Dual Use Research
of Concern
University Research Council
September 22, 2015
Jay Frerotte
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”
Dual Use Research of Concern (DURC)
Federal Government
Researchers
Managing
DURC
Institutions
Journal Publishers
and Editors
Dual Use Research of Concern (DURC)
Two US Government (USG) policies that address
the oversight of DURC
1. Policy for Oversight of Life Sciences Dual Use
Research of Concern (March 2012)
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:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
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
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:
1.
2.
3.
4.
5.
6.
7.
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
www.phe.gov/s3/dualuse
Impacted Pitt Research
8 Principal Investigators
(3 select agent users and 5 toxin users)
15 current protocols
Dual Use Research of Concern (DURC)
Two US Government (USG) policies that address
the oversight of DURC
1. Policy for Oversight of Life Sciences Dual Use
Research of Concern (March 2012)
2. Policy for Institutional Oversight of Life Sciences
Dual Use Research Of Concern (effective
September 2015)
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
Roles of Institutional Review Entity
(DURC Committee)
a. Ensure appropriate review of all research with DURC
agents and toxins
b. Ensure researchers are educated on DURC
c. Assist investigators
d. Develop risk mitigation plans, if necessary, in
collaboration with funding agency and PI
i.
ii.
Ensure compliance with risk mitigation plans
Perform annual review of risk mitigation plans
PI Responsibilities
a. 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
b. Ensure that all laboratory personnel conducting research
with any of the 15 agents have received education on DURC
PI Responsibilities (continued)
c.
Collaborate with DURC Committee to develop risk mitigation
plan, if necessary
d. Conduct DURC in accord with risk mitigation plan
e. Continue to assess research and results to determine if, at
any time, research becomes subject to DURC
f. Communicate DURC in a responsible manner, not only at the
point of publication; and in compliance with the risk
mitigation plan
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
Pitt DURC Committee
 Jeremy Somers, Chair, Office of the Sr. ViceChancellor 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
Pitt DURC Oversight
Program Resources at www.rcco.pitt.edu/durc
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
Pitt Institutional Contact for DURC
Jay Frerotte
Responsible Official for Select Agents
Director, Dept. of Environmental Health & Safety
412-624-9505
[email protected]