Institutional Biosafety Committee

DUAL USE RESEARCH OF CONCERN & THE INSTITUTIONAL REVIEW ENTITY

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Dual Use Research of Concern

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. The United States Government's (USG) 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. Currently, DURC regulations are applicable to research involving 15 specific agents and toxins and several categories of experiments conducted with such agents (see below).

Institutional Oversight

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern specifies the practices and procedures required to ensure that dual use research of concern is identified at the institutional level and risk mitigation measures are implemented as necessary. In accordance with this Policy, research institutions that receive USG funds for life sciences research and conduct or sponsor research with any of the the agents or toxins covered by DURC regulations must establish and implement internal policies and practices that provide for the identification and effective oversight of DURC, including establishment of an Institutional Review Entity (IRE) to assess proposed life sciences research that may fall under the definition of DURC.   

At LSUHSC-NO, the IBC functions as the IRE. Because DURC agents are a subset of the select agents and toxins on the Federal Select Agent Program list, the IBC works collaboratively with the Department of  Environmental Health & Safety to outline the roles and responsibilities of the University and its Principal Investigators, develop and implement risk mitigation measures, and ensure the institution's compliance with the federal DURC policy.

Investigators proposing to use DURC agents in a research project should first notify the IBC Office (IBCOffice@lsuhsc.edu) and then submit the protocol using the standard IBC protocol application in Kuali.

Listed Agents & Toxins 

Agents and Toxins - one or more of these agents must be identified in proposed research; there are no exempt quantities; attenuated strains are not included; Select Agent Regulations are not otherwise superseded; the list of agents may be amended by the U.S. Government.

1) Avian influenza virus (highly pathogenic)
2) Bacillus anthracis
3) Botulinum neurotoxin
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

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 listed agent or toxin

Resources