(Note: This document is also available at http://www.research.wayne.edu/compliance/Data_Ownership_5_2_062.pdf)

1.0 Purpose

Institutions of higher education have rights and responsibilities with regard to research data generated by their employees, students, staff or affiliates. The University is accountable for the preservation and integrity of research data even if its creator(s) has left the institution. Therefore, with some exceptions, all research data generated with University Support (see Definitions) are owned by the University. Data ownership by the University is essential in order for the institution to fulfill its legal and institutional responsibilities, to protect intellectual property rights, to manage research programs, to meet regulatory requirements, and to prevent or investigate allegations of scientific misconduct.

2.0 Definitions

Data are “recorded information, regardless of the form or medium on which it may be recorded, and includes writing, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data” (excerpted from the NIH Grants Policy Statement)

Investigator is any University employee, researcher, student or Trainee engaged in the conduct of research, or anyone using University Support, unless otherwise agreed in a prior contractual agreement

Research is a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalized knowledge.

Research data are “recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues” (from OMB Circular A-110).

Trainees include students at any level of education (undergraduate, graduate, or post-doctoral); volunteers in research laboratories or programs; and visiting scholars.

University Support means direct or indirect use of University funds, facilities or funds administered by the University or University services not available to the general public.

3.0 Guidelines

In its role as grantee or contractor, the University owns research data as a result of its contractual obligations. By tradition, and as a practical matter, the investigator retains possession of data on behalf of the institution. Thus, investigators are custodians or stewards of research data, while the institution retains ownership of such data. Both the institution and the investigator have rights and responsibilities with regard to access, use and maintenance of research data. In addition, consistent with University policy, these broad guidelines apply to internally funded and unfunded research.

In general, federal policy and guidance supports institutional ownership of research data generated by federally funded research. OMB Circular A-110 states that the rights to intangible property belong to the institutional grantee. In contrast, private sector contracts often seek to grant data ownership to the sponsor as a condition of the award. Terms addressing data ownership must be stated in the contract with the sponsor and reviewed by the University’s Office of the General Counsel. It is incumbent upon the investigator to read and understand the conditions of his/her grant or contract with regard to ownership of data and to inform the Office of the General Counsel of any special circumstances impacting data ownership.

When there are no stated contractual terms providing data ownership to a third party, or in the cases of internally-sponsored research, the University retains ownership of the data. Other unusual circumstances, such as restrictions on the use of sensitive data, must be reviewed by General Counsel on a case-by-case basis.

3.1 University rights and responsibilities

The University must ensure that research data are obtained in accordance with federal, state, and local regulations and guidelines.

The University must ensure that research data are recorded and used properly, are retained on-site under responsible custody, and are made available for review as appropriate.

The University is responsible for the retention and protection of data supporting its intellectual property rights.

The University retains ownership of research data, although the University may choose to transfer ownership of data to the investigator or another individual or institution with an assignment agreement.

3.2 Investigator rights and responsibilities

The investigator is responsible for the collection, management and retention of research data.

The investigator has the primary authority to make judgments involving the use and dissemination of the data.

The investigator is ultimately responsible for the maintenance and retention of research records. Appropriate record-keeping includes maintenance of sufficient detail to allow replication of the research, response to questions about unintentional error or misinterpretation, establishment of the data’s authenticity, and confirmation of their validity.

The investigator has the right to transfer a copyright, incorporating or based on data to be published, to the publisher of a journal or book. However, the investigator cannot transfer data ownership to the publisher.

3.3 Disputes about data ownership, retention, or access

Disputes regarding access to data should be settled at the lowest possible level, i.e. among the primary parties involved in the generation, analysis, and/or reporting of research data. The next level of arbitration would involve the Chair of the Department and/or the Dean of the College or School.

If disputes about data access cannot be resolved at these levels, then the parties may request that the Vice President for Research review the issues and render a recommendation for resolution. These requests will be handled on a case-by-case basis and may be denied and sent back to the parties for resolution. Alternatively, the parties may then request review by the Office of the Provost.

3.4 When investigators leave the university

If the investigator leaves the university, he or she is expected to negotiate an agreement on the disposition of research data with the Department Chair or Dean. In most cases, this will entail the orderly transfer of data to the new institution. The University reserves its rights to access the transferred data for a minimum of 5 years, unless data ownership is transferred pursuant to an assignment agreement (in such cases, the terms of the assignment agreement shall indicate WSU’s right to access the data) . In some cases, such as for data used in a patent application filed by the University, it may be necessary to keep the original data at the University. In this case, the investigator shall have the right to access and copy such data.

The HIPAA Privacy Rule does not allow investigators to transfer identifiable personal health information without appropriate authorization from the Privacy Board. At Wayne State University, the Human Investigation Committee serves as the Privacy Board.

3.5 Trainees

Trainees are not allowed to take original copies of data when they leave the institution without the express, written permission of their Department Chair or Dean. Removal of duplicate copies of data by trainees is subject to the permission of the principal investigator. It is strongly recommended that such arrangements, as well as issues related to authorship, be discussed among the parties at an early stage of the training experience. It may be helpful to formalize their understanding and agreements in writing.

4.0 Retention of data

Primary data should be preserved for a reasonable length of time to allow any questions raised by the scientific community to be answered. Federal guidelines require that data be kept for at least 3 years after the filing of a final expenditure report is filed. The Veteran’s Administration requires that IRB materials be archived for 5 years. Therefore, it is recommended that any research data be archived for a minimum of 5 years after the conclusion of a study.

Longer periods of retention may be required in order to protect intellectual property. This should be determined on a case-by-case basis with the University’s Office of the General Counsel.

Research data must be retained by investigators until any intercurrent allegations of scientific misconduct or conflicts of interest have been fully resolved.

During the retention period, access to the data must be provided to appropriate University officials, coauthors, coinvestigators, and collaborators. Sponsors and/or government officials are to be given access as appropriate.

(05/02/06)