Researchers and practitioners are increasingly using machine-generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue (...) of synthetic data is often understood to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use. (shrink)

Researchers and practitioners are increasingly using machine‐generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue (...) of synthetic data is often understood to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use. (shrink)

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes. With this in mind, the Science and Values Working Group (...) of the COST Action CHIP ME ‘Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives’ identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research. We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment. (shrink)

Effectively addressing ethical issues in precision medicine research in Africa requires a holistic social contract that integrates biomedical knowledge with local cultural values and Indigenous knowledge systems. Drawing on African epistemologies such as ubuntu and ujamaa and on our collective experiences in genomics and big data research for sickle cell disease, hearing impairment, and fragile X syndrome and the project Public Understanding of Big Data in Genomics Medicine in Africa, we envision a transformative shift in health research (...) data governance in Africa that could help create a sense of shared responsibility between all stakeholders in genomics and data‐driven health research in Africa. This shift includes proposing a social contract for genomics and data science in health research that is grounded in African communitarianism such as solidarity, shared decision‐making, and reciprocity. We make several recommendations for a social contract for genomics and data science in health, including the coproduction of genomics knowledge with study communities, power sharing between stakeholders, public education on the ethical and social implications of genetics and data science, benefit sharing, giving voice to data subjects through dynamic consent, and democratizing data access to allow wide access by all research stakeholders. Achieving this would require adopting participatory approaches to genomics and data governance. (shrink)

Background The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership. Main body In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk (...) mitigation, as well as technological, economic, and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees (DACs) or equivalent managed access processes, which can balance the elements of these two ownership frameworks. Conclusion Undifferentiated application of the ownership concept (private or public) is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society. (shrink)

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)

Background Improving the ways in which routinely-collected mental health data are shared could facilitate substantial advances in research and treatment. However, this process should only be undertaken in partnership with those who provide such data. Despite relatively widespread investigation of public perspectives on health data sharing more generally, there is a lack of research on the views of people with mental illness. Methods Twelve people with lived experience of mental illness took part in semi-structured interviews (...) via online video software. Participants had experience of a broad range of mental health conditions including anxiety, depression, schizophrenia, eating disorders and addiction. Interview questions sought to establish how participants felt about the use of routinely-collected health data for research purposes, covering different types of health data, what health data should be used for, and any concerns around its use. Results Thematic analysis identified four overarching themes: benefits of sharing mental health data, concerns about sharing mental health data, safeguards, and data types. Participants were clear that health data sharing should facilitate improved scientific knowledge and better treatments for mental illness. There were concerns that data misuse could become another way in which individuals and society discriminate against people with mental illness, for example through insurance premiums or employment decisions. Despite this there was a generally positive attitude to sharing mental health data as long as appropriate safeguards were in place. Conclusions There was notable strength of feeling across participants that more should be done to reduce the suffering caused by mental illness, and that this could be partly facilitated by well-managed sharing of health data. The mental health research community could build on this generally positive attitude to mental health data sharing by following rigorous best practice tailored to the specific concerns of people with mental illness. (shrink)

In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review (...) of the empirical evidence addressing patients’ and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

This paper conducts a comparative analysis of data governance mechanisms concerning the secondary use of health data in Taiwan and the European Union (EU). Both regions have adopted distinctive approaches and regulations for utilizing health data beyond primary care, encompassing areas such as medical research and healthcare system enhancement. Through an examination of these models, this study seeks to elucidate the strategies, frameworks, and legal structures employed by Taiwan and the EU to strike a delicate (...) balance between the imperative of data-driven healthcare innovation and the safeguarding of individual privacy rights. This paper examines and compares several key aspects of the secondary use of health data in Taiwan and the EU. These aspects include data governance frameworks, legal and regulatory frameworks, data access and sharing mechanisms, and privacy and security considerations. This comparative exploration offers invaluable insights into the evolving global landscape of health data governance. It provides a deeper understanding of the strategies implemented by these regions to harness the potential of health data while upholding the ethical and legal considerations surrounding its secondary use. The findings aim to inform best practices for responsible and effective health data utilization, particularly in the context of medical AI applications. (shrink)

Volume 24, Issue 10, October 2024, Page 101-103.

