Office of Research Policy on Research Data

Purpose
Definitions
     Investigator
     Report 
     Research
     Research Data
     University Member
Acquisition and Use of Research Data
Custody of Research Data
Retention of Research Data
Access to Research Data
Transfer of Research Data
Ownership of Research Data
Research Data Policy Oversight and Dispute Resolution

Purpose

Central to the role of an institution of higher education is the generation and transmission of new knowledge. Critical to this function are scholarly data that are primarily generated by research. Institutions of higher education, as stewards of the body of knowledge created within their respective environments, have both rights and responsibilities with respect to research data generated by their investigators, independent of whether or not outside financial or other such support, with its attendant compliance requirements, contributed to the creation of the research data. "Institutions that fail properly to define and exercise their rights and responsibilities with respect to research data risk noncompliance with significant and important academic and governmental imperatives as well as potential exposure to substantial legal and other attendant liabilities." (Council of Governmental Relations Guidelines, 1996)

Virginia Commonwealth University (the "University") has a responsibility to each University Member and, collectively, to the entire University community, to ensure that Research Data are recorded and used properly, are retained under responsible custody for a reasonable length of time, and made available for review under appropriate circumstances. The preparation and retention of records is an essential component of a research endeavor and includes all aspects of University research in which data are obtained, tested and evaluated through scholarly study.

Ownership by the University of original Research records is essential for a number of reasons. These reasons include the need for the University to be able to fulfill its legal and institutional responsibilities, to protect intellectual property rights of inventors, to be able to answer ongoing questions regarding management of a research program, to meet sponsor regulations, to prevent misappropriation of Research Data, and to address questions that may arise regarding the propriety of the conduct of research.

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Definitions

Investigator means any University Member engaged in the conduct of Research as either an employee or student of the University or using facilities owned or operated by, or resources administered by, the University. The Investigator has primary stewardship of Research Data on behalf of the University.

Report means any summary, statement or description of Research activities published in the open literature or provided to the public, the University, a sponsor, or other researchers by a University Member.

Research means a systematic investigation designed to develop or contribute to knowledge and may include the stages of development, testing and evaluation.

Research Data means recorded information, regardless of form or the media in which it may be recorded, which constitute the original observations and methods of a study and the analyses of these original data that are necessary for reconstruction and evaluation of the Report(s) of a study made by one or more Investigators. Research Data also includes all such recorded information gathered in anticipation of a Report. Research Data differ among disciplines. The term may include but is not limited to:

• technical information
• computer software
• laboratory and other notebooks
• printouts
• worksheets
• other media
• survey instruments
• memoranda
• evaluations
• notes
• databases
• clinical case history records
• study protocols
• statistics
• findings
• conclusions
• samples
• physical collections
• other supporting materials created or gathered in the course of the Research
• tangible Research products
• unique Research resources such as synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA as well as genetic sequences and mapping information, crystallographic coordinates, plants, animals and spectroscopic data
• other compilations formed by selecting and assembling preexisting materials in a unique way

The term does not include information incidental to administration, such as financial, administrative, cost or pricing, or management information.

University Member means any VCU full- or part-time faculty member, classified employee, administrative staff member, paid student assistant, student, volunteer, fellow or trainee, visiting faculty member or researcher. One is not a University Member when acting in a purely private role that in no way or manner implicates the University, unless the activity results in a Report in which the individual is identified as having a University affiliation.

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Acquisition and Use of Research Data

Investigators shall record original observations in accordance with the standards of their respective disciplines. The Investigator who gathers or creates Research Data may use the information as he/she deems appropriate and may authorize others to make appropriate use thereof, subject to University and personal contractual commitments and University policies. The use of Research Data gathered or created within a group of Investigators is subject to the reasonable control of the senior Investigator. For a project where a "Principal Investigator" is identified, that individual is the senior Investigator.

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Custody of Research Data

All Research Data shall be preserved in the custody of, or as arranged by, the senior Virginia Commonwealth University Investigator on behalf of the University.

The senior Investigator is charged with the integrity, preservation and security of Research Data, and appropriate marking of all University intellectual property that may be included in the Research Data. In the case of incapacity of the senior Investigator, that individual's supervisor will take custody of that individual's Research Data until other appropriate arrangements are made for alternative custody.

Senior members of Research teams have obligations to discuss responsibilities of data acquisition, use, management, access and retention with other members of a Research team.

