What is DURC?
Dual Use Research of Concern (DURC) is defined as: 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.
The National Institute of Health (NIH) has produced a short informational video to raise awareness and understanding about the issue of dual use life sciences research.
The United States Government’s (USG) oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. There are two USG policies that address the oversight of life sciences DURC:
- The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research Of Concern (September 2014) – describes the policies, practices, and procedures required to ensure DURC is identified and risk mitigation measures are implemented at the institutional level.
- The United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012) – establishes regular review by Federal agencies of USG-funded or conducted research with certain high-consequence pathogens and toxins for its DURC potential and to mitigate risks where appropriate.
DURC at CSU
Although few research activities at CSU would qualify as DURC under the definition in the Policy, CSU must comply with the USG Policy for Institutional Oversight of DURC where applicable. The Research Integrity & Compliance Review Office (RICRO) and the Institutional Biosafety Committee (IBC), with assistance from the Office of Vice President for Research, have developed the CSU’s DURC policy. The effective date of the policy is September 24, 2015.
All research with DURC potential at CSU will be reviewed as outlined in the SOP for IRE Review and Risk Mitigation Process. Several tools (below) have been developed to assist investigator in assessing their work for DURC potential.
FAQ About DURC at CSU
As a Principal Investigator (PI), what are my responsibilities under the Policy for Institutional Oversight of Life Sciences DURC? PIs must:
- Identify research involving one or more of the 15 agents and toxins listed in the Policy by filling out the appropriate AARF and PARF;
- Work with the IRE to assess the risks and benefits of the dual use research of concern and to develop risk mitigation measures where appropriate;
- Conduct DURC in accordance with the provisions in the risk mitigation plan;
- Be knowledgeable about and comply with all institutional and Federal policies and requirements for oversight of DURC;
- Ensure that laboratory personnel conducting life sciences research with any of the 15 agents and toxins listed in the Policy have received education and training on DURC; and
- Communicate DURC in a responsible manner.
What might a Risk Mitigation Plan involve?
Strategies for mitigating DURC-associated risks may include (but are not limited to):
- Applying specific biosecurity and/or biosafety measures
- Developing a plan for monitoring the research for findings with additional DURC potential
- Providing additional training to research staff regarding the specific risks related to the DURC
- Changing the design or conduct of the research or not conducting certain aspects of the DURC
- Developing plan for responsibly communicating the results of DURC
What is the “IRE”?
The IRE is the Institutional Review Entity responsible for reviewing research with DURC potential, as well as working with the PI to assess the risks and benefits of the DURC and to develop risk mitigation measures where appropriate. At CSU, our IBC serves as our IRE.
Who is the “ICDUR”?
The ICDUR is the Institutional Contact for Dual Use Research and serves as an institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of DURC as well as the liaison (as necessary) between the institution and the relevant USG funding agency. At CSU, our Vice President for Research, Alan Rudolph, serves as our ICDUR.
- Training slide set: Training on the US Government Policy for Institutional Oversight of Life Sciences Dual Research of Concern
- FAQs on the U.S. Government Policy for Institutional Oversight of Life Sciences DURC
- A Companion Guide to the U.S. Government Policies for Oversight of Life Sciences DURC
- Case Studies on the Implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences DURC
- USG Policy for Institutional Oversight of Life Science Dual Use Research of Concern – released September 24, 2014
- United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (“March 2012 DURC Policy”)
- Department of Health and Human Services (DHHS) general information on the USG Dual Use Research Policy
- National Institutes of Health (NIH) Office of Science Policy: DURC
Questions about DURC can be directed to the IBC Coordinator.