Dangerous Gain of Function (DGOF) Research Oversight Program

The University of Miami is committed to supporting groundbreaking life sciences research while ensuring that research activities are conducted responsibly, safely, and in compliance with applicable federal requirements.

The Dangerous Gain of Function (DGOF) Research Oversight Program provides institutional review, guidance, and oversight for research that may fall within the scope of the United States Government Policy for Stopping High-Risk Life Sciences Research, issued on July 20, 2026. This federal policy establishes requirements for identifying and addressing research activities that could significantly increase the danger posed by biological agents and create unacceptable risks to public health, agriculture, national security, or the environment.

Dangerous Gain of Function research generally refers to life sciences research that enhances the properties of a biological agent in ways that may increase the risk it poses to humans, animals, agriculture, or the environment. The federal policy identifies DGOF research as a category of research requiring heightened institutional and federal oversight and establishes restrictions on federally supported DGOF activities.

Research may warrant review when proposed experiments are reasonably anticipated to:

• Increase transmissibility
• Increase virulence or pathogenicity
• Increase toxicity
• Expand host range or tissue tropism
• Increase resistance to medical countermeasures
• Facilitate immune evasion
• Reduce detectability
• Increase dissemination potential
• Increase susceptibility of host populations

These experimental outcomes are consistent with the risk assessment criteria already incorporated into UM's biosafety and DURC-PEPP oversight processes.

Investigators should contact the DGOF Program if their research involves:

• human, animal, plant, or zoonotic pathogens
• Select agents or toxins
• Synthetic biology applications
• Recombinant or engineered microorganisms
• Pathogens with pandemic potential
• Novel pathogen engineering approaches
• Host-range modification studies
• Experimental enhancement of biological agent characteristics
• Research involving identified Category 1 agents, toxins, or other high-risk biological materials

Projects will require review before submission, funding, or initiation of experimental work.

Investigator Responsibilities:

• Assessing whether proposed research may fall within DGOF scope
• Completing required institutional screening documentation
• Providing accurate and complete research information
• Promptly reporting changes in project scope
• Participating in required training
• Implementing approved risk mitigation measures
• Providing annual updates
• Maintaining compliance with institutional and sponsor requirements