What is the Dual Use Research of Concern 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.”
Identifying agents and toxins subject to DURC 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
Applicable DURC Categories of Experimentation
- Enhances the harmful consequences of the agent or toxin
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification
- Confers 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
- Alters properties of the agent or toxin in a manner that would enhance its stability, transmissibility, or ability to be disseminated
- Alters the host range or tropism of the agent or toxin
- Enhances the susceptibility of a host population to the agent or toxin
- Generates or reconstitutes 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 (IBC), 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.
Principal Investigators and lab personnel working on DURC projects are required to undergo DURC training, read the Ohio State DURC Policy, and submit a certificate of completion to the Institutional Biosafety Committee. A training course is available via the Environmental Healthy & Safety Online Training website. Under EHS Online training, search for "Dual Use Research of Concern" to launch the training in Buckeye Learn. 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.