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Research Data Management

Responsible Department
Research & Engagement
Effective Date
01/31/2020
  1. .

    Policy Purpose

    1. All researchers at the University of North Georgia (“University”) create some type of data as part of the research workflow. This data represents the evidence underpinning academic endeavors and, in conjunction with publications, forms an important aspect of the scholarly record.

    2. The purpose of this policy is to:

      1. Identify model Research Data management practices for all Researchers (defined below) at the University;

      2. Foster responsible Research Data management through the promotion of best practices around preparation and use of Research Data management plans; and

      3. Ensure that Research Data, which is significant (as determined by the Researcher with guidance from the Office of Research and Engagement), is managed in accordance with the UNG Data Governance and Access policy; and is stored, retained, and disposed of securely in accordance with USG IT requirements.

    3. A robust Research Data Management Policy is required to demonstrate and ensure:

      1. Good research practice and procedures;

      2. Protection of intellectual property rights;

      3. Protection of intellectual property rights;

      4. Compliance with relevant legislation and regulations regarding data usage and rights in relation to data and privacy obligations; and

      5. Appropriate access to Research Data is maintained.

    4. This policy addresses the objective of making Research Data accessible to the wider academic community, including the public, where possible. This policy also recognizes that there are circumstances when access to Research Data must be restricted, either to achieve the highest standards for secure Research Data management, to fulfill commercialization requirements put in place by the University and/or sponsoring agencies, or to comply with laws.
  2. .

    Definitions

    1. Digital Object Identifier: A Digital Object Identifier is a token used to uniquely and permanently identify an article or document and link to it on an internal or external network.

    2. External Funding: An award, typically in the form of a grant, contract, or agreement, made to the University by an outside entity to carry out research activities led by the Principle Investigator employed by the University.

    3. Faculty Advisor: A University faculty member who mentors and oversees research conducted by graduate and undergraduate students at the University.

    4. Inquiry: An early stage of information-gathering and initial fact-finding to determine whether an allegation or apparent instance of a policy or procedure violation warrants further Investigation.

    5. Institutional Review Board (IRB): A committee empowered to provide ethical oversight for all research involving human subjects.

    6. Investigation: A formal examination and evaluation of all relevant facts and other evidence to determine if a policy or procedure violation has occurred and, if so, the person responsible for the violation and the seriousness of the violation.

    7. Principal Investigator or PI: The project director or lead investigator who is the programmatic point-of-contact on a project and is the primary person responsible for the design, conduct, and/or reporting of research activities undertaken by or on behalf of the University.

    8. Research: A systematic investigation, study, or experiment designed to develop or contribute to general knowledge relating broadly to any discipline of scholarly endeavor. This term encompasses basic research, translational research, applied research, product development, and other scholarly activities. As used in this Policy, “Research” includes any such activity undertaken by faculty, staff, or students at the University, regardless of whether funding is sought, available, or offered from internal or external sources.

    9. Researcher: An individual, regardless of title or position, who is involved in the design, conduct, or reporting of Research which shall include but not be limited to faculty, staff, students, and affiliates of the University.

    10. Research Data: Any information in digital, computer-readable, or paper-based format that:

      1. Is contained or presented in various ways including, but not limited to, notes, facts, figures, tables, images (still and moving), audio or visual recordings;

      2. Is collected, generated, or obtained during the course of or as a result of undertaking Research (which includes but is not limited to conducting field or laboratory experiments, conducting trials, surveys, interviews, focus groups or analysis of data); and

      3. Is subsequently used by the Researcher as a basis for drawing conclusions to develop, support or revise theories, practices and findings.

        Research Data includes information from or regarding data sets used in research; unpublished proprietary information; preliminary analyses; drafts of scientific papers; plans for future research; peer reviews or communications with colleagues; personal and medical information and similar information obtained from or about participants in a research study, the disclosure of which would violate their consent to participate in the study or information that could be used to identify a particular person in a research study

    11. Repository: The repository or repositories which the University owns or controls and makes available to Researchers for the storage of Research Data in a manner that is compliant with the university Data Governance Policy.

    12. Sponsoring Agency: External sponsor, agency, or organization; can be federal, state, or local, private or public agency providing funds to the University for activities related to a specific Research plan.

    13. University Research Community: Any person paid by, under the control of, enrolled as a student of, or affiliated with the University engaged in scientific or scholarly Research, including but not limited to, faculty, staff, scientists, fellows, guest researchers, visiting faculty or staff, graduate students, undergraduate students, trainees, technicians, support staff, and other faculty or staff members, , adjunct faculty when performing University work, and faculty or staff on leave without pay.
  3. .

