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

Agata Ferretti, Marcello Ienca, Mark Sheehan, Alessandro Blasimme, Edward S. Dove, Bobbie Farsides, Phoebe Friesen, Jeff Kahn, Walter Karlen, Peter Kleist, S. Matthew Liao, Camille Nebeker, Gabrielle Samuel, Mahsa Shabani, Minerva Rivas Velarde, Effy Vayena

Research output: Contribution to journalArticlepeer-review

Abstract

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.
Original languageEnglish
Article number51
Number of pages13
JournalBMC Medical Ethics
Volume22
Issue number1
DOIs
Publication statusPublished - 30 Apr 2021

Keywords

  • big data
  • research ethics
  • ethics
  • IRBs
  • RECs
  • ethics review
  • biomedical research

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