Access to and Retention of Research Data

Research data is created at the Health Science Center by faculty, staff, and students in the course of their scholarly activities and often while conducted sponsored programs funded by external sponsors. By tradition and for practical reasons, the creators of the data retain control to access and use of that data even though the Health Science Center, through contractual or other agreements with external sponsors, may be required to hold title to or own the data. Because of those obligations, the Health Science Center recognizes that it has responsibilities with respect to access and retention of data, particularly data generated under sponsored agreements.

Recent interpretations of federal regulations as well as congressional investigations into various issues concerning the government's support of research, including instances of scientific misconduct, have prompted the Health Science Center to develop this policy for retention and access to data. Of particular concern to the Health Science Center are the requirements of OMB Circular A-21 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations). Section __.53(a) specifies that financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained by the institution. In an April 11, 1994 letter, OMB stated that the term "all other records pertinent to an award" encompasses all records that were produced in connection with the award, including "laboratory data and primary data."

Policy

Research data created while individuals are pursuing research studies as faculty, staff, or students of the Health Science Center and data created by visiting scientists or the like utilizing the facilities of the Health Science Center are to be retained by the Health Science Center for a period of three (3) years after submission of the final report on the research project for which the data were collected, unless a longer period is specified by the sponsor.

The original research data shall be in the custody of the senior investigator on behalf of the Health Science Center, but must be returned to the Health Science Center upon request of the President or designee. Additionally, such data must be available to representatives of external sponsors of the research or designed government officials, when such access is appropriate. Such data must not be destroyed or altered during the time period referenced above unless explicit written approval for such disposition is received from the President or designee.

Information Related to Policy Statement

Definition of Data
As used in this policy data means recorded information, regardless of the form or the media that records it. The term includes computer software, computer programs, computer databases (and documentation thereof), and data of a scientific or technical nature. For the purposes of this policy the term does not include information incidental to award administration, such as financial, administrative, cost or pricing, or management information. In practice, scientific data includes, but is not limited to, materials contained in laboratory notebooks or other media such as computer disks and machine printouts. Data also includes both intangible data (statistics, findings, conclusions, etc.) and tangible data (notebooks, printouts, etc.)

Investigator Responsibilities at the Health Science Center
It is important that investigators have the ability to document the results of research, both for the sake of assisting the Health Science Center in meeting its scholarly and legal requirements as well as for the more traditional reasons of establishing priority for patentable items, publishing manuscripts, and the like. Senior members of research teams have obligations to discuss the responsibilities of data management and retention and other members of a research team. As a matter of practice, original data should be left with the senior investigator when a student leaves the institution, but copies of that data, where feasible to do so, should be provided to the student.

Investigator Responsibilities After Leaving the Health Science Center
When an investigator leaves the Health Science Center, he or she must recognize that the Health Science Center must have access to the data. It is neither feasible nor desirable for the original research records to remain at the Health Science Center. Departing investigators must understand that they have an obligation to hold these data in trust for the Health Science Center and that such data must be returned to the Health Science Center, if requested, during the three (3) year period after submission of the final report on the research project for which the data were collected, unless a longer retention period was specified by the sponsor.