    Policy Statement

    1. General

      1. Safeguarding Research integrity is fundamental to the mission of the University. This level of integrity is the expected standard and by the Sponsoring Agencies and the University. All members of the University Research Community must adhere to the highest ethical and professional standards as they pursue Research activities, as they share responsibility to ensure that the University’s high standards of scholarly integrity are preserved.  All members engaged in Research endeavors must comply with the legal, regulatory, and ethical requirements established by the University, regulatory agencies, funding sources and professional organizations.

      2. The University has explicit obligations to Sponsoring Agencies to safeguard Research Integrity. In seeking funds from agencies, the University must establish and abide by uniform policies and procedures for conducting Investigations and reporting instances of alleged or apparent research misconduct involving Research activities.  When a report of potential ethical misconduct or other wrongdoing is made, the University must investigate and implement corrective action, if necessary.

    2. Applicability

      1. All Research activities conducted by faculty, staff, students, and other members of University Research Community are covered under this policy. This includes research that is supported by Sponsoring Agencies, research that is internally funded, and unfunded research activities.

      2. This Policy also applies in full to undergraduate and graduate students whose research findings are included in published research outputs.

    3. Responsibilities of Researchers

      1. All Researchers must be aware of their and the University’s legal obligations and potential liability when collecting, processing, using, and storing data relating to human subjects. Researchers must ensure compliance with handling data protected by Federal, federal approved international, state, and local laws and regulations as defined by the University’s Data Governance Policy.

      2. For research that is Externally Funded or Internally Funded, all Researchers must adhere to the data management plan submitted as part of the grant application and adhere to the contractual obligations governing Research Data as defined in any relevant research contracts.

      3. All Researchers must ensure that the integrity and security of their data is maintained.

      4. All Researchers who are employees of the University must complete Responsible Conduct of Research (RCR) training every 3 (three) years to ensure integrity in the practice of scientific inquiry and proper handling of data.

    4. Principal Investigators and Researchers

      1. Researchers must develop a data management plan prior to commencing any research. Principal Investigators must adhere to the generated data management plan, updating it when necessary, and maintain a review process for the plan throughout the Research Data life cycle.

      2. The PI must ensure the data management plan addresses the matters set out in the Research Management Procedures.

    5. Student Researchers and Faculty Advisors

      The University believes that embedding Research Data management practice in early career researchers is critical to establishing an effective data management ethos. Good research practice requires students, both graduate and undergraduate, and their Faculty Advisor to plan the collection, storage, security and use of Research Data, in accordance with conventions in their fields of study and obligations from the University and any Sponsoring Agencies.

      In addition to the requirements for Researchers set out above, Faculty Advisors and students conducting research must:

      1. Establish collection and storage procedures for their Research Data, and ensure that data management is planned and documented in accordance with UNG standard practices at the outset of the research project in accordance with obligations as defined by any Sponsoring Agency, applicable University policies, and professional standards in the student’s area of study.

      2. Ensure the Data Management Plan is completed before data collection is started and regularly reviewed thereafter.

      3. Ensure a copy of their significant Research Data is deposited in an appropriate Repository on completion of their research.

    6. Administrative Support

      1. The Associate Provost for Research and Engagement and Chief Research Officer will serve under the supervision of the Provost as the responsible party for promoting, good practice in all aspects of research governance and integrity including Research data management. The Chief Research Officer must ensure that the University Research Community is aware of its responsibilities and obligations in effective management of Research Data and identify or promote training where gaps in these skills are identified.

      2. The Chief Research Officer is responsible for developing infrastructure and training to promote best practice in data management by the University Research Community.

      3. The Chief Research Officer is responsible for supporting Researchers to plan for data management and write data management plans for grant applications.

      4. The Chief Research Officer, in coordination with the Chief Information Officer and the Dean of Libraries, is responsible for establishing and maintaining an institutional catalogue of research datasets for Externally Funded research in line with Sponsoring Agency requirements.

    7. Ownership and Intellectual Property

      1. Where intellectual property rights exist (for non-registrable rights) or could exist (for registrable rights) over Research Data which is collected, created or generated by Researchers, then the first owner of the intellectual property right(s) (as between the University and the Researcher) will be determined in accordance with the University's Intellectual Property Policy.

      2. The University may be entitled to enter into agreements governing amongst other things the sale, supply, transfer, access to or use of the Research Data in question. These agreements will be subject to the intellectual property rights of third parties (if any) and the contractual obligations of the University.

      3. Where research involves External Funding and/or collaboration with other institutions or external parties, intellectual property rights ownership and rights of use must be addressed within the relevant contract prior to commencement of the project and adhered to by the Researchers. It is recommended the contract identify a process for Research Data management which is consistent with the broad objectives of this Policy.

