Update: UCOP International Affiliations Mandate Kairi Williams, Assistant Vice Chancellor, Research Administration Compliance Brian Warshawsky, Director, Research Ethics Compliance RAC FORUM February 28, 2024 Topics Recap: President
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Update: UCOP International Affiliations Mandate Kairi Williams, Assistant Vice Chancellor, Research Administration & Compliance
Brian Warshawsky, Director, Research Ethics & Compliance
RAC FORUM
February 28, 2024<br>
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Topics Recap: President Drake, August 28, 2023
1. Enhanced Review and Approval Process
2. Inventory of International Collaborations
3. Routine Reporting of Affiliations
Guidance on 1. Issued November 20, 2023
Guidance on 2. Issued February 1st, 2024
Due Date May 1st, 2024
Berkeley Implementation plans - Enhanced Review & Approval Process
Partnering Offices - SPO, IAO, UDAR, GEO
Intake focus on Countries of Concern
Emerging Technologies reviewed by RAC
Operationalizing the review process
SOPs
Tools - Intake Form
Research Security Review Form
Risk Assessment form draft
General Review
Export Control Review
Disclosure Review
Legal Review
Potential Need: Technology IRB
Submission Process TBD
Record Retention/Systems of Record
Challenges - Fundamental Research, General Review, Proposal notifications
Questions<br>
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RECAP - President Drake, August 28, 2023 Letter to Chancellors & LBNL<br>
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UCOP International Affiliations Mandate 1. Enhanced Review and Approval Process
2. Inventory of International Collaborations
3. Routine Reporting of Affiliations<br>
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Formula for “in-scope” activities Institutional Level Affiliations and Agreements Emerging Technology Country of Concern Requires “Enhanced Review and Approval” by UCOP<br>
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Affiliations and Agreements Engagements
Affiliations
Collaborations
Agreements including but not limited to:
non-federal proposals and sponsored research agreements (SPO, IAO)
gifts (UDAR)
international agreements and MOUs (GEO, IAO, SPO, RAC)
Institutional vs. Individual
Does not include individual collaborations, visits or travel<br>
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Countries of Concern include Democratic People's Republic of Korea (North Korea)
Islamic Republic of Iran
People's Republic of China (including Hong Kong and Macau)
Qatar
Russian Federation
Saudi Arabia
United Arab Emirates<br>
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International Engagement Enhanced
Review & Approval Guidance Guidance Issued November 20, 2023
Defines the criteria expected of UC locations to meet the new UCOP Presidential Mandate on international engagements.
This includes a robust Research Security Review Criteria to be performed by the location before completing a Submission Form to request Enhanced Review and Approval from UCOP.
Defined Elements of the Review Criteria include:
General Review
Export Control Review
Disclosure Review
Legal Review<br>
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International Engagement Enhanced
Review & Approval Guidance (Continued) Described options include:
Assigning the review to an official with the relevant knowledge, experience, and duties;
Convening a committee or other group to share the review responsibilities, including establishing a “Technology IRB” comprised of subject matter experts;
Creating a process that completes all the Review Criteria through various processes and areas of responsibility, which is intended to be coordinated by the export control officer, acting as the Research Security lead.<br>
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Activities Out of Scope Non-disclosure Agreement (NDA) or Confidentiality Agreement (CDA)
Federally Sponsored grants or contracts, federally sponsored research with foreign subawards, or federally sponsored research with foreign-located collaborators
Sales and Service Agreements
MTAs and DUAs
Patent/Intellectual Property licensing
Purchasing and Procurement
Gifts under $50k
Degree granting programs without a research component or exchange<br>
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Implementation Underway Campus-wide point of contact (Research Ethics and Compliance, REC)
Facilitate internal review and submission to UCOP
UC Berkeley SOP and intake form (drafts available)
Contract offices (SPO, UDAR, IAO & GEO) to work with faculty to communicate with REC
Leverage “Country of Concern” as our internal escalation criteria
Work on backend for UCOP approvals based on technology and type of affiliation
Initiate communication plan and develop web resources/guidance
Establish campuswide Research Security and Export Controls Committee<br>
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Tools SOPs
Intake Form
Research Security Review Form (RAC Internal)
Risk Assessment form draft
General Review
Export Control Review
Disclosure Review
Legal Review
Web Resources - Expanded Research Security Pages (in develop)
Systems of Record<br>
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Tools: Online Intake Forms<br>
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Submission to UCOP<br>
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Additional Implementation Considerations Technology IRB Committee vs reliance on PI Determination
Potential committee review model -
Berkeley Research Security and Export Control Committee
Status of Fundamental Research
General Review risk review questions
Proposal notification to sponsor
Additional guidance (Inventory) expected late January, early Feb, 2024 (draft guidance with the President)<br>
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Emerging technologies include… According to the mandate emerging technologies include:
Biotechnology (Note: currently, the government has identified the following areas of biotechnology as emerging technology: Nanobiology, Synthetic biology, Genomic and genetic engineering, Neurotech).
