DIY CRISPR

60 Pages Posted: 8 May 2019

See all articles by Christi J. Guerrini

Christi J. Guerrini

Baylor College of Medicine; University of Houston Law Center Intellectual Property and Information Law Institute

Evan Spencer

University of Houston Law Center

Patricia J. Zettler

Ohio State University (OSU) - Michael E. Moritz College of Law

Date Written: April 4, 2019

Abstract

Although scientists have been manipulating genomes since the 1970s, the recent discovery of Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”) has expanded the possibilities not only for what gene editing might accomplish, but also who might accomplish it. Because CRISPR is relatively easy, efficient, and inexpensive, it is accessible to individuals — known as “citizen scientists” — who work in nontraditional laboratory settings and may not have formal scientific training. Prompted by concerns about human applications of CRISPR, the United States is co-hosting a series of international summits on human gene editing, while organizations around the world race to issue their own reports and recommendations. For the most part, however, these efforts have focused on the use of CRISPR by professional scientists working in institutional settings who are already subject to layers of formal and informal oversight. They have largely overlooked the do-it-yourself (“DIY”) use of CRISPR by citizen scientists — even as instances of self-experimentation with CRISPR are being reported and raising unique concerns.

Drawing on qualitative interviews with almost forty citizen scientists and their supporters, critics, and observers, this Article provides a critical analysis of the practice and governance of DIY CRISPR in the United States. It concludes that existing laws and regulations potentially reach a number of DIY CRISPR activities, although their application to citizen science contexts is thus far untested. Meanwhile, DIY communities have developed mechanisms of self-regulation that appear to be working reasonably well thus far in discouraging potentially dangerous human applications of CRISPR by citizen scientists. However, we are concerned about the possibility that, as lay understanding of and proficiency with the technology increases, there will be an uptick in risky (if not illegal) human experimentation in the future. We therefore conclude with suggestions for shoring up the oversight readiness and capacities of regulatory bodies and DIY communities.

Keywords: CRISPR, Common Rule, FDA, DIY biology, biohacking, citizen science, gene editing, NIH Guidelines, self-regulation

Suggested Citation

Guerrini, Christi J. and Spencer, Evan and Zettler, Patricia J., DIY CRISPR (April 4, 2019). North Carolina Law Review, 2019. Available at SSRN: https://ssrn.com/abstract=3365421

Christi J. Guerrini (Contact Author)

Baylor College of Medicine ( email )

One Baylor Plaza
Apt 510
Houston, TX TX - Texas 77057
United States

HOME PAGE: http://https://www.bcm.edu/people/view/christi-guerrini-j-d/b1e79844-9aa9-11e4-907f-005056b104be

University of Houston Law Center Intellectual Property and Information Law Institute ( email )

4604 Calhoun Road
Houston, TX 77204-6060
United States

Evan Spencer

University of Houston Law Center

4604 Calhoun Road
Houston, TX 77204-6060
United States

Patricia J. Zettler

Ohio State University (OSU) - Michael E. Moritz College of Law ( email )

55 West 12th Avenue
Columbus, OH 43210
United States

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