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
BMC Medical Ethics 22 (1):1-13 (2021)
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Abstract |
BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee 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 these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large.
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DOI | 10.1186/s12910-021-00616-4 |
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References found in this work BETA
The Rise of Citizen Science in Health and Biomedical Research.Andrea Wiggins & John Wilbanks - 2019 - American Journal of Bioethics 19 (8):3-14.
The Ethics of Research with Human Subjects: Protecting People, Advancing Science, Promoting Trust.David B. Resnik - 2018 - Springer Verlag.
Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide.Kate Crawford & Jacob Metcalf - 2016 - Big Data and Society 3 (1).
Rethinking the Belmont Report?Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan - 2017 - American Journal of Bioethics 17 (7):15-21.
Big Data and Public-Private Partnerships in Healthcare and Research: The Application of an Ethics Framework for Big Data in Health and Research.Angela Ballantyne & Cameron Stewart - 2019 - Asian Bioethics Review 11 (3):315-326.
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Citations of this work BETA
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.
Emerging Paradigms for Ethical Review of Research Using Artificial Intelligence.James Shaw - 2022 - American Journal of Bioethics 22 (5):42-44.
A Systemic Approach to the Oversight of Machine Learning Clinical Translation.Effy Vayena & Alessandro Blasimme - 2022 - American Journal of Bioethics 22 (5):23-25.
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