Research Data Guidance
The University of California issued a Research Data Policy, effective July 15, 2022, that clarified "the Regents of the University of California owns Research Data generated or collected in the course of University Research, and exercises this responsibility to support research, collaboration, public dissemination of information, and to meet its responsibility under sponsored research awards and other research agreements." Ownership of Research Data by the University of California is a longstanding precept originally articulated in Regulation 4 (Academic Personnel Manual 020).
- Defines Research Data as recorded information embodying facts resulting from a scientific inquiry, regardless of the form or media in which they may be recorded. Research Data does not include:
- "Scholarly and Aesthetic Works" defined under the University of California's Copyright Ownership Policy;
- Informal notes, preliminary analyses, drafts of scientific papers, and communications with colleagues that do not include recorded information embodying facts resulting from a scientific inquiry;
- Administrative records incidental to award administration such as financial records, contract and grant records, or records related to institutional reviews and approvals; and
- Patient source documents and medical records created in the course of clinical care.
- Identifies Principal Investigators as the primary stewards of Research Data. Research Data will be retained by the Principal Investigator of a research project. However, the University may take custody of Research Data under certain circumstances, such as where necessary to perform any investigations associated with allegations of research misconduct, litigation, or to ensure continuity of research.
- Assigns responsibility for the interpretation, implementation, and oversight of the Policy to the Vice Chancellor for Research.
For more information, visit FAQs about UC's Research Data Policy.
Principal Investigator's Responsibilities
When Conducting Research
- The PI provides scholarly leadership pertaining to Research Data, including the collection, recording, managing, and disposal of Research Data.
- The PI determines use of Research Data by other University Researchers and collaborators on the project in accordance with relevant agreements, their scholarly discipline's practices, and the need for academic progress of academic appointees, postdoctoral scholars, degree candidates, and other students.
When University Researchers Leave UCI
- If a University Researcher is leaving UCI and requests a copy of the Research Data generated in the course of their UCI research, the Principal Investigator will review the request and any applicable requirements (sponsor, regulatory, legal, etc.).
- For any disputes, contact the Unit Head or Department Chair.
- If the Principal Investigator is leaving UCI and plans to take Research Data to new institution, contact Sponsored Projects Administration for Data Use Agreement to ensure compliance with applicable requirements (sponsor, regulatory, legal, etc.). Co-Principal Investigators (if applicable) will also be consulted.
- The departing PI must arrange with their school, department and/or other academic unit for the management or disposition of any Research Data that remain at UCI in accordance with University policies and/or legal, funder or contractual requirements.
When Research Project Completed
- The PI makes decisions regarding what Research Data should be preserved or dispositioned following the most stringent of these multiple requirements, based on the following:
- Legal, funder or contractual requirements (including incoming and outgoing data transfer and use agreements);
- Retention requirements of their scholarly discipline, campus departments, funding agencies, and applicable law and regulation;
- Protection of intellectual property and completion of University patenting and licensing procedures for inventions;
- Subject to allegations of research or other misconduct, investigations, or litigations;
- For research projects that involved articles regulated by Food and Drug Administration retention, consistent with 21 C.F.R. §§ 312.6 and 812.140- Retention of records for two years or as long as required following the date a marketing application is approved for the product; or if a marketing application is not filed or FDA-approved, for two years after the investigation is terminated, completed, or otherwise discontinued and the FDA is notified; or
- For student participation in research (in advancing to a degree), retention of Research Data connected to that research until the student has been awarded a degree, or until the student is no longer working on the project or is not enrolled in the University.
Research Data Procedures
Outgoing Research Data
When Researchers (other than the Principal Investigator) involved in a University research project leave UCI, they may take copies of the Research Data that they generated or collected during their University Research, subject to approval by the Principal Investigator and any applicable sponsor requirements. Since the ownership of the Research Data remains with UCI and Principal Investigators continue to be the primary stewards, Researchers must contact the Ancillary Agreements Officer in Sponsored Projects Administration to initiate a Data Transfer and Use Agreement before taking copies of the Research Data.
When a Principal Investigator leaves UCI and a University Research project is to be moved to another institution, the ownership of Research Data may be transferred or licensed to the new institution. Contact Ancillary Agreements Officer in Sponsored Projects Administration to start the process.
Incoming Research Data
If the research data provider is a for-profit (Industry), contact the Industry Sponsored Research Director. If the data is related to industry sponsored clinical trials, contact the Clinical Trials Director.
If the research data provider is a non-industry entity (universities, non-profits, research institutes, governments, etc.), contact Ancillary Agreements Officer in Sponsored Projects Administration.
Disposition of Research Data
Principal Investigator should review the "When Research Project Completed" section in the above Principal Investigator's Responsibilities chart and consult the appropriate Research Data Contacts to ensure there are no remaining retention obligations before disposing of the research data.
Data Transfer and Use Agreements
A data transfer and use agreement (DTUA) authorizes the transfer of a data set for specified limited purposes (e.g., conducting human research). DTUA terms typically address intellectual property, publication, confidentiality, etc. In some cases, these data use terms can be incorporated into an existing agreement for the transaction such as a subaward, material transfer agreement, clinical trial agreement, collaboration agreement, etc.
Entering into a DTUA is best practices any time UCI faculty is granting access and/or transferring UCI generated data to a non-UCI entity for research purposes. The DTUA will protect the data, ensure they remain under UCI ownership, and limit the purpose of how the data are used. If the data contains Protected Health Information (PHI), a DTUA is required.
- Federal Demonstration Partnership Data Transfer and Use Agreement Guidance Chart
- Research-Related Agreements Responsible Offices- information on other types of agreements
Research Data Contacts
|Industry (for-profit)||Industry Sponsored Research Director, David Gibbons (firstname.lastname@example.org)- Beall Applied Innovation Industry Sponsored Research|
|Non-Industry (non-profit, government, educational institution, etc.)||Ancillary Agreements Officer, Wanda Seang (email@example.com)- Sponsored Projects Administration|
|Clinical Trials||Clinical Trials Director, Tam Tran (firstname.lastname@example.org)- Clinical Trials Team|