Protecting human research participants in the age of big data.

Facebook’s experimental manipulation of newsfeed content and the subsequent PNAS publication of significant findings from it (1) have drawn attention to the regulation of human participation in academic research and to the differences between commercial and academic research. Those events were recognized in an Expression of Concern in PNAS (2). In commerce and on the Internet, experimentation is ubiquitous and invisible, and there are no protections for human participants beyond typically unread use agreements. In contrast, academic research is almost always governed by the provisions of the “Common Rule,” the US Department of Health and Human Services’ Code of Federal Regulations Title 45 Part 46 (45CFR46), “common” because it has been adopted by numerous federal agencies and applied to many research institutions. One might well wonder why academic research is more subject to ethical review than that of business enterprises. Unregulated (Facebook) and regulated (Cornell University) activities were combined in the PNAS publication (1), the former by experimenting with large numbers of unwitting participants, the latter by approving the use of preexisting experimental data as exempt from the university’s ethical review.