RES-002: Ownership, Retention, Safeguarding, Management, and Transfer of Research Records
Academic Division and the College at Wise.
The University is committed to the collection, maintenance, and safeguarding of research records in an accessible format. Requirements have been established to support verification of the research processes undertaken and of the resulting data as well as to comply with applicable laws and regulations.
Principal Investigator (PI):
The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically.
Any person who may be engaged in University research.
Significant University Resources:
The use of University resources is “significant” when it entails substantial and dedicated use of University equipment, facilities, or personnel. The use of a computer in a faculty office, incidental supplies, and occasional use of University personnel or shared facilities would typically not be considered significant use. In contrast, utilization of University laboratories or specialized research resources (e.g., special instrumentation, equipment, or software), dedicated assistance by University employees, special financial assistance, or extensive use of shared facilities would constitute significant use.
Any externally funded research, public service, or scholarly activity (including hosting or attending conferences) at the University that has a defined scope of work often including a set of specific programmatic objectives and/or deliverables, and line-item-based budget, providing the basis for sponsor expectations and awardee accountability (i.e., a reciprocal transfer of something of value). Sponsored programs are funded through agreements that usually include terms and conditions for the disposition of tangible properties and outcomes (e.g., equipment, records, specified technical reports, theses, or dissertations) or intangible properties and outcomes (e.g., rights in data, copyrights, and inventions). Note: The terms sponsored program, sponsored project, and/or sponsored activity are often used interchangeably.
Funds and facilities provided by governmental, commercial, industrial, or other private organizations which are administered and controlled by the University shall be considered University resources.
Recorded information that documents a transaction or activity by or with any appointed board member, officer, or employee of the University. Regardless of physical form or characteristic, the recorded information is a University record if it is produced, collected, received or retained in pursuance of law or in connection with the transaction of university business. The medium upon which such information is recorded has no bearing on the determination of whether the recording is a University record. University records include but are not limited to: personnel records, student records, research records, financial records, patient records, and administrative records. Record formats/media include but are not limited to: email, electronic databases, electronic files, paper, audio, video, and images (photographs).
One type of University record that includes, but is not limited to: grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files. In addition, research records include any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct.
The retention of accurately recorded and retrievable research records, including but not limited to research results and associated metadata, is of the utmost importance in the conduct of research. Researchers (e.g., faculty, research staff, fellows, assistants, technicians, students, and volunteers) shall maintain complete and verifiable records of the procedures they have followed in pursuing all research, and the subsequent data they have thereby obtained.
Individuals responsible for supervising the conduct of research are encouraged to regularly discuss their expectations and any applicable requirements (e.g., University, regulatory, or sponsor) for research data management (e.g., collection, storage, access, sharing, use, security, and backup) as part of broader discussions about research ethics and integrity.
Researchers, whether or not supported by sponsored programs, are responsible for compliance with all applicable University policies pertaining to the conduct and reporting of research.
Ownership and Retention:
Research records are the property of the University of Virginia if significant University resources, including sponsor-provided resources, are used to produce them (see University policy RES-001: Ownership Rights in Copyrightable Material).
Research records must be retained in accordance with the requirements of University policy IRM-017: Records Management, associated retention schedules and standards (for additional information, see Records and Information Management).
Original research records must be maintained under University control. For physical research records (e.g., laboratory notebook or logbook) this means in a secure University location (e.g., office or laboratory) or at a contracted vendor site (see Off-Site Records Storage for information) where they cannot be removed by an unauthorized person. When research records are created off-Grounds (e.g., at field sites), they are to be placed in a secure University location as soon as practicable.
Electronic research records must be maintained on University-owned and/or University-managed devices, systems, or services which include deposit with external data repositories consistent with sponsor requirements (e.g., NIH Data Management and Sharing Plans). Safeguarding must be in accordance with IRM-003: Data Protection of University Information, the applicable data protection standard (i.e., for highly sensitive, sensitive, internal use, or public data), and any associated procedures. Unpublished research records are categorized as “sensitive data” or “highly sensitive data.”
When a discrepancy exists between a University data protection standard and an applicable external data protection standard (e.g., law, regulation, sponsor, or other contractual requirement) the more stringent will apply and must be implemented. See the Research Data Security content on the Vice President for Research’s website for information on various sponsor requirements/expectations and links to UVA resources available to support research.
Research Data Management:
Researchers must establish, communicate, and enforce appropriate data management procedures consistent with applicable University policies, laws/regulations (e.g., the Health Insurance Portability and Accountability Act of 1996 (HIPPA) or the Family Educational Rights and Privacy Act (FERPA)), contractual agreements (e.g., data access/use agreements) and, in the case of human subject research, informed consent. This includes, but is not limited to, determining appropriate access permissions at the onset of the project and periodically throughout the project lifecycle. Best practice is to review permissions concurrent with changes in project personnel and/or assigned roles/responsibilities but at least annually.
Researchers are encouraged to include provisions for the backup of research records as part of their data management procedures. Best practice is to maintain backups in a separate location in the event primary records are lost, e.g., due to system failure, natural disaster, or ransomware attack.
In addition, principal investigators are responsible for developing data management procedures consistent with applicable sponsor terms and conditions such as restrictions on dissemination (e.g., prior approval requirements for access to research records, participation in the research, or publication/presentation of results) or data management and sharing (e.g., NIH Data Management and Sharing policy).
Transfer of Research Records (Original or Copies):
Researchers leaving the University of Virginia may transfer research data to another institution, provided that the Vice President for Research is informed of this transfer and approves of it. This shall be subject to the proviso that the University is given written assurance that the data will be retained for the period stipulated in the applicable retention schedule and be made available to the University upon request. Requests for approval from the VPR’s office may be submitted to firstname.lastname@example.org.
Any transfer of research records (original or copies) that include highly sensitive data (HSD) (e.g., HIPPA, FERPA, Controlled Unclassified Information (CUI), or export-controlled) require special considerations and must be approved by the responsible University office (e.g., Institutional Review Board for human subjects data or Office of Export Controls for controlled technical data). Questions should be addressed to email@example.com.
Research fellows, students, and visitors working on UVA sponsored research may take copies of research records with them when leaving the University only if approved in writing by the principal investigator and, if the research records include HSD, the responsible University office. Such approval should occur as part of the off-boarding process.
A principal investigator, or other employee overseeing the conduct of research, may approve the temporary transfer of a copy of research records to UVA team members’ personally owned device(s) to facilitate data analysis and reporting, provided all applicable safeguarding requirements are satisfied. Such temporary transfers neither change the ownership of nor confer rights for future use of the research records.
Compliance with Policy:
Fabrication, falsification, plagiarism, in proposing, performing, or reviewing research or in reporting research results is subject to University policy RES-004: Research Misconduct.
Failure to comply with requirements of this policy and/or its standards may result in disciplinary action up to and including termination or expulsion in accordance with relevant University policies.
Violation of this policy may also violate sponsor requirements, federal, state, or local laws.
Questions about this policy should be directed to the Office of the Vice President for Research.