10.09 Research and Other Sponsored Projects Data or Record Ownership and Retention

A. INTRODUCTION

The University of Texas at San Antonio (UTSA) has both rights and responsibilities for the retention of research or other data acquired or developed as a result of a grant, contract, cooperative agreement or other sponsored agreement.;  Accurate and appropriate research and programmatic records are an essential component of any research or sponsored project. UTSA and the Principal Investigator/Project Director (PI) have responsibilities and rights concerning access to, use of and maintenance of original data including scientific data. Except where precluded by the specific terms of sponsorship or other agreements, signed by an Authorized University Official of UTSA, tangible research or sponsored project property, including all data and other records conducted under the auspices of UTSA, belong to UTSA. Furthermore, data and records produced from federally sponsored research are increasingly subject to requirements not only from the OMB Circular A-110 Section C.36. Intangible Property and Section C.53. Retention and access requirements for records, but also from 45 CFR, as amended by 56 FR 28003 Use of Human Subjects in Research.

B. APPLICABILITY

This policy shall apply to all UTSA faculty, staff, students and any other persons at UTSA involved in the design, conduct or reporting of research or sponsored projects at or under the auspices of UTSA, and it shall apply to all research or sponsored projects on which those individuals work, regardless of the source of funding for the project. UTSA must retain research and sponsored project data in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy and compliance with laws and regulations governing the conduct of the research or sponsored project. It is the responsibility of the PI to determine what needs to be retained under this policy. Where research or a sponsored project is funded by a grant or contract with UTSA that includes specific provision(s) regarding ownership, retention of and access to technical data, the provision(s) of that agreement may supersede this policy.

C. DEFINITION

Research and sponsored project data includes laboratory notebooks and field notebooks as well as any other records that are necessary for the reconstruction and evaluation of reported results of research or a sponsored project and the events and processes leading to those results, regardless of the form or the media on which they may be recorded. Furthermore the term includes software (computer programs, computer databases and documentation thereof), and records of scientific or technical nature. In practice scientific data include both intangible (statistics, findings, conclusions, etc.) and tangible data.  Tangible data include but are not limited to notebooks, printouts, computer disks, photographs, slides, negatives, films, scans, images, videotapes, autoradiograms, electrophysiological recordings, gels, blots, spectra, samples, specimens, IRB consent forms, research reports, analytical results, analysis, data contained in theses and dissertations and all other materials that are relevant to the research or sponsored project. 

D. OWNERSHIP AND ACCESS

1. The university's ownership and stewardship of the scientific record for research and sponsored projects conducted at UTSA, under the auspices of UTSA, or with UTSA resources is based on both regulation (OMB Circular A-110, Sec. 53) and sound management principles. UTSA's responsibilities in this regard include, but are not limited to:
   1. Complying with the terms of research or sponsored projects agreements;
   2. ensuring the appropriate use of animals, human subjects, recombinant DNA, etiological agents, radioactive materials, and the like;
   3. protecting the rights of students, postdoctoral scholars, and staff, including, but not limited to, their rights to have access to data results from research or sponsored projects in which they participated;
   4. securing intellectual property rights; and,
   5. facilitating the investigation of charges, such as scientific misconduct or conflict of interest.
2. Both the PI and UTSA have responsibilities and rights concerning access to, use of, and maintenance of original research or sponsored project data. Research or sponsored project data belongs to UTSA. UTSA can be held accountable for the integrity of the data even after the PI(s) has left the university. Although the primary data should remain in the UTSA laboratory where it originated, consistent with the precepts of academic freedom and intellectual integrity, the PI may be allowed to retain copies of the research records and materials created by him/her. Also see Section F below.
3. Where necessary to assure needed and appropriate access, UTSA has the option to take custody of the data or records in a manner specified by the Vice President for Research. When a collaborative team is dissolved, UTSA will allow each member of the team to have reasonable access to the data and materials with which he/she had been working, unless some other agreement was established at the outset. The unique materials prepared in the course of the research or sponsored project should be available and accessible under negotiated terms of a Material Transfer Agreement (MTA).

E COLLECTION AND RETENTION

1. The retention of accurately recorded and retrievable research or sponsored project data is of utmost importance for the progress of scientific integrity. The PI is responsible for the recording, collection, management and retention of research or sponsored project data. These records should include sufficient detail to permit examination for the purpose of replicating the research or sponsored project, responding to questions that may result from unintentional error or misinterpretation, establishing authenticity of the records, and confirming the validity of the conclusions.

