Last Updated: February 24, 2015 2:26:47 PM PST
Get guidelines on ensuring that research records are appropriately documented, maintained, retained for a reasonable time, and accessible to the University for appropriate review and use.
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. Basic guidelines are set forth in this document to ensure that research records, including data relating to research and tangible research materials, are appropriately documented, maintained, retained for a reasonable time, and accessible to the University for appropriate review and use.
These Guidelines apply to all UCSD-employed or affiliated academic personnel, staff, trainees, and students, engaged in research or research-related activities at the University of California San Diego, regardless of funding source of such activities.
These Guidelines also apply to non-UCSD employees engaged in research or research-related activities at UC San Diego facilities under the auspices of the University or in collaboration with individuals with University appointments.
The Vice Chancellor for Research is responsible for oversight, interpretation and implementation of these Guidelines.
- “Research Data” is recorded information reflecting original observations and methods related to a research study, and documentation of such data needed to reconstruct and evaluate reported results of the study, regardless of the form or medium on which it may be recorded, that is: (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. Such data includes, but is not limited to, computer software, databases, and data of a scientific or technical nature, such as laboratory notebooks, field notes, electronic storage media, and printouts. Research Data also includes “Tangible Research Material”, as defined below. Research Data does not include records incidental to award administration such as financial records, contract and grant records, etc. All such records generated by University researchers, while not addressed in these guidelines, are the property of the University and may be subject to terms and conditions of individual sponsored projects, federal and state regulations, and University retention and disposition requirements.
- “Tangible Research Material” is 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.
- “Principal Investigator”: For the purposes of these guidelines, the “Principal Investigator” is the individual that has primary responsibility for the design, conduct and administration of a research project, regardless of the source of funding or status of that project.
Research Data is the property of The Regents of the University (see below). The Principal Investigator is the steward of Research Data owned by the University, and of any other data acquired or used during his or her research.
The Principal Investigator is responsible for ensuring that Research Data is maintained in accordance with these Guidelines and other applicable University policies, guidelines, and practices.
The Principal Investigator shall retain original Research Data on behalf of the University, in accordance with Section VII.b. of these Guidelines.
The Principal Investigator is responsible for ensuring that Research Data is recorded and stored in accordance with the standards of his or her 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 office 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.
The University of California San Diego supports the sharing of Research Data to advance public knowledge.
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).
- i. In most research contracts and grants, the University has committed to the sponsor that it will retain Research Data and make it available as appropriate.
- ii. Research agreements and clinical trial agreements with industry sponsors and other institutions require careful negotiations to avoid placing restrictions on the University’s access to, use of, and dissemination of Research Data.
- iii. The University must be able to protect the ability of its students, postdoctoral scholars, and staff to access Research Data from research in which they participated.
- iv. Research Data that is not a Tangible Research Material: Except in the case of Tangible Research Material, the Principal Investigator may take copies of Research Data produced by him or her or under his or her direction while at the University when a Principal Investigator leaves 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.
- v. Tangible Research Materials: If a Principal Investigator leaves 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.
- vi. 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.
Principal Investigator Responsibilities
- i. In general, Principal Investigators should retain all Research Data for as long as possible, but not less than a minimum of six years after final reporting, publication, completion or abandonment of the project, unless a longer retention period is indicated by the funding source or other relevant agreement. The University may require a longer retention period to comply with applicable law or regulations, to support patent or intellectual property claims, to perform any necessary investigations associated with allegations of research misconduct. If a student is involved, Research Data must be retained at least until the degree is awarded or it is clear that the student has abandoned the work. Research Data may not be destroyed while an audit, misconduct inquiry, investigation, public records request, or legal action involving such Research Data is pending.
- ii. If a co-investigator, student, trainee, or other member of a research team leaves the University, all original Research Data must be left with the Principal Investigator. Except with respect to Tangible Research Materials, the departing researcher may take copies of Research Data for projects on which they have worked. A co-investigator, student, trainee, or other member of a research team may not independently publish Research Data prior to first publication by the Principal Investigator without the written consent of the Principal Investigator. This should not be construed to prevent students from filing a copy of their dissertations or theses as required by their schools or departments, including depositing copies of their theses in archives as may be required by their schools or departments.
For more information, contact the ORA main desk at (858) 534-9758.