NINDS expects all NINDS-supported investigators to adhere to the NIH GDS Policy, and compliance with this Policy will be a special term and condition in the Notice of Award or the Contract Award for all applicable projects. Annual reporting is required, and restrictions may be placed on future year funding for non-compliance with the GDS policy.
Scope and Applicability
- The NIH GDS Policy applies to all NIH-funded research generating large-scale human or non-human genomic data and the use of these data for subsequent research
- All funding mechanisms (grants, cooperative agreements, contracts, and NINDS Intramural research program)
- No minimum threshold dollar amount for budget/Cost
- Does NOT apply to:
- T32s and other institutional training grants
- K12 or KL2s
- Individual fellowships (Fs)
-
Resource grants and contracts (Ss)
Examples of Projects that Fall Under the GDS Policy
Large-scale data can include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data.
What are examples of “large scale” genomic data? - NINDS Interpretation
Type of Data | Number of Human Specimens | Number of Non-Human Specimens* |
---|---|---|
SNP Array data from >500K Single Nucleotide Polymorphisms (SNPs) (e.g. GWAS data) |
500 | 250 |
DNA sequence data from < 100 genes or regions of interest (e.g. targeted sequencing) |
500 | 250 |
DNA sequence data from > 100 genes or regions of interest (e.g. targeted sequencing) |
100 | 50 |
Whole-Genome or Whole Exome Sequencing |
50 | 25 |
Genome-wide RNA sequencing (RNA-Seq) data (e.g. transcriptomic data) |
50 | 25 |
Genome-wide chromatin immunoprecipitation sequencing (Chip-Seq) data |
100 | 50 |
Genome-wide DNA methylation data |
100 | 50 |
* Large-scale non-human genomic data includes data from microbes, microbiomes, and model organisms. The data from microbes and microbiomes are considered non-human, if the human genomic data has been filtered and removed.
NINDS may also require sharing of data from studies that involve a smaller number of specimens that:
- Examine rare neurological disorders or rare subtypes
- Focus on under-studied populations
- Contain sequencing data from human iPSC lines or NINDS supported clinical trials
- Contain data of high value or urgent need as determined by NINDS program staff
Genomic Data Sharing Plan (Provided at time of application)
- To harmonize the GDS Policy with the expectation for the NIH Data Management and Sharing (DMS) Policy, NIH released Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.
- NINDS expects investigators to include genomic data sharing to be described in the DMS Plan submitted at the time of application, and not in a separate GDS Plan or at Just-in-Time, consistent with the changes described in NOT-OD-22-189.
- Genomic data sharing considerations, such as what type, where, and when genomic data will be shared, will be expected to be addressed in DMS Plans using the DMS Plan elements. For further details, see Writing a Data Management & Sharing Plan - Applications for Receipt Dates ON/AFTER Jan 25 2023.
Data Repositories (Provided at time of application)
- Human Genomic Data: Investigators should work with the NINDS Genomic Program Administrator (GPA) and register their studies with human genomic data in dbGaP.
- Investigators should submit data to the relevant NIH-designated data repository, e.g., dbGaP (for controlled access), the Single Nucleotide Polymorphism Database (dbSNP), GEO - Gene Expression Omnibus, or SRA - Sequence Read Archive, in a timely manner (see below).
- Investigators should also submit any information necessary to interpret the submitted genomic data, such as study protocols, data instruments, and survey tools.
- Non-Human Genomic Data: can be submitted to any widely used data repository (e.g., WormBase, Zebrafish Information Network (ZFIN), or Mouse Genome Informatics).
Data Submission and Release Timeline (Provided at time of application)
Genomic data submission is generally expected within 3 months of data generation, and data cleaning and quality control should occur during these 3 months. Release of genomic data should be no later than the time of publication or the end of the performance period, whichever comes first.
Data can be shared incrementally if there are several components in the discovery process.
The table below describes levels of expectations for data submission and release with different data types. Please refer to the Supplemental Information to the NIH GDS Policy for more information.
Level |
General Description of Data Processing |
Example Data Types |
Data Submission Expectation |
Data Release Timeline |
---|---|---|---|---|
0 |
Raw data generated directly from the instrument platform |
Instrument image data |
Human data: Not expected |
Human data: NA |
1 |
Initial sequence |
DNA sequencing reads, ChIP-Seq reads, RNA-Seq |
Human data: Not expected. |
Human data: NA. |
2 |
Data after an initial round of analysis or |
DNA sequence alignments |
Human data: Project specific; after data cleaning and quality control, which is generally within 3 months after data have been generated. |
Human data: No later than the time of publication or the end of the performance period, whichever occurs first |
3 |
Analysis to identify |
SNP or structural variant calls, expression peaks, |
Human data: Project specific; after cleaning and quality control, which is generally within 3 months after data have been generated. |
Human data: No later than the time of publication or the end of the performance period, whichever occurs first |
4 |
Final analysis that relates the genomic |
Genotype-phenotype |
Human data: Data submitted as analyses are completed. |
Human data: Data released with publication. |
Consent for Future Use and Broad Data Sharing (Human Studies Only)
- All NINDS-funded studies involving human subjects should seek consent for future research use and broad sharing of participant data via central databases, such as dbGaP during the informed consent process.
- Studies should seek consent for General Research Use of participant data instead of placing disease-specific or other data use limitations on future use of the data.
- Investigators should discuss with their NINDS Program Officials, prior to receiving the NINDS funding, about any potential issues that prevent them from obtaining consent for future research use and broad data sharing.
- NIH has provided Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the GDS Policy.
Exceptions to the GDS Policy (Human Studies only)
In cases where data submission to an NIH-designated data repository is not appropriate, investigators should provide a justification for any data submission exceptions requested in the funding application or proposal. NINDS will consider requests for an exception to data sharing expectations on a case-by-case basis.
Factors that may preclude data sharing include 1) International Laws, 2) concerns about harms to participating individuals or groups, and/or 3) other cases where expectations for data submission cannot be met. Requests for exceptions will be evaluated by NINDS Program staff. For transparency purposes, if the rationale for the exception is adequate and exceptions are granted, studies will still be registered in dbGaP, the reason for the exception will be included in the registration record, and an alternative data-sharing plan or resource will be provided.
Institutional Certification (Provided prior to award)
The Institutional Certification is the document institutions use to attest that the plans for submitting large-scale human genomic data to NIH meets the expectations of the GDS Policy.
Extramural investigators: Submit your Institutional Certification with the Principal Investigator and Institutional Signing Officials' signatures to the Program Officer and NINDS GPA by either attaching it in an email, or submitting with Just-in-Time funding material prior to award.
Intramural investigators: Address compliance with the GDS Policy prior to initiating applicable research. An Intramural Institutional Certification that is approved by the NINDS Scientific Director is required prior to the start of the research.
NIH Genomic Data Sharing Resources
- NIH GDS Policy
- Supplemental Information to the NIH GDS Policy
- NIH GDS Policy Website
- Completing an Institutional Certification Form
- Developing Genomic Data Sharing Plans
- NIH Data Sharing FAQs
- dbGaP Genomic Study Registration and Submission of Data Flowchart
- Guidance for Institutions Submitting Data under the NIH GDS Policy
- Request for Information on Potential Updates to the NIH GDS Policy