Investigator Responsibilities

In accordance with The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern Policy, PIs are to:

I. Notify the Institutional Review Entity (IRE) as soon as:

• The PI’s research involves one or more of the agents or toxins listed below;
• The PI’s research with one or more of the agents or toxins listed below also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven effects listed above or
• The PI’s research that is within the scope of using one or more of the 15 agents/toxins listed above may meet the definition of DURC

Agents/Toxins

Categories of Experiments

Avian influenza virus (highly pathogenic) Bacillus anthracis Botulinum neurotoxin (no exempt quantities) Burkholderia mallei Burkholderia pseudomallei Ebola virus Marburg virus Reconstructed 1918 Influenza virus Rinderpest virus Toxin-producing strains of Clostridium botulinum Foot-and-mouth disease virus Francisella tularensis Variola major virus Variola minor virus Yersinia pestis

Enhances the harmful consequences of the agent or toxin. Disrupts the 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.

II. The notification must include the PI’s assessment of whether any research involving these agents or toxins produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed below.

III. Work with the IRE to assess the dual use risks and benefits of the DURC and to develop risk mitigation measures.

IV. Conduct DURC in accordance with the provisions in the risk mitigation plan.

V. Be knowledgeable about and comply with all institutional and USG policies and requirements for oversight of DURC.

VI. Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) conducting life sciences research with one or more of the agents listed above have received education and training on DURC.

VII. Communicate DURC in a responsible manner. Communication of research and research findings is an essential activity for all researchers, and occurs throughout the research process, not only at the point of publication. Researchers planning to communicate DURC should do so in compliance with the approved risk mitigation plan.

Educational Materials and Resources

The Institutional Review Process Flow Chart
A Code of Conduct Toolkit

FIU Review Form

FIU IRE application needs to be submitted through the online TOPAZ Electronic Protocol Application System.

Investigators should complete the following form:

• Dual Use Research of Concern (DURC) Application

Information on the TOPAZ Electronic Protocol Application System

For Board Members

Companion Guide to U.S. government policies for oversight of DURC

Case studies on the implementation of U.S. government policy for institutional oversight of life sciences DURC

Federal Resources

United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (USG Policy), September 2014.

S3: Science Safety Security

National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)