Ethics review of big data research: what should stay and what should be reformed?

TY - JOUR

T1 - Ethics review of big data research: what should stay and what should be reformed?

AU - Ferretti, null

AU - Ienca, null

AU - Vayena, null

AU - Sheehan, null

AU - Blasimme, null

AU - Dove, null

AU - Farsides, null

AU - Friesen, null

AU - Kahn, null

AU - Karlen, null

AU - Kleist, null

AU - Liao, null

AU - Nebeker, null

AU - Samuel, Gabrielle

AU - Shabani, null

AU - Rivas Velarde, null

N1 - Funding Information: This article reports the ideas and the conclusions emerged during a collaborative and participatory online workshop. All authors participated in the ?Big Data Challenges for Ethics Review Committees? workshop, held online the 23-24 April 2020 and organized by the Health Ethics and Policy Lab, ETH Zurich. Funding Information: This research is supported by the Swiss National Science Foundation under award 407540_167223 (NRP 75 Big Data). MS1 is grateful for funding from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The funding bodies did not take part in designing this research and writing the manuscript. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/12

Y1 - 2021/12

N2 - Background: Ethics 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 text: In 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 (e.g., how big data projects may evade ERC review) 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. Conclusions: We 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.

AB - Background: Ethics 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 text: In 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 (e.g., how big data projects may evade ERC review) 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. Conclusions: We 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.

UR - https://www.scopus.com/pages/publications/85105408733

U2 - 10.1186/s12910-021-00616-4

DO - 10.1186/s12910-021-00616-4

M3 - Article

SN - 1472-6939

VL - 22

JO - BMC Medical Ethics

JF - BMC Medical Ethics

IS - 1

M1 - 51

ER -