iGEM and Gene Drives: A Case Study for Governance

Abstract

Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition's experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM's experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for widescale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.

Manipulating the Destiny of Wild Populations Using CRISPR

“…To this end, keystone leaders in the field have coauthored guidelines for the safe development of gene drives (1,4), focusing on ensuring safe practices for their study in laboratory settings with minimal risk of release into the environment. As this field advances and discussions of future field trials of these technologies take place, developers and other stakeholders are continuing to set forth self-governance and recommendations for the safe and ethical development of these technologies (71,82,111,118,132,146,160,223). These efforts have expanded to include standardizing the definition of gene drive (7) and core commitments with developers, social scientists, and other stakeholder signatories to outline the minimum requirements for fair partnership and transparency, product efficacy and safety, regulatory evaluation, risk-benefit assessment, and monitoring and mitigation (146).…”

Beyond Biosecurity by Taxonomic Lists: Lessons, Challenges, and Opportunities

“…These functional definitions have been reviewed and revised considering practical experience in their implementation. 57 …”

Bottlenecks and opportunities for synthetic biology biosafety standards

“…The international Genetically Engineered Machine (iGEM) competition, for example, uses a registry of standard biological parts that follow the BioBricks assembly standard 36 . iGEM can been seen as a testbed for standardization in synthetic biology 37 , biosafety 10 , 38 , and risk management 39 .…”