Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs

Ethics & Human Research
Volume 42, Issue 5 Pages: 1-40 September–October 2020


Participants with autism • Big data and pragmatic trials • Covid‐19 research
Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs
Agata Ferretti, Marcello Ienca, Samia Hurst, Effy Vayena
Pages: 17-28
First Published: 16 September 2020
The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft‐law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.