iGEM and Gene Drives: A Case Study for Governance.

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.

Implementing adaptive risk management for synthetic biology: Lessons from iGEM's safety and security programme.

Synthetic biology offers exciting possibilities to deal with local and global challenges over the coming decades. As we make greater use of biological engineering, it will be increasingly important to balance potential risks and benefits. The rate, scale, and diffusion of relevant capabilities will make this challenging. There will be a growing need for flexible risk management approaches, which can be rapidly adapted as technology and societal needs change. This study details efforts by the International Genetically Engineered Machine (iGEM) competition in creating and implementing an adaptive risk management approach. It concludes with key lessons and challenges: working with hazardous materials, such as dangerous pathogens, toxins and chemicals; managing risks to plants, animals and the environment; use of samples from people, animals, and the environment; improving the hazards identified; variations in risk perception and tolerance; variation in terminology that complicates interpretation of risk management plans; and connections with broader societal or ethical questions, such as animal use, gender and sexuality, or benefit sharing.