Ownership and Transfer of Research Data

Scope

This guidance regarding ownership and transfer of research data and applies to: 

• All research data generated with the support of Lehigh University resources
• All Lehigh University faculty members, staff members, postdoctoral appointees, trainees, students, consultants, and any others involved in the design, conduct, or reporting of Lehigh University research.

This guidance does not change current material transfer, copyright, patent, equipment, and record retention policies or guidance, which also apply to research. See Related Resources below.

Guidance Statement

Accurate and appropriate research records are an essential component of any research project. Both the University and Lehigh University researchers have responsibilities and rights concerning access to, use of, and maintenance of original research data. 

Lehigh University researchers are custodians of research and data generated with the support of Lehigh University resources. Lehigh University researchers have the academic freedom to determine the course and publication of any research, subject to legal requirements, Lehigh University policy, ethical standards, and the terms and conditions of sponsored programs. Lehigh University’s ownership and stewardship of research data and materials for programs conducted at the University, and under the auspices of the University, or with University resources are based on both regulation and sound management principles and in support of its mission to advance learning through the integration of teaching, research, and service to others.    

Definitions

Ownership

Lehigh University’s ownership and stewardship of research data and materials for projects conducted at the University, under the auspices of the University, or with University resources are based on both regulation and sound management principles and apply in all cases except where precluded by the specific terms of sponsorship or other agreements.

Similarly, any intellectual property rights in research data and related materials shall remain with the University unless otherwise specified by law or in a duly executed agreement. The Lehigh University Intellectual Property Policy provides that generally, books, articles, and other scholarly writings by a faculty member are deemed the property of the writer, who is considered to be entitled to determine how the works are to be disseminated and to keep any income they produce, unless otherwise provided by law. 

Retention

There are many different guidelines and regulations regarding how long research data necessary to validate findings should be retained. Lehigh University policy requires that research data and materials related to grant proposals, awards, and supporting documentation must be retained by the researchers for three (3) years after publication of the findings or until all required final reports (e.g., progress and financial) for the project have been submitted to the sponsor, unless a longer period is provisioned. 

Longer retention periods may be required by other Lehigh University policies, publishers, sponsors, and applicable law. Lehigh University researchers are responsible for consulting these requirements, and retaining research data in accordance with the most stringent applicable requirement. 

Some key provisions and circumstances are as follows:

• Research data must be kept until any patentable invention resulting from the work is protected by the filing of a patent application or, if a decision is made by Lehigh University not to file for patent protection, until rights to the invention are returned to the inventor.
• If charges of academic misconduct or conflict of interest noncompliance have been made in relation to a research project, the research data must be retained by Lehigh University as long as required by any sponsoring agency’s requirements, and at least until all charges are resolved and final action taken. The research data must be retained until the Office of General Counsel has issued instructions regarding its disposition.
• Research data involving human subjects presents special requirements. Lehigh University researchers must consult University policy as well as federal and state laws and regulations related to research data retention, including but not limited to HIPAA, as applicable.
• If a student is involved in a research project, the research data must be retained until the student has been awarded a degree or it is clear that the student has abandoned the work.
• If the research data are appraised by the University to have long term cultural, historical, economic, environmental, or other acknowledged value, then the University may require a longer retention period.
• If the research involves FDA regulated articles, consistent with 21 C.F.R. §§ 312.6 and 812.140, the investigator must keep records for two years following the date a marketing application is approved for the product; or if a marketing application is not filed or not approved by the FDA, for two years after the investigation is terminated, completed, or otherwise discontinued and the FDA is notified. If other regulations, sponsor policies, or guidelines require longer retention periods, research data must be kept in accordance with the most stringent requirement. 

Transfer

When Lehigh University researchers who are PIs or co-PIs on research projects at Lehigh University leave the University, they may generally take copies of research data for projects on which they have worked. Taking copies of data or materials subject to confidentiality or other legal restrictions, including but not limited to data and materials that are covered by HIPAA and other human subjects protections, germane to disputes and investigations, or necessary for patent protection, may be restricted and require permission from the Office of the Vice Provost for Research.

