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

Agata Ferretti; Marcello Ienca; Samia Hurst; Effy Vayena

doi:10.1002/eahr.500065

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

Ethics Hum Res. 2020 Sep;42(5):17-28. doi: 10.1002/eahr.500065.

Authors

Agata Ferretti¹, Marcello Ienca², Samia Hurst³, Effy Vayena⁴

Affiliations

¹ PhD candidate in Bioethics at the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.
² Senior researcher at the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.
³ Professor of medical ethics and director of the Institute for Ethics, History, and the Humanities & Department of Community Health and Medicine, University of Geneva, Switzerland.
⁴ Professor of bioethics and director of the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.

Abstract

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.

Keywords: big data; big data research; biomedical research; institutional review board (IRB); research ethics.

MeSH terms

Big Data*
Biomedical Research / ethics*
Ethical Review*
Ethics Committees, Research*
Humans