      4. Where a research project involves use of data (which may include Research Data) owned or controlled by a third party (who is not a collaborating party), each Researcher must abide by the terms of contract governing the use of that data and ensure that the use of this data will not place the University in breach of its contractual or funding obligations arising under agreements with any Sponsors nor violate any provision in the university’s Data Governance Policy.

    8. Stewardship of Research Data

      1. Data Coordinators (as defined in the university’s Data Governance Policy) for Research data must be employees of the University. All Data Coordinators must be trained in the responsible management of Research Data, including applicable international, Federal, and state laws and regulations.

      2. The Principal Investigator (PI), or the Faculty Advisor for student research projects, is the designated primary Data Coordinator for all Research Data generated or acquired in the conduct of a research program or project.

      3. Researchers participating in the Research, but not designated as Data Coordinators, will be designated as Data Users as defined in the university’s Data Governance Policy.  All Data Users must be trained in the responsible use of Research Data.

      4. The Chief Research Officer assumes responsibility of Research Data once the primary Data Coordinator leaves the University. This role may be delegated to a dedicated Data Coordinator or Coordinators to act as custodian of such data on the University’s behalf until it is destroyed.

    9. Storage and Maintenance of Research Data

      1. All Researchers must ensure that all Research Data in digital and computer-readable form:

        1. Is stored securely in a durable format appropriate for the type of Research Data in question;

        2. Is stored with adequate metadata and/or documentation to facilitate identification and support effective reuse of Research Data where this is appropriate;

        3. Is backed-up regularly in accordance with best practice in the relevant field of research;

        4. Is deposited in a Repository or an appropriate national or international repository where it is more appropriate to do so. Where Research Data is stored in another repository, an entry must be made in the Repository indicating where the Research Data has been stored; and

        5. Is referenced in associated research papers which should include a short statement describing how the supporting Research Data may be accessed, including a Digital Object Identifier for datasets held in the Repository.

      2. Non-digital Research Data unsuitable for digitization but which is significant must be:

        1. Stored securely;

        2. labelled, indexed or categorized appropriately in order to identify the Research Data in question and support effective reuse of Research Data where this is appropriate; and

        3. Indexed in the Repository, with an entry identifying that the Research Data in question is held by the University.

    10. Retention of Research Data

      1. Retention periods for Research Data depend on the nature of the Research project, whether the project is Externally Funded, the type of data, and whether the data are deemed “significant.”  Guidance on how to determine what is significant is available from the Office of Research Integrity and reflects best practices and the USG Records Retention Guidelines.

        1. All Research Data that documents the results of laboratory testing performed on humans, animals, or agricultural products must be treated as significant Research Data.

        2. Work completed by graduate students related to a thesis or dissertation must be treated as significant Research Data.

        3. All Research Data resulting from work undertaken by undergraduate students or work completed by any student during an independent study project would fall into this category and need not be retained after the degree has been awarded unless the research is Externally Funded; the Research Data documents the results of laboratory testing performed on humans, animals, or agricultural products; or publication or presentation of the research is planned.

      2. All Research Data that documents the results of laboratory testing performed on humans, animals, or agricultural products must be retained in accordance with USG Records Retention Schedule Number 0472-09-004.

        1. Projects of major national or international significance, interest, or controversy, or where the principal investigator has a widely acknowledged influence on the area of scholarship: PERMANENT.

        2. Projects that are not of major significance but there are potential long-term effects: Retain 70 years after completion of project.

        3. Projects that are not of major significance and where the research does not have potential long term affects: Three years after completion of research project.

      3. All other significant Research Data which is stored in accordance with this Policy must be held for a minimum period of three years from collection, creation or generation of the Research Data or publication of the research results (whichever is the later) provided appropriate safeguards are in place to protect any personal data necessary to achieve the research objectives contained within it.

      4. Research Data must be retained for longer than this three year period:

        1. Where an increased retention period is required to meet the University's statutory obligations, contractual obligations, or the guidelines of the Sponsor;

        2. Where the results of the research have resulted in a patent application; or

        3. Where the results of the research become contentious or subject to challenge at any time during the initial three year retention period, in which case Research Data must be retained pending review and not destroyed or otherwise disposed of until the matter is fully resolved.

      5. Research Data may be retained for longer than this three year period where the research has a public interest or heritage value.

    11. Disposal and Destruction

      1. The agreed processes for the timing, manner, and recording of Research Data disposal and destruction must be included in data planning and stored with other project information and documentation.

