What Genomic Studies are covered by the Data Management and Sharing (DMS) 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) | 1,000 | 500 | ||
DNA sequence data from < 100 genes or regions of interest (e.g. targeted sequencing) | 1,000 | 500 | ||
DNA sequence data from ≥ 100 genes or regions of interest (e.g., targeted sequencing, whole exome sequencing, whole genome sequencing) | 100 | 50 | ||
Genome-wide RNA sequencing (RNA-seq) data (e.g., transcriptomic data) | 100 | 50 | ||
Genome-wide DNA methylation data (e.g., bisulfite sequencing data) | 100 | 50 | ||
Genome-wide chromatin immunoprecipitation sequencing (ChIP-seq) data (e.g. transcription factor ChIP-seq, histone modification ChIP-seq) | 100 | 50 | ||
Metagenome (or microbiome) sequencing data (e.g., 16S rRNA sequencing, shotgun metagenomics, whole-genome microbial sequencing) | 100 | 50 | ||
Metatranscriptome sequencing data (e.g., microbial/microbiome transcriptomics) | 100 | 50 |
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 scientific 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 Genomic Data Sharing:
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.