ENVIRONMENTAL HEALTH & SAFETY

DURC - Institutional Review Entity (IRE)

The Institutional Review Entity (IRE) reviews any research or work conducted at, or on behalf of the University of Virginia that involves one of the 15 agents or toxins* and any categories of experiments designated as Dual Use Research of Concern (DURC) by the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern or DURC.

DURC is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.

IRE Charge - pdf

Mission

The IRE will ensure that all research involving the acquisition, use, handling storage and disposal of DURC materials is reviewed for DURC potential. Furthermore, the committee is responsible for reviewing all proposed research subject to DURC conducted by faculty, staff, students and/or visiting scientists, creating draft mitigation plans when required, and submitting these plans to the United States Government (USG) agency funding the proposed research. If the research is non-Federally funded the plan is submitted to NIH for review or referral. The IRE will also annually review active mitigation plans, and report any changes in DURC or mitigations plans to the appropriate USG agency within 30 days.

*DURC research applies to the following agents and categories of experiments:

• Agents:
1. Avian influenza virus (highly pathogenic)
2. Bacillus anthracis
3. Botulinum neurotoxin (note: there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin is included.)
4. Burkholderia mallei
5. Burkholderia pseudomallei
6. Ebola virus (BSL4)
7. Foot-and-mouth disease virus
8. Francisella tularensis
9. Marburg virus (BSL4)
10. Reconstructed 1918 Influenza virus
11. Rinderpest virus
12. Toxin-producing strains of Clostridium botulinum
13. Variola major virus (BSL4)
14. Variola minor virus
15. Yersinia pestis
• Categories of experiments:
1. Enhance the harmful consequences of a biological agent or toxin
2. Disrupt immunity or effectiveness of an immunization against a biological agent or toxin without clinical or agricultural justification
3. Confer to a biological agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies
4. Increase the stability, transmissibility, or the ability to disseminate the agent or toxin;
5. Alter the host range or tropism of the agent or toxin
6. Enhance the susceptibility of a host population to a biological agent or toxin
7. Generation of a novel pathogenic agent, or reconstitution of an eradicated or extinct biological agent

IRE Meeting Schedule

If you would like to attend a meeting, please contact Paul Skoglund at ps5d@virginia.edu or 434-243-0726, by the date the Registration Documents are due.

Note: All meetings are on the usual first Tuesday of the Month except in November.

IRE Members

Prof. Barbara J. Mann
IRE Chair
Associate Professor
Department of Medicine, Infectious Diseases
434-924-9666

Kumari Andarawewa
IRE Member
Associate Director of the Center for Comparative Medicine
434-924-2090

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

Marie Burdick
IRE Member
Principal Scientist
Department of Medicine, Pulmonary and Critical Care
434-243-7363

Glynis L. Kolling
IRE Member
Assistant Professor of Medicine
Department of Biomedical Engineering
434-924-5630

Tom Leonard
IRE Member
Responsible Official (Select Agents)
EHS Director
434.982.4911

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

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

Prof. Scott Vande Pol
IRE Member
Associate Professor
Department of Pathology
434-924-1603

Paul Skoglund
IRE Coordinator
434-243-0726