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REQUIREMENTS AND POLICIES MANUAL

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    Title:

    Research Data

    Publication date:

    5/20/2022

    Effective date:

    5/20/2022

    BRIEF

    Policy Summary

    This policy applies to all research data for which Lawrence Berkeley National Laboratory (Berkeley Lab) holds ownership or use rights. The policy provides a framework for the managing and sharing of research data at the Lab. It sets forth principles for the ownership, availability, and access of research data, on data management and the creation of data management plans, as well as the sharing of research data at the time of publication of research. Additional requirements apply in the event that an investigator leaves Berkeley Lab.

    Who Should Read This Policy

    This policy applies to employees, affiliates, joint faculty, staff, volunteers, contractors, researchers, postdocs, student workers, student supporting/performing research, medical center staff/personnel, clinicians, student interns, student volunteers, or persons working for Berkeley Lab in any capacity or through any other augmentation to Berkeley Lab staffing levels, who are involved in the design, conduct or reporting of research, regardless of the funding source for such activities. Read more about the policy implementation on the Research Compliance Office's FAQs page.

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    Contact Information

    Research Compliance Office
    [email protected]
    For further contact information, see Section L, "Contact Information."

    Title:

    Research Data

    Publication date:

    5/20/2022

    Effective date:

    5/20/2022

    POLICY

    A. Purpose

    This policy covers the use, management, and sharing of research data generated at Lawrence Berkeley National Laboratory (Berkeley Lab). Its aim is to provide a framework for the managing and sharing of research data in support of Berkeley Lab's mission of bringing science solutions to the world. The researchers at Berkeley Lab contribute their knowledge and work to the mission of the Laboratory; they are the stewards of the research data generated and facilitate the sharing and dissemination of their work.

    B. Persons Affected

    This policy applies to employees, affiliates, joint faculty, staff, volunteers, contractors, researchers, postdocs, student workers, student supporting/performing research, medical center staff/personnel, clinicians, student interns, student volunteers, or persons working for Berkeley Lab in any capacity or through any other augmentation to Berkeley Lab staffing levels, who are involved in the design, conduct or reporting of research, regardless of the funding source for such activities. Read more about the policy implementation on the Research Compliance Office's FAQs page.

    C. Exceptions

    1. This policy applies to all research data for which Berkeley Lab holds ownership or use rights. It does not apply to information that is not research data.
    2. Research data generated at Berkeley Lab Designated User Facilities is governed by the policies and user agreements at these facilities.

