Requirements for Data and Biospecimen Activities Involving Countries of Concern
Sender:
Vice Chancellor Roger M. Wakimoto and Associate Vice Chancellor Mark Krause
Office of the Vice Chancellor for Research, Innovation & Creative Activities
Ethics, Compliance & Audit
To:
Faculty and Staff
Dear Colleagues:
The U.S. Department of Justice (DOJ) and the National Institutes of Health (NIH) have issued requirements that impact UCLA activities involving access to sensitive personal data, government-related data and certain human biospecimens of U.S. persons. These requirements restrict or prohibit certain research collaborations, data-sharing arrangements, data access, material transfers and vendor relationships involving countries of concern, including individuals and entities in or associated with a country of concern. Currently, the DOJ and NIH consider countries of concern to be
China (including Hong Kong and Macau), Cuba, Iran, North Korea, Russia and Venezuela.
The
DOJ Bulk Data Rule prevents access to U.S. bulk sensitive data, including genomic, biometric, health, geolocation and other personal or government-related data of U.S. persons, by countries of concern.
UCLA requires prior institutional review and approval before engaging in a proposed transaction, collaboration, data access arrangement, transfer or other activity involving a country of concern.
What You Need to Do
•
Work with appropriate UCLA offices to facilitate institutional reviews before proceeding with any engagement involving a country of concern, including individuals and entities in or associated with a country of concern. The countries of concern are: China (including Hong Kong and Macau), Cuba, Iran, North Korea, Russia and Venezuela.
•
Set up a Material Transfer Agreement (MTA) or Data Use Agreement (DUA) through UCLA TDG for any transfers of material or data involving a country of concern.
•
Consult UCLA Export Control before engaging with any comprehensively sanctioned country (Cuba, Iran, North Korea, certain regions of the Ukraine).
•
Account for additional time for review and approval.