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  1. 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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  • 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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  • Co-design and ethical artificial intelligence for health: An agenda for critical research and practice.Joseph Donia & James A. Shaw - 2021 - Big Data and Society 8 (2).
    Applications of artificial intelligence/machine learning in health care are dynamic and rapidly growing. One strategy for anticipating and addressing ethical challenges related to AI/ml for health care is patient and public involvement in the design of those technologies – often referred to as ‘co-design’. Co-design has a diverse intellectual and practical history, however, and has been conceptualized in many different ways. Moreover, AI/ml introduces challenges to co-design that are often underappreciated. Informed by perspectives from critical data studies and critical digital (...)
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  • A Research Ethics Framework for the Clinical Translation of Healthcare Machine Learning.Melissa D. McCradden, James A. Anderson, Elizabeth A. Stephenson, Erik Drysdale, Lauren Erdman, Anna Goldenberg & Randi Zlotnik Shaul - 2022 - American Journal of Bioethics 22 (5):8-22.
    The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...
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  • Brain disorders? Not really: Why network structures block reductionism in psychopathology research.Denny Borsboom, Angélique O. J. Cramer & Annemarie Kalis - 2019 - Behavioral and Brain Sciences 42:e2.
    In the past decades, reductionism has dominated both research directions and funding policies in clinical psychology and psychiatry. The intense search for the biological basis of mental disorders, however, has not resulted in conclusive reductionist explanations of psychopathology. Recently, network models have been proposed as an alternative framework for the analysis of mental disorders, in which mental disorders arise from the causal interplay between symptoms. In this target article, we show that this conceptualization can help explain why reductionist approaches in (...)
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  • 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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