    D. Policy Statement

    D.1 Ownership, Availability, and Public Access

    1. The Department of Energy (DOE) owns all research data (also referred to as technical data and scientific and technical information (STI)), whether it is copyrightable or not, that is first produced in accordance with the Management and Operating Contract No. DE-AC02-05CH11231 between the Regents of the University of California and the DOE.
    2. Researchers at Berkeley Lab are the stewards of the data they generate, and in accordance with this policy, DOE or sponsor requirements have certain usage rights to the data, including public dissemination in academic journals and in data repositories. Section D.4 of this policy outlines the procedures in the event that a researcher leaves Berkeley Lab.
    3. As a DOE Lab that is managed and operated by the University of California, Office of the President (UCOP), Berkeley Lab requires that researchers follow UCOP's Research Data Policy for any research data created by or at the direction of University of California researchers or principal investigators during the course of University of California research, unless specifically agreed otherwise by the university under sponsorship or other related agreements.
    4. This policy is intended to provide the governing policies and principles to support Berkeley Lab researchers' ability to conduct research, transmit research data to collaborators, independently publish the outcomes of their research, or create scholarly works.
    5. To fulfill Berkeley Lab's mission of outstanding research and the broad exchange of ideas as well as to meet obligations with legal, funder, and collaborator requirements, it is the responsibility of researchers at Berkeley Lab to be aware of the relevant policies and conditions of use of any research data created at Berkeley Lab and to ensure that all research data are properly curated, collected, securely stored, managed, and fully accessible, and appropriate stewardship of research data throughout the research life cycle, from the point of research design to preservation.
    6. In the performance of our DOE contractual obligations, Berkeley Lab must manage research data produced under the contract as a direct and integral part of our work and ensure the broad availability of Berkeley Lab research data by making research data available to:
      1. DOE's central STI coordinating office (OSTI) per DOE O 241.1B or its successor version; and
      2. The public or scientific community for the purpose of scientific research, knowledge and education through all manner of communication and distribution channels.
    7. Berkeley Lab researchers are encouraged to widely disseminate research data and results through such means as publishing in academic, technical, or professional journals; depositing supporting data in established repositories; and releasing data, code, models, and software in accordance with this policy and any DOE program or other sponsor requirements.
    8. Separate policies and agreements may cover the use of data and assertion of copyright by Berkeley Lab in data and software. The appropriate technology transfer expert in the Intellectual Property Office (IPO) should be consulted prior to release and assertion of copyright. Data obtained from collaborators or purchased from external sources may be licensed under agreements that limit the use of the data or their public dissemination. The IPO should be consulted during the licensing process or where licensing terms are not clear.
    9. Separate agreements may cover rights in data or research results if research work is sponsored by other agencies or industry partners, such as through Cooperative Research and Development Agreements (CRADAs), User Agreements, and Strategic Partnership Projects (SPP), or if generated by Berkeley Lab collaborators and partners through research and supplier subcontracts issued by Berkeley Lab. While typically the sponsor, Berkeley Lab and the DOE maintain unlimited rights in all generated information in sponsored research projects. Except for information disclosed in a subject invention disclosure being considered for patent protection, the grant of permission to assertion of copyright may depend on the specific contract, and researchers should review the applicable agreement terms prior to sharing or release of data.
    10. Principal investigators (PI) must retain research data as long as required by funders, publishers, Berkeley Lab policies, compliance or regulatory bodies, and applicable law, and as indicated in other relevant agreements. To ensure proper preservation, PIs must have systems or practices for maintaining and retaining research data in accordance with stated requirements and with the standards of their scholarly disciplines and of Berkeley Lab. PIs are responsible for consulting these requirements and must follow the most stringent requirement for retaining research data.
    11. Research data that demonstrate a path to discovery are considered scientific Research & Development records and need to be managed and retained in accordance with Berkeley Lab's Archives and Records Management Policy. These records include research data used to provide a direct input to forming government policy. In using the term "path to discovery," our definition follows Research & Development Records Schedule Item 12 that describes raw data as "used for reference in arriving at determinations in the conduct of research projects or determined to have probable value for secondary evaluations or future experiments."
    12. Separate considerations apply to computer software and data generated by subcontractors of Berkeley Lab. Subcontract requesters and technical representatives should consider the project, data, and intellectual property needs when engaging subcontractors, and should be aware of the Rights in Data clause that is applied in Berkeley Lab subcontracts. Under Berkeley Lab subcontracts, data and software generated by subcontractors are not always deemed works-for-hire as a default. In most cases, for software and data generated under subcontracts, the subcontractor needs to request permission from the DOE to own and assert copyright in such software or data in the event the DOE has not provided pre-approval or grant of approval in their subcontract. Pre-approval is often granted for academic and non-profit institutional subcontractors conducting research and on an individual request basis with industry or large business subcontractors. For instances where the software or data generated are special works or there are specific DOE or program needs, subcontract requesters and technical representatives should consult with IPO or Lab counsel to discuss the individual project and subcontract data needs. Accordingly, while the data copyright will generally belong to subcontractors, the DOE reserves a non-exclusive license to data and copyrighted material for itself and the government's use, to which Berkeley Lab may access such data via its government use license.

