405 Oversight of Dual Use Research of Concern
Approved by President
Effective Date: June 5, 2017
Responsible Division: Academic Affairs
Responsible Office: Vice Provost for Research
Responsible Officer: Vice Provost for Research
I. Purpose and Scope
It is the policy of Middle Tennessee State University (MTSU or University) that all research projects involving biological agents or toxins specified in the federal policy U.S. Government Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern (Policy) are subject to review and approval by the institution prior to project initiation. This policy complies with the Policy, which applies to institutions receiving federal funding to conduct certain types of life science research. The policies are intended to preserve the benefits of life sciences while ensuring safe research practices and mitigating risks.
A. Dual Use Research of Concern (DURC). 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. DURC is research that involves one or more of the agents/toxins below that is also used in one or more of the stated Experiments of Concern.
B. Non-attenuated Agents and Toxins of Concern. Those so defined by federal policy, which may be updated periodically, including, but not limited to:
1. Avian influenza virus,
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 strain of Clostridium botulinum,
13. Variola major virus,
14. Variola minor virus, and
15. Yersinia pestis.
The fifteen (15) agents and toxins listed in this policy are subject to the select agent regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121), which set forth the requirements for possession, use, and transfer of select agents and toxins, and have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products.
This policy does not apply to research involving use of any of the fifteen (15) listed agents in attenuated forms of these agents or the genes from these agents.
C. Experiments of Concern. Research that produces, aims to produce, or can be reasonably anticipated to produce one or more of the following experimental effects:
1. Enhances the harmful consequences of the agent or toxin;
2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification;
3. 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;
4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
5. Alters the host range or tropism of the agent or toxin;
6. Enhances the susceptibility of a host population to the agent or toxin; or
7. Generates or reconstitutes an eradicated or extinct agent or toxin listed under agents and toxins of concern.
D. Institutional Biosafety Committee is established pursuant to Policy 32 University Committees, Institutional Biosafety Committee (Special Purpose).
III. Responsibility of Researchers
Principal Investigators (PI’s) are responsible for properly identifying research which they plan to undertake that will involve non-attenuated agents and toxins of concern and could meet the definition of an experiment of concern. Researchers shall consider whether their research requires review under this policy throughout the lifecycle of the research. They shall conduct a review of the research for DURC potential whenever any of the following conditions exist:
A. The research directly involves non-attenuated forms of one or more of the listed agents or toxins; or
B. The research produces, aims to produce, or can be reasonably anticipated to produce one or more of the listed experimental effects; or
C. The research may meet the definition of DURC.
If any of the preceding three conditions are identified, the PI must make a disclosure to the IBC for review as potentially DURC.
PI’s must conduct each review and disclosure pursuant to the guidelines and procedures as set forth in Tools for the Identification, Assessment, and Responsible Communication of Dual Use Research of Concern, A Companion Guide to the United States Government for Institutional Oversight of Life Sciences Dual Use Research of Concern (the Guide), Part B and associated appendices.
IV. Responsibility of the Institutional Biosafety Committee
The IBC shall review and act upon disclosures received from PI’s, pursuant to the guidelines and procedures set forth in the Guide, Parts B, C, D, E, and F, and associated appendices.
The IBC may consult with specialists who are not members of the IBC, and may or may not be affiliated with the University, as needed to adequately address any disclosure.
A. The IBC shall ensure that the University community receives adequate education and training regarding the applicability and implementation of this policy.
B. It is the responsibility of the Office of Research delegate to the IBC to ensure that the University, the IBC, and other parties to which this policy is applicable have access to the most current versions of the Policy and the Guide.
C. Decision Making and Communication Flow Chart presents a flow chart for decision-making and communication pursuant to this policy.
References: U.S. Government Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern; 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121; Policy 32 University Committees.