Genome Editing and Security: Governance of Non-Traditional Research Communities?

By Katherine Paris*

In a recent webinar hosted by the U.S. National Academies of Sciences, Engineering, and Medicine, Dr. Piers Millet and Dr. Todd Kuiken explored their work on the development of safety and security practices in non-traditional research communities (i.e., communities that are outside of private or academic research institutions). The webinar expanded on discussions from the international workshop on “Assessing the Security Implications of Genome Editing Technology” held in Germany in October 2017.  At the workshop, concerns were expressed over the extent that advancements in technology allow a greater range of people to access, and possibility misuse, genome editing technologies.  Dr. Millet and Dr. Kuiken addressed these concerns during the webinar by describing what two non-traditional research communities—the International Genetically Engineered Machine (iGEM) competition and do-it-yourself biology (DIYbio) community laboratories—are doing to foster biosafety and biosecurity.

To begin, Dr. Millet, Vice President of Safety and Security at iGEM, described the system put in place at iGEM to manage and mitigate biosafety and biosecurity risks. The iGEM competition is an international synthetic biology competition in which teams of students use standard biological parts to genetically engineer organisms to address real world problems.  Last year, approximately 6,000 participants from 45 countries were part of the iGEM competition. At iGEM, everyone is responsible for safety, so teams, supervisors, and principal investigators are expected to take an active role. Resources on the iGEM Safety and Security Hub support the projects. iGEM also has its own Safety Committee to meet the needs of participants and ensure the projects are safe. Commercial partners augment the screening process and help to flag potential risks, which are resolved directly with teams or referred to the iGEM Safety Committee.  Another commercial partner screens the parts used in the competition. Overall, parts used in the competition are not dangerous; however, parts that could pose a risk if used a certain way in a certain organism are flagged. Projects that wish to use flagged parts must provide additional justification before permission is granted.

Dr. Millet used case studies of past projects conducted at iGEM to demonstrate how the biosafety and biosecurity system works in practice. In one case study, Dr. Millet explained how a 2016 team from Minnesota was close to making a gene drive. Genome editing technologies, such as CRISPR, can be used to create gene drives to drive genes through a population, which increase the odds that all offspring will inherit the modification. As a result of the project, iGEM created a definition for gene drives as well as a policy that teams cannot use gene drives unless the iGEM Safety Committee grants a special exception. In another case study, the Lethbridge 2013 team from Canada examined whether frameshifting could be used to circumvent the methods used by companies to screen for dangerous orders. Ultimately, the companies did flag the orders. The Lethbridge 2017 team, however, warned how its cell-free synthetic biology system could be misused to recode biology and circumvent screening at gene synthesis companies. The 2017 study revealed loopholes in screening that should be closed. The Lethbridge 2017 team developed software toolsto help decrease the risk of misuse.

Following the discussion of the iGEM competition, Dr. Kuiken, Senior Research Scholar at the Genetic Engineering and Society Center at North Carolina State University, addressed biosafety and biosecurity practices in the DIYbio community. Since its inception in 2008, DIYbio has grown to include over 100 community biology laboratory spaces around the globe. Over the years, the DIYbio community has dealt with inaccurate narratives communicated by the popular press. Older narratives suggest DIYbio laboratories could create doomsday pathogens, while newer narratives depict reckless individuals who self-inject their own DIY gene therapies. The desire to disprove misleading narratives along with the culture of responsibility shared among DIYbio spaces led the DIYbio community to develop its own biosafety and biosecurity practices such as its DIYbio codes of ethics.

In a discussion of self-governance versus government oversight, Dr. Kuiken conveyed the need to promote openness in non-traditional research communities while still maintaining biosafety and biosecurity.  He suggested that we use the following categories to help organize our discussion of governance strategies:

  1. Funding
  2. DIYbio/Community Labs
  3. Scientific Journals/Information Exchange
  4. Digital DNA Databases

First, access to funding has changed, and funding sources have moved beyond government agencies and private equities to crowdfunding platforms such as Kickstarter. Dr. Kuiken suggested that we consider the role of crowdfunding platforms and how to include them in the discussion of responsible research. Second, Dr. Kuiken advised us to look at the DIYbio community’s proactive approach to biosafety and biosecurity. Third, Dr. Kuiken suggested we consider the role of scientific journals and information exchange.  Additionally, he expressed the need for the press to communicate accurate information. Finally, Dr. Kuiken suggested that digital DNA databases and access to materials, such as genomic sequences, are more accessible, so we should consider who can access these sources as well as where and how they are used.

We can use the biosafety and biosecurity models put in place by iGEM and DIYbio to think about different forms of governance and whether to take a top-down or bottom-up approach. Both of these non-traditional research communities take a proactive approach to biosafety and biosecurity. The communities raise awareness of biosafety and biosecurity and provide their members ample access to resources to encourage good practices. Furthermore, iGEM and DIYbio promote a shared culture of responsibility where individuals who participate are part of the greater community.

*Katherine Paris is a Biodefense PhD Candidate at the Schar School of Government and Policy at George Mason University.  She is currently pursuing research in support of her dissertation on an assessment of the risk of misuse of genome editing technologies. 

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