Artificial intelligence (AI) and machine learning
Positioning and navigational technology
Microelectronics or Semiconductors
Advanced computing
Data analytics technology
Quantum information and sensing
Additive manufacturing
Robotics and autonomous systems
Brain-computer interfaces
Hypersonics
Advanced materials
Advanced surveillance
New regulations have no exclusion for fundamental research<br>
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Inventory of UC Engagements with Countries of Concern Guidance Issued February, 1, 2024
Defines the criteria expected of UC locations to submit inventory
Timing: 90 Days (May 1st)
NOT limited by Emerging Technologies<br>
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UCOP: Which offices should locations coordinate to gather the requested information? We suggest you coordinate, minimally, with the following offices at your locations to gather the information requested. Other offices should be consulted at location discretion:
• Procurement
• Contracts & Grants
• Intellectual Property and Industry Research Offices
• Development/Institutional Advancement Offices
• The International Scholars and Student Office and offices that can enter into International Agreements
• Extension
• Academic Deans/Department Chairs
• Departments, Schools or Organized Research Units<br>
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Inventory of UC Engagements with Countries of Concern REC Working with contracting units across campus to compile this data
IAO
GEO
BCBP
SPO
Others/Depts
Challenge: Units/Departments that fall outside of known systems of record such as PHOEBE or CADS<br>
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Inventory of UC Engagements with Countries of Concern EXCLUDED Agreements<br>
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Inventory of UC Engagements with Countries of Concern Working with contracting units across campus to compile this data
IAO
GEO
BCBP
SPO
UDAR
Others
Challenge: Units/Departments that fall outside of known systems such as PHOEBE or CADS<br>
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Inventory of UC Engagements with Countries of Concern Information needed includes:
1. International Entity(ies) Involved
2. Country(ies) of Concern Involved
3. Start Date (Actual or Proposed)
4. End Date (if applicable)
5. Status (Active or Pending)
6. Type of Engagement (MOU, gift, contract, etc.)
7. Description of UC Location’s Involvement (i.e. MOU for student exchange program)
8. Support (Financial, in-kind or other valued received by UC as a result of the engagement)
9. Responsible party (PI, Dept Chair, Etc) or Engagement Point of Contact (include their titles)
10. Engagement Title
11. Department or Unit
12. Other information (optional)<br>
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Inventory of UC Engagements with Countries of Concern Engagements for this effort include only “Institutional Level” activities.
As defined, an Institutional Level activity is one undertaken by or on behalf of the University, a location or any of its components are considered at the Institutional Level. In contrast, “Individual Level” activities (which are not included in the definition of "Engagements," and which therefore do NOT need to be included in the location inventories) include activities undertaken by a researcher acting in their individual capacity.
Gifts over $50K<br>
