DRAFT NIH Policy for Data Management and Sharing
November 2019

DRAFT NIH Policy for Data Management and Sharing
I.

PurposeThe NIH Policy for Data Management and Sharing (herein referred to as the Policy) reinforces
NIH's longstanding commitment to making the results and outputs of the research that it fundsand conducts available to the public. Data sharing enables researchers to rigorously test thevalidity of research findings, strengthen analyses through combined datasets, reuse hard-togenerate data, and explore new frontiers of discovery. In addition, NIH emphasizes theimportance of good data management practices, which provide the foundation for effective
data sharing and improve the reproducibility and reliability of research findings. NIH
encourages data management and data sharing practices consistent with the NIH Plan for
Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded
Scientific Research and the FAIR (Findable, Accessible, Interoperable, and Reusable) data
principles.
To promote effective and efficient data management and data sharing, NIH expects researchers
to manage scientific data resulting from NIH-funded or conducted research and prospectively
plan for which scientific data will be preserved and shared. Under this Policy, individuals andentities would be required to provide a Data Management and Sharing Plan (Plan) describing
how scientific data will be managed, including when and where the scientific data will bepreserved and shared, prior to initiating the research study. Shared data should be madeaccessible in a timely manner for use by the research community and the broader public. ThisPolicy is intended to establish expectations for Data Management and Sharing Plans uponwhich other NIH Institutes, Centers and Offices (ICO) may supplement as appropriate.
II.

Definitions

For the purposes of this Policy, terms are defined as follows:•Data Management and Sharing Plan (Plan): A plan describing how scientific data
will be managed, preserved, and shared with others (e.g., researchers, institutions, thebroader public), as appropriate.

•Data Management: The process of validating, organizing, securing, maintaining,and processing scientific data, and of determining which scientific data to preserve.

•Data Sharing: The act of making scientific data available for use by others (e.g.,researchers, institutions, the broader public).

•Metadata: Data describing scientific data that provide additional information to makesuch scientific data more understandable (e.g., date, independent sample and variable
description, outcome measures, and any intermediate, descriptive, or phenotypicobservational variables).

•Scientific Data: The recorded factual material commonly accepted in thescientific community as necessary to validate and replicate research findings,
regardless of whether the data are used to support scholarly publications.
Scientific data do not include laboratory notebooks, preliminary analyses,

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DRAFT NIH Policy for Data Management and Sharing
November 2019

completed case report forms, drafts of scientific papers, plans for future research,peer reviews, communications with colleagues, or physical objects, such aslaboratory specimens. NIH expects that reasonable efforts will be made to digitize
all scientific data.
III.

Scope

This Policy applies to all research, funded or conducted in w hole or in part by NIH, that resultsin the generation of scientific data. This includes research funded or conducted by extramural
grants, contracts, intramural research projects, or other funding agreements regardless of NIH
funding level or funding mechanism.
IV.

Effective Date(s)The effective date of this Policy and subsequent implementation deadlines are dependent upon
feedback on this proposal. This Policy is proposed to be effective for NIH-funded orconducted research, including:•Competing grant applications that are submitted to NIH for a future receipt date orsubsequent receipt dates (date yet to be determined);•Proposals for contracts that are submitted to NIH on or after a future date (date yetto be determined);•NIH Intramural research conducted on or after a future date (date yet to bedetermined); and•

Other funding agreements (e.g., Other Transactions) that are executed on or after afuture date (date yet to be determined), unless otherwise stipulated by NIH.

V.

Requirements

This Policy would require:•Submission of a Data Management and Sharing Plan (Plan) outlining how
scientific data will be managed and shared, taking into account any potential
restrictions or limitations.

•Compliance with the NIH ICO-approved Plan, prospectively describing effective
management and timely sharing of scientific data (as appropriate) and accompanying
metadata resulting from NIH-funded or conducted research.

The funding NIH ICO may request additional or specific information to be included within thePlan in order to meet expectations for data management and data sharing in support ofprogrammatic priorities or to expand the utility of the scientific data generated from theresearch. Costs associated with data management and data sharing may be allowable under thebudget for the proposed project (Supplemental DRAFT Guidance: Allowable Costs for DataManagement and Sharing).

