Giordano James, DiEuliis Diane
Center for Disruptive Technologies and Future Warfare, Institute of National Strategic Studies, National Defense University, Washington, DC, USA.
Center for the Study of Weapons of Mass Destruction, Institute of National Strategic Studies, National Defense University, Washington, DC, USA.
mSphere. 2025 Jun 25;10(6):e0028925. doi: 10.1128/msphere.00289-25. Epub 2025 Jun 4.
The current U.S. administration has recently proposed a pause on all domestic gain-of-function (GoF) research in order to fully revise existing policy. However, domestic controls on GoF research cannot mandate that other nations follow suit and thus do not prohibit non-compliant nations from engaging in such work. In fact, such national constraints may facilitate opportunities for competitor and adversarial nations (and non-state actors) to advance efforts in this space toward nefarious applications. Moreover, certain groups may argue that GoF research may be necessary for advancing biomedical science (A. Casadevall, F. C. Fang, and M. J. Imperiale, mSphere 9:e00714-23, 2024, https://doi.org/10.1128/msphere.00714-23) and global health security and, through this stance, conduct GoF research that has direct dual-use viability. In this light, we argue that all GoF research should be conducted under a robust framework of enhanced BSL controls that explicitly define its dual usability, classify any such enterprise as DURC, engage regulatory oversight, and establish ethical responsibility within the scope and tenor of international law. This essay describes the possible burdens and risks of GoF research, and in addressing the challenges posed by such work, proposes recommendations for future policy toward sustaining beneficial outcomes and preventing or mitigating threats to public health and global biosecurity.
美国现政府最近提议暂停所有国内的功能获得性（GoF）研究，以便全面修订现有政策。然而，对GoF研究的国内管控无法强制其他国家效仿，因此无法禁止不遵守规定的国家开展此类工作。事实上，这种国家层面的限制可能会为竞争对手和敌对国家（以及非国家行为体）提供机会，促使它们在这一领域朝着恶意应用的方向推进相关工作。此外，某些团体可能会辩称，GoF研究对于推动生物医学科学（A. 卡萨德瓦尔、F. C. 方和M. J. 因佩里亚莱，《mSphere》9：e00714 - 23，2024，https://doi.org/10.1128/msphere.00714 - 23）以及全球卫生安全而言可能是必要的，并通过这一立场开展具有直接两用可行性的GoF研究。有鉴于此，我们认为所有GoF研究都应在强化生物安全水平（BSL）管控的强大框架下进行，该框架应明确界定其两用性，将任何此类活动归类为两用研究关注对象（DURC），进行监管监督，并在国际法的范围和主旨内确立道德责任。本文描述了GoF研究可能带来的负担和风险，并在应对此类工作带来的挑战时，就未来政策提出建议，以维持有益成果并预防或减轻对公众健康和全球生物安全的威胁。
