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Institutional Review Entity for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential

Notice: Upcoming Policy Change on May 6, 2025

On May 6, 2025, the U.S. government will implement a new policy addressing Dual Use Research of Concern (DURC) and Pathogens of Enhanced Pandemic Potential (PEPP). This policy supersedes the 2012 DURC policy and the 2017 Policy Guidance for Potential Pandemic Pathogen Care and Oversight (P3CO Framework), reflecting a proactive approach to addressing the evolving landscape of biological research and its potential implications for global health and security.

The °Ç¸çºÚÁÏ Institutional Review Entity (IRE) Committee provides oversight for DURC and PEPP.

  • DURC: Life sciences research anticipated to provide knowledge, information, products or technologies that could be used in a manner resulting in harm or threats to society. 
  • PEPP: A pathogen with pandemic potential that has been enhanced experimentally such that it poses a significant threat to public health, the capacity of health systems to function, or national security.

Learn about May 6 changes in DURC/PEPP policy. 
 

Current DURC Policy and Guidelines

Prior to the implementation of the new policy, CWRU will follow the 2014 USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, outlined below.

Research conducted at or sponsored by CWRU—or by CWRU faculty members or students on the main campus of CWRU—must be evaluated for DURC potential if it uses one or more of the following agents or toxins.

  • Avian influenza virus (highly pathogenic)
  • Bacillus anthracis
  • Botulinum neurotoxin (no exempt quantities)
  • Burkholderia mallei
  • Burkholderia pseudomallei
  • Ebola virus
  • Marburg virus
  • Reconstructed 1918 Influenza virus
  • Rinderpest virus
  • Toxin-producing strains of Clostridium botulinum
  • Foot-and-mouth disease virus
  • Francisella tularensis
  • Variola major virus
  • Variola minor virus
  • Yersinia pestis

Researchers using any of the above agents must follow CWRU IRE procedures and complete a CWRU IRE DURC form.

All forms will be reviewed by the CWRU IRE Committee. Additional registration and review may be required by the appropriate CWRU compliance body, including the CWRU Institutional Biosafety Committee and CWRU’s Export Control Program.

A mitigation plan, developed by the IRE and principal investigator, will be required if the research produces, aims to produce or can be reasonably anticipated to produce one or more of the following effects:

  • Enhances the harmful consequences of the agent or toxin
  • Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
  • Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
  • Increases the stability, transmissibility or the ability to disseminate the agent or toxin
  • Alters the host range or tropism of the agent or toxin
  • Enhances the susceptibility of a host population to the agent or toxin
  • Generates or reconstitutes an eradicated or extinct agent or toxin (listed above)

The mitigation plan will be filed with the research funding agency, as per CWRU IRE procedures and the United States Government Policy For Institutional Oversight of Life Sciences Dual Use Research of Concern.

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