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DRAFT NIH Policy for Data Management and Sharing
November 2019

VI.

Data Management and Sharing Plans

Researchers with NIH-funded or conducted research projects resulting in the generation ofscientific data are required to submit a Plan to the funding NIH ICO as part of Just-in­ Time forextramural awards, as part of the technical evaluation for contracts, as part of the NIH
Intramural Annual Report, or prior to release of funds for other funding agreements. Plans
should explain how scientific data generated by a research study will be managed and which ofthese scientific data will be shared. Plans may be updated by researchers (with appropriate NIH
ICO approval) during regular reporting intervals if changes are necessary or at the request ofthe NIH ICO to reflect changes in the previously documented approach to data managementand data sharing throughout the research project, as appropriate. NIH encourages sharedscientific data to be made available as long as it is deemed useful to the research community or
the public. Plans should also identify strategies or approaches to ensure data security andcompliance with privacy protections are in place throughout the life of the scientific data. NIH
may make Plans publicly available.
NIH prioritizes the responsible management and sharing of scientific data derived from humanparticipants. Applicable Federal, Tribal, state, and local laws, regulations, statutes, guidance,and institutional policies dictate how research involving human participants should beconducted and how the scientific data derived from human participants should be used.
Researchers proposing to generate scientific data derived from human participants should
outline in their Plans how human participants' privacy, rights, and confidentiality will beprotected, i.e., through de-identification or other protective measures. NIH recognizes thatcertain factors (e.g., legal, ethical, technical) may limit the ability to preserve and share data.
Plans should include consideration of these factors, when applicable, in describing theapproach to data management and data sharing. NIH encourages the use of establishedrepositories for preserving and sharing scientific data.
Plan Elements: Consider addressing specific elements outlined in Supplemental DRAFT
Guidance: Elements of An NIH Data Management and Sharing Plan
Plan Assessment: The funding NIH ICO will assess the Plan, through the following processes:•Extramural Awards: Plans will undergo a programmatic assessment by NIH staff
within the proposed funding NIH ICO. NIH encourages potential awardees to workwith NIH staff to address any potential concerns regarding the Plan prior tosubmission.

•Contracts: Plans will be included as part of the technical evaluation performed by NIHstaff.

•

Intramural Research Projects: Plans will be assessed by the Scientific Director (ordesignee) or Clinical Director (or designee) of the researcher's funding NIH ICO.

•

Other funding agreements: Plans will be assessed in the context of other funding
agreement mechanisms (e.g., Other Transactions).

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DRAFT NIH Policy for Data Management and SharingNovember 2019

VII.

Compliance and Enforcement

During the Funding or Support Period:
During the funding period, compliance with the Plan will be determined by the funding NIH
ICO. Compliance with the Plan, including any Plan updates, will be reviewed during regular
reporting intervals (e.g., at the time of annual Research Performance Progress Reports(RPPRs)) at a minimum.
•Extramural Awards: The Plan will become a Term and Condition of the Notice ofAward. Failure to comply with the Terms and Conditions may result in an enforcement
action, including additional special terms and conditions or termination of the award,and may affect future funding decisions.

•Contracts: The Plan will become a Term and Condition of the Award, andcompliance with and enforcement of the Plan will be consistent with the award andthe Federal Acquisition Regulations (FAR), as applicable.

•Intramural Research Projects: Compliance with and enforcement of the Plan will beconsistent with applicable NIH policies established by the NIH Office of Intramural
Research and the applicable NIH ICO.

•

Other funding agreements: Compliance with and enforcement of the Plan will beconsistent with applicable NIH policies.

Post Funding or Support Period
After the end of the funding period, non-compliance with the NIH ICO-approved Plan may betaken into account by the funding NIH ICO for future funding decisions for the recipient
institution (e.g., as authorized in the NIH Grants Policy Statement, Section 8.5, Special Award
Conditions, and Remedies for Noncompliance (Special Award Conditions and Enforcement
Actions)).

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