The GDS policy applies to all NIH-funded extramural and intramural research that generates large-scale genomic data as follows:
- Competing grant applications submitted for the January 25, 2015 due date or later
- Contract proposals submitted on or after January 25, 2015
- NIH intramural projects generating genomic data on or after August 31, 2015
There is no minimum cost threshold provided the data are considered large-scale. Find definitions and examples of large-scale genomics projects at NIH GDS Policy Supplemental Information.
Does this project generate large-scale genomic data?
A project is subject to the NIH GDS policy if it will generate any of the following:
- More than 100 isolates of an infectious organism, metagenomes, or transcriptomes
- Sequencing of a single gene for more than 1,000 participants or organisms
- Sequencing of more than 100 genes in more than 100 participants or organisms
- Identification of more than 300,000 variants in more than 1,000 participants or organisms
- 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
- Comparisons of genome-wide methylated sites across more than 10 cell types or organisms
- 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)
Additionally, NIAID may choose on a case-by-case basis to apply the GDS policy to projects generating genomic data on a smaller scale. This decision will be driven by the following:
- The state of the available genomic resources in the specific field of research
- The needs of the research community
- The programmatic priorities of the Institute
Therefore, investigators should consult with appropriate NIAID program officers or intramural scientific director as early as possible during the planning of genomic projects. Examples of smaller-scale projects for which NIAID may require data sharing include, but are not limited to, the following:
- Genomic sequencing of insect vectors
- Projects examining rare pathogens or rare diseases
- Projects focusing on understudied populations
Beginning on January 2023, applicants will provide genomic data sharing information as part of the new Data Management and Sharing Plan, rather than submitting a separate Genomic Data Sharing Plan.
Exceptions to the GDS Policy
NIAID recognizes that there may be circumstances where broad sharing of genomic data sets will not be possible or may need to be delayed. In most cases, NIAID expects that these limitations will be defined in the data sharing plan for the project. However, some limitations may also develop during the course of the research project. NIAID may grant exceptions to the GDS policy on rare occasions. To request an exception, investigators should contact the NIAID program officer or intramural scientific director as early as possible during planning of genomic projects.