26 found
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  1.  62
    Ethics review of big data research: What should stay and what should be reformed?Effy Vayena, 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 & Agata Ferretti - 2021 - BMC Medical Ethics 22 (1):1-13.
    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 oversight. Second, we map (...)
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  2.  34
    Health Research with Big Data: Time for Systemic Oversight.Effy Vayena & Alessandro Blasimme - 2018 - Journal of Law, Medicine and Ethics 46 (1):119-129.
    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 have the desired impact unless oversight activities by different stakeholders (...)
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  3.  94
    Biomedical Big Data: New Models of Control Over Access, Use and Governance.Alessandro Blasimme & Effy Vayena - 2017 - Journal of Bioethical Inquiry 14 (4):501-513.
    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. Such conditions can be openly stated (...)
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  4.  25
    Digital bioethics: introducing new methods for the study of bioethical issues.Manuel Schneider, Effy Vayena & Alessandro Blasimme - 2023 - Journal of Medical Ethics 49 (11):783-790.
    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 integration of such digital methods to (...)
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  5. Wearable Technologies for Healthy Ageing: Prospects, Challenges, and Ethical Considerations.Stefano Canali, Agara Ferretti, Viola Schiaffonati & Alessandro Blasimme - 2024 - Journal of Frailty and Aging 2024:1-8.
    Digital technologies hold promise to modernize healthcare. Such opportunity should be leveraged also to address the needs of rapidly ageing populations. Against this backdrop, this paper examines the use of wearable devices for promoting healthy ageing. Previous work has assessed the prospects of digital technologies for health promotion and disease prevention in older adults. However, to our knowledge, ours is one of the first attempts to specifically address the use of wearables for healthy ageing, and to offer ethical insights for (...)
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  6.  76
    Becoming partners, retaining autonomy: ethical considerations on the development of precision medicine.Alessandro Blasimme & Effy Vayena - 2016 - BMC Medical Ethics 17 (1):67.
    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, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to (...)
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  7.  17
    The plasticity of ageing and the rediscovery of ground-state prevention.Alessandro Blasimme - 2021 - History and Philosophy of the Life Sciences 43 (2):1-18.
    In this paper, I present an emerging explanatory framework about ageing and care. In particular, I focus on how, in contrast to most classical accounts of ageing, biomedicine today construes the ageing process as a modifiable trajectory. This framing turns ageing from a stage of inexorable decline into the focus of preventive strategies, harnessing the functional plasticity of the ageing organism. I illustrate this shift by focusing on studies of the demographic dynamics in human population, observations of ageing as an (...)
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  8.  22
    Democratizing Health Research Through Data Cooperatives.Alessandro Blasimme, Effy Vayena & Ernst Hafen - 2018 - Philosophy and Technology 31 (3):473-479.
    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 personal data, as well as more democratic (...)
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  9.  30
    A Systemic Approach to the Oversight of Machine Learning Clinical Translation.Effy Vayena & Alessandro Blasimme - 2022 - American Journal of Bioethics 22 (5):23-25.
    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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  10.  31
    Humanised models of cancer in molecular medicine: the experimental control of disanalogy.Paolo Maugeri & Alessandro Blasimme - 2011 - History and Philosophy of the Life Sciences 33 (4).
    This paper explores the epistemology of extrapolation from model organisms to humans in molecular medicine. We take into account two common views on the issue, the homology view and the disanalogy view. In response to both interpretations, we argue that the foundational basis of extrapolations cannot simply be provided by homology and that relevant disanalogies can, thanks to the techniques of molecular biology, be experimentally controlled and exploited to allow useful and reliable extrapolations. The case of "humanised mice" in the (...)
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  11.  33
    Big Data, precision medicine and private insurance: A delicate balancing act.Ine Van Hoyweghen, Effy Vayena & Alessandro Blasimme - 2019 - Big Data and Society 6 (1).
    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 access to such rapidly accumulating biomedical Big Data or to (...)
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  12.  28
    Genomic Incidental Findings: Reducing the Burden to Be Fair.Velizara Anastasova, Alessandro Blasimme, Sophie Julia & Anne Cambon-Thomsen - 2013 - American Journal of Bioethics 13 (2):52-54.
  13.  39
    Genes wide open: Data sharing and the social gradient of genomic privacy.Tobias Haeusermann, Marta Fadda, Alessandro Blasimme, Bastian Greshake Tzovaras & Effy Vayena - forthcoming - AJOB Empirical Bioethics:1-15.
