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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., Journal of Business Ethics, ISSN:0167-4544, ISSN:1573-0697

Objectives This article aims to measure the willingness of the Swiss public to participate in personalised health research, and their preferences regarding data management and governance. Setting Results are presented from a nationwide survey of members of the Swiss public. Participants 15 106 randomly selected Swiss residents received the survey in September 2019. The response rate was 34.1% (n=5156). Respondent age ranged from 18 to 79 years, with fairly uniform spread across sex and age categories between 25 and 64 years. Primary and secondary outcome measures Willingness to participate in personalised health research and opinions regarding data management and governance. Results Most respondents preferred to be contacted and reconsented for each new project using their data (39%, 95% CI: 37.4% to 40.7%), or stated that their preference depends on the project type (29.4%, 95% CI: 27.9% to 31%). Additionally, a majority (52%, 95% CI: 50.3% to 53.8%) preferred their data or samples be stored anonymously or in coded form (43.4%, 95% CI: 41.7% to 45.1%). Of those who preferred that their data be anonymised, most also indicated a wish to be recontacted for each new project (36.8%, 95% CI: 34.5% to 39.2%); however, these preferences are in conflict. Most respondents desired to personally own their data. Finally, most Swiss respondents trust their doctors, along with researchers at universities, to protect their data. Conclusion Insight into public preference can enable Swiss biobanks and research institutions to create management and governance strategies that match the expectations and preferences of potential participants. Models allowing participants to choose how to interact with the process, while more complex, may increase individual willingness to provide data to biobanks., BMJ Open, 12 (8), ISSN:2044-6055

Supplemental material, sj-docx-1-jre-10.1177_15562646211053538 for The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study by Agata Ferretti, Marcello Ienca, Minerva Rivas Velarde, Samia Hurst and Effy Vayena in Journal of Empirical Research on Human Research Ethics

Supplemental material, sj-docx-1-jre-10.1177_15562646211053538 for The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study by Agata Ferretti, Marcello Ienca, Minerva Rivas Velarde, Samia Hurst and Effy Vayena in Journal of Empirical Research on Human Research Ethics

Multisite medical data sharing is critical in modern clinical practice and medical research. The challenge is to conduct data sharing that preserves individual privacy and data usability. The shortcomings of traditional privacy-enhancing technologies mean that institutions rely on bespoke data sharing contracts. These contracts increase the inefficiency of data sharing and may disincentivize important clinical treatment and medical research. This paper provides a synthesis between two novel advanced privacy enhancing technologies (PETs): Homomorphic Encryption and Secure Multiparty Computation (defined together as Multiparty Homomorphic Encryption or MHE). These PETs provide a mathematical guarantee of privacy, with MHE providing a performance advantage over separately using HE or SMC. We argue MHE fulfills legal requirements for medical data sharing under the General Data Protection Regulation (GDPR) which has set a global benchmark for data protection. Specifically, the data processed and shared using MHE can be considered anonymized data. We explain how MHE can reduce the reliance on customized contractual measures between institutions. The proposed approach can accelerate the pace of medical research whilst offering additional incentives for healthcare and research institutes to employ common data interoperability standards., Comment: 19 pages, 2 figures, 1 table

Emerging trends in pervasive computing and medical informatics are creating the possibility for large-scale collection, sharing, aggregation and analysis of unprecedented volumes of data, a phenomenon commonly known as big data. In this contribution, we review the existing scientific literature on big data approaches to dementia, as well as commercially available mobile-based applications in this domain. Our analysis suggests that big data approaches to dementia research and care hold promise for improving current preventive and predictive models, casting light on the etiology of the disease, enabling earlier diagnosis, optimizing resource allocation, and delivering more tailored treatments to patients with specific disease trajectories. Such promissory outlook, however, has not materialized yet, and raises a number of technical, scientific, ethical, and regulatory challenges. This paper provides an assessment of these challenges and charts the route ahead for research, ethics, and policy., Frontiers in Medicine, 5, ISSN:2296-858X

This opionion paper is published on Elephant in the lab – a blog journal on science policy. It is part of a series of articles analysing the meaning and future of scientific impact. Follow the blog: http://www.elephantinthelab.org/ – Twitter: @EITL_blog

