ELEMENT 1: DATA TYPE

Briefly describe the scientific data to be managed and shared

A. Types and Amount  Summarize the types and amount of scientific data to be generated and/or used in the research.

Describe your data in general terms (e.g., 256-channel EEG data and fMRI images from ~50 research participants). Descriptions may indicate the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing that has occurred (i.e., how raw or processed the data will be)

Consider phrasing as below, replacing the bracketed information with your specifics.

This project will produce [Data type, e.g., imaging, sequencing, experimental measurements] data generated/obtained from [e.g., instrument, method, survey, experiment, data repository].  Data will be collected from [number] of research participants/specimens/experiments, generating [number] datasets totaling approximately [amount of data] in size. To protect research participant identities, [individual, aggregated, summarized] data will be made available for sharing.

Example:

• Human subjects data from ~100 research participants will be acquired and will include demographic, clinical, and fMRI imaging data. Data will be de-identified prior to sharing.

B. Preservation and Sharing  Describe which scientific data from the project will be preserved and shared and provide the rationale for this decision.

Preservation: Briefly describe which data will be preserved, referencing any applicable funder or institutional requirements for preservation/records retention

UVA specifics: see UVA RES-002: Ownership, Retention, Safeguarding, Management, and Transfer of Research Records and the UVA Research Records site.

Sharing: Briefly describe which data will shared and your reasoning

Note what documentation will accompany the shared data to aid reuse, e.g. readme files, data dictionaries, metadata, survey instruments.

Learn more about Documentation

ELEMENT 2: RELATED TOOLS, SOFTWARE AND/OR CODE

Describe whether specific software programs or tools are required to open or re-analyze shared datasets. Consider important attributes such as the software version and any needed packages or extensions, and where they can be found. It is not necessary here to document what software/tools were used to generate the data (this could be included in your documentation).

Examples:

• Tabular data will be shared as .csv files; no specialized tools will be needed to access 
• Analysis will be conducted in R; code will be shared publicly on GitHub and as supplements to any publications

ELEMENT 3: STANDARDS

Describe what standards, if any, will be applied to the scientific data and associated metadata

State what common data standards will be applied to the scientific data and associated metadata to enable interoperability of datasets and resources, 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. 

List which common data standards exist for your scientific data considering standards for terminology, content, and/or data exchange (e.g. ICD-10, CDISC, MINSEQE, DICOM, etc.). Decide which ones you will employ, thinking about what standards would help someone understand the data you collect and potentially combine it with other related datasets. If the repository you have chosen requires specific standards, list those here.

If there are no consensus data standards for your research area, state that here.

Learn more about Standards

ELEMENT 4: DATA PRESERVATION, ACCESS, AND ASSOCIATED TIMELINES

Give plans and timelines for data preservation and access

A. Repository  Provide the name of the repository(ies) where scientific data and metadata arising from the project will be archived

B. Findability  Describe how the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools.

C. When and How Long  Describe when the scientific data will be made available to other users (i.e., no later than time of an associated publication or end of the performance period, whichever comes first) and for how long data will be available.

If you are sharing data:

Indicate what repository you have chosen to share your data, considering NIH's desired characteristics. In this section you will provide information about the repository, such as whether it will provide a DOI for your data set and how long it will preserve the data deposited there (found on the repository website). You will also need to indicate when you plan to publish your data.

Learn more about Repositories

If you are not sharing data:

Describe how, and for how long, your data will be preserved.

How long to maintain data

Note that under Section 8.4.2 of the NIH Grants Policy Statement, grantee institutions are required to keep the data for 3 years following closeout of a grant or contract agreement. Contracts may specify different time periods. UVA retention rules are described in UVA RES-002: Ownership, Retention, Safeguarding, Management, and Transfer of Research Records.

ELEMENT 5: ACCESS, DISTRIBUTION, OR REUSE CONSIDERATIONS

Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to any considerations that may limit the extent of data sharing

A. Factors  NIH expects that in drafting Plans, researchers maximize the appropriate sharing of scientific data. Describe and justify any applicable factors or data use limitations affecting subsequent access, distribution, or reuse of scientific data related to informed consent, privacy and confidentiality protections, and any other considerations that may limit the extent of data sharing. See Frequently Asked Questions for discussion of justifiable reasons for limiting sharing of data.

B. Access Control  State whether access to the scientific data will be controlled (i.e., made available by a data repository only after approval).

C. Protections  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).

Limiting Factors for data sharing may include institutional policies, patent and intellectual property rules, data size limitations, informed consent that doesn't allow for sharing (HIPAA), revised Common rule, federal, state, local rules, and tribal rules. Genomic data rules also should be considered.

For Access Control, describe any controlled access practices (e.g. via a Data Sharing Agreement); if using a repository, reference its options for limiting access (note that Vivli, dbGAP, NIMH's Data Archive (NDA) and many others offer controlled access options).

Refer to any Protections utililized such as de-identification methods.

Learn more about how to address access to data from Human Subjects research in your Data Management and Sharing Plan.

ELEMENT 6: OVERSIGHT OF DATA MANAGEMENT AND SHARING

Indicate how compliance with the DMS plan will be monitored and managed

Describe how compliance with this Plan will be monitored and managed, frequency of oversight, and by whom at your institution (e.g., titles, roles).

Describe oversight and reporting responsibilities, e.g. updating and revising the DMS Plan if necessary.

View UVA sample language on Oversight/Compliance for your plan.

Consider describing data management responsibilities, e.g., data capture, documentation, quality review, storage and backup, and who will be responsible, e.g. positions and roles; data preservation and/or sharing responsibilties, e.g. data deposit (and utilization of any access controls if needed) and name those responsible (as above).

What Should I Know?

NIH's new Scientific Data Sharing website contains the latest information from NIH. It includes:

• the Data Management & Sharing Policy Overview site for the new policy

• pages on Writing a Data Management & Sharing Plan including a Data Management and Sharing Plan format page.

• the 2023 Data Management & Sharing Policy FAQs

Selected NIH Policies

NOT-OD-21-013 - Final NIH Policy for Data Management and Sharing (October 29, 2020)

NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy (August 5, 2022)

NOT-OD-21-013 - Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data (September 21, 2022)

NOT-OD-21-014 - Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data (September 21, 2022)

Webinars and Training

UVA Webinar: NIH’s New Data Management and Sharing Policy (12/15/22)

• Slide Deck
• Videorecording

Additional learning opportunities, including informational webinars and accompanying slide decks