Handbook of Operating Procedures

I. POLICY AND GENERAL STATEMENT

To discharge its legal, financial, ethical, and academic responsibilities, The University of Texas Health Science Center at Houston ("University") has established this policy concerning retention of, internal access to, ownership of and use of research data and materials. The intent of this policy is to ensure that University parties with a legitimate interest in research results have access to and use of such data and materials. This policy sets forth specific guidelines for research data and materials at the University.

Research data are created and research materials are developed and produced by University employees, trainees, collaborators, and visiting researchers in the course of scholarly activities.

If an investigator believes any research data or materials developed during research at the University constitute a new discovery, creation, and/or invention, he or she must notify the Office of Technology Management (OTM) in a timely manner in accordance with HOOP 201, Intellectual Property. If an investigator wants to transfer or grant external access to research data and/or materials, he or she must contact Sponsored Projects Administration.

II. DEFINITIONS

Data: For the purpose of this policy, "data" are defined as recorded and/or retained information regardless of the form or the media on which they may be recorded or retained. The term includes laboratory notebooks and worksheets, primary data, methods of procedures and analyses, memoranda, original notes or exact copies of notes that are the result of original observation, video recordings, clinical protocols, spectra, computer files and digital data (including software source code), print-outs, images or any other records necessary for replication, reconstruction, and evaluation of the results of a study. This definition is consistent with the Federal Acquisition Regulation. It does not include information incidental to research administration such as financial, administrative, cost or pricing, or management information.

Materials: For the purpose of this policy, "materials" are defined as unique tangible materials and resources such as synthetic or natural compounds, body fluids/products/tissues (human and non-human species), organisms, cell lines, viruses, cell products, recombinant DNA, antibodies, mapping data, spectroscopic or x-ray data, software and computer codes developed in the course of research, and such new tangible resources that emerge as science and technology progress.  This definition is based on the Public Health Service definition of research materials.

Access.  For purposes of this policy, “access” refers to access by University personnel, government officials, sponsors, and others with an appropriate need to access data and materials for regulatory, administrative, review, oversight, reporting, or other required purpose.

Principal Investigator (PI).   The PI of a research endeavor is the person who bears primary responsibility for the overall conduct of the research or scholarly activity.  In the case of sponsored research, the PI is the individual designated in the award. For research conducted with internal institutional funds (e.g., start-up support, departmental funds, gifts, endowment funds, development funds.), the individual responsible for the expenditure of the funds is considered the PI for purposes of this policy. In the case of University employees and trainees who hold subcontracts for projects in which the overall PI is at another institution, the University investigator designated in the subcontract is considered the PI for the purposes of this policy for those aspects of the project performed at the University.

For purposes of this policy, the faculty advisor for students or fellows is considered the PI, even if the student or fellow may otherwise be designated as the PI for a project.

III. PROCEDURE

A. Ownership

The University owns research data and materials generated by employees, trainees, visiting researchers, collaborators, and any other individuals conducting research within University facilities or using University resources or funds irrespective of the performance site, unless specified otherwise in advance by written agreements approved in accordance with The University of Texas System Board of Regents’ Rule 90101. See also HOOP 201, Intellectual Property.  Under certain conditions, the University may own research data and materials generated at other locations by its employees or trainees as specified in relevant inter-institutional agreements.

B. Responsible Party

The PI of a research endeavor bears primary responsibility for the overall conduct of the research or scholarly activity and is responsible for the retention of data and materials and provision of access required by this policy, including any associated costs. See also HOOP 175 - Roles and Responsibilities for University Information Resources and University Data.   

If the PI leaves the University, his/her department chair is responsible for the retention of data required by this policy and any associated costs. OTM will determine whether any materials need to be retained, and if so, the party responsible for retention, including any associated costs (see Section III.E below).

• For both sponsored research and research conducted with internal institutional funds, the PI has the responsibility for fulfilling the requirements of this policy. When sponsored research has Co-PIs, the Co-PI agreement shall specify the responsibility for data and material retention and access and sharing.
• For complex projects with multiple investigators, the PI is responsible for meeting requirements of this policy at all performance sites.
• In the case of University employees, students, and other trainees who hold subcontracts for projects in which the overall PI is at another institution, the University investigator designated in the subcontract is responsible for meeting the requirements of this policy at the University.
• In the case of University employees, students, and other trainees who perform research at another institution (such as during a faculty development leave or research elective), the data access and retention policy of the host institution will apply, although the ownership of any data and material generated by the University employee should be specified in advance by an agreement between the University and the host institution.
• The PI is responsible for the sharing of data and materials as appropriate (e.g., when the research is supported by an award, gift, another funding source, and/or agreement that has data and/or materials sharing requirements).

