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Reference notes

Coverage

NIH DMS Policy · 11 funder mandates · 14 repositories

Sources

NIH DMS Policy + publisher guidelines

Last reviewed

February 2026

Prepared by the Manusights editorial team.

Compliance-and-repository guide

Data Sharing Requirements for Biomedical Research

Data sharing in biomedicine went from optional to expected to mandatory over the last decade. The NIH Data Management and Sharing Policy, which took effect January 25, 2023, now requires every NIH-funded researcher to submit a data management plan, and actually share their data.

This guide covers what the NIH policy requires, what major journals ask for in data availability statements, where to deposit different types of biomedical data, and what FAIR principles mean in practice.

Quick orientation

Use this page when the manuscript is getting close to submission and the data-sharing plan needs to be concrete, not aspirational.

This guide helps translate policy language into operational choices: what the NIH expects, what journals usually require in the statement itself, which repository fits the data type, and what “FAIR” means at the moment of deposit.

NIH policy summary11 journal-policy records14 repository optionsFAIR in practice

The NIH Data Management and Sharing Policy (2023)

The NIH DMS Policy applies to all NIH-funded research that generates scientific data: including grants, contracts, and intramural research. It applies to all applications and proposals submitted on or after January 25, 2023.

The policy requires:

  1. 1.Submit a Data Management and Sharing (DMS) Plan with your grant application
  2. 2.Data must be deposited in an established repository as soon as possible: no later than publication or end of award
  3. 3.Data Management costs are allowable as direct costs (up to ~$30,000/year without special justification)
  4. 4.Cite the shared dataset in any resulting publications
What "scientific data" means under the policy: Recorded factual material commonly accepted in the scientific community as necessary to validate research findings, not lab notebooks, preliminary analyses, or materials that would typically be in a methods section.
Exceptions: Data may be exempt from sharing if sharing is restricted by law (HIPAA, tribal law), contract, or if the data contains information that can't be de-identified. Document the reason in your DMS Plan.
NIH Institute-specific policies: Some NIH institutes have stricter requirements on top of the base policy: NHGRI for genomics, NCI for cancer data. Check your funding institute's data sharing policy in addition to the base DMS Policy.

Other Major Funder Data Sharing Mandates

Wellcome Trust

Since 2017 (updated 2021)

Strong data sharing mandate. Requires a data management plan, data sharing in an appropriate repository, and a data availability statement in all publications. All publications must be OA (CC BY), and the underlying data must be available.

UKRI (all councils)

Since 2015 (RCUK policy, now UKRI)

Research outputs including data must be made available as openly as possible. Data underlying publications must be deposited in an appropriate repository. Applies to BBSRC, MRC, ESRC, EPSRC, and other UKRI councils.

Gates Foundation

Since 2017

One of the strictest. It requires CC BY for all publications and immediate open access to underlying data. Data sharing plan required with grant application.

European Research Council (ERC)

Since 2017 (expanded Horizon Europe)

Open Research Data pilot is now the default for all funded projects. Requires a Data Management Plan and deposition in a trusted repository where possible.

FAIR Principles in Practice

FAIR data principles (Findable, Accessible, Interoperable, Reusable) are now the standard framework for data sharing. NIH, Wellcome, UKRI, and most major journals reference FAIR compliance as the goal. Here's what each means operationally:

F

Findable

Deposit in a repository that assigns a persistent identifier (DOI or accession number). Include rich metadata so search engines can index it. Don't just put data on a lab website that disappears.

A

Accessible

Data should be retrievable via open protocols. For controlled-access data (e.g., dbGaP), the access procedure itself must be publicly documented. The process for requesting access counts as 'accessible' even if the data aren't open.

I

Interoperable

Use standard file formats (CSV over Excel, FASTQ over proprietary formats, TSV over custom delimiters). Include a data dictionary. Make it so someone without your specific software can use the data.

R

Reusable

Attach a license (CC BY for open data). Include enough provenance (how the data were collected, processed, and what quality checks were applied) so that someone else can reproduce your decisions.

Practical note

Three data-sharing mistakes that create late-stage submission problems

Waiting until the manuscript is drafted to identify the repository, accession timing, or data-availability wording the journal expects.
Assuming a general-purpose repository is always acceptable when a domain-specific archive is the norm for that data type.
Treating FAIR as a slogan rather than a deposit checklist covering identifier, metadata, format, and reuse information.

Most data-sharing problems surface late, when the manuscript is already in editorial review. Run a pre-submission check on your data-availability statement to catch a missing repository, accession, or FAIR gap before an editor does.

References

  1. National Institutes of Health. (2023). NIH Data Management and Sharing Policy. U.S. Department of Health and Human Services. [sharing.nih.gov ↗]
  2. Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016;3:160018. [doi.org/10.1038/sdata.2016.18 ↗]
  3. UK Research and Innovation (UKRI). Research data management and sharing policy. Retrieved February 2026. [ukri.org ↗]
  4. Zenodo. About Zenodo: open repository for research. CERN. Retrieved February 2026. [zenodo.org ↗]
  5. Figshare. About figshare: open data repository. Digital Science. Retrieved February 2026. [figshare.com ↗]
  6. Dryad. About Dryad: open data repository. Dryad Digital Repository. Retrieved February 2026. [datadryad.org ↗]
Data note: NIH policy information sourced from sharing.nih.gov. Journal policies sourced from individual journal author instructions as of February 2026. Funder and journal data sharing policies evolve: always check your funder's current policy and the journal's author guidelines before submission. These pages are permanently maintained. For accuracy corrections or updates, contact hello@manusights.com.

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Related guides in this collection

Frequently Asked Questions

Are data sharing requirements mandatory for all research types?

Requirements vary by journal, publisher, and research type. Nature Portfolio journals, Cell Press, PLOS journals, and BMJ require data sharing for all original research by default, with exceptions for privacy-restricted data. Most journals with data sharing policies require a Data Availability Statement in the manuscript regardless of whether data can be fully shared. If data cannot be shared, you must explain why - privacy, legal restrictions, or third-party ownership are all accepted reasons at most journals.

Where should I deposit research data before submitting a manuscript?

The right repository depends on your data type. Genomics data goes to NCBI (GEO for gene expression, SRA for raw sequencing, dbGaP for controlled human genomics data). Protein structures go to the RCSB Protein Data Bank. Clinical trial data goes to ClinicalTrials.gov. For general research data without a domain-specific repository, Zenodo, Figshare, or Dryad are widely accepted. Most journals provide a list of recommended repositories in their data sharing policy.

What should a Data Availability Statement include?

A Data Availability Statement should specify: (1) where the data can be accessed (repository name and URL or DOI), (2) any access restrictions and the reason for them, and (3) the accession number or identifier for the deposited dataset. If all data are in the manuscript itself (in figures and tables), state that explicitly. If data cannot be shared due to privacy or ethical restrictions, state the restriction and whether data can be requested from the corresponding author. Many journals provide a template - use it, since reviewers and editors check the statement during review.