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  14.  28
    Rethinking ageing: introduction.Alessandro Blasimme, Giovanni Boniolo & Marco J. Nathan - 2021 - History and Philosophy of the Life Sciences 43 (3):1-8.
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  15. Towards adaptive governance in big data health research : implementing regulatory principles.Effy Vayena & Alessandro Blasimme - 2021 - In Graeme T. Laurie (ed.), The Cambridge handbook of health research regulation. New York, NY: Cambridge University Press.
     
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  16.  50
    What mechanisms can’t do: Explanatory frameworks and the function of the p53 gene in molecular oncology.Alessandro Blasimme, Paolo Maugeri & Pierre-Luc Germain - 2013 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 44 (3):374-384.
    What has been called the new mechanistic philosophy conceives of mechanisms as the main providers of biological explanation. We draw on the characterization of the p53 gene in molecular oncology, to show that explaining a biological phenomenon implies instead a dynamic interaction between the mechanistic level—rendered at the appropriate degree of ontological resolution—and far more general explanatory tools that perform a fundamental epistemic role in the provision of biological explanations. We call such tools “explanatory frameworks”. They are called frameworks to (...)
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  17.  39
    Disclosing Results to Genomic Research Participants: Differences That Matter.Alessandro Blasimme, Alexandra Soulier, Sophie Julia, Samantha Leonard & Anne Cambon-Thomsen - 2012 - American Journal of Bioethics 12 (10):20-22.
    The American Journal of Bioethics, Volume 12, Issue 10, Page 20-22, October 2012.
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  18.  50
    “Tailored-to-You”: Public Engagement and the Political Legitimation of Precision Medicine.Alessandro Blasimme & Effy Vayena - 2016 - Perspectives in Biology and Medicine 59 (2):172-188.
    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 understanding of the biological (...)
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  19.  45
    Informed Consent and the Disclosure of Clinical Results to Research Participants.Effy Vayena, Samia A. Hurst, Celine Moret & Alessandro Blasimme - 2017 - American Journal of Bioethics 17 (7):58-60.
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  20.  28
    How Do Molecular Systems Engineering Scientists Frame the Ethics of Their Research?Renan Gonçalves Leonel da Silva, Alessandro Blasimme, Effy Vayena & Kelly E. Ormond - 2024 - AJOB Empirical Bioethics 15 (3):226-235.
    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 participants view ethics as related to (...)
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  21.  36
    Reprogramming Potentiality: The Co-Production of Stem Cell Policy and Democracy.Alessandro Blasimme, Bettina Schmietow & Giuseppe Testa - 2013 - American Journal of Bioethics 13 (1):30-32.
  22.  26
    Accelerated drug approval: Meeting the ethical yardstick.Mattia Andreoletti & Alessandro Blasimme - 2023 - Bioethics 37 (7):647-655.
    Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and efficacy of (...)
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  23. Intentionality and the welfare of minded non-humans.Alessandro Blasimme & Lisa Bortolotti - 2010 - Teorema: International Journal of Philosophy 29 (2):83-96.
     
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  24.  19
    Talking Ethics Early in Health Data Public Private Partnerships.Constantin Landers, Kelly E. Ormond, Alessandro Blasimme, Caroline Brall & Effy Vayena - 2023 - Journal of Business Ethics 190 (3):649-659.
    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 (...)
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  25.  19
    Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National Study.Brian Hutler, Alessandro Blasimme, Rachel Gur-Arie, Joseph Ali, Anne Barnhill, Amelia Hood, Jeffrey Kahn, Nancy L. Perkins, Alan Regenberg & Effy Vayena - 2022 - Journal of Law, Medicine and Ethics 50 (4):791-804.
    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 governance surveillance. The ethical and effective use of (...)
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  26.  49
    Genome Editing and Dialogic Responsibility: “What's in a Name?”.Alessandro Blasimme, Ignacio Anegon, Jean-Paul Concordet, John De Vos, Anne Dubart-Kupperschmitt, Marc Fellous, Pierre Fouchet, Nelly Frydman, Carine Giovannangeli, Pierre Jouannet, Jean-Loius Serre, Julie Steffann, Emmanuelle Rial-Sebbag, Mogens Thomsen & Anne Cambon-Thomsen - 2015 - American Journal of Bioethics 15 (12):54-57.
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