Selected Instruments to Enhance Biosecurity, Mitigate Dual-Use Risks, and Promote Safe, Secure, and Ethical Research in Biology

WHO Global Guidance Framework for the Responsible Use of the Life Sciences

The World Health Organization (WHO) published its Global Guidance Framework for the Responsible Use of the Life Sciences in 2022. It is a comprehensive and practice-oriented reference document aimed at aiding states in their development of national biorisk management strategies and focusing on biosafety, laboratory biosecurity, and the oversight of dual-use research. It provides an assessment of the current situation and offers some guiding values and principles for biorisk governance as well as specific tools and mechanisms, tailored to specific types of stakeholders. In its annex, it also offers seven hypothetical scenarios in which elements from the Global Guidance Framework could be applied, and three illustrative case studies of research that required risk mitigation and management strategies. The Global Guidance Framework is intended as a supporting resource for states; its implementation is not mandatory.

Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists

The Tianjin Guidelines for Codes of Conduct for Scientists¹ were developed jointly by representatives of Tianjin University in China, the Johns Hopkins Center for Health Security in the USA, and the Interacademy Partnership (IAP). They are intended as a contribution to preventing the misuse of biological sciences, including for weapons purposes, by raising awareness of the dual-use and misuse potential of biological research. The guidelines contain principles for the responsible use of biosciences that could be incorporated in national biosecurity regulations and codes of conduct. This initiative builds on a proposal for a model voluntary code of conduct for biological scientists which was first presented in 2016 by China and Pakistan.² At the BWC Review Conference in 2022, China, Pakistan, along with Brazil as co-sponsor, submitted the Tianjin Guidelines to BWC states parties for endorsement.³ While the guidelines could not be formally endorsed by the Review Conference, they enjoyed very wide support among BWC members.

The Framework for Handling Security-Relevant Research in Germany

Governance of security-relevant research in Germany follows a bottom-up approach and emphasizes the responsibility of individual researchers and research institutions, in recognition of the basic right to the freedom of research as codified in Article 5 of the German Basic Law (constitution).⁴

Following the publication of controversial ‘gain-of-function’ experiments with a bird flu virus (H5N1) in 2012, the German Ethics Council, as well as the German Research Council (Deutsche Forschungsgemeinschaft, DFG) and the National Academy of Sciences Leopoldina developed recommendations on the handling of dual-use research in the life sciences. The two documents emphasized the freedom of research and the need to raise awareness among scientists of potential dual-use risks associated with their work. Whereas the Ethics Council⁵ also suggested a top-down regulatory approach, which was not implemented, the DFG and Leopoldina⁶ focused on the self-governance of science and the responsibility of individual researchers and research institutions in the handling of security-relevant research.

The latter approach is being actively promoted by the DFG and Leopoldina. Among other things, it encourages research institutions to establish local Committees for Ethics in Security-Relevant Research (Kommissionen für Ethik sicherheitsrelevanter Forschung, KEF) to provide guidance and advice to researchers who have identified potential security risks in their research. Through the Joint Committee on the Handling of Security-Relevant Research, established in 2014 to support the implementation of their recommendations, the DFG and Leopoldina also undertake outreach and awareness-raising efforts⁷ in Germany’s scientific community.