•  599
    AI4People—an ethical framework for a good AI society: opportunities, risks, principles, and recommendations
    with Luciano Floridi, Josh Cowls, Monica Beltrametti, Raja Chatila, Patrice Chazerand, Virginia Dignum, Christoph Luetge, Robert Madelin, Ugo Pagallo, Francesca Rossi, Burkhard Schafer, and Peggy Valcke
    Minds 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
  •  347
    Key ethical challenges in the European Medical Information Framework
    with Luciano Floridi, Christoph Luetge, Ugo Pagallo, Burkhard Schafer, Peggy Valcke, Janet Addison, Nigel Hughes, Nathan Lea, Caroline Sage, Bart Vannieuwenhuyse, and Dipak Kalra
    Minds 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
  •  120
    Research led by participants: a new social contract for a new kind of research
    with Roger Brownsword, Sarah Jane Edwards, Bastian Greshake, Jeffrey P. Kahn, Navjoyt Ladher, Jonathan Montgomery, Daniel O'Connor, Onora O'Neill, Martin P. Richards, Annette Rid, Mark Sheehan, Paul Wicks, and John Tasioulas
    Journal of Medical Ethics 42 (4): 216-219. 2016.
  •  94
    Towards a Governance Framework for Brain Data
    with Marcello Ienca, Joseph J. Fins, Ralf J. Jox, Fabrice Jotterand, Silja Voeneky, Roberto Andorno, Tonio Ball, Claude Castelluccia, Ricardo Chavarriaga, Hervé Chneiweiss, Agata Ferretti, Orsolya Friedrich, Samia Hurst, Grischa Merkel, Fruzsina Molnár-Gábor, Jean-Marc Rickli, James Scheibner, Rafael Yuste, and Philipp Kellmeyer
    Neuroethics 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
  •  86
    Biomedical Big Data: New Models of Control Over Access, Use and Governance
    with Alessandro Blasimme
    Journal 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
  •  64
    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
  •  57
    Ethics review of big data research: What should stay and what should be reformed?
    with Minerva Rivas Velarde, Mahsa Shabani, Gabrielle Samuel, Camille Nebeker, S. Matthew Liao, Peter Kleist, Walter Karlen, Jeff Kahn, Phoebe Friesen, Bobbie Farsides, Edward S. Dove, Alessandro Blasimme, Mark Sheehan, Marcello Ienca, and Agata Ferretti
    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
  •  55
    The place of human rights and the common good in global health policy
    Theoretical 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
  •  44
    Digital Medicine and Ethics: Rooting for Evidence
    American Journal of Bioethics 18 (9): 49-51. 2018.
  •  43
    “We the Scientists”: a Human Right to Citizen Science
    Philosophy 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
  •  40
    Public involvement in the governance of population-level biomedical research: unresolved questions and future directions
    with Sonja Erikainen, Phoebe Friesen, Leah Rand, Karin Jongsma, Michael Dunn, Annie Sorbie, Matthew McCoy, Jessica Bell, Michael Burgess, Haidan Chen, Vicky Chico, Sarah Cunningham-Burley, Julie Darbyshire, Rebecca Dawson, Andrew Evans, Nick Fahy, Teresa Finlay, Lucy Frith, Aaron Goldenberg, Lisa Hinton, Nils Hoppe, Nigel Hughes, Barbara Koenig, Sapfo Lignou, Michelle McGowan, Michael Parker, Barbara Prainsack, Mahsa Shabani, Ciara Staunton, Rachel Thompson, Kinga Varnai, Oli Williams, Max Williamson, Sarah Chan, and Mark Sheehan
    Journal 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
  •  39
    Informed Consent and the Disclosure of Clinical Results to Research Participants
    with Samia A. Hurst, Celine Moret, and Alessandro Blasimme
    American Journal of Bioethics 17 (7): 58-60. 2017.
  •  36
    Some patients tolerate a given drug well, without adverse reactions. For others, though, an identical dose of the same medication can have toxic effects. Moreover, while a drug can be effective at relieving symptoms for some patients, it may fail to do the same for others suffering with the same disease. With such variability in treatment responses, tailoring medical interventions to individual patients has long been an aspiration of medicine. Until recently, however, medicine lacked a clear und…Read more
  •  32
    Is there a duty to participate in digital epidemiology?
    with Brent Mittelstadt, Justus Benzler, Lukas Engelmann, and Barbara Prainsack
    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
  •  32
    Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research
    with James Shaw, Joseph Ali, Caesar A. Atuire, Phaik Yeong Cheah, Armando Guio Español, Judy Wawira Gichoya, Adrienne Hunt, Daudi Jjingo, Katherine Littler, and Daniela Paolotti
    BMC 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
  •  31
    Genes wide open: Data sharing and the social gradient of genomic privacy
    with Tobias Haeusermann, Marta Fadda, Alessandro Blasimme, and Bastian Greshake Tzovaras
    AJOB Empirical Bioethics 1-15. forthcoming.
  •  30
    Philanthropy 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
  •  29
    Health Research with Big Data: Time for Systemic Oversight
    Journal 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
  •  28
    A Systemic Approach to the Oversight of Machine Learning Clinical Translation
    with Alessandro Blasimme
    American 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....
  •  28
    A Code of Ethics for Ethicists: What Would Pierre Bourdieu Say? “Do Not Misuse Social Capital in the Age of Consortia Ethics”
    with Vural Özdemir, Hakan Kılıç, Arif Yıldırım, Edward S. Dove, Kıvanç Güngör, Adrian LLerena, and Semra Şardaş
    American Journal of Bioethics 15 (5): 64-67. 2015.
  •  26
    Big Data, precision medicine and private insurance: A delicate balancing act
    with Ine Van Hoyweghen and Alessandro Blasimme
    Big 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
  •  24
    Direct-to-Consumer Neurotechnology: What Is It and What Is It for?
    American Journal of Bioethics Neuroscience 10 (4): 149-151. 2019.
  •  23
    How Do Molecular Systems Engineering Scientists Frame the Ethics of Their Research?
    with Renan Gonçalves Leonel da Silva, Alessandro Blasimme, and Kelly E. Ormond
    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
  •  19
    Digital bioethics: introducing new methods for the study of bioethical issues
    with Manuel Schneider and Alessandro Blasimme
    Journal 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
  •  19
    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
  •  18
    Democratizing Health Research Through Data Cooperatives
    with Alessandro Blasimme and Ernst Hafen
    Philosophy 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
  •  18
    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
  •  15
    How Interactive Visualizations Compare to Ethical Frameworks as Stand-Alone Ethics Learning Tools for Health Researchers and Professionals
    with Joanna Sleigh, Kelly Ormond, Manuel Schneider, and Elsbeth Stern
    AJOB 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
  •  15
    Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National Study
    with Brian Hutler, Alessandro Blasimme, Rachel Gur-Arie, Joseph Ali, Anne Barnhill, Amelia Hood, Jeffrey Kahn, Nancy L. Perkins, and Alan Regenberg
    Journal 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