Dual Use Research of Concern

Overview of Dual Use Research of Concern (DURC) Program

The U.S. government and the Ohio State University recognize that there are certain types of research, conducted for legitimate purposes, which can be utilized for both harmful and beneficial purposes. Dual Use Research of Concern (DURC) is a subset of such research that when misapplied could pose significant health and safety threats with broad potential consequences. DURC is defined by the US Government (USG) 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.”
Under the current regulations, DURC applies to research conducted involving one of the 15 select agents/toxins listed below that may result in one or more of seven specific categories of experimental outcomes as described below.

15 Select Agents/Toxins:
1. Avian influenza virus (highly pathogenic)
2. Bacillus anthracis
3. Botulinum neurotoxin (in any quantity)
4. Burkholderia mallei
5. Burkholderia pseudomallei
6. Ebola virus
7. Foot-and-mouth disease virus
8. Francisella tularensis
9. Marburg virus
10. Reconstructed 1918 Influenza virus
11. Rinderpest virus
12. Toxin-producing strains of Clostridium botulinum
13. Variola major virus
14. Variola minor virus
15. Yersinia pestis

Applicable DURC Categories of Experimentation
Does the research…
1. Enhance the harmful consequences of the agent or toxin?
2. Disrupt immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification?
3. Confer to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates its ability to evade detection methodologies?
4. Alter properties of the agent or toxin in a manner that would enhance its stability, transmissibility, or ability to be disseminated?
5. Alter the host range or tropism of the agent or toxin?
6. Enhance the susceptibility of a host population to the agent or toxin?
7. Generate or reconstitute an eradicated or extinct agent or toxin listed above?

Institutional Review Process

The US Government instituted a policy effective September 24, 2015 which requires institutions to establish practices for the identification and management of DURC, create an Institutional Review Entity (IRE) to oversee the determination of whether or not research constitutes DURC, and to develop risk mitigation plans as necessary.
As part of the application to the Institutional Biosafety Committee, a Principal Investigator will be asked to indicate whether his/her research involves any of the 15 select agents and justify whether or not the research produces, aims to produce, or can reasonably be anticipated to produce one of the seven categories of experimentation described above. If the research involves one of the 15 select agents, the IBC will forward the application and protocol for review to the IRE.
If the IRE determines that the project does meet one of the above criteria, the IRE must then determine whether or not the research meets the definition of DURC. If the research is deemed to be DURC, a risk mitigation plan must be developed and approved by the governmental funding agency within 90 days.
A risk mitigation plan indicates the specific measures to be employed to reduce the identified risks and address whether existing biosafety and biosecurity measures are adequate, the applicability of existing countermeasures, educational and training measures for research staff, the plan for monitoring the conduct of the research, and the plan for responsible communication of the research findings. The IRE will review all active DURC protocols and risk mitigation plans annually and modify the plans as needed.
When the IRE has been engaged in the review of a protocol, no research activities may begin until the approval of the IRE and other review committees have been received. Additionally, Principal Investigators are required to notify the IRE immediately of any changes in the research or any unexpected results that might implicate one of the seven categories of experimentation.

Training

Principal Investigators and any lab personnel working on Dual Use Research of Concern projects are required to undergo DURC training, read the OSU DURC Policy, and submit a certificate of completion to the Institutional Biosafety Committee.

Training Course available via the Environmental Health & Safety Online Training website. The training module can be found under the Biosafety Program area. Completing the DURC training module through the EHS Training website will generate a Training Report, which can be printed or accessed by the individual, EHS staff, and Institutional Biosafety Committee staff. This Training Report serves as a certificate of completion.

Policies & Procedures

Questions or requests for additional information should be directed to the Institutional Contact for Dual Use Research (ICDUR), Tina Bogac, at bogac.1@osu.edu or 292-2950.

Regulations and Resources