I. Policy

1. Research data are created at the University of South Carolina by faculty, staff and students in the course of their scholarly activities, and often while conducting 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 University, through contractual or other agreements with external sponsors, may be required to hold title to or own the data. Because of those obligations, the University recognizes that it has responsibilities with respect to access and retention of data, particularly data generated under sponsored agreements.

Research data created while individuals are pursuing research studies as faculty, staff or students of the University of South Carolina, and data created by visiting scientists utilizing the facilities of the University of South Carolina, are to be retained by the University 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 retention period is specified by the sponsor. If an investigation, legal action or an official inquiry concerning a research project is underway; all data related to the project must be retained and made accessible until the issue is resolved.

The original research data shall be in the custody of the senior investigator on behalf of the University, but must be returned to the University upon request of the Provost. Additionally, such data must be available to representatives of external sponsors of the research or designated governmental 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 Provost or designee.

2. The term "data" in this regard is defined as:
1. recorded information, regardless of the form or the media on which it is recorded. The term includes computer software (computer programs, computer databases, and appropriate and required documentation of all components thereof), and data of a scientific or technical nature;
2. in practice, scientific data include, but are not limited to, materials contained in laboratory notebooks or other media such as computer disks and machine printouts. Data include both intangible data (statistics, findings, conclusion, etc.) and tangible data (notebooks, printouts, etc.);
3. for the purposes of this policy, the term "data" does not include information incidental to award administration, such as financial, administrative, cost or pricing, or management information.
3. 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 University to develop this policy for retention and access to data. Of particular concern to the University are the requirements of OMB Circular A-110 (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 encompass all records that were produced in connection with the award, including laboratory data and primary data."

II. Procedure

1. Investigator Responsibility at the University

It is important that investigators have the ability to document the results of research, both for the sake of assisting the University 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. To this end, research investigators are responsible for:

1. maintaining records in sufficient detail to permit examination for purposes of replicating the research, responding to questions, establishing their authenticity, and confirming the validity of the conclusions.
2. maintaining, where appropriate, a laboratory manual that describes all major procedures.
3. discussing the responsibilities of data management and retention with other members of the research team if the research investigator serves as a senior member of that research team. As a matter of practice, original data should be left with the senior investigator when a student leaves the institution. Copies of those data, when feasible to do so, may be provided to the student with the consent of the academic unit.
2. Investigator Responsibilities after Leaving the University
1. When an investigator leaves the University, a written Agreement on Disposition of Research Data shall be negotiated by the investigator and the department chair or dean to allow the investigator's data, notebooks, and other data retention materials (other than clinical research records) to be transferred to the new institution.
2. To fulfill its obligations to funding sources and others, the University will ensure in such agreements access to the transferred data for purposes of review. Under the terms of the agreement the investigator has the obligation to hold these data in trust for the University.
3. In unusual cases (e.g., data used for a patent application filed by the University) it may be necessary for original data to be kept at the University. In such cases, an individual written agreement may be signed which allows the investigator to access and copy (where practical) such data.
4. In cases of multi-institutional studies, the institution of the primary study director shall be responsible for guaranteeing appropriate access to, use of, and retention of primary data.