Dangerous Gain of Function (DGOF)

PIs are responsible for:

• Having knowledge about, complying with, and following all applicable institutional and U.S. government policies, requirements, and regulations for oversight of the use, movement, and modifications of biological agents that may fall under DGOF research, potential DGOF research (pDGOF), research involving Countries or Entities of Concern, and other iInternational research determined “risky."
• Timely updating Biohazard Use Authorizations (BUA).
• Assessing research at the proposal stage, attesting whether the research falls within the definitions of DGOF research, potential DGOF research (pDGOF), research involving Countries or Entities of Concern, and other international research determined “risky”, and continuously monitoring the research progress to determine if it may eventually meet one or more of those definitions.
• Notifying the Institutional Contacts for Dangerous Gain of Function when their research has potential for gain of function or providing information concerning the research to Biosafety or concerning the collaboration to Export Control.
• Implementation of a Risk Mitigation Plan when required by IRE.
• Implementing contract and grant terms and conditions supporting the research.

Assessment

Before commencing life science research, the PI must first determine whether the research:

1. Meets the criteria for Dangerous Gain of Function
2. Has the potential to meet the criteria for Dangerous Gain of Function
3. Involves entities or countries that meet the criteria of International Research of Concern

If research does not meet the any of these criteria, the PI must monitor research on an ongoing basis and notify the IRE of changes that may alter the initial IRE determination. PI should consult with Export Control if collaborating with a country or entity of concern.

Submit Summary

The PIs will submit documentation indicating reasons research does or does not involve gain of function through the existing Biohazard Use Authorization program.  The Biosafety team will evaluate the risk of Dangerous Gain of Function and provide documentation for review by the UCSD Institutional Review Entity (IRE).

Implement Risk Mitigation

If research is determined to meet Dangerous Gain of Function criteria, the use of federal funding is prohibited. If not federally funded, the institution will review the proposed research using the steps set forth for pDGOF.

If research is determined to have the potential to meet Dangerous Gain of Function criteria (pDGOF), the PI is expected to:

1. Collaborate with the IRE to develop and implement the Risk Mitigation Plan.
2. Notify the ICDGOFs of any substantive changes in the conduct of the DURC, including if it may no longer qualify as Dangerous Gain of Function;
3. Confirm 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 received appropriate education and training on Dangerous Gain of Function;
4. Be knowledgeable about and comply with all UC and federal policies and requirements for oversight of DURC; and,
5. Communicate about the DURC in a responsible manner and in compliance with the approved risk mitigation plan.

Research involving International Research of Concern is prohibited if federally funded.

If the research involves partners who meet the USG Policy of Other Risky International Research, federal funding is permissible. The PI is expected to develop a risk-based assessment and potential threat analysis in collaboration with the Institutional Review Entity.

The UCSD IRE Evaluates research with potential for Dangerous Gain of Function or International Research of Concern.

The UC San Diego Institutional Review Entity (IRE) performs initial risk-benefit analysis of Potential DGOF Research, oversees implementation of the PI risk mitigation plans and experimental modifications, and annually reviews risk mitigation plans.

IRE is administratively managed and supported by Environmental Health and Safety. For questions related to IRE, contact IRE@ucsd.edu.

UC San Diego’s Vice Chancellor for Research designates Sheryl Mansour, Biosafety Officer and Laura Provencher, Director of Export Control & Facility Security, to serve as UC San Diego’s internal resources for issues regarding compliance with and implementation of the requirements for oversight of Dangerous Gain of Function as well as the liaison between the University and the relevant Federal funding agencies. 

Principal Investigators (PIs) must notify the Institutional Contacts for Dangerous Gain of Function (ICDGOF) when they identify potential for Gain of Function in their research.

For guidance or assistance with:

Potential for Dangerous Gain of Function, please contact Sheryl Mansour, snmansour@ucsd.edu or ehsbio@ucsd.edu.

Research Involving Countries or Entities of Concern, please contact Laura Provencher, lprovencher@ucsd.edu or export@ucsd.edu.

Biosafety refers to IRE any protocols on Biohazard Use Authorizations (BUA) that indicate potential for Dangerous Gain of Function.

Initial Review

If the IRE determines the research meets the Dangerous Gain of Function criteria outlined by the U.S. government, it will notify parties as required by UC and federal policy. The IRE will work with the PI to remove DGOF components and create a Risk Mitigation Plan.

Continuing Research

The IRE will review at least annually all active Risk Mitigation Plans at the University. The IRE and the PI will modify Risk Mitigation Plans as needed to mitigate risks.

U.S. Policy for Stopping High-Risk Life Sciences Research