Employees, trainees, collaborators, and visiting researchers who are involved in the research endeavor are required to make research data and materials obtained at the University, or using University time, resources or funds, readily available to the PI upon request.

C. Retention of Data

The PI must retain research data for all projects in accordance with the University’s Records Retention Schedule. During the retention period, the PI must provide data and materials to University administration (e.g., University officials with a need to access data and materials for regulatory, administrative, review, oversight, reporting, to comply with the requirements of a material transfer agreement (MTA), or other appropriate purposes upon request) and to representatives of external sponsors and designated government officials upon appropriate requests.  

If the PI leaves the University, the procedure provided in Section III.E, below, must be followed and the departing PI’s department is responsible for the required retention, as per the University’s Records Retention Schedule, of the original data or a copy, including any associated costs, unless other arrangements are approved in advance by the Executive Vice President & Chief Academic Officer (EVP/CAO) or designee.  

D. Retention of Materials

1. Third Party Materials: Materials obtained from another entity via a MTA must be retained, used, shared, distributed, and managed by the PI as specified in the MTA. If the PI leaves the University, the procedure provided in Section III.E, below, must be followed. 

2. University Materials: Materials developed or produced by research conducted at the University must be appropriately stored, managed, and retained by the PI. If the PI leaves the University, the procedure provided in Section III.E, below, must be followed.

E. Procedure When a PI Leaves the University (PI Separation)

The transfer of research data and materials is managed through the Office of the EVP/CAO. When a PI separates from the University, the research data and materials shall remain the property of and in the possession of the University. To ensure an appropriate separation from the University, the PI must complete the PI Separation Checklist that includes information about research project close-out, including any required retention of research data and materials.

If the PI wishes to take either a copy or the original data and/or materials, the PI must submit an initial written request to his/her Department Chair specifying the specific data or materials, whether the request is for the original data or a copy, the reason the original data or a copy are requested, arrangements for any costs associated with copying materials, and any other issues appropriate to the request. After review, the Department Chair will forward a recommendation to the EVP/CAO or designee for review and a final decision on the request. This process may take several months, so a departing PI should submit such requests as soon as possible, but no less than 90 days before the data and/or materials need to be transferred.

The EVP/CAO or designee may seek recommendations from other units including but not limited to the following considerations:

• Sponsored Projects Administration
• Considerations including whether an ongoing grant or contract that supported the research will be transferred to another institution or will remain at the University under direction of a new PI, any requirements or stipulations of the research sponsor, the nature and format of the data or materials involved, the ease and expense of copying the data, the real or potential value of the materials, and any other relevant considerations.
• The transfer of any third party or University materials to another institution will require execution of an MTA signed by the departing investigator and the Office of Sponsored Projects prior to the removal of the materials from University premises.

• Capital Assets Management
• For the transfer of equipment or other capital assets, Capital Assets Management should be contacted.

• Office of Technology Management (OTM)
• Ensure that all intellectual property rights to research data and related materials belong to the University unless otherwise specified by the President in an agreement signed by the departing investigator and the appropriate institutional official.
• Ensure that transfer of the original or a copy of research data and materials are permitted under an existing license or option agreement with the University.
• If OTM believes the University should retain any research materials developed at the University (see Section I and definition of "materials" above) when an investigator leaves the institution, OTM will develop a retention plan for the materials including the length of time the materials should be retained and the party responsible for retention, including any costs.  

• Office of Legal Affairs (Privacy Officer) and Institutional Review Board
• The departing investigator may not take the original or copies of any protected health information (“PHI”) unless specified in an agreement signed by the departing investigator and the appropriate institutional official, as determined by the Office of Legal Affairs.

The departing investigator will be responsible, in the sole discretion of the University, for any expenses related to removing the original data or making a copy for removal. If the PI is allowed to take the original data, he or she must retain it and provide reasonable access to such data by the University and any collaborators for the minimum period of time the data are required to be retained under the University's Records Retention Schedule and must leave with the University a complete and accurate copy of all data that is still within the retention period specified in the Records Retention Schedule.  To the extent that the PI is allowed to take materials, the PI will be responsible for any associated expenses.  The University may impose such additional stipulations on the removal of data or materials as the EVP/CAO or designee deems appropriate or necessary under the particular circumstances.

Students, fellows and co-investigators may take a copy of research data and/or materials only with permission of the PI.  If a student, fellow or co-investigator wishes to take the original data and/or materials, he or she must obtain permission from the PI and follow the approval process outlined above.

IV. CONTACTS

• • Office of the Executive Vice President & Chief Academic Officer
  • 713-500-3622
  • https://www.uth.edu/evpara/contact-us/leadership.htm
  • http://www.uth.edu/index/research.htm

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