The Investigator will consider their project (during planning stages and an ongoing basis) to determine if any of nonattenuated forms of High-Consequence Agents and Toxins will be involved.  In some cases, the USG funding agency may notify the Institution that the research is DURC.  Prior to initiation of work with (or purchase/receipt of) these agents/toxins, the Investigator must notify Regulatory Services (817-272-3723 or regulatoryservices@uta.edu) and submit the DURC Application Form.

Regulatory Services will confirm involvement of nonattenuated forms of High-Consequence Agents and Toxins and determine applicability of USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.  Projects determined to be under the scope of USG DURC policies will be reviewed by the IRE.

Regulatory Services will coordinate the process of forming an IRE appropriately constituted in accordance with USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern and with expertise necessary to review the proposed research.

The Investigator will provide details of the proposed experiments involving High-Consequence Agents and Toxins via the DURC Application Form for evaluation by the IRE.

The IRE will review the experimental details and determine whether the proposed research produces, aims to produce, or is reasonably anticipated to produce one or more of the effects described in Section 3 above.  In conducting its review, the IRE will utilize the guidance provided in USG’s Companion Guide to U.S. government policies for oversight of DURC and the IRE DURC Assessment Form.

The ICDUR will notify the Export Control Officer.  The fifteen High-Consequence Agents and Toxins are all included in the EAR control list (for the complete list, see Part 774 of the EAR available under the “Regulations” tab on the Bureau of Industry and Security homep­age at www.bis.doc.gov). This means that transfers of these materials, and/or information or technology related to their development, production, or manipulation, are subject to the EAR and may require an export license or a deemed export license. The Export Control Officer will evaluate the use and personnel involved in the research and advise the IRE on any additional security provisions that may need to be included in the risk mitigation plan.  The Export Control Officer will be responsible for securing any necessary export licenses.

UTA may consult with the USG department or agency that is funding the research in question for advice on matters related to DURC. Such consultations will be coordinated by the ICDUR. The funding agency program officers can provide guidance on DURC issues. Questions regarding non-USG funded research will be directed to NIH or to the USG funding agency to which NIH refers the institution based on the nature of the research in question. Consultation with the funding agency is not mandatory or intended as a substitute for institutional dual use review or the reporting requirements. Such consultations may be appropriate when

1. The IRE requires guidance on developing an adequate risk mitigation plan in cases where the potential risks are perceived as particularly high; 
2. The IRE considers the only viable risk mitigation measure to be not conducting or not communicating the research in question; 
3. The PI does not agree with the finding of the IRE and so the institution would like to request outside advice;
4. The research in question represents a particularly complex case or appears to fall outside the scope of this Policy, but still seems to present significant concerns; or
5. Guidance is required to ensure a clear understanding of how the USG interprets the definition of DURC and related terms. 

Within 30 calendar days of the IRE’s determination, UTA will notify the USG funding agency (via the Form for 30-Day Report of DURC to USG) whether the research meets or does not meet the definition of DURC.  If the IRE determines that the research in question does not meet the definition of DURC, the research is not subject to additional DURC oversight, but the institution shall notify the appropriate USG funding agency of the institutional review findings. For non-USG funded research, notification will be made to the NIH which will receive the notification for administrative purposes and will in turn refer the notification to an appropriate agency based upon the nature of the research

1. This initial notification will include: the grant or contract number related to the research (if the research is funded by the USG); the name(s) of PI(s); the name(s) of the High-Consequence Agent(s) or Toxin(s); and a description of why the research is deemed to produce one or more of the experimental effects listed in Section 3. For research that is determined by the IRE to meet the definition of DURC, the notification should also include: the name of the investigator (if different from the PI) responsible for the performance of the DURC; and a description of the IRE’s basis for its determination.

The IRE will perform a risk assessment to identify all potential risks, and also identify the anticipated benefits of the research.  In cooperation with the Investigator, the IRE will draft a risk mitigation plan to guide the conduct and communication of the DURC.  The IRE will utilize the guidance provided in USG’s Companion Guide to U.S. government policies for oversight of DURC to draft a risk mitigation plan.

The institution will work with the USG funding agency or for non-Federally funded DURC, the NIH-designated USG agency, to complete and provide the draft risk mitigation plan within 90 calendar days of the IRE’s determination that the research is DURC

The USG funding agency will finalize the risk mitigation plan within 60 calendar days of receipt of the draft plan.

Following approval of the risk mitigation plan by the USG funding agency, the Investigator may implement the plan and initiate work.

Risk mitigation plans will be evaluated by the IRE at least annually and modified as necessary for the duration of the research.

The IRE will develop a plan for continuing review and/or monitoring to ensure that the DURC is conducted in accordance with the risk mitigation plan.

The Investigator will conduct and/or communicate research according to their risk mitigation plan.

UTA will provide the USG with notification within 30 calendar days, of: 1) any change in the status of a DURC project at the institution (including whether the research is determined by the IRE to no longer meet the definition of DURC), and 2) details of any changes to risk mitigation plans (such changes need to be approved by the funding agency).