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32Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in researchBMC Medical Ethics 25 (1): 1-9. 2024.Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized by the World Hea…Read more
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20How Do Molecular Systems Engineering Scientists Frame the Ethics of Their Research?AJOB Empirical Bioethics. forthcoming.Background There are intense discussions about the ethical and societal implications of biomedical engineering, but little data to suggest how scientists think about the ethics of their work. The aim of this study is to describe how scientists frame the ethics of their research, with a focus on the field of molecular systems engineering.Methods Semi-structured qualitative interviews were conducted during 2021–2022, as part of a larger study. This analysis includes a broad question about how part…Read more
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38Public involvement in the governance of population-level biomedical research: unresolved questions and future directionsJournal of Medical Ethics 47 (7): 522-525. 2021.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…Read more
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14Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National StudyJournal of Law, Medicine and Ethics 50 (4): 791-804. 2022.This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The “data protection model” emphasizes privacy protections at the expense of public health benefit, while the “emergency response model” sacrifices transparency and accountability, prompting concerns about excessive …Read more
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24Direct-to-Consumer Neurotechnology: What Is It and What Is It for?American Journal of Bioethics Neuroscience 10 (4): 149-151. 2019.
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8Talking Ethics Early in Health Data Public Private PartnershipsJournal of Business Ethics 190 (3): 649-659. 2023.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 r…Read more
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42“We the Scientists”: a Human Right to Citizen SciencePhilosophy and Technology 28 (3): 479-485. 2015.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 …Read more
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57Ethics review of big data research: What should stay and what should be reformed?BMC Medical Ethics 22 (1): 1-13. 2021.BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical…Read more
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54The place of human rights and the common good in global health policyTheoretical Medicine and Bioethics 37 (4): 365-382. 2016.This article offers an integrated account of two strands of global health justice: health-related human rights and health-related common goods. After sketching a general understanding of the nature of human rights, it proceeds to explain both how individual human rights are to be individuated and the content of their associated obligations specified. With respect to both issues, the human right to health is taken as the primary illustration. It is argued that the individuation of the right to he…Read more
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14How Interactive Visualizations Compare to Ethical Frameworks as Stand-Alone Ethics Learning Tools for Health Researchers and ProfessionalsAJOB Empirical Bioethics 14 (4): 197-207. 2023.Background Despite the bourgeoning of digital tools for bioethics research, education, and engagement, little research has empirically investigated the impact of interactive visualizations as a way to translate ethical frameworks and guidelines. To date, most frameworks take the format of text-only documents that outline and offer ethical guidance on specific contexts. This study’s goal was to determine whether an interactive-visual format supports frameworks in transferring ethical knowledge by…Read more
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18Health data privacy through homomorphic encryption and distributed ledger computing: an ethical-legal qualitative expert assessment studyBMC Medical Ethics 23 (1): 1-13. 2022.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 …Read more
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1Towards adaptive governance in big data health research : implementing regulatory principlesIn Graeme T. Laurie (ed.), The Cambridge handbook of health research regulation, Cambridge University Press. 2021.
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87Towards a Governance Framework for Brain DataNeuroethics 15 (2): 1-14. 2022.The increasing availability of brain data within and outside the biomedical field, combined with the application of artificial intelligence (AI) to brain data analysis, poses a challenge for ethics and governance. We identify distinctive ethical implications of brain data acquisition and processing, and outline a multi-level governance framework. This framework is aimed at maximizing the benefits of facilitated brain data collection and further processing for science and medicine whilst minimizi…Read more
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19Digital bioethics: introducing new methods for the study of bioethical issuesJournal of Medical Ethics 49 (11): 783-790. 2023.The online space has become a digital public square, where individuals interact and share ideas on the most trivial to the most serious of matters, including discussions of controversial ethical issues in science, technology and medicine. In the last decade, new disciplines like computational social science and social data science have created methods to collect and analyse such data that have considerably expanded the scope of social science research. Empirical bioethics can benefit from the in…Read more
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27A Systemic Approach to the Oversight of Machine Learning Clinical TranslationAmerican Journal of Bioethics 22 (5): 23-25. 2022.Machine learning heralds highly transformative approaches to the automation of numerous clinical tasks, from diagnosis to risk assessment, and from prognosis to informing treatment decisions....