    D.2 Data Management

    1. As of July 1, 2023, all research projects or programs at Berkeley Lab that are sponsored by the DOE, external funders, or through the Laboratory Directed Research and Development (LDRD) program require a data management plan (DMP) that covers the research performed. Where a research funder does not require the submission of a DMP, it is the responsibility of a PI or program lead to draft and store the DMP either in their records or upload it to a suitable repository. Research funders and sponsors may have additional requirements on DMPs, and researchers should review any additional applicable agreement terms for specific projects.
    2. The aim of DMPs is to ensure an efficient and effective use of government funding resources, and to facilitate the appropriate sharing of research data through documentation of how the data are generated, stored, and organized.
    3. Any data ownership, management, use, and licensing questions should be clarified and developed between research collaborators at the proposal stage and reflected in DMPs as necessary.
    4. DMPs must address the following requirements, with all applicable topics included in the DMP:
      1. Confidential or personal data: as applicable, DMPs must consider measures to protect confidentiality, personal privacy, personally identifiable information, and U.S. national, homeland, and economic security; recognize proprietary interests, business confidential information, and intellectual property rights; avoid significant negative impact on innovation, and U.S. competitiveness; and otherwise be consistent with all applicable laws, regulations, and DOE orders and policies, including Berkeley Lab's Controlled and Prohibited Information Categories Policy. Research Projects identified as being Export Controlled and/or Restricted (e.g., on the Science & Technology Risk Matrix) require DMPs in accordance with applicable DOE orders and policies. All of these topics must be considered prior to the collection of relevant research data, and any necessary permissions and approvals must be obtained in advance.
      2. Intellectual property: Berkeley Lab recognizes the value of research that could lead to economic or commercial benefit. If applicable, such opportunities should be documented and the appropriate technology transfer expert consulted. There is no requirement to share proprietary research data prior to protecting intellectual property.
      3. Data collection: DMPs should describe data collection and organization, including information about what type of data will be produced, what size or volume of data is expected, what tools or instruments will be used, and what types of analyses are planned.
      4. Data management: DMPs should consult and reference available information about data management resources to be used in the course of the proposed research. In particular, DMPs that explicitly or implicitly commit data management resources at a facility beyond what is conventionally made available to approved users should be accompanied by written approval from that facility. In determining the resources available for data management at Office of Science User Facilities, researchers should consult the published description of data management resources and practices at that facility and reference it in the DMP. Information about other Office of Science facilities can be found in the additional guidance from the sponsoring program. Roles and responsibilities in data preservation and curation should be clearly defined.
      5. Data preservation: DMPs should describe whether and how data generated in the course of the proposed research will be shared and preserved, and what methods or software tools will be needed to access and use the data. If the plan is not to share and/or preserve certain data, then the plan must explain the basis of the decision (for example, cost/benefit considerations, other parameters of feasibility, scientific appropriateness, or limitations discussed in Section D.1., "Ownership, Availability and Public Access"). At a minimum, DMPs must describe how data sharing and preservation will enable validation of results, or how results could be validated if data are not shared or preserved.
      6. Data sharing: DMPs should provide a plan for making all research data intended for publication or dissemination open, machine actionable, and digitally accessible to the public at the time of publication, in accordance with Section D.3., "Data Sharing."
      7. Data sharing practices: DMPs should reference community best practices for data when applicable, including for the specific data type and field as well as FAIR data principles (see Section D.3, "Data Sharing"). For non-standard data types, a description of planned processing and definitions should be included.
      8. Data formats: Deposited data should use openly documented data formats and metadata standards.
      9. Machine actionable DMP: Where applicable, DMPs should be provided in a machine actionable format.
      10. Copyrighted data: Research projects with the potential intent to assert copyright of the data for licensing should discuss sharing limitations, and the appropriate technology transfer expert should be consulted.
      11. Data license: A DMP should declare the intended data license, for example to assert copyright for research data for a sponsored research project.
    5. DMPs must be updated throughout a research project or program if there are changes to the research that affect a DMP in any area of the above list of requirements.
    6. In accordance with the Archives and Records Management Policy, the Research & Development retention schedules are 10 years for raw data as described in Research & Development Records Schedule Item 12, and anywhere from 10 years to permanent for evaluated or summarized data depending on the significance of a project.

