Objectives To construct a risk management tool for Dual-Use Research of Concern (DURC) in biotechnology that is applicable to China's context, aiming to fill the gap in refined regulatory tools of dual use biotechnology biosafety risk and promote the transformation of the regulatory paradigm from reactive response to proactive prevention.

Methods Through a systematic review of relevant domestic and international policies, regulations, and literature, a decision tree model for identifying DURC in biotechnology was developed based on the “Capability-Intent-Consequences” framework. Integrating the ISO 31000 risk management framework with systems science and Responsible Research and Innovation theory, a risk assessment indicator system comprising multi-level indicators was established. Subsequently, a standardized review mechanism encompassing project leader self-assessment and institutional review was designed.

Results An integrated risk management tool, combining “rapid screening (decision tree), precise assessment (indicator system), standardized process (review mechanism)” was developed. The decision tree can clearly determine whether a research qualifies as DURC in biotechnology. The risk assessment system, comprising 6 first-level indicators and 30 second-level indicators, categorizes DURC in biotechnology into three risk levels: low (0-10 points), medium (11-20 points), and high (21-30 points). The review mechanism specifies the specific requirements for all responsible parties. Validation through typical cases, such as H5N1 gain-of-function research, poliovirus synthesis and production of human insulin by engineered Escherichia coli demonstrated that the system possesses good sensitivity, discrimination, and specificity.

Conclusion The risk management tool system of DURC in biotechnology constructed in this study offers both theoretical basis and practical value, providing scientific decision support for the regulatory review of dual use biotechnology biosafety risk in China and contributing to the enhancement of governance capabilities.