UC Davis is committed to supporting life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
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 Federal policies define “life sciences” as those that pertain to the study of living organisms (e.g., microbes, human beings, animals, and plants) and their products, and includes all of the diverse sub-disciplines and methodologies of biology as well as all applications of the biological sciences.
The United States Government’s 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.
Federal agencies and research institutions have a shared responsibility for minimizing the risks associated with the misuse of the products of their research.
All institutions (and their investigators) that receive Federal funding for life sciences research and that conduct research (funded by any source) involving any of 15 agents and toxins listed in the policy are subject to Federal policies regarding DURC.
DURC determination follows the three steps below sequentially.
- Life science research on one or more of the 15 agents and toxins listed in the Federal DURC policies. Complete the DURC Questionnaire form for review by the Institutional Contact for Dual Use Research (ICDUR).
- Produces, or is reasonably anticipated to produce, one or more of the “categories of experiments” that are subject to DURC.
- Determine whether or not the life science research meets the definition of DURC.
The 15 agents and toxins listed in the Federal DURC policies are:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (For the purposes of the Federal policy on DURC, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential).
- 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
Experimental effects of concern (the following 7 categories of experiments):
- Enhances the harmful consequences of the agent or toxin
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
- Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
- Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
- 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
DURC review process
Once a Principal Investigator (PI) or the ICDUR identifies life science research involving at least one of the 15 agents or toxins, then the UC Davis Institutional Review Entity (IRE) will evaluate the research to determine if it falls into at least one of the seven categories of experiments. If the IRE determines that the life science research does not fall into at least one of the seven categories of experiments, no further action is needed. Even in this case, the PI must inform the IRE if there is a change in experiments that might make it DURC.
If the IRE determines that the life science research falls into at least one of the seven categories of experiments then it must review whether or not it meets the definition of dual use research of concern. No matter the outcome of the review at this level, UC Davis will need to notify the US funding agency of the IRE’s determination.
The University must:
- Establish and implement internal policies and practices that provide for the identification and effective oversight of DURC;
- Designate an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource for issues regarding compliance with and implementation of the requirements for the oversight of research that falls within the scope of Federal DURC policies;
- Establish an Institutional Review Entity (IRE) to execute the requirements of Federal DURC policies; a range of mechanisms for fulfilling the role of an IRE are acceptable as long as the review entity is appropriately constituted and authorized by the institution to conduct the dual use review;
- Provide education and training on DURC for individuals conducting life sciences research that involves any of the 15 agents and toxins listed in Federal DURC policies; and
- Report instances of noncompliance with Federal DURC policies, as well as mitigation measures undertaken by the institution to prevent recurrences of similar noncompliance, within 30 calendar days.
Principal investigators must:
- Identify research involving one or more of the agents and toxins listed in the Federal DURC policies;
- 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 Federal DURC policies have received education and training on DURC; and
- Communicate DURC in a responsible manner.