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Learn what is expected of investigators and institutions under the NIH Genomic Data Sharing Policy.
NIH expects the broad and responsible sharing of human as well as non-human genomic data resulting from NIH-funded research because the timely sharing of research results can accelerate discoveries that improve our ability to diagnose, treat, and prevent disease.
To comply with the NIH Genomic Data Sharing Policy, NIH expects that investigators and institutions:
- Develop and provide a plan for sharing genomic data as a part of the Data Management and Sharing Plan
- Provide an Institutional Certification form at Just-in-Time, if working with human data
- Submit genomic data in a timely manner to an appropriate repository
- Responsibly use controlled-access data
- Appropriately cite controlled-access data in publications and presentations
Individual NIH Institutes, Centers, or Offices may have additional expectations (see GDS Policy Expectations by NIH Institute & Center (IC)).
Applicability
Is funded by the NIH and generates large-scale human or non-human genomic data.
Examples of such data include, but are not limited to:
- Sequence data from more than one gene or region of comparable size in the genomes of more than 1,000 human research participants.
- Sequence data from more than 100 genes or region of comparable size in the genomes of more than 100 human research participants.
- Data from 300,000 or more variant sites in more than 1,000 human research participants.
- Sequence data from more than 100 isolates from infectious organisms.
- Sequence data from more than 100 metagenomes of human or model organism microbiomes.
- Sequence data from more than 100 metatranscriptomes of human or model organism microbiomes.
- Whole genome or exome sequence data of more than one model organism species or strain.
- Comprehensive catalog of transcripts and non-coding RNA from one or more model organism species or strains.
- Catalog of more than 100,000 single nucleotide polymorphisms (SNPs) from one or more model organism species or strains.
- Comparisons of genome-wide methylated sites across more than 10 cell types.
- Comparisons of differentially methylated sites genome-wide at single-base resolution within a given sample (e.g., within the same subject over time or across cell types within the same subject).
See GDS Policy expectations by NIH Institutes and Centers for more information on IC policy implementation.
There are a few circumstances where a project generates genomic data but it is not within the Policy's intended scope. Examples of such projects include, but are not limited to:
What about research initiated before 2015?
Investigators performing ongoing research that was initiated before 2015 should work with their funding NIH IC to come into alignment with the GDS Policy, to the extent possible, in a reasonable timeframe. Although the GDS Policy does not apply to research submitted prior to January 25, 2015, the NIH nonetheless strongly encourages all NIH-funded research to comply with the expectations outlined in the Policy. This includes:
- An updated genomic data sharing plan to the funding NIH IC in the submission of the standard annual NIH Research Performance Progress Report.
- If applicable, investigators are expected to plan to transition to a consent for future research uses and broad sharing, if possible, particularly for new or additional collections of specimens.
Planning, Submitting, and Accessing Genomic Data
If you’ve determined that your research is subject to the GDS Policy, follow the steps below to understand the process for preparing to submit/access genomic data.
| Before Submitting Genomic Data | |
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The NIH GDS Policy applies to all studies generating large scale genomic data and some smaller scale projects too. Familiarize yourself with NIH's requirements for genomic data sharing, and the steps you have to take before sharing.
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| Submitting Genomic Data | |
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The GDS Policy requires the sharing of genomic data generated with NIH funds. Learn where you can submit genomic data, and what steps are involved in the submission process.
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| Accessing Genomic Data | |
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NIH has some of the world's largest biomedical data repositories. Discover what data is available, how to access the data, and what you must do to protect the data you download.
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