1. Dual Use Research of Concern
University Research Council
September 22, 2015
Jay Frerotte

2. Dual Use Research of Concern (DURC)
Current US Government Definition of DURC
“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, materiel, or national security”

3. Dual Use Research of Concern (DURC)
Managing DURC
Federal Government
Researchers
Institutions
Journal Publishers and Editors

4. Dual Use Research of Concern (DURC)
Two US Government (USG) policies that address the oversight of DURC
Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012)

5. Dual Use Research of Concern (DURC)
Research that directly involves any of the following 15 agents and toxins is currently covered by the USG policy:
Avian influenza virus (highly pathogenic)
Bacillus anthracis
Botulinum neurotoxin (in any quantity)
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
Francisella tularensis
Marburg virus
Reconstructed 1918 Influenza virus
Rinderpest virus
Toxin-producing strains of Clostridium botulinum
Variola major virus
Variola minor virus
Yersinia pestis

6. Dual Use Research of Concern (DURC)
Research that directly involves any of the 15 agents and toxins and has any of 7 experimental effects is potentially DURC:
Enhances harmful consequences of agent or toxin
Disrupts immunity or the effectiveness of an immunization against agent or toxin (without clinical and/or agricultural justification)
Confers resistance to useful prophylactic or therapeutic interventions, or facilitates ability to evade detection methodologies
Increases stability, transmissibility, or ability to disseminate
Alters the host range or tropism
Enhances susceptibility of a host population
Generates or reconstitutes an eradicated or extinct agent or toxin

8. Impacted Pitt Research
8 Principal Investigators
(3 select agent users and 5 toxin users)
15 current protocols

9. Dual Use Research of Concern (DURC)
Two US Government (USG) policies that address the oversight of DURC
Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012)
Policy for Institutional Oversight of Life Sciences Dual Use Research Of Concern (effective September 2015)

10. USG Policy for Institutional Oversight for DURC
Policy covers same 15 agents and toxins along with same 7 experimental effects
Appoint an Institutional Contact
Designate an Institutional Review Entity, and develop/document an oversight framework

11. Roles of Institutional Review Entity (DURC Committee)
Ensure appropriate review of all research with DURC agents and toxins
Ensure researchers are educated on DURC
Assist investigators
Develop risk mitigation plans, if necessary, in collaboration with funding agency and PI
Ensure compliance with risk mitigation plans
Perform annual review of risk mitigation plans

12. PI Responsibilities
Notify DURC Committee of all proposed research involving one or more of the agents or toxins listed in the Policy, along with their assessment of the 7 experimental effects
Ensure that all laboratory personnel conducting research with any of the 15 agents have received education on DURC

13. PI Responsibilities (continued)
Collaborate with DURC Committee to develop risk mitigation plan, if necessary
Conduct DURC in accord with risk mitigation plan
Continue to assess research and results to determine if, at any time, research becomes subject to DURC
Communicate DURC in a responsible manner, not only at the point of publication; and in compliance with the risk mitigation plan

14. Risk Mitigation Plans for DURC
DURC risk mitigation strategies may include:
Alter the design of the research
Apply specific security and/or biosafety measures
Develop a plan for monitoring the research
Develop a plan for responsibly communicating the results

15. Pitt DURC Committee
Jeremy Somers, Chair, Office of the Sr. Vice-Chancellor for the Health Sciences
Kelly Cole, rDNA/Biosafety Committee
Bruce McClane, MMG
Lisa Parker, GSPH
Molly Stitt-Fischer, University Biosafety Officer
Patrick Thibodeau, MMG
Jennifer Woodward, Office of the Provost

16. Pitt DURC Oversight
Program Resources at

17. Pitt Compliance Milestones: USG Policy for Institutional Oversight for DURC
Designate Institutional Contact
Assemble Review Panel
Develop documented framework
Establish web-site
Develop tools for educating lab staff and tracking
Notify impacted PIs
Review protocols

18. Pitt Institutional Contact for DURC
Jay Frerotte
Responsible Official for Select Agents
Director, Dept. of Environmental Health & Safety