Protections for Human Subjects in Research: Old Models, New Needs?

Abstract

Research within the United States that involves collecting and analyzing certain types of data from individual people has been subject to regulation since 1974. The rules governing research with so-called “human subjects” emerged out of specific research practices in the biomedical and social sciences within the government, as well as in response to revelations of egregious abuses of participants. Among other provisions, the federal regulations require prior review of certain proposed research projects by an institutional review board, or IRB. Many of the features of the federal regulations, including requirements for securing “informed consent” from research participants, focus on protections at the point of data collection. More recent research projects in computing and the data sciences, which rely upon large volumes of human-sourced data and information, have often collected their data via third-party platforms rather than via direct interaction with individual human subjects. As a result, such projects have rarely been subject to formal IRB review. Given the potential for harm to individuals and groups that have been identified for some computing projects, such as racial discrimination and loss of privacy, is it time to revisit or expand the existing human-subjects regulations?