Other co-investigators may take copies of research data for projects (or the portions of projects) on which they have worked only with the permission of the PI or PIs., and if the PI or PIs and the individual leaving cannot reach agreement, with the permission of the Office of the Vice Provost for Research. In all cases, the original data must be retained at Lehigh University.

In appropriate circumstances, Lehigh University may transfer ownership of research data to a third party pursuant to a duly executed sponsored award or other agreement. The Lehigh University Office of Research and Sponsored Programs is responsible for reviewing, negotiating, and executing all sponsored awards. 

• For data, the transfer of ownership from Lehigh University to another institution requires prior written approval of the Office of the Vice Provost for Research. It will generally be granted only when the research project itself is being transferred to the other institution and will be pursuant, at a minimum, to a written agreement executed by the recipient institution that guarantees (1) its acceptance of ongoing custodial responsibilities for the data, and (2) Lehigh University having access to the original data, should access become necessary for any reason. The transfer will be in accordance with relevant confidentiality restrictions, when Lehigh University deems them appropriate or necessary or as required by law (e.g., HIPAA). When Lehigh retains ownership of research data, the University sets the terms of the use, re-use, or storage of that data by any other entity. The terms are governed by a Data Use Agreement.
• For tangible research materials, transfer between Lehigh and another organization that intends to use it for its own research purposes is governed by a material transfer agreement (MTA). The MTA must be executed by Lehigh University and the recipient institution prior to the removal of the materials or equipment from the University premises. The Lehigh University Office of Technology Transfer manages the MTA process. 

Sharing and Access

A key precept of Lehigh University is to share research data and materials that are commonly accepted in the scientific community as necessary to validate research findings with members of the University community, external collaborators, and others for legitimate purposes.

Research data and materials shall be made publicly available to the extent feasible while minimizing harm to the legitimate interests of the University, to research subjects, and to other parties, subject to Lehigh University policy and to legislative, regulatory, contractual, ethical or other obligations, including but not limited to whether providing such public access would be cost prohibitive.

Where necessary to assure needed and appropriate access, the University has the option to take custody of the data in a manner specified by the Provost.

Lehigh University researchers who are PIs or co-PIs on research projects at Lehigh University have a right to access research data for projects on which they have worked. Other co-investigators may access research data for projects (or the portions of projects) on which they have worked only with the permission of the PI or PIs or, if the PI or PIs and the individual leaving cannot reach agreement, with the permission of the Office of the Provost.

Roles and Responsibilities

Related Resources

Lehigh University Intellectual Property Policy: https://www.lehigh.edu/~policy/university/ip.htm

Lehigh University, Office of Technology Transfer. “Copyrights”: https://techtransfer.lehigh.edu/copyrights

Lehigh University, Office of Technology Transfer. “Patents”: https://techtransfer.lehigh.edu/patents

Lehigh University Records Management and Retention Policy: https://www.lehigh.edu/~policy/documents/Record_Retention_Policy_Final_07.05.2023.pdf

Lehigh University, Office of Research and Sponsored Programs. “Sponsored Research Agreements”: https://research.lehigh.edu/proposal-contract-submissions/submit-contract-review-negotiation-and-final-approval/sponsored

Lehigh University, Office of the Vice Provost for Research. “Other Agreements”: https://research.lehigh.edu/manage-award-or-project/submit-contract-review-negotiation-and-final-approval/other-agreements

Lehigh University, Office of the Vice Provost for Research. Research Essentials Handbook, Data Management and Stewardship of Research Materials: https://research.lehigh.edu/explore-trainings-education/research-handbook-understand-popular-terms/handbook-data-management-and#:~:text=Data%20Use%20Agreements%20ensure%20that%20the%20parties,by%20which%20data%20is%20stored%20and%20used.

Lehigh University, Office of Technology Transfer. CDA/NDA and MTA: https://techtransfer.lehigh.edu/cdanda-and-mta