Research Instructions for NIH and Other PHSAgencies - Forms Version H Series
R.400 - PHS 398 Research Plan Form
Elements of a Data Management and Sharing Plan:
Data Type: Briefly describe the scientific data to be managed, preserved, and shared,
including a general summary of the types and estimated amount of scientific data to be
generated and a description of which scientific data from the project will be preserved and
shared as well as the rationale for doing so. Briefly list the metadata, other relevant data, and
any associated documentation (e.g., study protocols and data collection instruments) that will
be made accessible to facilitate interpretation of the scientific data.
Related Tools, Software and/or Code: State whether specialized tools are needed to access or
manipulate shared scientific data to support replication or reuse, and name(s) of the needed
tool(s) and software. If specialized tools or software are needed, provide the name(s) of the
needed tool(s) and software and specify how they can be accessed.
Standards: State what common data standards will be applied to the scientific data and
associated metadata to enable interoperability of datasets and resources (e.g., data formats,
data dictionaries, data identifiers, definitions, unique identifiers, and other data
documentation), and provide the name(s) of the data standards that will be applied and
describe how these data standards will be applied to the scientific data generated by the
research proposed in this project. If applicable, indicate that no consensus standards exist.
Data Preservation, Access, and Associated Timelines: Provide plans and timelines for data
preservation and access, including the name of the repository(ies) where scientific data and
metadata arising from the project will be archived (do not include hyperlinks); how the
scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other
standard indexing tools; and when (i.e., no later than time of an associated publication or end
of the performance period, whichever comes first) the scientific data will be made available to
other users (e.g., the larger research community, institutions, and/or the broader public) and
for how long. See Selecting a Data Repository on the NIH Scientific Data Sharing website.
Access, Distribution, or Reuse Considerations: NIH expects that in drafting Plans, researchers
maximize the appropriate sharing of scientific data generated from NIH-funded or conducted
research, consistent with privacy, security, informed consent, and proprietary issues. Describe
and justify any applicable factors affecting subsequent access, distribution, or reuse of
scientific data related to informed consent, privacy and confidentiality protections, any
restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or
anticipated agreements, or any other considerations that may limit the extent of data sharing.
See Frequently Asked Questions for examples of justifiable reasons for limiting sharing of
data. State whether access to the scientific data will be controlled (i.e., made available by a
data repository only after approval).
Genomic Data Sharing Policy: For proposed research subject to the GDS Policy, state
whether data, including genomic summary results, will be made available through controlled
or unrestricted access; see instructions for describing Genomic Summary Results in Data
Management and Sharing Plans.
If generating scientific data derived from humans, describe how the privacy, rights, and
confidentiality of human research participants will be protected (e.g., through de-
identification, Certificates of Confidentiality, and other protective measures). See NIH’s
Scientific Data Sharing page for additional information on protecting human research
participant privacy when sharing data.
Genomic Data Sharing Policy: For proposed research generating human genomic data
within the scope of the GDS Policy, applicants should complete the Data Management and
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