    D.3 Data Sharing
    Berkeley Lab's mission is to develop solutions to the real-world challenges faced by people, the planet, and the nation. In support of our Stewardship Principles, our research is open, and sharing our research is part of our tradition and mission.
    Responsible practices for open data sharing include:

    1. Data sharing must follow all applicable laws and regulations as well as Berkeley Lab policies. The sharing of data may be restricted by regulations such as privacy policies, licensing restrictions, confidentiality agreements, export control regulations, or security policies. Berkeley Lab's Controlled and Prohibited Information Categories policy must be followed.
    2. Where research is being made public and the data are not restricted by policies and regulations, data sharing is an integral part of Berkeley Lab's mission. Shared data sets and metadata as well as related research methods and protocols support the reuse, reproducibility, and replication of research at Berkeley Lab. Typically, minimal shared data sets include summary tables for published figures and relevant underlying processed data, but may also include raw data in accordance with the relevant community standards. These minimal data sets and metadata, as well as related research methods and protocols underlying research findings, must be shared at the time of publication of the research.
    3. The sharing of software must follow the Software Disclosure and Distribution Policy. Computer Scripts that are used to access, analyze, or process freely and widely available data sets can be included under the same general Creative Commons license of the data set or the publication they are associated with. Interactive documents or notebooks that analyze research data can be published under the license of the research output they are associated with.
    4. Research data or academic software published by others used for research conducted at Berkeley Lab must be acknowledged where appropriate for academic credit, for example through data or software citations. The reuse of data or software published by others must comply with the usage license under which these items have been shared and should follow all applicable principles and norms of the relevant research communities. Sufficient information should be provided to ensure reproducibility of the research, for example by including information such as version numbers or software configurations.
    5. Data sharing should follow the FAIR Principles to ensure Findability, Accessibility, Interoperability, and Reusability of data and metadata. For example, persistent identifiers for researchers sharing the data (e.g., ORCIDs) and for research data (e.g., digital object identifiers (DOI)) should be used. In addition, citation and acknowledgement information should be provided with the shared data.
    6. Data sharing should preferably use any relevant subject-specific data repositories, and if not applicable, general data repositories should be used where possible. Subject-specific repositories are often able to support the reuse of data sets by providing suitable data structures and metadata information with the content.
    7. Published journal articles and preprints should indicate how the shared data can be accessed if it is not contained within the article itself. The citation to the data set should appear in the body of the article with a corresponding reference in the reference list.
    8. Data sharing should use appropriate data licenses, such as Creative Commons licenses CC0, CC-BY, or CC-BY-NC.
    9. Berkeley Lab encourages the publication and sharing of null and negative research findings and associated research data.

    D.4 Procedures in the Event that an Investigator Leaves Berkeley Lab

    1. When researchers other than the PI who have been involved in a Berkeley Lab research project leave Berkeley Lab, they may in general, take copies of research data that they generated or collected in the course of their Berkeley Lab research, subject to agreement by the PI and in accordance with DOE regulations, proper acknowledgements or authorship, and any applicable sponsor and licensing restrictions. Any current licenses on the data will remain in full force and effect unless agreed otherwise. Research data must be retained by the PI on behalf of Berkeley Lab.
    2. When a PI leaves Berkeley Lab, and a Berkeley Lab research project is to be moved to another institution, copies of research data may be transferred only with the approval of:
      1. The applicable division or facility.
      2. If applicable, the PI's new institution, pursuant to a written agreement between Berkeley Lab and such institution that guarantees (a) acceptance of custodial responsibilities for the research data and (b) Berkeley Lab's access to the research data as necessary.
      3. Any sponsor that requires prior approval. Berkeley Lab may impose conditions on such transfer or may require the PI to leave copies of the research data with Berkeley Lab.
      4. In addition, other Berkeley Lab investigators associated with a collaborative research project may make copies of research data prior to a permitted transfer by the PI, unless restricted by the specific terms of an applicable agreement with the sponsor of the research.
    3. The custodial ownership of research data can only be transferred to other DOE institutions. Transfer to other federal agencies is possible with permission from the National Archives and Records Administration (NARA). Custodial ownership of research data must remain with Berkeley Lab in all other situations.
    4. Any individual who leaves Berkeley Lab, whether to move to another institution or to retire, must arrange with their supervisor for the storage of any research data that remains at Berkeley Lab in accordance with any policy adopted by the division or facility. 
    5. A departing PI must return the research data to Berkeley Lab if requested.
    6. In addition, such research data must be available to external sponsors, designated governmental officials and other Berkeley Lab investigators who are collaborators with the departing PI. Any disputes with respect to access to research data shall be resolved in the first instance by the applicable division or center director, and if not so resolved, by the Deputy Director for Research or their designee(s).

