Research Administration > RSAWA > Dual Use Review Entity (DURE)

Dual Use Review Entity (DURE)

 

Dual use research refers to scientific activities conducted for legitimate purposes that generate knowledge, information, technologies, and/or products that can be utilized for both benevolent and harmful purposes. Conceivably, much of research could be considered dual use. The effective oversight of dual use research of concern (DURC) is based on identifying potential dual use research and its associated risks, then devising ways to mitigate these risks. In accordance with the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern and the University of California system-wide Policy, Institutional & Investigator Oversight of Life Sciences Dual Use Research of Concern, the UCLA DURE is charged with oversight of, and education on, life sciences research involving the use of potential DURC agents. The Committee advises and reports to the Chancellor through the Vice Chancellor for Research.

 

Latest DURE News

PI Notification to the IRE 

Definitions

 

Dual Use Research

Research conducted for legitimate purposes that can be utilized for both benevolent and harmful purposes.

 

Dual Use Research of Concern (“DURC”)

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. [1]

 

DURC Agents

Agents and toxins specified by the U.S. Government as governed by its DURC policy.  The below list of agents and toxins will be subject to revision to reflect future changes in federal DURC policy, but as currently defined, the following 15 agents and toxins, in any quantity, are governed by federal and University policy on DURC:

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

 

Experimental Effects of Concern

Research involving any DURC agent must be evaluated to determine whether it produces, aims to produce, or can be reasonably anticipated to produce one or more of the following effects:

  1. Enhances the harmful consequences of the agent or toxin.
  2. Disrupts immunity or 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.
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed in the definition of DURC Agents above.

 

Principal Investigator (“PI”)

A PI is an individual who is designated by UC to direct a project or program and who is responsible to the funding agency or UC for the scientific and technical direction of that project or program. There may be more than one PI on a research grant or project.

 

Institutional Review Entity (“IRE”)

The campus committee charged with establishing and implementing internal policies and practices that allow for the identification and oversight of DURC, and that reviews proposed research that will utilize a DURC Agent. The committee shall be appointed by the Chancellor or Chancellor’s designee and composed of 5 or more members, including at least 2 scientists with appropriate expertise, the campus ICDUR (defined below), the campus Biosafety Officer, and other members who can provide the IRE expertise with regard to ethics and compliance, export controls regulations and other know-how as determined by the campus.

 

Institutional Contact for Dual Use Research (“ICDUR”)

The individual designated by the campus Chancellor or designee to be the institutional campus point of contact for researchers’ questions relating to compliance with this Policy and to serve as the liaison with the relevant U.S. Government funding agencies.

 

Risk Mitigation Plan

A plan that describes the DURC-associated risks identified by the IRE, the specific risk mitigation measures to be employed, and how these measures address the identified risks.

 

U.S. Funding Agency

The U.S. Government agency that is funding the subject research. If a federal department or agency simply passes through funding from another federal department, agency or non-federal entity to support life sciences research involving one or more of the DURC Agents, the agency originally providing the funding shall be considered the U.S. Funding Agency. Where the agency providing funding is a non-federal entity, the program shall be reviewed as if NIH were the U.S. Funding Agency. 

  

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Mandate

 

  • The DURE shall ensure that no research with DURC Agents will be conducted unless the Principal Investigators conducting research with one of more of DURC Agents have received education and training on DURC. This education and training must be sufficient to allow them to undertake an initial assessment to determine whether the research they wish to undertake is potentially DURC.
  • The DURE will work with PIs to assess whether research that uses one or more of the DURC Agents also produces, aims to produce, or is reasonably anticipated to produce one or more of the Experimental Effects of Concern. For research anticipated to produce at least one of the seven effects, the DURE will perform a risk assessment to determine whether the research meets the definition of DURC. Anticipated benefits of the research will be considered in conjunction with the previously identified risks in order to develop a draft risk mitigation plan to guide the conduct and communication of the DURC; this plan must be approved by the relevant USG funding agency, if applicable.
  • At the conclusion of its review of research that the DURE determines meets the definition of DURC, the DURE will submit its findings and recommendations as to the elements of the draft Risk Mitigation Plan to the PI and to the Vice Chancellor for Research.
  • For research determined to be DURC, the DURE shall review, at least annually, all active Risk Mitigation Plans at the University. In reviewing such Plans, the DURE will follow the guidance on points to consider in drafting a Risk Mitigation Plan that can be found in the USG Companion Guide. The DURE, working with the PI, shall modify the applicable Risk Mitigation Plan as needed to ensure that the Plan still adequately mitigates the risks associated with the DURC.

 

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Committee Structure and Administration

 

In accordance with the USG Policy, the DURE shall be composed of at least five members and include persons with sufficient breadth of expertise to assess the dual use potential of the range of relevant life sciences research conducted at a given research facility and persons with knowledge of relevant USG policies and understanding of risk assessment and risk management considerations, including biosafety and biosecurity. In accordance with the UCOP Policy, the DURE shall also include the ICDUR and Biosafety Officer.

 

Committee Chair
The position of Chair shall be appointed by the Vice Chancellor for Research from the existing voting membership of the committee. The position of Chair is a one-year appointment and is renewable.

 

Committee Composition

  • Scientist Members (voting)
  • Ex Officio Members (voting)
    • The UCLA ICDUR
    • The UCLA Biosafety Officer
  • Additional Voting Members
    • Ethicist
    • Occupational Health expert
  • Ad hoc Members (non-voting)
    • Export Control expert

 

Committee Appointments

Voting members are appointed by the Vice Chancellor for Research.

 

Terms of Appointment

  • Ex officio members remain appointed to the DURE for the duration which they hold their position (i.e., as ICDUR and UCLA Biosafety Officer).
  • Non ex officio members are appointed for one-year terms and may be reappointed to additional terms.
  • The term of appointment for a non-voting ad hoc member is contingent on the advisory need as determined by the DURE.

 

Committee Administration

Administrative and secretarial services for the Committee will be provided by the office of the Vice Chancellor for Research through the Office of Research Administration (ORA).

  

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Meetings and Operations

 

Voting

  • The Committee shall act by majority vote of the voting members present.
  • A quorum shall be a majority of the voting membership.
  • Electronic voting for all DURE business matters is acceptable at the discretion of the Chair provided a complete electronic document of all issues relating to the item is forwarded to each voting member for their appraisal, comment and approval. Electronic voting shall require a three-day response to the Chair. The ability to vote electronically shall not be regarded as a reason for DURE meeting nonattendance.

 

Meeting Frequency

The DURE shall convene on an as-needed basis to review research involving DURC Agents, and meet no less than annually to review all active Risk Mitigation Plans at the University for research determined to be DURC. Meetings shall be scheduled by ORA after consultation with the DURE Chair.

 

Agenda
ORA shall prepare an agenda in consultation with the Chair and distribute it to all members prior to each meeting.

 

Meeting Minutes
ORA shall provide administrative support to record, maintain and distribute minutes of meetings and other records. Copies of the minutes shall be sent electronically to all members of the DURE.

 

 

[1] The definition for Dual Use Research of Concern provided here is drawn from the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014) and what constitutes a “significant threat with broad potential consequences” is not further described in that policy, or in federal regulation. Under federal policy, the final determination of whether federally-funded life sciences research meets this definition will be made by the relevant U.S. Funding Agency on a case-specific analysis, and inconsideration of factors suggested at Section C.2.3 of the Companion Guide, and for non-federally-funded research, that determination will be made by the NIH.

[2] For purposes of this Policy, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential.

  

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