Hundreds of articles have been written over the past several decades delineating the ethical tensions of health data commercialization, empirically querying the preferences of data contributors, an...

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The frameworks aim to govern coordinated processing, sharing and transfer of health data across borders thus placing burdens on researchers who are willing or obligated to (...) share data. In this paper, we investigate ethical values and legal principles that can be applied to ensure a more streamlined approach in the governance of cross-border health data sharing during global health emergencies. A scoping review approach was used to better understand emerging evidence about issues related to the ethical and legal governance of cross-border health data sharing. We first highlight the challenges of sharing health data across borders. We then discuss how the challenges might be overcome through the application of ethical values and legal principles that have been identified in literature. This is followed by a proposal for possible ways of streamlining the governance of health data sharing from ethical and legal perspectives in a bid to better prepare for future global health emergencies and promote the responsible sharing of health data. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for (...) some studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

Here, we analyze the public health implications of recent legal developments — including privacy legislation, intergovernmental data exchange, and artificial intelligence governance — with a view toward the future of public health informatics and the potential of diverse data to inform public health actions and drive population health outcomes.

The inclusion of members of structurally marginalized communities in data-intensive innovation initiatives, such as precision medicine projects, is an urgent contemporary issue. On the one hand, th...

For the first time, the revised Common Rule specifies that public health surveillance activities are not research. This article reviews the historical development of the public health surveillance exclusion and implications for other foundational public health practices.

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when (...) research is judged to be of particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

Data infrastructure includes the bureaucratic, technical, and social mechanisms that assist in actions like data management, analysis, storage, and sharing. While issues like data sharing have been addressed in depth in bioethical literature, data infrastructure presents its own ethical considerations, apart from the actions (such as data sharing and data analysis) that it enables. This essay outlines some of these considerations—namely, the ethics of efficiency, the visibility of infrastructure, the power of standards, and the (...) impact of new technologies—in order to invite the bioethics community to participate in conversations about infrastructure, as their expertise is both needed and welcomed. (shrink)

Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their health data for healthcare and research. Few studies have addressed consumers’ views on electronic data sharing and fewer still have explored the dual purposes of healthcare and research together. The objective of the study is to explore factors that affect consumers’ willingness to share electronic health (...) information for healthcare and research. This study involved a random-digit dial telephone survey of 800 adult Californians conducted in English and Spanish. Logistic regression was performed using backward selection to test for significant associations of each explanatory variable with the outcome variable. The odds of consent for electronic data sharing for healthcare decreased as Likert scale ratings for EHR impact on privacy worsened, odds ratio = 0.74, 95% CI [0.60, 0.90]; security, OR = 0.80, 95% CI [0.66, 0.98]; and quality, OR = 0.59, 95% CI [0.46–0.75]. The odds of consent for sharing for research was greater for those who think EHR will improve research quality, OR = 11.26, 95% CI [4.13, 30.73]; those who value research benefit over privacy OR = 2.72, 95% CI [1.55, 4.78]; and those who value control over research benefit OR = 0.49, 95% CI [0.26, 0.94]. Consumers’ choices about electronically sharing health information are affected by their attitudes toward EHRs as well as beliefs about research benefit and individual control. Design of person-centered interventions utilizing electronically collected health information, and policies regarding data sharing should address these values of importance to people. Understanding of these perspectives is critical for leveraging health data to support learning health care systems. (shrink)

New data-driven ideas of healthcare have increased pressures to reform existing data infrastructures. This article explores the role of data governing institutions during a reform of both secondary health data infrastructure and related legislation in Finland. The analysis elaborates on recent conceptual work on data journeys and data frictions, connecting them to institutional and regulatory issues. The study employs an interpretative approach, using interview and document data. The results show the stark contrast (...) between the goals of open and Big Data inspired reforms and the existing institutional realities. The multiple tensions that emerged during the process indicate how data frictions emanate to the institutional level, and how mundane data practices and institutional dynamics are intertwined. The article argues that in the Finnish case, public institutions acted as sage-guards of public interest, preventing more controversial parts from passing. Finally, it argues that initiating regulatory and infrastructural reforms simultaneously was beneficial for solving the tensions of the initiative and analysing either side separately would have produced misleading accounts of the overall initiative. The results highlight the benefits of analysing institutional dynamics and data practices as connected issues. (shrink)

Public health authorities (PHAs), including Tribal nations, have the right and responsibility to protect and promote the health of their citizens. Although Tribal nations have the same need and legal authority to access public health data as any other PHA, significant legal challenges continue to impede Tribal data access.

BackgroundIncreasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and (...) processing of patient data, allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations.MethodsTo conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform.ResultsFor our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation.ConclusionOur findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 277-288.

This article focuses on key roles that the ill-defined concept of ‘public benefit’ plays in accessing the public health data held by the UK’s National Health Service. Using the concept of the ‘trade-off fallacy’, this article argues that current data access and governance structures, based on particular construals of public benefit in the context of public health data, largely negate the possibility of effective control by individuals over future uses of personal health (...) class='Hi'>data. This generates a health data version of the trade-off fallacy that enables widespread involvement of commercial actors in personal data, despite public concerns over commercial involvement in, and potential exploitation of, public health data. The article suggests that, despite ostensibly robust regulatory and governance structures, this publicly held data is potentially subject to similar logics of accumulation as seen elsewhere in the digital economy, highlighting the inadequacies of current data regulatory frameworks in the digital era. (shrink)

Wearable self-tracking devices capture multidimensional health data and offer several advantages including new ways of facilitating research. However, they also create a conflict between individual interests of avoiding privacy harms, and collective interests of assembling and using large health data sets for public benefits. While some scholars argue for transparency and accountability mechanisms to resolve this conflict, an average user is not adequately equipped to access and process information relating to the consequences of consenting to further (...) uses of her data. As an alternative, this paper argues for fiduciary relationships, which put deliberative demands on digital health data controllers to keep the interests of their data subjects at the forefront as well as cater to the contextual nature of privacy. These deliberative requirements ensure that users can engage in collective participation and share their health data at a lower risk of privacy harms. This paper also proposes a way to balance the flexible and open-ended nature of fiduciary law with the specific nature and scope of fiduciary duties that digital health data controllers should owe to their data subjects. (shrink)

The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed (...) with one in which consent is engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes. (shrink)

In this article, we use the theory of Information Ethics to argue that deceased people have a prima facie moral right to privacy in the context of health data research, and that this should be reflected in regulation and guidelines. After death, people are no longer biological subjects but continue to exist as informational entities which can still be harmed/damaged. We find that while the instrumental value of recognising post-mortem privacy lies in the preservation of the social contract (...) for health research, its intrinsic value is grounded in respect for the dignity of the post-mortem informational entity. However, existing guidance on post-mortem data protection is available only in the context of genetic studies. In comparing the characteristics of genetic data and other health-related data, we identify two features of DNA often given as arguments for this genetic exceptionalism: relationality and embodiment. We use these concepts to show that at the appropriate Level of Abstraction, there is no morally relevant distinction between posthumous genetic and other health data. Thus, genetic data should not automatically receive special moral status after death. Instead we make a plea for ‘contextual exceptionalism’. Our analysis concludes by reflecting on a real-world case and providing suggestions for contextual factors that researchers and oversight bodies should take into account when designing and evaluating research projects with health data from deceased subjects. (shrink)

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a (...) rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data, ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: The role of HDSSs in research using public health data and data-sharing; Ownership and funding are critical factors influencing data-sharing; Other factors discourage data-sharing; Promoting and sustaining data-sharing; Ethical guidance structures; and Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching ‘share’ as a default. (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of (...) their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

BackgroundThe advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a (...) promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec.MethodsEight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software.ResultsOur findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions.ConclusionsThis qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec. (shrink)

The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of (...) specific consent, broad consent, blanket consent or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years. Most users indicate 1) that they find the choices they are asked to make easy to understand, 2) that the application is easy to use, and 3) that this kind of choice should be offered to people. It is possible to collect meta consent preferences in the general, adult population using a smartphone app. (shrink)

