Biosecurity Research at Section Political Science of the Department of Cultural and Social Sciences, University of Osnabrueck, Osnabrueck, Germany.
Adv Appl Microbiol. 2022;120:79-111. doi: 10.1016/bs.aambs.2022.06.002. Epub 2022 Jul 13.
The term Gain-of-Function (GoF) describes the gain of new functions by organisms through genetic changes, which can naturally occur or by experimental genetic modifications. Gain-of-Function research on viruses is enhancing transmissibility, virus replication, virulence, host range, immune evasion or drug and vaccine resistance to get insights into the viral mechanisms, to create and analyze animal models, to accelerate drug and vaccine development and to improve pandemic preparedness. A subset is the GoF research of concern (GOFROC) on enhanced potentially pandemic pathogens (ePPPs) that could be harmful for humans. A related issue is the military use of research as dual-use research of concern (DURC). Influenza and coronaviruses are main research targets, because they cause pandemics by airborne infections. Two studies on avian influenza viruses initiated a global debate and a temporary GoF pause in the United States which ended with a new regulatory framework in 2017. In the European Union and China, GoF and DURC are mainly covered by the legislation for laboratory safety and genetically modified organisms. After the coronavirus outbreaks, the GoF research made significant advances, including analyses of modified MERS-like and SARS-like viruses and the creation of synthetic SARS-CoV-2 viruses as a platform to generate mutations. The GoF research on viruses will still play an important role in future, but the need to clarify the differences and overlaps between GoF research, GOFROC and DURC and the need for specialized oversight authorities are still debated.
功能获得（Gain-of-Function，GoF）描述了生物体通过遗传变化获得新功能的过程，这种变化可以自然发生，也可以通过实验遗传修饰来实现。对病毒的功能获得研究旨在提高病毒的传染性、复制能力、毒力、宿主范围、免疫逃避能力或对药物和疫苗的耐药性，以深入了解病毒的机制、创建和分析动物模型、加速药物和疫苗的开发，并提高大流行的准备水平。其中一个子集是对增强型潜在大流行病原体（Enhanced Potentially Pandemic Pathogens，ePPPs）的功能获得研究关切（Gain-of-Function of Concern，GOFROC），这些病原体可能对人类造成危害。一个相关的问题是研究的军事用途，即双重用途研究关切（Dual-Use Research of Concern，DURC）。流感病毒和冠状病毒是主要的研究目标，因为它们通过空气传播感染引起大流行。两项关于禽流感病毒的研究引发了全球辩论，并在美国暂时暂停了功能获得研究，最终在 2017 年制定了新的监管框架。在欧盟和中国，功能获得和双重用途研究主要由实验室安全和转基因生物立法涵盖。在冠状病毒爆发后，功能获得研究取得了重大进展，包括对改良的类 MERS 和类 SARS 病毒的分析，以及创建合成的 SARS-CoV-2 病毒作为产生突变的平台。在未来，病毒的功能获得研究仍将发挥重要作用，但仍需要澄清功能获得研究、GOFROC 和 DURC 之间的差异和重叠，以及是否需要专门的监督机构，这些问题仍在争论中。
