Previous DURC-PEPP Policy

The procedure by which research proposed to be conducted at the University of Virginia is evaluated for its potential to fall within the scope of Category 1 or Category 2 research as defined Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential. The IRE reviews research or work for any categories of experiments designated as Category 1 or Dual Use Research of Concern (DURC), or designated as Category 2 Research Experimental Outcomes or Actions.  Please also see the latest News & Announcement page from the NIH Office of Science Policy.

Definitions:

Dual Use Research of Concern (DURC) or Category 1 is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm 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, or national security.

Pathogen with enhanced pandemic potential (PEPP) or Category 2 is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a pathogen’s transmissibility or 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. Wild-type pathogens that are circulating in or have been recovered from nature are not PEPPs but may be considered PPPs because of their pandemic potential.

Pathogen with pandemic potential (PPP) or Category 2 is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.

PI Responsibility: PIs must notify the funding agency and their institution by submitting or modifying an IBC IAR if it might be in scope of the USG DURC and PEPP policy.

The UVA Institutional Biosafety Committee (IBC) requires PIs to submit an initial and at least annual online Inventory and Activity Registration (IAR) that prompts investigators to identify all biological agents and toxins anticipated to be used or stored.  For efficiency and investigator awareness, the IAR concurrently prompts PIs to address whether any of the declared biological agents will result or are reasonably anticipated to result in one of the experimental outcomes/actions as specified in sections 4.1.2 or 4.2.2 of the USG Policy. If the response to any of the questions is affirmative, the IBC will refer the protocol to the Institutional Review Entity (IRE) for review.

The IRE reviews the PI’s initial assessment and requests any additional information needed to determine if the proposed research is within the scope of Category 1 or Category 2 research as defined by the USG Policy. The IRE will conduct a risk-benefit assessment and work with the PI to draft a suitable mitigation plan for the conduct and communication of research. The IRE will coordinate with the ICDUR to submit the risk-benefit assessment and draft mitigation plan to the federal funding agency.

PIs must continually assess their IBC approved research to determine if it potentially is within the scope of Category 1 or Category 2.  If so, the PI must pause further work, notify the federal funding agency and IRE for further assessment. 

IRE Meeting Schedule

If you would like to attend a meeting, please contact Paul Skoglund at [email protected] or 434-243-0726, by the date the Registration Documents are due.

Note: All meetings are held on the first Tuesday except moved to Wednesday in September (to avoid a meeting right after the Labor Day holiday) and November (to avoid the UVA Election Day holiday).

IRE Members

Prof. Glynis L. Kolling
IRE Chair
Research Associate Professor
Department of Biomedical Engineering
434-982-6267

Prof. Danielle Cook
IRE Member
Research Assistant Professor of Medicine
Department of Hematology and Oncology
425-691-8333

Prof. Matthew Crawford
IRE Member
Research Assistant Professor
Department of Infectious Disease
434-924-5267

Jennifer Kershner
UVA Biosafety Officer
Alternate Responsible Official (Select Agents)
434.982.4911

Tom Leonard
IRE Member
Responsible Official (Select Agents)
Director - Environmental Health & Safety
434.982.4911

Raphael Malbrue
IRE Member
Director - Center for Comparative Medicine
434.924.5058

Prof. Aaron L. Mills
IRE Member
Professor
Department of Environmental Sciences
434-924-0564

Prof. Brett Moreau
IRE Member
Research Assistant Professor
Department of Infectious Disease
434-243-2764

Prof. Ira Schulman
IRE Member
Associate Professor
Department of Pharmacology
434-924-5682

Paul Skoglund
IRE Coordinator
434-243-0726