BackgroundHealth data-driven activities have become central in diverse fields (research, AI development, wearables, etc.), and new ethical challenges have arisen with regards to privacy, integrity, and appropriateness of use. To ensure the protection of individuals’ fundamental rights and freedoms in a changing environment, including their right to the protection of personal data, we aim to identify the ethical approaches adopted by scientists during intensive data exploitation when collecting, using, or sharing peoples’ health data.MethodsTwelve scientists who (...) were collecting, using, or sharing health data in different contexts in Sweden, were interviewed. We used systematic expert interviews to access these scientists’ specialist knowledge, and analysed the interviews with thematic analysis. Phrases, sentences, or paragraphs through which ethical values and norms were expressed, were identified and coded. Codes that reflected similar concepts were grouped, subcategories were formulated, and categories were connected to traditional ethical approaches.ResultsThrough several examples, the respondents expressed four different ethical approaches, which formed the main conceptual categories: consideration of consequences, respect for rights, procedural compliance, and being professional.ConclusionsTo a large extent, the scientists’ ethical approaches were consistent with ethical and legal principles. Data sharing was considered important and worth pursuing, even though it is difficult. An awareness of the complex issues involved in data sharing was reflected from different perspectives, and the respondents commonly perceived a general lack of practical procedures that would by default ensure ethical and legally compliant data collection and sharing. We suggest that it is an opportune time to move on from policy discussions to practical technological ethics-by-design solutions that integrate these principles into practice. (shrink)

Background The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and explores whether this approach (...) may be useful in terms of ensuring the autonomy of data subjects in personal health data usage. Methods This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items. Results A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use. Conclusions Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages. (shrink)

We have investigated attitudes towards the use of health data among the Swedish population by analyzing data from a survey answered by 1645 persons. Health data are potentially useful for a variety of purposes. Yet information about health remains sensitive. A balance therefore has to be struck between these opposing considerations in a number of contexts. The attitudes among those whose data is concerned will influence the perceived legitimacy of policies regulating health (...) data use. We aimed to investigate what views are held by the general public, and what aspects matter for the willingness to let one’s data be used not only for one’s own care but also for other purposes. We found that while there is a broad willingness to let one’s data be used, the possibility to influence that use is considered important. The study also indicated that when respondents are required to balance different interests, priority is typically given to compulsory schemes ensuring that data are available where needed, rather than voluntary participation and data protection. The policy implications to be drawn from this are not self-evident, however, since the fact that a majority has a certain attitude does not by itself determine the most adequate policy. (shrink)

Health research ethics training is highly variable, with some researchers receiving little to none, which is why ethical frameworks represent critical tools for ethical deliberation and guiding responsible practice. However, these documents' voluntary and abstract nature can leave health researchers seeking more operationalised guidance, such as in the form of checklists, even though this approach does not support reflection on the meaning of principles nor their implications. In search of more reflective and participatory practices in a pandemic context (...) with distance learning, this study explored whether co-design could support engagement and reflection on ethical principles amongst early-stage health researchers. In a pilot test using the Swiss Personalized Health Network's ethical framework for Responsible Usage of Personal Data in Health Research as a case study, we engaged health researchers to design visuals of four ethical principles. In two online workshops, participants (N = 10, N = 8) completed activities such as individual reflection, collaborative ideation, sketching, prototyping, discussion, and feedback. Our analysis shows that the co-design process helped foster in-depth engagement and reflection on the meaning and relevance of the SPHN ethical principles. Participants reported enjoying the experience, and most felt that visuals could motivate engagement with ethical frameworks. This study demonstrates the feasibility of a participatory, design-oriented approach to promote engagement with research ethics among early-career health researchers and highlights key challenges and lessons learned. In doing so, it lays the foundation for future research to investigate the impact of design-oriented, participatory learning to foster reflection and deliberation in ethics education. (shrink)

The European Commission produces the European Core Health Indicators, a database containing different tools used to compare European Union countries and recommend policy changes. The ECHI feeds multiple reports and documents and finds its way into health policies. From this arises the main research question addressed in this paper: How is health in Europe influenced by ECHI data practices? Specifically, we look at how some health issues or populations are prioritized or dismissed, which ultimately shapes (...) the meaning of and knowledge about health in Europe. To do so, we first develop the conceptual framework of “data performativity,” underlining how data practices shape their object/subject. We then explore the politics of evidence behind the ECHI health data that materialize into the absence of some health issues and populations and the hypervisibility of neoliberal health. In the end, we argue, the ECHI serves as a site of individual, collective, and political identity enunciation. (shrink)

