Research Revolution or Status Quo?: The New Common Rule and Research Arising From Direct-to-Consumer Genetic Testing

Abstract

The confluence of the 2017 revisions to the Common Rule and the evolving research model utilizing biospecimens and personal information collected by direct-to-consumer genetic testing companies necessitates a deeper consideration of the present ethical, legal, and regulatory issues that arise from personal genomic research. This article addresses the question of whether the revised Common Rule appropriately protects individuals who use direct-to-consumer genetic testing services and whose information and biospecimens are used in future research protocols. It concludes that despite extended efforts to revise the Common Rule to address the use of biospecimens in human subjects research, there is little in the revised Rule to direct or guide direct-to-consumer genetic testing companies to ensure a more robust informed consent process for the use of customers' biospecimens and data.