Guidelines on the Ownership of Data University of Louisville
I. Definitions of Data
A. As used in this policy, "data" means information that is generated in or as a result of empirical research activities and recorded in any tangible or electronic medium, including without limitation laboratory notebooks and worksheets, memoranda, notes, clinical protocols, computer databases, computer images, and all other records.
II. Ownership of Data
A. The University of Louisville is the administrative organization ultimately responsible for all tangible and intangible products resulting from activities at the University. As such, the University has the responsibility to ensure the preservation and availability of research data and can be held accountable for the integrity of research data even after the creator(s) have left the University. Therefore, except in the circumstances indicated in III.A., below, all research data generated by personnel of the University or created with University facilities, regardless of the nature or sponsorship of such research, shall be owned by the University and its affiliates (e.g. ULRF). In addition, as a public institution and in keeping with the traditions of academic freedom, all such research data and protocols shall be unrestricted as to its public dissemination, except in the circumstances indicated in III.A.
B. In view of these directives, except in those circumstances noted below, the University of Louisville will not accept research projects nor conduct research activities that regulate the ownership of data, limits the right to divulge the source of support, or restrict access to the data or dissemination of results.
C. The University may, at its discretion, transfer the ownership of data to the creator(s) of said data with a property transfer agreement between the University and the creator(s).
D. The University or its employees may agree to delays in the dissemination of data or the reporting of research results in order to protect proprietary information or to permit external sponsors time to consider patent applications. Sponsors may also be given advanced access to data or manuscripts resulting from their externally sponsored research. However, agreements with external sponsors may not restrict the rights of investigators to publish their findings nor to communicate their research results freely in a timely fashion. Only in the circumstances indicated in III.A., below, would sponsors be permitted to require withholding of information or limitations on the material to be presented or published.
III. Contracts to Control Ownership or Restrict Access to Data
A. The University might be a participant in research projects in which the ownership, control, or access to research data would be stipulated as well as where restrictions on the communication or reporting of research results would be necessary. Examples might include (1) classified research where the dissemination would jeopardize national security; (2) clinical trials or psychological studies where the identity of individual participants could be disclosed or where the sponsor requires ownership of the data (e.g., multi-center clinical trials.) Any provisions for extramural ownership of data or restrictions to access or communication of results must be indicated in writing under a specific Research Contract between the external sponsor and the University which must be agreed to by the participants (principal investigator or other personnel directly involved in the project) and approved by the Office of the Senior Vice President for Research. In the absence of such a contract, the University will retain ownership of all data generated with University facilities and there could be no restriction on access to or dissemination of the data or results.
B. Work that is restricted in any way may not be used for personnel actions or academic evaluations until it is publicly available.
IV. Retention of Data
A. Whereas the University is normally the owner of research data, the creators of the data, normally the Principal Investigators of research projects, are responsible for the collection, management and retention of research data. Research data must be archived for a minimum of five years after the conclusion of a study, with the original data retained wherever possible. In addition, some circumstances may require longer periods of retention. For example, it may be necessary to retain data to protect intellectual property. Also, if charges regarding the research arise, such as allegations of scientific misconduct or conflicts of interest, data must be retained until such charges are fully resolved. Additionally, if a student is involved in a research project, data must be retained until the degree is awarded or there is clear documentation that the student has left the project. Beyond the five-year period of retention, or other period as specified above, the destruction of research records is at the discretion of the Principal Investigator.
B. During the retention period, access to the data must be provided to appropriate University officials or administrators; to coauthors, coinvestigators, collaborators, students or fellows involved in the research; and to representatives of external sponsors or designated government officials as appropriate.
C. If a creator of research data transfers to a new institution, the data generated by said individual may also be transferred with the permission of the University and with the express understanding that the University retains ownership and has access to the data for a minimum of five years unless a transfer of ownership has been conferred as indicated in II.C., above.
(Final draft, 10/9/01)