EDUCERE is a government funded research and development project. EDUCERE objectives are to investigate, develop, and evaluate innovative solutions for society to detect changes in psychomotor development through the natural interaction of children with toys and everyday objects, and perform stimulation and early attention activities in real environments such as home and school. In the EDUCERE project, an ethical impact assessment is carried out linked to a minors’ data protection rights. Using a specific methodology, the project has achieved some (...) promising results. These include use of a prototype of smart toys to detect development difficulties in children. In addition, privacy protection measures which take into account the security concerns of health data, have been proposed and applied. This latter security framework could be useful in other Internet of Things related projects. It consists of legal and technical measures. Special attention has been placed in the transformation of bulk data such as acceleration and jitter of toys into health data when patterns of atypical development are found. The article describes the different security profiles in which users are classified. (shrink)

Before the EU General Data Protection Regulation entered into force in May 2018, we witnessed an intense struggle of actors associated with data-dependent fields of science, in particular health-related academia and biobanks striving for legal derogations for data reuse in research. These actors engaged in a similar line of argument and formed issue alliances to pool their collective power. Using descriptive coding followed by an interpretive analysis, this article investigates the argumentative repertoire of these actors and (...) embeds the analysis in ethical debates on data sharing and biobank-related data governance. We observe efforts to perform a paradigmatic shift of the discourse around the General Data Protection Regulation-implementation away from ‘protecting data’ as key concern to ‘protecting health’ of individuals and societies at large. Instead of data protection, the key risks stressed by health researchers became potential obstacles to research. In line, exchange of information with data subjects is not a key concern in the arguments of biobank-related actors and it is assumed that patients want ‘their’ data to be used. We interpret these narratives as a ‘reaction’ to potential restrictions for data reuse and in line with a broader trend towards Big Data science, as the very idea of biobanking is conceptualized around long-term use of readily prepared data. We conclude that a sustainable implementation of biobanks needs not only to comply with the General Data Protection Regulation, but must proactively re-imagine its relation to citizens and data subjects in order to account for the various ways that science gets entangled with society. (shrink)

Throughout the Global North, policymakers invest in large-scale integration of health-data infrastructures to facilitate the reuse of clinical data for administration, research, and innovation. Debates about the ethical implications of data repurposing have focused extensively on issues of patient autonomy and privacy. We suggest that it is time to scrutinize also how the everyday work of healthcare staff is affected by political ambitions of data reuse for an increasing number of purposes, and how different purposes (...) are prioritized. Our analysis builds on ethnographic studies within the Danish healthcare system, which is internationally known for its high degree of digitalization and well-connected data infrastructures. Although data repurposing ought to be relatively seamless in this context, we demonstrate how it involves costs and trade-offs for those who produce and use health data. Even when IT systems and automation strategies are introduced to enhance efficiency and reduce data work, they can end up generating new forms of data work and fragmentation of clinically relevant information. We identify five types of data work related to the production, completion, validation, sorting, and recontextualization of health data. Each of these requires medical expertise and clinical resources. We propose that the implications for these forms of data work should be considered early in the planning stages of initiatives for large-scale data sharing and reuse, such as the European Health Data Space. We believe that political awareness of clinical costs and trade-offs related to such data work can provide better and more informed decisions about data repurposing. (shrink)

Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first (...) explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment. (shrink)

Existing ethics guidelines, influential literature and policies on ethical research generally focus on real-time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data raise new challenges to their application. Unlike traditional research, RUPD is population-based, aligned to public health activities, and often reliant on pre-collected longitudinal data. These characteristics, when considered in relation to the (...) generally lower protective ethico-legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South. (shrink)