    E. Roles and Responsibilities

    Role

    Responsibility

    Researchers

    As stewards of Berkeley Lab's research data, researchers shall:

    1. Securely collect, record, manage, and store research data throughout the research life cycle, from design to preservation.
    2. Manage and share research data in accordance with the standards of their scholarly discipline, and/or any relevant DMP, Berkeley Lab or DOE policies, legal requirements, and the terms and conditions of applicable third-party agreements (such as sponsored awards, material transfer agreements, or data use agreements).
    3. Consult with the PI and/or Deputy Director for Research (or their designee) for clarification of obligations and resolution of disputes related to research data.

    Principal Investigators

    PIs shall, in the conduct of Berkeley Lab research, have the primary responsibility to:

    1. Implement the requirements of this policy and follow best academic practices with respect to collecting, recording, managing, storing, and sharing of research data and for drafting and maintaining DMPs.
    2. Determine use of the research data by other researchers on the project in accordance with relevant agreements and their scholarly discipline's practices and DOE policies, and taking into account the need for academic progress of academic appointees, post-doctoral scholars, degree candidates, and other students.
    3. Retain research data on behalf of Berkeley Lab and DOE. Pis are responsible for knowing retention requirements of their scholarly discipline, funding agencies, and applicable laws and regulations including records management, and for following the most stringent of these multiple requirements. PIs must take the following key circumstances into account when determining the retention period:
    4. Inventions: research data must be kept in accordance with the Archives and Records Management Policy as long as necessary to protect intellectual property and to complete Berkeley Lab patenting and licensing procedures for inventions.
    5. Allegations, Investigations, and Litigation: If any allegations regarding the research arise, such as allegations of research misconduct, research data must be retained and maintained as long as required by the funder's requirements and federal regulations, but retained and maintained at least until all charges have been resolved and final action and appeals taken. If research data are the subject of litigation or investigation, Berkeley Lab and researchers shall preserve potentially relevant information until the Deputy Director for Research (or their designee), in consultation with Berkeley Lab Counsel, issues instructions regarding disposition.
    6. Regulatory Requirements: Retention must follow all applicable regulatory requirements. For example, if a research project involves articles regulated by the U.S. Food and Drug Administration (FDA), consistent with 21 CFR §§ 312.6 and 812.140, PIs must keep records for two years or as long as required following the date a marketing application is approved for the product; or if a marketing application is not filed or FDA-approved, for two years after the investigation is terminated, completed, or otherwise discontinued and the FDA is notified.
    7. Student Participation in Research: If, in advancing to a degree, a student participates in the design, conduct, or reporting of research, the research data connected to that research shall be retained in accordance with Berkeley Lab guidelines and until the student has been awarded a degree or is no longer working on the project.

    Deputy Director for Research

    The Deputy Director for Research or their designee(s) is responsible for the interpretation, implementation, and oversight of this policy and shall:

    1. Establish policies or procedures as necessary for implementing this policy, such as proposed minimum retention policies.
    2. Assure Berkeley Lab compliance with obligations concerning research data arising by law, regulation, or agreement.
    3. Have unfettered access to research data for Berkeley Lab purposes including for the purposes of carrying out Berkeley Lab responsibilities (including sequestration, as may be needed) related to conducting an inquiry or investigation pursuant to Berkeley Lab obligations, such as research misconduct investigations, or in response to agency inquiries or legal process.
    4. Implement procedures to manage the transfer of research data or copies of research data, for example upon the separation or death of a researcher or when a researcher can no longer fulfill responsibilities (see Section D.4., "Procedures in the Event that an Investigator Leaves Berkeley Lab").
    5. Implement local policies and procedures to settle disputes over control, use, and publication of research data among researchers and their collaborators, according to established campus, academic discipline, and journal standards.

    I. Definitions/Acronyms

    Term

    Definition

    Research Data

    Recorded information reflecting original observations, methods, or technical data that demonstrate the path to a research finding, regardless of the form or medium on which the information is recorded, that are generated or collected in connection with research (1) within the course and scope of a researcher's assigned or assumed duties; (2) using Berkeley Lab research facilities or other Berkeley Lab research resources; or (3) with funding from or through Berkeley Lab. Examples of recorded information include Berkeley Lab notebooks, field notes, digital images, data files, computer software, statistical records, etc. Administrative records, such as medical records, that are not created exclusively for research purposes are excluded from this definition and are governed by other policies. Administrative records that are used in connection with research become research data once they are assembled for research purposes and the relevant data request proposal has been approved by the Institutional Review Board (IRB), IT Policy group, and other relevant bodies on the basis of privacy concerns and other key risks.