Preservation and security of Research Data is an allowable direct cost of conducting research and can be a budgeted item in a sponsored program agreement.

In cases involving misconduct in research and scholarly activities, the threat of imminent loss of custody, maintenance of intellectual property records or for other justifiable causes, the University, acting through the Vice President for Research or designee, may take immediate custody of Research Data.

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Retention of Research Data

Senior Investigators of each Research program must ensure that Research Data documenting the methods and accuracy of data collection and interpretation is retained. Research Data disclosed or referenced in publications, including the primary experimental results, must be retained for a minimum of five (5) years (or as otherwise defined by state regulations or agreement) to allow analysis and replication by others. Research Data resulting from sponsored programs are to be retained by the University for a minimum of five (5) years after submission of the final Report on the Research project, unless a longer retention period is specified by the sponsor.

If an investigation, legal action or official inquiry concerning a Research activity is ongoing, all Research Data related to the project must be retained and made accessible until all issues are resolved.

If a student is involved, Research Data must be retained at least until the degree is awarded to the student or it is clear that the student has abandoned the work.

In addition, Research Data should be kept for as long as may be required to protect any patents or other intellectual properties resulting from this work.

This policy does not create an obligation to retain Research Data of an unfunded project unless it results in a Report in which the investigator is identified as a University Member, constitutes a record of University intellectual property, or involves the use of animal or human subjects.

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Access to Research Data

The University has the right to access Research Data for all Research that is either performed at the University, supported by University administered funds, or conducted using University facilities, provided such access shall be for reasonable cause, at reasonable times and after reasonable notice, except in the event of a bona fide emergency. The University's right of access shall continue regardless of the location of the responsible Investigator or of the Research Data.

Information or data that would violate the confidentiality of sources or subjects involved in the Research shall not be disclosed except in accordance with law or regulation. The University and appropriate external officials shall have access to Research Data concerning matters of compliance with human or animal research subject laws, regulations and policies. Subject to provisions of law, human subjects may be allowed to access Research Data that pertains to themselves but not to access Research Data pertaining to others.

Extramural sponsors providing support for Virginia Commonwealth University or appropriate governmental officials also may have the right to review the Research Data resulting from that extramural support.

Investigators, co-Investigators, staff, students, visiting researchers, and trainees who are an integral part of a Research project have the right to review all Research Data that they gathered or created, or which support publications for which they are named authors, even after departure from the University, to the extent that such Research Data continues to exist and can be identified.

Tangible Research materials or products generated by the Research may be shared with other researchers or institutions under the terms of a University-approved Materials Transfer Agreement.

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Transfer of Research Data

When an Investigator separates from the University, a written Agreement on Disposition of Research Data shall be negotiated between the Investigator and the Investigator's department chair or dean. In most cases, this agreement shall allow the Investigator's Research Data (other than personally identifiable clinical Research records) to be transferred with the Investigator. To fulfill the University's obligations to funding sources and other supporting entities and for research compliance purposes, the department chair or dean will ensure by such agreements appropriate access to the transferred Research Data. Under the terms of the agreement, the Investigator shall have the obligation to hold these Research Data in trust for the University.

In some cases (e.g., Research Data supporting a patent application, Research Data generated and/or used by other University Investigators, some tangible Research products, or as required by the terms of extramural funding agreements), it may be necessary for original Research Data to be retained at the University. In such cases, this agreement shall allow the Investigator to access and, where practical, to copy Research Data. In cases of multi-institutional studies, the institution of the primary study director shall be responsible for arranging appropriate access to, use of, and retention of Research Data.

When required by law, regulation or contract, or to fulfill other obligations, the University may transfer title or custody of Research Data and records at its discretion. In such cases, the University, insofar as possible, will ensure access by Investigators and other appropriate individuals to that Research Data.

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Ownership of Research Data

Consistent with federal policy and prevailing higher education practice, Research Data belong to the University. The University may make disposition of these Research Data and related property rights in a manner that is consistent with law and policy, including, but not limited to, the VCU Policy on Intellectual Property and the VCU Policy and Procedure for Misconduct in Research and Scholarly Activities.

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Research Data Policy Oversight and Dispute Resolution

The Vice President for Research has responsibility for oversight of and resolution of disputes resulting from this policy. If an Investigator desires to contest the decision of the Vice President for Research, this can be done through written appeal to a committee of researchers appointed by the President from the Research Advisory Council.

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