Regulating genetic biohacking

Just as the popularization of computers in the late 1970s and early 1980s gave rise to computer hacking, the recent accessibility and affordability of relatively easy (and widely hyped) genome-editing technologies and resources has spurred interest in genetic “biohacking”—molecular genetics experiments performed outside institutional laboratories by individuals who may have little formal scientific training.

Regulation of the work of professional scientists and traditional scientific institutions is robust—although it still faces scrutiny in the wake of He Jiankui’s genome-editing experiments on Chinese twins. However, regulation of genetic biohacking has received far less attention, even though, like traditional scientific research, it is likely to produce a range of innovations while posing a number of risks to public health.

In this paper, we explore these risks and the consequences of understanding that some instances of regulatory failure for biohacking are inevitable. And, where they are not, we suggest that agencies, policy makers, and private parties have the opportunity to improve oversight of genetic biohacking using the tools they currently possess.

Please cite this paper as: Patricia J. Zettler, Christi J. Guerrini, Jacob S. Sherkow. Regulating Genetic Biohacking, 365 SCIENCE 34 (2019).

DIY CRISPR

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 citizen scientists who work in nontraditional laboratory settings and may not have formal scientific training. Prompted by concerns about human applications of CRISPR, organizations around the world are racing to issue 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 DIY use of CRISPR by citizen scientists—even as instances of self-experimentation with CRISPR are being reported and raising unique concerns.

This paper 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 make suggestions for shoring up the oversight readiness and capacities of regulatory bodies and DIY communities.

Please cite this paper as: Christi J. Guerrini, G. Evan Spencer, Patricia J. Zettler. DIY CRISPR, 97 N.C. LAW REV. 1399 (2019).

Citizen science, public policy

As a result of the enhanced role of the public in citizen science initiatives, citizen science demonstrates more diversity and flexibility than traditional science and can encompass efforts that have no institutional affiliations and are funded entirely by participants. As citizen science continues to surge in popularity and engage divergent interests, vulnerable populations, and sensitive data, it is important to consider whether public policies should be adjusted to complement or improve on voluntary efforts of citizen scientists to address issues in three domains: intellectual property (IP), scientific integrity, and participant protections.

Please cite this paper as: Christi J. Guerrini, Mary A. Majumder, Meaganne J. Lewellyn, Amy L. McGuire. Citizen Science, Public Policy, 361 SCIENCE 134 (2018).