Dual Use Research of Concern (DURC) and Dangerous Gain-of-Function Research

On May 5, 2025, the Executive Order on Improving the Safety and Security of Biological Research was issued. This paused the implementation of a revised Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential policy to allow for a new policy to be written focused on dangerous gain-of-function research.

The Executive Order puts funding restrictions in place for any research meeting the definition of dangerous gain-of-function.

Dangerous Gain-of-Function Research is defined as research on infectious agents or toxins that enhances their disease-causing potential. Covered activities include those that could result in significant societal consequences by:

Enhancing Virulence: Increasing the harmful consequences or pathogenicity of the agent.
Evading Countermeasures: Disrupting immune responses, creating resistance to treatments/vaccines, or facilitating detection evasion.
Improving Transmission: Increasing stability, transmissibility, or ease of dissemination.
Altering Biology: Expanding the host range or increasing human susceptibility.
Reconstitution: Generating or reviving eradicated or extinct pathogens.

Any research activities (proposed or ongoing) that might meet the definition of dangerous gain-of-function research can be identified using the PI Assessment document and in consultation with the Biosafety Office (biosafety@case.edu).

PI Assessment - Dangerous Gain-of-Function

Current DURC Policy and Procedures

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.