Big Data and Group Harm: The Scope of IRB Review
Megan Doerr, Sara Meeder
Much of precision medicine is driven by big health data research—the analysis of massive datasets representing the complex web of genetic, behavioral, environmental, and other factors that impact human well-being. But how well does the Common Rule—the regulation governing federally funded human subjects research—fit the regulatory needs of this type of research? This article suggests that harms that may arise from artificial intelligence and machine-learning technologies used in big health data research—and the increased likelihood that this research will affect public policy—mean it is time to consider whether the current human research regulations prohibit comprehensive, ethical review of big health data research that may result in group harm.
Also in this issue:
Laura K. Sedig, E. Hill De Loney, Sarah B. Bailey, Kayte Spector-Bagdady, Bianca Ghita, Lydia Koh Krienke, Raymond Hutchinson
Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions
Julie R. Bromberg, Evelyn Nimaja, Andrew W. Kiragu, Karla A. Lawson, Lois Lee Isam, W. Nasr, Charles Pruitt, Stephanie M. Ruest, Michael J. Mello
Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic
Andrea Shin, Huiping Xu
Table of contents of the July-August 2022 Ethics & Human Research: https://onlinelibrary.wiley.com/toc/25782363/2022/44/4