ABSTRACT
Background: In recent years, biomedicine has witnessed rapid advancements in applying synthetic biology. While these advancements have brought numerous benefits to patients, they have also given rise to a series of safety concerns. Methods: This article provides a succinct overview of the current research on synthetic biology's application in biomedicine and systematically analyzes the safety risks associated with this field. Based on this analysis, the article proposes fundamental principles for addressing these issues and presents practical recommendations for ethical governance. Results: This article contends that the primary safety risks associated with the application of synthetic biology in biomedicine include participant safety, biosafety risks, and biosecurity risks. In order to effectively address these risks, it is essential to adhere to the principles of human-centeredness, non-maleficence, sustainability, and reasonable risk control. Guided by these fundamental principles and taking into account China's specific circumstances, this article presents practical recommendations for ethical governance, which include strengthening ethical review, promoting the development and implementation of relevant policies, improving legal safeguards through top-level design, and enhancing technical capabilities for biocontainment. Conclusion: As an emerging field of scientific technology, synthetic biology presents numerous safety risks and challenges in its application within biomedicine. In order to address these risks and challenges, it is imperative that appropriate measures be implemented. From a Chinese perspective, the solutions we propose serve not only to advance the domestic development of synthetic biology but also to contribute to its global progress.
ABSTRACT
Synthetic biology (SynBio) is a high-profile interdiscipline combining engineering with science. As a dual-purpose discipline, SynBio is bringing large changes to many fields and providing great benefits to humans. However, due to its characteristic of complexity and uncertainty, SynBio also presents potential biosafety and biosecurity risks. Biosecurity risks refer to unauthorized access, loss, theft, misuse, diversion or intentional release. If a biosecurity accident happens, it would pose a huge threat to humans and nature. Therefore, it is crucial to establish a set of regulations and management practices for the biosecurity risks of SynBio. In this paper, we summarized the sources of the biosecurity risks of SynBio, from its research materials, products, technologies, information to Do-it-yourself synthetic biology. We reviewed and analyzed the current situation of regulation and management of biosecurity for SynBio in the international community and in China. We found that in most countries and regions, SynBio risks commonly follow the regulation and management of Genetically Modified Organisms which has loopholes if applied to the regulation for SynBio without any amendments. Here, we proposed suggestions for the Chinese-featured regulation and management of biosecurity for SynBio, including a top-to-bottom governing framework, a think-tank implementation mechanism, a Synthetic Biology Laboratory Biosecurity Manual safeguarding system, and strengthening biosecurity education on synthetic biology and self-regulation awareness among relevant personnel. Through this work, we aim to improve the standardized process of biosecurity regulation and management for SynBio in China and thereby map out a peaceful, profitable, and practical development path for synthetic biology.
