Posted January 31, 2025 by Dan Moser
A new National Institutes of Health policy will expand the scope of research that falls within federal and institutional oversight. The policy, which takes effect May 6, aligns with the updated federal framework for conducting and managing certain types of federally funded life sciences research on biological agents and toxins.
NIH’s policy will require certain oversight actions that begin when a federal agency is considering funding a proposal and continue throughout the lifespan of the work. All research – including current projects and proposals being submitted for funding – may be subject to the new policy. Nebraska researchers must promptly report these research activities to the Institutional Biosafety Committee via the UNL Biosafety Program, 402-472-9554 or 402-472-4925.
A summary of “Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential,” or DURC/PEPP, follows.
Category 1
Research involving all risk group 4 biological agents and Select Agents and Toxins, and a subset of risk group 3 biological agents that may result in any of the following experimental outcomes:
- Increase transmissibility of a pathogen within or between host species.
- Increase virulence of a pathogen or convey virulence to a non-pathogen.
- Increase resistance to a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions.
- Increase the toxicity of a known toxin or produce a novel toxin.
- Increase the stability of a pathogen or toxin in the environment or increase the ability to disseminate a pathogen or toxin.
- Alter the host range or tropism of a pathogen or toxin.
- Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods.
- Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of pre-existing immunity, via immunization or natural infection, against the pathogen or toxin.
- Enhance the susceptibility of a host population to a pathogen or toxin.
Category 2
Research involving a human pathogen or potential human pathogen that is likely to spread uncontrollably and cause moderate to severe disease and/or mortality in humans and can reasonably be expected to result in any of the following experimental outcomes:
- Enhance transmissibility of the pathogen in humans.
- Enhance the virulence of a pathogen in humans.
- Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection.
- Generate, use, reconstitute or transfer an eradicated or extinct pathogen with pandemic potential, or a previously identified pathogen with enhanced pandemic potential.
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