Powered by ‘big health data’ and enormous gains in computing power, artificial intelligence and related technologies are already changing the healthcare landscape. Harnessing the potential of these technologies will necessitate partnerships between health institutions and commercial companies, particularly as it relates to sharing health data. The need for commercial companies to be trustworthy users of data has been argued to be critical to the success of this endeavour. I argue that this approach is mistaken. (...) Our interactions with commercial companies need not, and should not, be based on trust. Rather, they should be based on confidence. I begin by elucidating the differences between trust, reliability, and confidence, and argue that trust is not the appropriate attitude to adopt when it comes to sharing data with commercial companies. I argue that what we really should want is confidence in a system of data sharing. I then provide an outline of what a confidence-worthy system of data sharing with commercial companies might look like, and conclude with some remarks about the role of trust within this system. (shrink)

Data access and data sharing are vital to advance medicine. A growing number of public private partnerships are set up to facilitate data access and sharing, as private and public actors possess highly complementary health data sets and treatment development resources. However, the priorities and incentives of public and private organizations are frequently in conflict. This has complicated partnerships and sparked public concerns around ethical issues such as trust, justice or privacy—in turn raising an important (...) problem in business and data ethics: how can ethical theory inform the practice of public and private partners to mitigate misaligned incentives, and ensure that they can deliver societally beneficial innovation? In this paper, we report on the development of the Swiss Personalized Health Network’s ethical guidelines for health data sharing in public private partnerships. We describe the process of identifying ethical issues and engaging core stakeholders to incorporate their practical reality on these issues. Our report highlights core ethical issues in health data public private partnerships and provides strategies for how to overcome these in the Swiss health data context. By agreeing on and formalizing ethical principles and practices at the beginning of a partnership, partners and society can benefit from a relationship built around a mutual commitment to ethical principles. We present this summary in the hope that it will contribute to the global data sharing dialogue. (shrink)

BackgroundThe ability of healthcare to protect sensitive personal data in medical records and registers might influence public trust, which in turn might influence willingness to allow healthcare to use such data. The aim of this study was to examine how the general public’s trust relates to their attitudes towards uses of health data.MethodsA stratified sample from the general Swedish population received a questionnaire about their willingness to share health data. Respondents were also asked about (...) their trust in the management and protection of electronic health data.ResultsA large majority (81.9%) of respondents revealed high levels of trust in the ability of healthcare to protect electronic patient data. Good health was associated with significantly higher levels of trust compared to bad health. Respondents with low levels of trust were significantly less willing to allow personal data to be used for different purposes and were more inclined to insist on being asked for permission beforehand. Those with low levels of trust also perceived risks of unauthorized access to personal data to be higher and the likely damage of such unauthorized access worse, compared to those with high levels of trust.ConclusionsTrust in the ability of healthcare to protect electronic health is generally high in Sweden. Those with higher levels of trust are more willing to let their data be used, including without informed consent. It thus seems crucial to promote trust in order to be able to reap the benefits that digitalization makes possible through increased access and use of data in healthcare. (shrink)

We welcome Ballantyne & Schaefer’s discussion of the issues concerning consent and use of health data for research. In response to their acknowledgement of the need for public debate and discussion, we provide evidence from our own public consultation on this topic.

Developments in medical big data analytics may bring societal benefits but are also challenging privacy and other ethical values. At the same time, an overly restrictive data protection regime can form a serious threat to valuable observational studies. Discussions about whether data privacy or data solidarity should be the foundational value of research policies, have remained unresolved. We add to this debate with an empirically informed ethical analysis. First, experiences with the implementation of the General (...) class='Hi'>Data Protection Regulation (GDPR) within a European research consortium demonstrate a gap between the aims of the regulation and its effects in practice. Namely, strictly formalised data protection requirements may cause routinisation among researchers instead of substantive ethical reflection, and may crowd out trust between actors in the health data research ecosystem; while harmonisation across Europe and data sharing between countries is hampered by different interpretations of the law, which partly stem from different views about ethical values. Then, building on these observations, we use theory to argue that the concept of trust provides an escape from the privacy-solidarity debate. Lastly, the paper details three aspects of trust that can help to create a responsible research environment and to mitigate the encountered challenges: trust as multi-agent concept; trust as a rational and democratic value; and trust as method for priority setting. Mutual cooperation in research—among researchers and with data subjects—is grounded in trust, which should be more explicitly recognised in the governance of health data research. (shrink)