The ethical use of publicly available datasets with human data for which consent has not been explicitly given needs urgent attention from researchers, funders, research institutes and publishers. A specific challenging case is research involving hacked data and this Perspective discusses whether and under what conditions it is morally and ethically justified to conduct such research. Hacked data-data obtained in an unauthorized manner through illicit access to a computer or computer network-are increasingly being used in scientific research. Examples include conflict modelling studies based on WikiLeaks datasets, and studies on sexual behaviour based on data leaked from Ashley Madison, a dating website hacked in 2015. Studies of this kind are prima facie lawful because the researchers who processed the data had no involvement in the data breach itself, and the hacked datasets were made publicly available. However, research integrity is not simply reducible to lawfulness. We contend that the ethical acceptability of using datasets of illicit origin cannot simply be presumed, but requires ethical justification. Therefore, the scientific community is urged to address a fundamental ethical question: whether, and under which conditions, conducting research using hacked data can be considered morally justifiable behaviour. This contribution will discuss and critically evaluate the ethical boundaries of research involving hacked data. This emerging ethical dilemma will be examined by analogy with previous debates on the ethics of research using data of unethical origin, such as research with data from Nazi medical experiments. Furthermore, we discuss the compatibility of research involving hacked data with current research ethics instruments such as the Belmont Report and the Oviedo Convention. We posit that research using hacked data should be deemed ethically problematic. However, exceptions may be acknowledged, depending on how the data are processed and the overall value of the study to society. To this end, we propose six ethical and procedural requirements for conducting research with hacked data in an ethically responsible manner.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

The flourishing of citizen science is an exciting phenomenon with the potential to contribute significantly to scientific progress. However, we lack a framework for addressing in a principled and effective manner the pressing ethical questions it raises. We argue that at the core of any such framework must be the human right to science. Moreover, we stress an almost entirely neglected dimension of this right—the entitlement it confers on all human beings to participate in the scientific process in all of its aspects. We then explore three of its key implications for the ethical regulation of citizen science: (a) the positive obligations imposed by the right on the state and other agents to recognize and promote citizen science, (b) the convective nature of the participation in science facilitated by the right and (c) the potential to mobilize the right in rolling back the unprecedented expansion of intellectual property regimes., Philosophy & Technology, 28 (3), ISSN:2210-5433, ISSN:2210-5441

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Health-related research is increasingly drawing on novel sources of online data, such as crowdsourced information about disease outbreaks, consumer-supplied information provided to health or wellness Web sites, Internet search queries about personal health, and social network postings that identify health behaviors. We offer examples of online sources and their uses, identify ethical and policy issues they generate, and formulate key questions for future discussion and investigation. Further work in this area will require cross-disciplinary collaboration to develop ethics and policy guidance for the ethical use of these novel data sources in health-related research.

Die Debatte um die personalisierte Genomik und deren Rolle in der personalisierten Medizin wurde gewissermassen entfremdet zur Diskussion um die kommerziell erhältlichen Gentests, die der Konsument direkt nach Hause bestellen kann. Die klinische Aussagekraft und Nützlichkeit dieser Tests ist umstritten, weshalb die meisten Richtlinien zur DTC-Genomik davon abraten. Andererseits sehen Befürworter, insbesondere die DTC-Industrie, einen persönlichen Nutzen im Erlangen genomischer Information. Es ist wichtig, Risiken und Nutzen von DTC-Gentests zu diskutieren. Dabei sollten wir aber nicht aus den Augen verlieren, welche Bedeutung die Genomik in der medizinischen Praxis und im Gesundheitswesen gewinnt. Durch den Einsatz von genomischen Informationen stehen uns wichtige Veränderungen bevor, weshalb wir auf deren mögliche Auswirkungen, wie genetische Diskriminierung, Schutz der Privatsphäre und Chancengleichheit im Gesundheitswesen, konzentrieren sollten. Die personalisierte Genomik wird ohne Zweifel nicht nur unsere Medizin, sondern vor allem auch unsere sozialen Normen herausfordern. Es geht dabei um mehr als die Frage «DTC Genomik ja oder nein», und darauf sollte die Debatte fokussieren.

Personal health data supplied by users of mobile devices, health apps, and the social Web and data from tracking of consumers’ online behavior — coupled with advanced bioinformatics tools — offer opportunities for use in health research. A central ethical question is whether individuals who have provided personal information online in nonresearch contexts have consented to research uses. Here, we explore this issue of informed consent, discuss some limitations of current practices, and offer recommendations for improving consent practices through a more tailored, context-sensitive approach that makes use of the dynamism of the Web-based context. Our proposals are rooted in the ethical imperative of protecting individual rights and respecting autonomy while enabling a dynamic research environment for the advancement of clinical medicine and public health.

Note: Editorial Reference EPFL-ARTICLE-214482doi:10.1371/journal.pcbi.1003904 Record created on 2015-12-10, modified on 2017-05-12