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570AI4People—an ethical framework for a good AI society: opportunities, risks, principles, and recommendationsMinds and Machines 28 (4): 689-707. 2018.This article reports the findings of AI4People, an Atomium—EISMD initiative designed to lay the foundations for a “Good AI Society”. We introduce the core opportunities and risks of AI for society; present a synthesis of five ethical principles that should undergird its development and adoption; and offer 20 concrete recommendations—to assess, to develop, to incentivise, and to support good AI—which in some cases may be undertaken directly by national or supranational policy makers, while in oth…Read more
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317Key ethical challenges in the European Medical Information FrameworkMinds and Machines 29 (3): 355-371. 2019.The European Medical Information Framework project, funded through the IMI programme, has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice to ensure the privacy protect…Read more
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26Big Data, precision medicine and private insurance: A delicate balancing actBig Data and Society 6 (1). 2019.In this paper, we discuss how access to health-related data by private insurers, other than affecting the interests of prospective policy-holders, can also influence their propensity to make personal data available for research purposes. We take the case of national precision medicine initiatives as an illustrative example of this possible tendency. Precision medicine pools together unprecedented amounts of genetic as well as phenotypic data. The possibility that private insurers could claim acc…Read more
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117Research led by participants: a new social contract for a new kind of researchJournal of Medical Ethics 42 (4): 216-219. 2016.
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19“Hunting Down My Son’s Killer”: New Roles of Patients in Treatment Discovery and Ethical UncertaintyJournal of Bioethical Inquiry 17 (1): 37-47. 2020.The past few years have witnessed several media-covered cases involving citizens actively engaging in the pursuit of experimental treatments for their medical conditions—or those of their loved ones—in the absence of established standards of therapy. This phenomenon is particularly observable in patients with rare genetic diseases, as the development of effective therapies for these disorders is hindered by the limited profitability and market value of pharmaceutical research. Sociotechnical tre…Read more
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30Is there a duty to participate in digital epidemiology?Life Sciences, Society and Policy 14 (1): 1-24. 2018.This paper poses the question of whether people have a duty to participate in digital epidemiology. While an implied duty to participate has been argued for in relation to biomedical research in general, digital epidemiology involves processing of non-medical, granular and proprietary data types that pose different risks to participants. We first describe traditional justifications for epidemiology that imply a duty to participate for the general public, which take account of the immediacy and p…Read more
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31Genes wide open: Data sharing and the social gradient of genomic privacyAJOB Empirical Bioethics 1-15. forthcoming.
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44Digital Medicine and Ethics: Rooting for EvidenceAmerican Journal of Bioethics 18 (9): 49-51. 2018.
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18Democratizing Health Research Through Data CooperativesPhilosophy and Technology 31 (3): 473-479. 2018.Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct control over…Read more
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86Biomedical Big Data: New Models of Control Over Access, Use and GovernanceJournal of Bioethical Inquiry 14 (4): 501-513. 2017.Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Su…Read more
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39Informed Consent and the Disclosure of Clinical Results to Research ParticipantsAmerican Journal of Bioethics 17 (7): 58-60. 2017.
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30Philanthropy on trial: can the rich rescue shelved compounds?Journal of Medical Ethics 43 (11): 737-738. 2017.Translational medicine has excited expectations of the drug development process seeing better days. Hope is much needed, as the process in its current form is ‘unsustainable’1 and its yield unimpressive. Only a small percentage of highly promising molecular discoveries find their way into a clinical trial and even a smaller percentage ends up in a pharmaceutical product marketed for clinical indications. Various reasons contribute to this problem ranging from purely biomedical, safety and effica…Read more
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28Health Research with Big Data: Time for Systemic OversightJournal of Law, Medicine and Ethics 46 (1): 119-129. 2018.To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot hav…Read more
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64Becoming partners, retaining autonomy: ethical considerations on the development of precision medicineBMC Medical Ethics 17 (1): 67. 2016.Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engag…Read more