Institutional Review Entity for Dual Use Research of Concern

The Case Western Reserve University Institutional Review Entity (IRE) Committee provides oversight for Dual Use Research of Concern (DURC). DURC is defined as 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.

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.