Project Overview
UC Berkeley must comply with new Federal compliance regulations by May 2025 otherwise we risk the potential for research being misused to pose a threat to public health or national security. If we do not demonstrate internal review under new DURC Plan we can lose Principle Investigator grant funding and stop research progress on our campus. We also could harm the university image and reputation in research if we are not compliant and allow and misuse of agents covered in new Federal Policy.
Project Details
Project Charter (Expand)
Problem Statement
New federal regulations require UC Berkeley to implement a Dual Use Research of Concern (DURC) Plan by May 2025. This plan requires UC Berkeley to actively review research that falls under USG Policy for Oversight of DURC and Pathogens with Enhanced Pandemic Potential which expands from 13 to 65 Biological Agents (bacteria, virus, fungi, protozoa, microorganisms and proteins). Many aspects of the regulatory compliance are novel and will involve multi-departmental collaboration to develop and implement required changes to comply with new Federal regulations. Currently no Committee exists within UC Berkeley to review and assess research projects for Dual Use to maintain compliance under new federal regulation.
Objectives
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Draft and implement new UC Berkeley Dual Use Research of Concern (DURC) Plan before May 2025 - satisfying the requirements of newUSG Policy for Oversight of DURC and Pathogens with Enhanced Pandemic Potential.
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Implement Proposed Solution: Develop, Draft, and Implement new Institutional Review Entity (IRE) which operates separate from IBC and serves as official review committee within the university to oversee research projects that could be considered “Dual Use Research of Concern” by assessing whether a research project involves certain biological agents and toxins that could be used for harmful purposes.
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IRE Conducts thorough risk assessment to determine potential harm and develops plan to mitigate risks and works with Principal Investigators of a research project to ensure appropriate safety measures are in place and addresses any concerns with misuse of research findings.
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Provide Comments on new UCOP Policy by March 2025 and align UC Berkeley’s DURC plan with UC Systemwide Policy and DURC UC Systemwide Committee initiatives.
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Determine and Appoint IRE Committee Members and draft IRE bylaws
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Determine and appoint ICDUR rep for UC Berkeley and Define ICDUR responsibilities- role?
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Develop DURC sustainable ownership/accountability sponsorship model and associated key stakeholders for sustaining DURC policy and compliance in future state
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Develop required Change Management plan to drive communications, including associated trainings
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Design and Map DURC Processes to operationalize DURC Plan
Success Metrics
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UC Berkeley DURC plan is documented, transparent to stakeholders, and operational prior to May 2025
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New IRE is operational and assessing research projects and compliant with DURC Federal Policy
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Number of Research Projects Reviewed and Assessed by IRE on annual basis
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How many DURC Awards are currently on campus today? Predicted in future?
Project Leaders
Sponsor: Kairi Williams
Project Manager: Chris DeMarco
Project Team Members:
- Jim Baugh (Functional Lead EH&S)
- Ingrid Castro Rodriguez (EH&S)
- Lily Montoya (HCLD/EHS)
- Brian Mitchell Warshawsky (RAC)
- Iris Ortega (RAC)
- Natalie Godfrey (RAC)
- Sam Chiang (EH&S)
- Marisa Mariscal (EH&S)
- Angela Ford (SPO)
- Ken Geis (RAC IT)
- Noam Pines (SPO)
- Elizabeth Brashers (VCRO)
- Satellite Team Members as needed:
- Joerg Heber (LBNL)
- Ask Angela Ford
- Mike Murphy/Russ Chung (SCM)
- Sanji Kumar/Kathy Yelic (Faculty/Principle Investigator)
- Gino Segre (HUB, BakerBIO, Incubators, Companies)
- Taylor Marcus (Skydeck)
- Eric Giegerich (IAO)
- Liv Hasset (Legal)
- ICDUR - Kairi Williams
