High Consequence Research Oversight
S3: Science Safety Security
Research involving biological agents and toxins is essential to the scientific advances that underpin improvements in national and global health and safety. However, there are biosafety and biosecurity risks associated with undertaking such research that should be carefully considered and appropriately mitigated in order to safely realize these benefits. The U.S. government has existing statutes, regulations, policies, and guidelines that address potential biosafety and biosecurity risks, including those associated with research oversight and management. Together, these authorities, policies, and guidelines provide a foundation for ensuring that scientific research is conducted safely and securely.
Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. The intent of research oversight is to increase the awareness of researchers, research institutions, and federal funding agencies about the biosafety and biosecurity concerns associated with certain types of research and to ensure that appropriate risk mitigation measures are in place to prevent biosafety incidents (e.g., unintended personal exposure or release of an agent outside of containment) or biosecurity incidents (e.g., theft or intentional misuse of information, knowledge, products, or technology). The 2012 Federal DURC policy, the 2014 Institutional DURC policy, and the 2017 P3CO Framework have been key components of the federal oversight framework for research involving biological agents and toxins. Scientists, institutions, and federal funding agencies have gained valuable insight from implementing these policies over the past decade.
