Comparison of International Guidance for Biosafety Regarding Work Conducted at Biosafety Level 3 (BSL-3) and Gain-of-Function (GOF) Experiments.

In December 2014, the National Academies of Sciences convened the first of 2 meetings to discuss the potential risks and benefits of so-called gain-of-function (GOF) research, which was defined by the National Scientific Advisory Board for Biosecurity as research toward increasing the transmissibility, pathogenicity, or ability to evade countermeasures of pathogens with pandemic potential. The symposium was part of a deliberative process undertaken by the United States (US) government to inform in developing guidelines for the safe conduct of GOF research. Participants discussed scientific, technical, and ethical aspects regarding the conduct of research, biosafety measures in the US, and, to a minimal degree, biosafety in other countries. The dearth of information available regarding codified international biosafety requirements and norms, as well as the stringency and verification of their implementation, is particularly troubling as many countries conduct or plan to conduct GOF research. This analysis was conducted to inform policy makers, scientists, and biosafety professionals on a global scale of strengths and potential safety weaknesses by comparing publicly available regulations, laws, guidelines, and published articles describing biosafety processes and measures in other developed countries that may conduct GOF research compared to measures in place in the US. As GOF research has the potential to cause pandemic illness, the findings in this review can be applied to address potential safety gaps by countries with established biosafety capabilities and can serve as a comprehensive guide for countries with nascent or developing biosafety capability working with high-consequence pathogens or contemplating conducting GOF research.