science and Technology Studies, the article draws attention to the physical presence of data, the material configuration of digital service, and the space occupied by data. It then explains how this material and situated character of data raises questions concerning the ethics of the increasingly fashionable Big Data discourses. It argues that attention should be paid to (1) the vocabulary currently used when discussing the governance of data initiatives; (2) the internal tension between current data initiatives and environmental policies; (3) issues of fair distribution. The article explains how taking into account these aspects would allow for a more responsible behaviour in the context of data storage and production.

SERIES: eHealth in primary care. Part 2: Exploring the ethical implications of its application in primary care practice.

Background: eHealth promises to increase self-management and personalised medicine and improve cost-effectiveness in primary care. Paired with these promises are ethical implications, as eHealth will affect patients' and primary care professionals' (PCPs) experiences, values, norms, and relationships.Objectives: We argue what ethical implications related to the impact of eHealth on four vital aspects of primary care could (and should) be anticipated.Discussion: (1) EHealth influences dealing with predictive and diagnostic uncertainty. Machine-learning based clinical decision support systems offer (seemingly) objective, quantified, and personalised outcomes. However, they also introduce new loci of uncertainty and subjectivity. The decision-making process becomes opaque, and algorithms can be invalid, biased, or even discriminatory. This has implications for professional responsibilities and judgments, justice, autonomy, and trust. (2) EHealth affects the roles and responsibilities of patients because it can stimulate self-management and autonomy. However, autonomy can also be compromised, e.g. in cases of persuasive technologies and eHealth can increase existing health disparities. (3) The delegation of tasks to a network of technologies and stakeholders requires attention for responsibility gaps and new responsibilities. (4) The triangulate relationship: patient-eHealth-PCP requires a reconsideration of the role of human interaction and 'humanness' in primary care as well as of shaping Shared Decision Making.Conclusion: Our analysis is an essential first step towards setting up a dedicated ethics research agenda that should be examined in parallel to the development and implementation of eHealth. The ultimate goal is to inspire the development of practice-specific ethical recommendations.

A mobile revolution for healthcare? Setting the agenda for bioethics.

Mobile health (mHealth) is rapidly being implemented and changing our ways of doing, understanding and organising healthcare. mHealth includes wearable devices as well as apps that track fitness, offer wellness programmes or provide tools to manage chronic conditions. According to industry and policy makers, these systems offer efficient and cost-effective solutions for disease prevention and self-management. While this development raises many ethically relevant questions, so far mHealth has received only little attention in medical ethics. This paper provides an overview of bioethical issues raised by mHealth and aims to draw scholarly attention to the ethical significance of its promises and challenges. We show that the overly positive promises of mHealth need to be nuanced and their desirability critically assessed. Finally, we offer suggestions to bioethicists to engage with this emerging trend in healthcare to develop mHealth to its best potential in a morally sound way.

Beyond individualism: Is there a place for relational autonomy in clinical practice and research?

The dominant, individualistic understanding of autonomy that features in clinical practice and research is underpinned by the idea that people are, in their ideal form, independent, self-interested and rational gain-maximising decision-makers. In recent decades, this paradigm has been challenged from various disciplinary and intellectual directions. Proponents of 'relational autonomy' in particular have argued that people's identities, needs, interests - and indeed autonomy - are always also shaped by their relations to others. Yet, despite the pronounced and nuanced critique directed at an individualistic understanding of autonomy, this critique has had very little effect on ethical and legal instruments in clinical practice and research so far. In this article, we use four case studies to explore to what extent, if at all, relational autonomy can provide solutions to ethical and practical problems in clinical practice and research. We conclude that certain forms of relational autonomy can have a tangible and positive impact on clinical practice and research. These solutions leave the ultimate decision to the person most affected, but encourage and facilitate the consideration of this person's care and responsibility for connected others.

Lessons about So-Called "Difficult" Patients from the UK Controversy over Patient Access to Electronic Health Records.

Increasing numbers of patients have direct access to their electronic health records (EHRs). Proponents of direct access argue that it empowers patients by making them more informed and offering them more control over their health and care. According to some proponents of patients' access to EHRs, clinicians' concerns about potential negative implications are grounded in a form of paternalism that protects clinicians' authority. This paper draws upon narratives from patients in the United Kingdom (UK) who have access to their EHRs and suggests strategies for moving beyond these controversies between proponents and critics of the system. It additionally shows that the very organizational, procedural, and technological infrastructure that promises patients' increased access to records can also exacerbate some patients' "difficult" behaviors.