The U.S. Government has defined two broad categories of life sciences research posing the highest risk to our nation's security:
- Dangerous gain-of-function (DGOF) research. Research with a biological agent that seeks, achieves, or has a substantial risk of achieving one or more of the outcomes listed in the Policy and could result in significant negative societal consequences.
- International research of concern (IROC). Research conducted in a country of concern or outside of the United States by individuals or institutions of concern; or research that could reasonably pose a threat to public health, public safety, and economic or national security conducted in a country with inadequate oversight.
At Georgia Tech, the Institutional Review Entity (IRE) is charged with overseeing research that falls under these definitions as established by the U.S. Government Policy for Stopping High-Risk Life Sciences Research.
On July 20, 2026, the U.S. Government released the U.S. Government Policy for Stopping High-Risk Life Sciences Research to establish the requirements for the oversight of DGOF and IROC. Implementation guidance for this new policy is expected in November of 2026.
For more background information on the IRE and it's oversight authority, visit the NIH's notice NOT-OD-26-101.