Synthetic biology seeks to design and construct biological systems for a growing range of applications. These developments raise questions about the meaning and value of life, the responsibilities of researchers and innovators, the assessment of biosafety and biosecurity risks, and the adequacy of existing regulatory frameworks. This edited volume examines these questions from ethical, legal, and policy perspectives.

Organized into three parts—ethical debates, risk analysis, and governance countermeasures—the book considers whether synthetic biology constitutes a paradigm shift and examines organismic metaphors, “playing God,” biocentrism, and responsibility in DNA synthesis. It also analyzes biosafety, biosecurity, ethics dumping, and international regulation, with discussions of synthetic viruses, synthetic biofuels, mirror life, gene editing, and other emerging applications.

The final part examines approaches to the responsible governance of synthetic biology, with particular attention to solidarity, precaution, public and stakeholder participation, and ongoing benefit–risk assessment. It considers how regulatory institutions can respond to scientific uncertainty, dual-use concerns, and technological change at both national and international levels. The volume will be of interest to researchers and students in bioethics, philosophy of technology, science and technology studies, law, and public policy, as well as policymakers and professionals involved in the governance of emerging biotechnologies.

Ruipeng Lei is Professor, Vice Dean of the Advanced Institute of Humanities and Social Sciences, and Director of the Center for Ethics and Governance of Science and Technology at the University of Electronic Science and Technology of China (UESTC). She co-founded the Research Center for Bioethics at Huazhong University of Science and Technology in Wuhan in 2002 and served as its Executive Director until 2022. Her research focuses on the ethical and governance challenges posed by emerging technologies, including synthetic biology, xenotransplantation, human genome editing, neurotechnology, artificial intelligence, and robotics. She has published more than 100 research articles, reviews, and commentaries and has authored or edited ten books in Chinese and English. In 2019, she was the first author of the Nature commentary ‘Reboot Ethics Governance in China.’ She completed a National Key R&D project (2019-2024) and currently leads two national key projects as principal investigator on synthetic biology, biobanks, and biomedical and health data. Her international service includes work with The Hastings Center, the WHO Ethics and COVID-19 Working Group, and the UNESCO Working Group on the Draft Recommendation on the Ethics of Neurotechnologies.