Dual Use Research of Concern (DURC)

Overview of Dual Use Research of Concern (DURC)

Definitions

Agents and Toxins subject to this policy* (hereafter referred to as Agents of Concern)

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

Strains of above considered to be ‘attenuated’ and appearing on the Select Agents and Toxins Exclusions List are not subject to this policy , unless the research in question proposes any manipulation that restores or enhances its virulence or toxic activity.

Dual Use Research of Concern (DURC)

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.

Experiments of Concern

Experiments of Concern Use of Agents and Toxins subject to this policy in research that involves:

  • 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 or
  • Generates or reconstitutes an eradicated or extinct agent or toxin subject to this policy

Life Science Research

Life Science Research is the study of living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, microbiology, synthetic biology, virology, molecular biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches to understanding life at the level of ecosystems, populations, organisms, organs, tissues, cells, and molecules.

Responsibilities of the Principal Investigator

Prior to commencing with any activity involving agents of concern, Investigators must:

  • Contact the Department of Environmental Health and Safety (EH&S) to obtain the necessary approvals for access to Biological Select Agents and Toxins (BSAT).
  • Ensure that all personnel, working on the research activity (including him/herself) involving the agents of concern undergoes training in DURC. The ‘DURC Training Certification Form’ is to be used to confirm such training, and is available in the forms and template;library of IRBNet
    • Training is required and involves substantive review and PI-led discussion of the following:
      • FAQs on the US Government for Institutional Oversight of Life Sciences Dual Use Research of Concern, and
      • Training on the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
  • Submit to the IRE a completed Dual Use Research of Concern (DURC) Application, available in the forms and template library of IRBNet.
  • Await outcome of review from the IRE regarding applicability of the research as it pertains to this policy (outlined in section II below).
    • If the IRE determines that the research constitutes DURC, and is subject to this Policy: Do not commence with the research until an approved risk mitigation plan is in place.
  • Once an approved risk mitigation plan is in place, and the IRE approves the research to commence, the investigator must conduct and/or communicate the research in accordance with the provisions of the risk mitigation plan

Submission Guidelines

  • DURC projects are submitted to the IRE via the IBC Module in IRBNet (www.irbnet.org)
  • DURC projects require the submission of a DURC application, and e-signature of the PI on the study package

IRE Committee Members

James Bliska, PhD Chair, Professor, Dept. of Molecular Genetics & Microbiology
Jeronimo Cello Research Scientist, Molecular Genetics & Microbiology
Susan Donelan, MD Director - Healthcare Epidemiology Dept., Assistant Professor, Infectious Diseases
Patrick Hearing, Ph.D. Professor, Department of Molecular Genetics and Microbiology
Jesse Hollister, Ph.D. Assistant Professor, Department of Ecology and Evolutionary Biology
Christopher Hubert Cold Spring Harbor Laboratory
Glenn Howard Community Member, Glen Cove, NY
Kristen Panella, M.S., CSP, CHO Community member, Wantagh, NY
Tom Zimmerman, DVM Director, Division of Laboratory Animal Resources, Animal Expert
Christopher Kuhlow Interim Biosafety Officer (BSO)
Mary O'Neill Assistant Director, Research Compliance
   
Judy Matuk, M.S. Executive Secretary, non-voting member

      

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