UCOP International Affiliations Mandate Overview
The update from UCOP highlights the focus on enhanced review and approval processes, inventory of international collaborations, and routine reporting of affiliations. President Drake's directives emphasize guidance issuance and implementation plans, along with challenges faced in maintaining record retention systems and addressing potential technology IRB submissions. The formula for in-scope activities underscores the requirement for enhanced review by UCOP for institutional-level affiliations and agreements, especially concerning countries of concern and emerging technologies.
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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
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 a. SOPs b. Tools - Intake Form c. Research Security Review Form d. 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
RECAP - President Drake, August 28, 2023 Letter to Chancellors & LBNL
UCOP International Affiliations Mandate 1. Enhanced Review and Approval Process 2. Inventory of International Collaborations 3. Routine Reporting of Affiliations
Formula for in-scope activities Institutional Level Affiliations and Agreements Requires Country of Concern Emerging Technology Enhanced Review and Approval by UCOP
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
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
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
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.
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
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
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
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)
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
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
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
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
Inventory of UC Engagements with Countries of Concern EXCLUDED Agreements
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
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)
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
