UC San Diego SearchMenu

DURC: PI Responsibilities

Learn about PI responsibilities related to Dual Use Research of Concern (DURC).

Principal Investigators are responsible for assessing whether their research is DURC, reporting this assessment to the DURC Institutional Review Entity (IRE), and, if applicable, implementing a risk mitigation plan.

Assessment

Before commencing research with DURC Agents, the Principal Investigator (“PI”) must first make a determination about whether:

  1. The research directly involves non-attenuated forms of one or more of the potential DURC Agents; or
  2. The research with non-attenuated forms of one or more of the potential DURC Agents also produces, aims to produce or can reasonably be anticipated to produce one or more Experimental Effects of Concern; or
  3. The PI concludes that his/her research may meet the definition of DURC. If research is determined not to meet the DURC criteria, it is the responsibility of the principal investigator to monitor his other research on an ongoing basis and notify the Institutional Review Entity (IRE) if anything changes that may alter the initial IRE determination.

Submit summary

The PI’s assessment in regarding the above should be summarized in writing and this summary shall be registered and retained with the UCSD DURC Institutional Review Entity (IRE) via the Institutional Contact for Dual Use Research (ICDUR) through the existing Biohazard Use Authorization program.

The PI will provide the ICDUR with documentation in accordance with local campus policies and procedures, indicating the reasons for concluding that his/her research involves, or does not involve potential DURC, along with sufficient data to permit the IRE to complete the review required.

Implement risk mitigation

If the IRE determines that the proposed research is DURC, the PI will be expected to:

  1. Collaborate with the IRE to develop the Risk Mitigation Plan.
  2. Conduct DURC in accordance with the final Risk Mitigation Plan;
  3. Notify the ICDUR of any substantive change in the on-going conduct of the DURC;
  4. Notify the ICDUR if for whatever reason (e.g., changes in the research, new discoveries), he/she feels that the research should no longer be considered DURC;
  5. 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 research with one of more of DURC Agents have received appropriate education and training on DURC;
  6. Be knowledgeable about and comply with all UC and federal policies and requirements for oversight of DURC; and
  7. Communicate about the DURC in a responsible manner and in compliance with the approved risk mitigation plan.