Research Policies

IV-99.01(A)

UMB POLICY REGARDING OWNERSHIP, MANAGEMENT, AND SHARING OF RESEARCH DATA

Administration   |   Approved May 4, 2017


Responsible VP/AVP

Bruce Jarrell, MD, FACS


Policy Statement

I.          INTRODUCTION

The retention and retrieval of Research Data is important for maintaining scientific integrity and complying with requirements of the federal government and other research sponsors. Research Data produced from federally sponsored research are subject to federal regulations, rules, and policies regarding maintenance, retention and dissemination. Similarly, research that is regulated by specific governmental entities, such as clinical investigations, may be subject to more specific data management requirements.

In addition, increased mobility of University researchers in recent years has changed the continuity of scientific research, necessitating the development of institutional policies on data access, retention, and transfer.

II.         APPLICABILITY

This policy applies to Research Data that result from research activity performed at or under the auspices of UMB, regardless of funding source. It applies to all UMB faculty, staff, postdoctoral fellows, students, visitors, and others (including consultants) who are involved in the design, conduct, or reporting of research performed at or under the auspices of UMB.

This policy is designed to complement, but not supersede, other applicable federal, UMB, and other policies, including without limitation protection of human subjects, HIPAA, intellectual property, financial management, etc. In the event of a conflict of this policy with federal requirements, federal requirements will prevail.

This policy provides an umbrella approach to Research Data across UMB. School policies may also apply, but are not to conflict with this policy or federal requirements.

III.        DEFINITIONS

  1. Research Data: Information which is recorded or collected (regardless of the form or media), and which is commonly accepted in the scientific community as necessary to reconstruct, validate, and evaluate reported or otherwise published results.
    1. Research Data includes without limitation such information which results from human subjects research, animal research, and laboratory research.
    2. Research Data may be in hard-copy form (including research notes, laboratory notebooks, or photographs), or in electronic form (such as computer software, computer storage/backup, or digital images).
    3. Research Data are not limited to raw experimental results and instrument outputs. They encompass associated protocols, numbers, graphs, tables, and charts used to collect and reconstruct the data. Research Data include without limitation field notes or observations, procedures for data analysis and/or reduction, data obtained from interviews or surveys, computer files and databases, research notebooks or laboratory journals, slides, audio/video recordings, photographs, case report forms, regulatory documents, and other information of a scientific, technical, or potentially commercial nature that is relevant to the research project.
  2. Principal Investigator (PI): The individual who bears primary responsibility for technical, programmatic, fiscal, and administrative requirements of the research project for which Research Data will be collected.

IV.        OWNERSHIP, MANAGEMENT, AND SHARING OF RESEARCH DATA

  1. UMB owns Research Data.
    1. However, UMB may agree to assign ownership of Research Data to a sponsor of a grant or sponsored research agreement, subject to the University’s right to use and reproduce the Research Data for research and educational purposes. UMB's president or designee shall approve any such agreement.
  2. Anyone who leaves UMB may request to take copies (but not originals) of Research Data created by or on his/her behalf. However, no copies of Research Data may be taken, unless prior written approval is granted by the Dean or designee. In no event may anyone take originals of Research Data.
  3. The Principal Investigator has primary responsibility for the Research Data that result from any research project or program under the PI’s supervision. This includes responsibility for recording, retaining, storing, and disseminating the Research Data. The Principal Investigator also has primary responsibility for ensuring that use of the Research Data complies with applicable ethical use standards, legal requirements, and UMB policy.
  4. Research Data must be managed so as to reasonably ensure that they are available for access and re-use where appropriate and under appropriate safeguards.
  5. The PI is responsible to determine what information needs to be retained in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy, and compliance with laws and regulations governing the conduct or research.
  6. The PI is responsible to inform all persons involved in the research of their obligations regarding Research Data, and for protecting UMB’s rights and ability to meet obligations related to the Research Data.
  7. Research Data must be maintained, managed, archived, and disseminated in accordance with all applicable requirements of: (a) research sponsors, including without limitation requirements of governmental sponsors (such as those of the National Institutes of Health and the National Science Foundation); (b) the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) (if applicable); and (c) all applicable laws, rules regulations, and guidelines (including without limitation the Maryland Public Information Act).
  8. Persons involved in the research should maintain such detail as is necessary to permit examination for the purpose of replicating the research, responding to questions that may result from error or misinterpretation, establishing authenticity of the records, and confirming the validity of the conclusions. Such detail should include, for example, research notes, protocols, images, dates, and times.
  9. Persons involved in the research should maintain such detail as is necessary to permit the filing of patent applications, including sufficient data: to substantiate the date of conception or reduction to practice of any invention made in the course of the research; and to identify the inventor and any co-inventor(s).
  10. Research proposals should include a Research Data management plan or protocol where required or appropriate. For example, the plan or protocol could address data capture, management, integrity, confidentiality, retention, sharing, access, and publication.
  11. Exclusive rights to reuse or publish Research Data should not be assigned to commercial publishers or other agents, unless it is (a) a condition of funding, (b) a result of UMB policy or licensing choices, and (c) approved by the applicable Dean or designee. (Non-exclusive rights to reuse or publish Research Data may be assigned to commercial publishers or other agents without such approval.)
  12. Underlying Research Data accompanying a research publication, where the research is supported with federal funding, should be shared upon request with the other investigators if mandated by federal requirements. Identifiable human data, proprietary data, confidential data, or intellectual property being considered for patentability by UMB, may not be released without the approval of UMB.
  13. Dissemination of Research Data is subject to all applicable requirements regarding the maintenance of confidentiality.

V.         APPROVED METHODS FOR ARCHIVING RESEARCH DATA

  1. Requirements for recording and storing Research Data will vary by discipline. The PI should adhere to guidance provided by funding bodies, professional guidance where available, any principles set out at the School level, as well as policies endorsed or adopted by CITS.
  2. Research Data should be stored using a method that permits a complete retrospective audit, if necessary. Unless ethical/professional/local or funding body guidance requires otherwise, Research Data should be archived in a durable form and in a secure location that is immune to subsequent tampering and falsification.

VI.        RELATED POLICIES

Section III-1.10(A) UMB Policy and Procedures Concerning Research Misconduct

Section IV - 2.20 University System of Maryland Policy on Classified and Proprietary Work

Section IV - 3.20 University System of Maryland Policy on Intellectual Property

Section X - 99.06(A) UMB Data Classification Policy

Section X - 99.07(A) UMB Data Retention-Archival Policy

Section X - 99.21(A) UMB Policy Regarding Cloud Computing for Confidential or Regulated Data

UMB Human Research Protection Program Plan (HRP 101)

UMB Investigator Manual (HRP 103)

VII.       VIOLATIONS

Violations of this Policy may result in corrective or disciplinary action.

VIII.      APPEALS/WAIVERS

Any appeal regarding an application of this Policy, or any request for any waiver from the requirements of this Policy, may only be granted by the President, CARO, or designee.

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