Does the Genomic Data Sharing Policy Apply to My Research?

When does the NIH GDS Policy apply?

NIH’s GDS Policy applies to research that:

• 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).
     
• Generates small-scale genomic data that NIH or the funding Institutes or Centers (ICs) determines should be shared because of the state of the science, programmatic priorities, utility, and/or value of the data for the research community.
  See GDS policy expectations by NIH Institutes and Centers for more information on IC policy implementation.

When does the NIH GDS Policy NOT apply?

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:

• Instrument calibration exercises.
• Statistical or technical methods development.
• Use of genomic data for control purposes, such as for assay development.

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.

Still have questions? Please contact an NIH program officer or genomic program administrator.