RISKY BIOLOGICAL RESEARCHDefining Risk in Biological Research: Why Researchers Need Clearer Oversight Frameworks
Policymakers and researchers need a consistent and transparent way to weigh the risks and benefits of risky biological research to facilitate review processes and oversight.
At the United Nations General Assembly in September, President Trump highlighted his concerns about risky biological research. Significant questions remain, however, about how oversight of high-consequence research will be put into practice. Policymakers and researchers need a consistent and transparent way to weigh the risks and benefits of such research to facilitate review processes and oversight.
New RAND research provides the foundation for such a tool: structured scoring systems that apply well-defined criteria from past policies while adapting them to more modern biosecurity concerns, including emerging technologies. The tool provides a systematic way to evaluate proposed and ongoing research efforts, helping ensure oversight is evidence based.
In recent months, there has been renewed interest in heightening oversight of biological research. In May, President Trump released Executive Order 14292, which called for increased accountability and public transparency in dangerous gain-of-function research (DGoF). In July, the Senate Homeland Security and Governmental Affairs Committee approved the Risky Research Review Act, which proposed creating a Life Sciences Research Security Board to review federally funded “high-risk” research.
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“Gain-of-function research refers to experiments where scientists introduce new abilities or enhance existing properties of an organism.”
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Gain-of-function (GoF) research refers to experiments where scientists introduce new abilities or enhance existing properties of an organism. These methods are used in legitimate ways across many fields, like agriculture or cancer biology, and often do not involve pathogens. However, in policy discussions, GoF research has almost exclusively come to mean work that enhances pathogenic properties. The phrase gained more notoriety during the COVID-19 pandemic, as it was foundational to the ongoing discussion about whether the SARS-CoV-2 virus originated from GoF research in Wuhan, China.
The confusion over what dangerous gain-of-function (DGoF) means in policy has created uncertainty in what types of research can or cannot be conducted. This complicates efforts to regulate or oversee this research, as policies must prevent misuse while at the same time promoting legitimate beneficial scientific progress. Without precise definitions, important research could be inadvertently restricted, or genuinely dangerous work may escape appropriate scrutiny.