2. PIs should adopt an orderly system of data organization and should communicate the chosen system to all members of a research or sponsored project group and to the appropriate administrative personnel, where applicable. Particularly for long-term research or sponsored projects, PIs should establish and maintain procedures for the protection of essential records in the event of a natural disaster or other emergency.

3. The experimental notebook and field notebook are the most common mediums for documentation of experiments and field work and their proper maintenance is of utmost importance. In addition to the study title, the investigator's name(s), and the study hypothesis, the experimental notebook and field notebook should include detailed information on the materials used, sources of the materials, experimental methodology, statistical treatments, results and conclusions so as to enable replication of the experiments by others at any time. Experimental notebooks and field notebooks should be signed daily by the person(s) entering information or data into the notebook. In the event that it is not possible, explicit instructions as to where the data can be found (e.g. location of disks, samples, specimens, etc.) should be included in the notebook.

4. For studies involving several investigators/collaborators, possibly in more than one laboratory, it is recommended that the PI of record maintain a master log that catalogues the experiments of the whole study and provides the location of other experimental and field notebooks, data, and relevant materials stored in other laboratories or at other locations.

5. There are state and federal regulations prescribing the length of time researchers must maintain the original data. The times required to retain data vary from three to seven years depending on the governmental organization. Unless a longer period is specified by the State of Texas, or The University of Texas System, or the sponsor, research data should be kept for a minimum of three years after the project ends or, if funded research, three years after all of the final project close-out documents have been sent to the government. In addition, any of the following circumstances may justify longer periods of retention:
   1. data must be kept for as long as may be necessary to protect any intellectual property resulting from the work;
   2. if any charges regarding the research or sponsored project arise, such as allegations of scientific, scholarly or financial misconduct or conflict of interest, data must be retained until such charges are fully resolved; or,
   3. if a student is involved, data must be retained at least until the degree is awarded or it is clear that the student has abandoned the work.
      
      
6. Beyond the period of retention specified herein, the destruction of the research or sponsored project record is at the discretion of the PI and his or her department or laboratory. Records will normally be retained in the unit where they are produced. Research and sponsored project records must be retained on the UTSA campus, or in facilities under the auspices of UTSA, unless specific permission to do otherwise is granted in writing by the Vice President for Research or his/her designee.
   

F. TRANSFER OF RECORDS AND DATA

1. In the event that the PI or other key researchers or project managers leave UTSA, they may negotiate an Agreement for the Disposition of Research or Sponsored Project Data, which has been determined to not be proprietary to UTSA, for projects on which they have worked. Original data, however, must be retained at UTSA for the period specified in Section E, Subsection 5 and 6 in this document.
   1. A written Agreement on Disposition of Research or Sponsored Project Data or Records must be negotiated by the PI or other key researchers or project managers and the Department Chair or Unit Manager and approved in writing by the Dean or appropriate Vice President, and the Vice President for Research or his/her designee to allow transfer of research or sponsored project data or records. Without an Agreement on Disposition of Research or Sponsored Project Data or Records in place, no PI, other key researcher or project manager, may take data with them when they leave UTSA. Students leaving UTSA or remaining at UTSA but leaving a particular laboratory, who have worked on a Sponsored Research Project or other Sponsored Project must have an agreement in place with the PI of the project they worked on in accordance with this subsection before they may take data or records off campus or to another laboratory or unit.
      1. Agreement(s) on Disposition of Research or Sponsored Project Data or Records will be kept in the Department or Unit.
   2. If a PI leaves UTSA with a funded research project or other funded sponsored project and the project is to be moved to another institution, ownership of the data may be transferred with the approval of the Vice President for Research or his/her designee and with written agreement from the PI's new institution that guarantees:
      1. The new institution's acceptance of custodial responsibilities for the data; and,
      2. UTSA's access to the data, should that become necessary.
   3. All Agreements on Disposition of Research or Sponsored Project Data must include a provision that UTSA has the right of access to all research records and materials, after reasonable prior notice to the PI or the PI's place of employment, regardless of the location of the PI, other key researcher or project personnel for the period of time specified in Section E, Subsection 5 and 6 in this document.

G. REFERENCES

Office of Management and Budget (OMB) Circular A-110 Uniform Administrative Requirements for Grants & Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations, Section C.36. Intangible Property and Section C.53. Retention and access requirements for records.

45 CFR, as amended by 56 FR 28003 Use of Human Subjects in Research

http://research.utsa.edu/oric/

Http://ori.dhhs.gov/education