BMC Medical Ethics 22 (1):1-13 (2021)

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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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Rethinking the Belmont Report?Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan - 2017 - American Journal of Bioethics 17 (7):15-21.

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