Research Data Access, Use and Management

Last Updated: July 22, 2024 3:21:35 PM PDT

Learn about the University of California Research Data Policy that applies to all Research Data generated or collected during the course of University Research.

The University of California (UC) Research Data Policy (Policy) was issued on August 9, 2022, and went into effect on July 15, 2022. This Policy applies to all Research Data generated or collected during the course of University Research. The Policy intends to clarify the ownership of and responsibility for Research Data generated during the course of University Research, encourage active data management and sharing practices, and provide guidance with respect to procedures when a researcher leaves the University.

The collection and generation of data and tangible research materials is an integral part of any research project. Accurate and appropriately recorded Research Data, including materials, enables scholars to report, replicate, and refute research findings, which advances the research enterprise.

The University, its faculty, staff and trainees have legal, institutional and ethical obligations to manage and retain such records of research conducted at the University.

Both the University and researchers have responsibilities concerning access to, use of, and maintenance of Research Data and research materials.

These obligations are not new and are not unique to the University, they arise from express provisions in awards and agreements with federal and other research sponsors, overarching regulatory requirements relating to funded research, and fundamental precepts of research integrity.

University access to records of research is critical for oversight purposes, including responding to audits, to establish that past use of University or research sponsor funds had been appropriate, to respond to government demands or subpoenas, to defend research findings, to facilitate research misconduct proceedings, and to assure proper conduct of research with humans or animals.

Definitions

Principal Investigator(s): The University Researcher primarily responsible for a research project, including design, conduct and reporting, regardless of funding source or formal title.
Research Data: Recorded information embodying facts resulting from a scientific inquiry, regardless of the form or media in which they may be recorded. Research data includes “Tangible Research Material”, as defined below. Research Data do not include:
- “Scholarly & 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.

University Research: Research conducted by the Principal Investigator or University Researcher that is within the course and scope of their assigned or assumed duties, uses University resources, and/or is funded by or through the University.
University Researchers: The academic appointees, faculty, staff, post-doctoral scholars, trainees, clinicians, and any others involved in the design, conduct or reporting of University Research regardless of the funding source. Students who participate in the design, conduct or reporting of a Principal Investigator’s research project are considered University Researchers for the purpose of this Policy.
Tangible Research Material: A tangible item: (i) produced under a University researcher’s scope of employment; (ii) produced using University research facilities or other research resources; or (iii) produced using gift, grant or contract funds provided by or through the University. Tangible Research Material includes but is not limited to biological specimens, environmental samples, devices, prototypes, circuits, chemical compounds, genetically engineered organisms, cell lines, cell products, viruses, genetic material, plants, and animals.

Scope and Responsibilities

The Policy applies to all Research Data generated or collected during the course of University Research. University of California Regulation No. 4 (APM-020) provides that original records of the research are the property of the University. This states that the Regents of the University of California retain the ownership of Research Data created by University Researchers or Principal Investigators during the course of their University Research, unless otherwise agreed upon by the University.

Vice Chancellor for Research: The Vice Chancellor for Research is responsible for interpretation, implementation and oversight of the UC Research Data Policy. This includes establishing policies/procedures necessary for implementing this Policy, providing any guidance to Research Data users, and if necessary, sequestering any Research Data that is required for investigation and protecting the rights of University Researchers to their data.
University Researchers: University Researchers are responsible for following best academic practices with regards to research integrity, including collection, recording and storing of Research Data. University Researchers are also responsible for managing and sharing Research Data in accordance with all University policies, legal requirements and any third party agreements. Please consult with Principal Investigator and/or Vice Chancellor of Research for any clarification of obligations and resolution of disputes related to Research Data.
Principal Investigators: Principal Investigators are the stewards of Research Data owned by the University, and of any other data acquired or used during their research. They are to provide scholarly leadership pertaining to Research Data, which includes all aspects of data collection, inclusive of data management, retention and disposal. Principal Investigators are responsible to determine the use of the Research Data by other University Researchers and collaborators on the project. Principal Investigators are also responsible for knowing the retention requirements for their Research Data. When determining retention periods, Principal Investigators need to take into consideration inventions, allegations, investigations, litigation and FDA regulations and student participation in research. The Principal Investigator is also responsible for ensuring that Research Data is recorded and stored in accordance with the standards of his/her/their respective discipline and any requirements of applicable federal or state law or regulations, University guidelines, or sponsored awards. Further, the Principal Investigator is responsible for the appropriate use of Research Data, whether generated by the Principal Investigator or obtained through material transfer agreements, license agreements or other means, and is responsible for ensuring that such use does not violate University contractual commitments. The Principal Investigator should consult the appropriate campus offices regarding the use and stewardship of Research Data that may be subject to applicable export control regulations, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), or other applicable laws and regulations.

In the event that the Principal Investigator leaves the University and/or a University Research project is to be moved to another institution:
- The Principal Investigator may take copies of the Research Data produced by him/her/them or under his/her/their direction while at the University. Original Research Data may be transferred with approval of the Vice Chancellor for Research, generally under a written consent between the University and Principal Investigator. In all cases, the University reserves the right to access the original Research Data. The University has the ability to impose conditions of this transfer of data or may require that the Principal Investigator leave copies of the Research Data with the University.
- Tangible Research Materials shall remain at the University. Subject to any third-party restrictions, Tangible Research Materials may only be transferred with the approval of the Vice Chancellor for Research or a delegated authority, generally under a material transfer agreement between the University and the Principal Investigator’s new employer.
- The stewardship and storage of Research Data should be discussed as part of the exit process when a Principal Investigator leaves the University to ensure that Research Data is accessible to the University in accordance with this guidance.

Data Sharing

UC San Diego is committed to disseminating research results as widely as possible. As part of this mission, and in accordance with numerous University policies, the University supports the free and unfettered dissemination of information, knowledge, and discoveries generated by University Researchers.

In the interest of advancing knowledge, the University expects Principal Investigators to release and share final Research Data for use by other investigators and researchers in a timely manner, consistent with the practices of the discipline involved, and in accordance with existing University policies and guidelines, including those related to intellectual property, sponsor requirements, and applicable laws and regulations, such as laws relating to protecting the rights and privacy of human subjects.

The National Institutes of Health policies on data sharing and sharing of biomedical research resources are models that investigators may find useful when planning for the sharing of Research Data (in all instances, Principal Investigators should consult individual award terms to determine whether an individual award is subject to any special handling of Research Data).

Procedures when a Researcher leaves the University

In the event that the Principal Investigator leaves the University and/or a University Research project is to be moved to another institution, the ownership of Research Data may be transferred to the new institution pending approval. The University has the ability to impose conditions of this transfer of data or may require that the Principal Investigator leave copies of the Research Data with the University.

Please see the UC Data Policy for more information.