What is the Genomic Data Sharing Policy?

Sharing research data supports the mission of the National Institutes of Health (NIH) and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. To set forth expectations that ensure the broad and responsible sharing of genomic research data, NIH issued the Genomic Data Sharing (GDS) Policy. The GDS Policy applies to all NIH-funded research (e.g., grants, contracts, and intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of these data for subsequent research. 

The Trans-NCI Genomic Data Sharing Working Group was created to guide NCI in implementing the NIH data sharing policies. This Working Group has developed a framework document to guide the implementation of GDS policy across the extramural and intramural programs.  

How do I comply with the GDS Policy?

The GDS policy applies to all genomic data that appear in a publication or fall under the policy for other reasons (see below).  Use guidance in the next section to determine whether a study falls under the policy. If there are questions, contact the CCR Genomics Program Administrator, Kathy Calzone.

If the policy applies:

  1. Complete a data sharing plan by following the  "Establishing a Genomic Data Sharing Plan" SOP.
  2. For studies on clinical specimens and human cell lines, complete an institutional certification by following the "Establishing GDS Institutional Certification" SOP.
  3. If the data are destined to be "controlled access", such as human sequencing or SNP data, complete the dbGaP submission process by following the "Registering a Clinical Trial in dbGAP" SOP.
  4. Finally, submit the data to a NIH data repository.

CCR recognizes that in rare cases sharing of genomic data may not be appropriate. If you think your study should be exempt from genomic data sharing please apply for an exception request by following the "Requesting a Genomic Data Sharing Exception" SOP. 

What studies are covered by the GDS Policy?

Examples of projects for which the NCI anticipates data sharing (regardless of study design) include, but are not limited to:

 

 

# of Specimens 

 

Human

(Including human cell lines)

Model Organisms,

Non-Human Cell Lines,

Infectious Organisms  

SNP array data from >500K single nucleotide polymorphisms (SNPs) (e.g., GWAS data)1,000500
DNA sequence data from < 100 genes or regions of interest (e.g. targeted sequencing)1,000500
DNA sequence data from ≥ 100 genes or regions of interest  (e.g., targeted sequencing, whole exome sequencing, whole genome sequencing) 10050   
Genome-wide RNA sequencing (RNA-seq) data (e.g., transcriptomic data)  10050   
Genome-wide DNA methylation data  (e.g., bisulfite sequencing data)  10050   
Genome-wide chromatin immunoprecipitation sequencing  (ChIP-seq) data (e.g. transcription factor ChIP-seq, histone modification ChIP-seq)  10050
Metagenome (or microbiome) sequencing data (e.g., 16S rRNA sequencing, shotgun metagenomics, whole-genome microbial sequencing)  10050
Metatranscriptome sequencing data (e.g., microbial/microbiome transcriptomics)  10050

NOTE: The number of samples includes distinct individuals, species, strains, samples, treatments, time points, and tissues. For example, data from 25 patients at 4 time points after treatment would reach a 100-sample threshold, as would data from 50 tumor-normal comparisons.

Additionally, individual NIH Institutes or Centers (IC) may choose on a case-by-case basis to apply the Policy to projects generating data on a smaller scale depending on the state of the science, the needs of the research community, and the programmatic priorities of the IC, therefore investigators should consult with appropriate NIH Program Officers or your intramural Scientific Director as early as possible.

Guidance on Genomic Data Sharing for rare diseases and rare cancers

Guidance issued from the Office of the Director, CCR mandates sharing of genomic data for projects examining rare diseases and rare cancers. There are no minimum thresholds to meet for such projects.  The Trans-NCI Genomic Data Sharing Working Group has adopted the definition of rare disease – a disease that affects less than 200,000 persons in the United States, that has been set forth by the U.S Food and Drug Administration (FDA).

Examples of Research outside the Scope of the GDS Policy:

Examples of NIH-funded research or research-related activities that are outside the Policy’s scope include, but are not limited to, projects that do not meet the criteria in the above examples and involve:

  • Instrument calibration exercises.
  • Statistical or technical methods development.

 Glossary of Terms available: Glossary

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