Dual Use Research of Concern
According to U.S. Government Policy, "dual use research of concern" (DURC) is
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.
U.S. Government Policy requires that insitutions conducting DURC have an Internal Review Entity (IRE) to oversee that research to ensure institutional and research compliance with federal policy, regulations, and laws. The purpose of the IRE generally is to preserve the benefits of DURC while minimzing the risks of misuse of the knowledge, information, products, or technologies provided by such research. The IRE has oversight over research involving the following 15 agents and toxins.
Avian influenza virus (highly pathogenic)Bacillus anthracisBotulinum neurotoxin of any quantityBurkholderia malleiBurkholderia pseudomalleiEbola virusFoot-and-mouth disease virusFrancisella tularensisMarburg virusReconstructed 1918 Influenza virus 'Rinderpest virusToxin-producing strains of Clostridium botulinumVariola major virus Variola minor virusYersinia pestis
The Office for Research Protections (ORP) is responsible for coordinating DURC reviews and approvals for all University campuses and colleges except for the College of Medicine and for providing DURC training to those University researchers involved in research using one or more of the above listed agents and toxins. The Office of Vice Dean for Research is responsible for coordinating DURC reviews and approvals at the College of Medicine.
Before receipt of one or more of the 15 select agents and toxins, Penn State researchers must have IRE approval, and before research can begin, researchers must ensure that they, and all the personnel involved in the research, have received education and training regarding DURC. At this time, DURC training can be accomplished by reviewing and understanding the following slides prepared by the Program on Biosecurity and Biosafety Policy at NIH: http://absaconference.org/absaconfwp/wp-content/uploads/2014/06/III-1-Harris-1100.pdf. The ORP will collect and maintain email certification from the PI that the PI and all involved research personnel have completed this DURC training.
Furthermore, any activities associated with the agents and toxins identified in this policy must also comply with Federal Export Control Regulations. Consequently, the DURC review must be supplemented with an export compliance review if the research involves any foreign triggers, such as foreign sponsorship, foreign collaborations and/or international travel. More information about Penn State Export Compliance policies and procedures is available at export.psu.edu.
For more information on DURC and IRE review, contact us at ORP-Biosafety@mymail.psu.edu.
Research involving one of the 15 select agents and toxins will likely also require separate review and approval by other compliance committees, such as the Institutional Biosafety Committee and/or the Institutional Animal Care and Use Committee; the staff within the ORP can help you understand what compliance reviews and approvals are needed for your research