High-Risk Life Sciences Research Oversight

Life-science research is foundational to understanding how the human body works and how diseases develop, to supporting community and population health, and to protecting ecosystems and improving food security. Such research is necessary to ensure the United States maintains global leadership in biotechnology, biosecurity, and health and agricultural research, as well as readiness against biological threats.

However, some types of research are dangerous and require increased safeguards and oversight. Dangerous gain-of-function (DGOF) research is a type of research that poses the highest societal risks without commensurate benefits. This research involves experiments with biological agents that have the potential to cause harm by enhancing the agent’s virulence, pathogenicity, or toxicity, or increasing its transmissibility.  DGOF activities are those that seek, achieve, or have the potential to result in one or more of the following outcomes and could result in significant negative societal consequences: 

• Enhancing the harmful consequences of the biological agent; 

• Disrupting beneficial immunological response or the effectiveness of an immunization against the biological agent;

• Conferring to the biological agent resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that biological agent or facilitating their ability to evade detection methodologies;

• Increasing the stability, transmissibility, or the ability to disseminate the biological agent;

• Altering the host range or tropism of the biological agent;

• Enhancing the susceptibility of a human, animal, or plant host population to the biological agent; or

• Generating or reconstituting an eradicated or extinct biological agent.

In addition, any federally funded life sciences research that is conducted outside of the United States must meet, exceed, or comply with U.S. oversight standards and policies. International research of concern (IROC) is life sciences research involving entities of concern, or life sciences research that could reasonably pose a threat to public health, public safety, or economic or national security, conducted in a country with inadequate biosafety and biosecurity oversight. 

The Trump administration’s goal is to balance the prevention of catastrophic consequences with maintaining readiness against biological threats and driving global leadership in biotechnology, biological countermeasures, biosecurity, and health research. The United States Government (USG) must ensure that life-science research in the United States benefits American citizens without posing unnecessary risks to public health, economic security, or national security.

The USG will continue to share its knowledge, products, and results of life-science research, and maintain compliance with current domestic legislation and international treaties, obligations and frameworks while striving to improve the biosafety and biosecurity of life-science research performed worldwide. The USG recognizes the importance of international engagement to promote oversight of life-science research that balances scientific progress with risk mitigation and encourages global cessation of DGOF and other risky research.