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Institutional Review Entity for DURC

Institutional Review Entity for DURC

Institutional Review Entity Potential Dual Use Research of Concern

The Case Western Reserve University (CWRU) Institutional Review Entity (IRE) Committee provides oversight of potential dual use research of concern (DURC).  Research conducted at or sponsored by CWRU, or research conducted 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.  Researchers using any of the following must complete a CWRU IRE DURC Form

  • 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

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 Export Control

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 United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

 

CWRU Procedures

CWRU IRE Procedures for the Review and Use of DURC

 

CWRU Review Form

CWRU IRE DURC form

 

Federal Resources

United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (USG Policy), September 2015.

https://osp.od.nih.gov/biotechnology/dual-use-research-of-concern

National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), November 2016.

http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines

 

 

CWRU Resources

CWRU Institutional Biosafety Committee

CWRU Export Control

CWRU Export Control---Shipping Guidance

CWRU Environmental Health & Safety

 

CWRU Export Control

The federal export control regulations prohibit the unlicensed export of certain commodities. Most CWRU exports do not require government licenses.  However, investigators should not make that determination themselves. Before internationally shipping, or hand-carrying, the materials relating to this project, CWRU personnel should contact either CWRU Environmental Health & Safety or the CWRU Compliance Office so that one of those offices can determine whether an export license is needed prior to making the export. The Compliance Office can be reached by contacting Lisa Palazzo, University Chief Compliance, Export Control and Privacy Management Officer, at 216.368.5791, or email exportcontrol@case.edu . For more information, see http://www.case.edu/compliance/exportcontrol/.

 

CWRU Contacts

Colleen Karlo, IRE Manager at jck2@case.edu or 216.368.0838

Heidi Page, Biosafety Officer at hep14@case.edu or 216.368.5864

Lisa Palazzo, University Chief Compliance, Export Control and Privacy Management Officer at lxp66@case.edu or 216.368.5791

Kim Volarcik, Institutional Contact DURC at kav6@case.edu or 216.368.0134