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

41 Pages Posted: 11 Mar 2018 Last revised: 5 Oct 2018

Valerie Gutmann Koch

University of Chicago - MacLean Center for Clinical Medical Ethics; DePaul University - College of Law

Kelly Todd

Duke University School of Law; Duke University - Duke Initiative for Science & Society

Date Written: March 1, 2018

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.

Keywords: Common Rule, Human Subjects Research, Genetics, Administrative Law

Suggested Citation

Gutmann Koch, Valerie and Todd, Kelly, Research Revolution or Status Quo?: The New Common Rule and Research Arising From Direct-to-Consumer Genetic Testing (March 1, 2018). 56(1) HOUSTON LAW REVIEW 81 (2018) . Available at SSRN: https://ssrn.com/abstract=3132849 or http://dx.doi.org/10.2139/ssrn.3132849

Valerie Gutmann Koch (Contact Author)

University of Chicago - MacLean Center for Clinical Medical Ethics ( email )

5841 S Maryland Ave
Chicago, IL 60637-1470
United States

DePaul University - College of Law ( email )

25 E. Jackson Blvd.
Chicago, IL Cook County 60604-2287
United States

Kelly Todd

Duke University School of Law ( email )

Durham, NC
United States

Duke University - Duke Initiative for Science & Society ( email )

Erwin Mill, Bay A, #201-205
2024 W. Main Street
Durham, NC 27705
United States

Register to save articles to
your library

Register

Paper statistics

Downloads
56
rank
344,671
Abstract Views
193
PlumX