What must be included in a DMS plan?
Data Type
Description, dictionary, study protocol,
Collection instruments
Modality: imaging, genomic, survey
Level of aggregation: individual, grouped, summarized
Level of data processing: raw v. processed data
Genomic Data Sharing Policy: Data types expected to be shared under the GDS Policy should be described in this element. Note that the GDS Policy expects certain types of data to be shared that may not be covered by the DMS Policy’s definition of “scientific data”. For more information on the data types to be shared under the GDS Policy, consult Data Submission and Release Expectations
Related Tools, Software and/or Code
Any additional tools/software needed to access or manipulate data
Names of specific software tools
Availability of tools
Expected lifespan of the tools v. length of data availability
Standards [ e.g., OnCore, REDCap ...]
Data formats
Data dictionaries
Common data elements
Identifiers
Definitions
Indicate if no consensus standard exists
Data Preservation, Access and Associated Timelines
Name of repository where data and meta data will be deposited
How will data be made identifiable
When the data will be available and for now long
For data subject to the Genomic Data Sharing Policy:
For human genomic data:
Investigators are expected to submit data to a repository acceptable under the Genomic Data Sharing Policy. See Where to Submit Genomic Data.
Human genomic data is expected to be shared according to NIH’s Data Submission and Release Expectations, but no later than the end of the performance period, whichever comes first.
For Non-human genomic data:
Investigators may submit data to any widely used repository.
Non-human genomic data is expected to be shared as soon as possible, but no later than the time of an associated publication, or end of the performance period, whichever is first.
Access, Distribution or Reuse Considerations
Limitations due to informed consent, privacy or confidentiality protections
Controlled access protections (e.g., author approval, DUA)
Restrictions imposed by federal, tribal or state laws, regulations or policies (e.g., HIPAA)
Expectations for human genomic data subject to the GDS Policy:
Informed Consent Expectations:
For research involving the generation of large-scale human genomic data from cell lines or clinical specimens that were created or collected AFTER the effective date of the GDS Policy (January 25, 2015):
NIH expects that informed consent for future research use and broad data sharing will have been obtained. This expectation applies to de-identified cell lines or clinical specimens regardless of whether the data meet technical and/or legal definitions of de-identified (i.e. the research does not meet the definition of “human subjects research” under the Common Rule).
For research involving the generation of large-scale human genomic data from cell lines or clinical specimens that were created or collected BEFORE the effective date of the GDS Policy:
There may or may not have been consent for research use and broad data sharing. NIH will accept data derived from de-identified cell lines or clinical specimens lacking consent for research use that were created or collected before the effective date of this Policy.
Institutional Certifications and Data Sharing Limitation Expectations:
DMS Plans should address limitations on sharing by anticipating sharing according to the criteria of the Institutional Certification.
In cases where it is anticipated that Institutional Certification criteria cannot be met (i.e., data cannot be shared as expected by the GDS Policy), investigators should state the institutional Certification criteria in their DMS Plan, explaining why the element cannot be met, and indicating what data, if any, can be shared and how to enable sharing to the maximal extent possible (for example, sharing data in a summary format). In some instances, the funding NIH ICO may need to determine whether to grant an exception to the data submission expectation under the GDS Policy.
Genomic Summary Results:
Investigators conducting research subject to the GDS Policy should indicate in their DMS Plan if a study should be designated as “sensitive” for the purposes of access to Genomic Summary Results (GSR), as described in NOT-OD-19-023.
Oversight of DMS plan
Describe how compliance will be monitored & managed
Identify key roles within research project
Additional DMS plan policies by NIH Institute or Center: https://sharing.nih.gov/other-sharing-policies/nih-institute-and-center-data-sharing-policies
Formatting a NIH Data Management & Sharing policy
Hypertext (URLs, web links, etc.) prohibited
Recommended length is two pages
Use appropriate template and/or refer to example plans [see Appendix]
Use DMPTool – free, online data management sharing plan tool: https://dmptool.org
[use the single sign on (SSO) using your WSU AccessID]
[recording of December webinar; includes PPT slides]
Upload as PDF into 398 Research Plan tab in grant package