      2. Prior to any scheduled disposal and destruction, the relevant Research Data records which have been stored and retained in accordance with sections I and J of this policy must:

        1. Be reviewed with a view to their suitability for destruction by the appropriate University Faculty; and

        2. Where found to be suitable for destruction and disposal, the process must be managed in line with any legal, regulatory, and contractual obligations, and as appropriate relative to the sensitivity of the data in question.

      3. A record of the disposal or deletion of Research Data originally stored or retained in a Repository must be logged in the Repository. The record must include a precise description of the nature of the data and the reason for deletion.

    12. Access

      1. The University recognizes the benefits of making Research Data accessible to the public or wider academic community. However, the University also recognizes that before Research Data is shared, it is essential to consider whether this is permissible in light of intellectual property ownership, ethical requirements, privacy requirements, confidentiality requirements, or any legal, regulatory, or funding restrictions. In addition, Researchers must consider whether Research Data has commercial potential and in consultation with the University's Office of Research and Engagement consider if it is suitable for protection and/or transfer under the University's Intellectual Property Policy.

      2. During the course of a research project, the default policy for access to Research Data must be to restrict access to members of the research team for that specific project, including any collaborators who are not affiliated with the University. In limited cases, Research Data may be shared with other researchers or organizations that are not part of the research team or with the public during the course of a research project only if it is permissible in light of intellectual property ownership, ethical, privacy, confidentiality requirements, and any legal, regulatory, or funding restrictions.

      3. Researchers are encouraged to make Research Data accessible to the public or wider academic community after a project is completed or as part of the publication process whenever it is permissible in light of intellectual property ownership, ethical, privacy, confidentiality requirements, and any legal, regulatory, or funding restrictions.

      4. Before sharing Research Data that contains identifiable, private, or sensitive information about human subjects with other researchers or organizations that are not part of the research team or with the public, Researchers must ensure that any ethical, privacy, and confidentiality requirements have been managed in accordance with the data management plan approved by the Institutional Review Board.

      5. The Research Integrity Officer, members of Research Misconduct Inquiry or Investigation Panels, and staff supporting assessments, Inquiries, and Investigations will have access to all Research Data required to complete these tasks as detailed in the Research Misconduct Policy and Procedures.

    13. Institutional Sharing of Research Data

      1. Research Data acquired from other institutions or shared with other institutions must use a limited Material Transfer Agreements, Protected Data Transfer Agreements, Data Use Agreements, or similar contractual agreement between the respective institutions. These agreements must be negotiated on a project-by-project basis with a narrow scope.

      2. The Chief Research Officer, in consultation with the General Counsel, will be responsible for ensuring that any agreements in which the University acquires data or shares data are compliant with this Policy, other relevant University policies, any relevant Federal or state laws or regulations, and requirements of any Sponsoring Agencies.

    14. Provisions for Special Data Types

      1. All Research Data from projects involving human subjects research must be managed in accordance with the research protocol approved by the University’s Office of Research Integrity (for research deemed by ORI to be exempt under the Revised Common Rule as defined in 45 CFR 46. 104) or the Institutional Review Board.  ORI and the IRB will ensure that all approved research protocols include appropriate protections for the management and security of identifiable private information used for Research.

      2. Any Research that involves the use of recombinant DNA or synthetic nucleic acid molecules (rDNA) must follow the requirements for protection of Research Data specified in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

      3. All systems and processing, including the handling of Research Data, that involve Controlled Unclassified Information must be compliant with the security controls applied to CUI and systems and processes involved with this data as specified in Special Publication 800-871 (NIST 800-871).

      4. Prior to conducting any research projects that involve information to which the Federal Government applies a security classification, the University must establish a set of procedures for that project that comply with the requirements, restrictions, and other safeguards to prevent the disclosure of classified information as specified in the National Industrial Security Program Operating Manual (NISPOM) and other applicable Federal laws and regulations. These procedures must be approved by the Chief Research Officer, the Chief Information Officer, the Provost, and the President of the University prior to the acquisition, collection, or use of classified Research Data.
  4. .

    Support Information

    1. Related University policies include:

      1. Research Integrity

      2. Research Misconduct

      3. Research with Human Subjects

      4. Data Governance and Access Policy

      5. Privacy Policy

      6. Intellectual Property Policy

    2. Related USG policies and guidelines include:

      1. Records Retention (BOR Policy Manual section 6.24)

      2. USG Records Retention Schedules for Research

    3. Related Federal regulations and guidelines include:

      1. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

      2. Special Publication 800-871 (NIST 800-871)

      3. Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations (NIST 800-171)
  5. .

    Procedures

    Any related operating procedures must comply with and should reference this policy.

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