Biosafety
Institutional Review Entity (IRE), Dual Use Research of Concern (DURC), Pathogens with Enhanced Pandemic Potential (PEPP) and Dangerous Gain of Function (DGOF)
The Institutional Review Entity (IRE) at UGA is managed by the Office of Biosafety and the Institutional Biosafety Committee (IBC). Per Federal Policy the IRE is charged with governing federally funded life sciences research on biological agents and toxins which, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security. The IRE’s oversight is to include:
- Dual Use Research – research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes.
- Dual use research of concern (DURC) – dual use research becomes DURC when it can be reasonably anticipated that the result could be misapplied with no, or only minor modification to pose a significant threat with potential consequences to:
- Public health and safety
- Agricultural crops and other plants
- Animals
- The environment
- Material
- National security
- Pathogen with pandemic potential (PPP) – pathogen likely capable of wide and uncontrollable spread in a human population which would likely cause moderate to severe disease and/or mortality in humans.
- Pathogen with enhanced pandemic potential (PEPP) – type of PPP resulting from experiments that enhance a pathogen’s transmissibility, virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security.
Dangerous Gain of Function Research – Executive Order 14292
Dangerous gain-of-function (DGOF) research is defined as scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility. Covered research activities are those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:
- enhancing the harmful consequences of the agent or toxin;
- disrupting beneficial immunological response or the effectiveness of an immunization against the agent or toxin;
- conferring to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitating their ability to evade detection methodologies;
- increasing the stability, transmissibility, or the ability to disseminate the agent or toxin;
- altering the host range or tropism of the agent or toxin;
- enhancing the susceptibility of a human host population to the agent or toxin; or
- generating or reconstituting an eradicated or extinct agent or toxin.
PI Responsibilities regarding DURC, PEPP, PPP and DGOF
- Know and comply with institutional and USG policies, requirements, and regulations for oversight of biological research.
- Assess research continuously throughout its lifecycle to identify whether it is or could be reasonably anticipated to be within the scope of Category1, Category 2 or DGOF.
- Notify the federal funding agency AND the IRE when Category1, Category 2 or DGOF research is identified.
- Be prepared to develop a risk-benefit assessment and a risk mitigation plan.
- See Implementation Guidance for assistance in interpreting and implementing all PI responsibilities for Category 1 and Category 2
- See Policy on DGOF research for assistance in reviewing your research
PI and Staff Training on DURC, PEPP and PPP
All researchers conducting life sciences research on biological agents or toxins are required by the Federal Policy to be trained in their ability to assess their work for DURC, PEPP and PPP. At UGA, the required training on DURC, PEPP and PPP is conducted through the Professional Education Portal (PEP). Log into PEP and search for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.
UGA DURC, PEPP, PPP and DGOF Contacts:
The IRE will be managed by the Office of Biosafety and the UGA IBC. At UGA, the IBC Coordinator will serve as the Institutional Contact for Dual Use Research (ICDUR) designated by the research institution to serve as an internal resource for application of this Policy.
UGA ICDUR – Andrea Ferrero-Perez
UGA Director of Biosafety – Patrick Stockton