    Metadata

    Data that provide additional information required to make research data interpretable and reusable (e.g., date, independent sample and variable construction and description, methodology, data provenance, data transformations, any intermediate or descriptive observational variables).

    Raw Data

    Unprocessed research data as it is directly obtained, for example from a device or instrument. As it represents unaltered and unprocessed raw facts, raw data have no protection under the copyright law. Raw data that have been processed may be copyrightable if adequate human interaction or authorship is involved.

    Data Management

    The process of validating, organizing, protecting, maintaining, and processing research data to ensure the accessibility, reliability, and quality of the research data for its users.

    Data Sharing

    Making data available to people other than those who have generated them. Examples of data sharing range from bilateral communications with colleagues, to providing free, unrestricted access to the public through, for example, a web-based platform or repository.

    Data Management and Sharing Plan

    A plan describing the data management, preservation, and sharing of research data and accompanying metadata.

    Researchers

    An employee, affiliate, joint faculty, staff, volunteer, contractor, researcher, postdoc, student worker, student supporting/performing research, medical center staff/personnel, clinician, student intern, student volunteer, or person working for Berkeley Lab in any capacity or through any other augmentation to Berkeley Lab staffing levels, who are involved in the design, conduct, or reporting of research, regardless of the funding source for such activities.

    Principal Investigator (PI)

    The researcher who has primary responsibility for a research project, including the design, conduct, or reporting of the project, regardless of the source of funding or formality of the designation. For the purpose of this policy, the term PI is used whether or not it is a formal title designated by an external research sponsor.

    Requirements and Recommendations

    The keywords "must," "required," "shall," "should," "recommended," and "may" in this document are to be interpreted as described in IETF RFC 2119.

    J. Recordkeeping Requirements

    See above

    K. Implementing Documents

    L. Contact Information

    Questions around the use, management, and sharing of research data should be directed to the relevant PI or to the applicable research division, data repository, or facility. Questions around licensing or patenting of research data should be directed to the Intellectual Property Office (IPO) at [email protected]. Questions about the implementation of this policy should be directed to the Research Compliance Office (RCO) at [email protected].
    Concerns or disputes over the control, use, and integrity of research data or violations of this policy should be directed to the Research Integrity Officer (RIO) at [email protected]. The RIO may discuss concerns informally, which may include discussing them anonymously and/or hypothetically. If the circumstances described by an individual do not suggest research policy violations, the RIO will refer the matter to other offices or officials with responsibility for resolving a concern.
    Questions about applicable export control regulations should be directed to the Export Compliance Office (ECO) at [email protected]. For security concerns or in cases of accidental disclosure of personally identifiable information or protected health information, contact [email protected]. Questions about records retention should be directed to the Records Management Office (RMO) at [email protected]

    M. Revision History

    Date

    Revision

    By Whom

    Revision Description

    Section(s) Affected

    Change Type

    5/20/2022

    0

    J. Heber

    New policy

    All

    New 

    DOCUMENT INFORMATION

    Title:

    Research Data

    Document number

    10.02.004.000

    Revision number

    0

    Publication date:

    5/20/2022

    Effective date:

    5/20/2022

    Next review date:

    5/20/2025

    Policy Area:

    Scientific and Technical Publications

    RPM Section (home)

    Information Management

    RPM Section (cross-reference)

    Conduct of Research and Development

    Functional Division

    Research Compliance Office

    Prior reference information (optional)


    Source Requirements Documents

    • Contract 31, Clause I.138, DEAR 970.5227-3, Technology Transfer Mission(AUG 2019) [SC alternate APR 2018] (prev. I.092)
    • DOE Order 241.1B, Scientific and Technical Information Management
    • S. Food and Drug Administration (FDA), 21 CFR 312.6, Labeling of an Investigational New Drug and 21 21 CFR 812.140, Records

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