NIH Genomic Data Sharing Requirements Information

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NIH issued the Genomic Data Sharing (GDS) Policy on August 27, 2014, in the NIH Guide Grants and Contracts
(available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html), and on August 28, 2014, in
the Federal Register (available at https://federalregister.gov/a/2014-20385).
The GDS Policy became effective on January 25, 2015, and applies to all NIH-funded 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. Data include genome-wide association studies (GWAS), single nucleotide
polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.
This includes non-coding RNAs and “model organisms” such as C. elegans.
Data Sharing Plan. Information regarding how a research project will share large-scale genomic data should be
described in the Resource Sharing Plan section of the grant application or as per instructions in a Request for
Proposals for a contract. Certain NIH Funding Opportunities and Notices may specify different instructions.
At a minimum, such data sharing plan should include:
• type of data that will be shared (i.e., the type of genomic data, relevant associated data, and information
necessary to interpret the data)
• the data repository to which the data will be submitted
• the timeline for the data to be shared
• any limitations on the secondary research uses of the data, if the study involved human data
• acknowledgement that the Institutional Certification will be submitted and assurance by the Institutional
Review Board (IRB) that the data can be shared through NIH-designated data repositories, consistent with
data sharing under the NIH GDS Policy
REQUIRED DOCUMENTS FOR NIH:
NIH-GDS: Genomic Data Sharing plan template (Choose East Carolina University and sign in with Pirate ID.
Select "Create New DMP," "Select Template," open "National Institutes of Health" and select "NIH-GDS:
Genomic Data Sharing" from drop-down menu): https://dmptool.org/user_sessions/institution
ECU Single Site Certification: https://www.ecu.edu/cs-acad/osp/upload/Institutional-Certification-for-Single-SiteStudies.docx
RESOURCES & TOOLS:
NIH Genome Data Sharing Home Page: https://gds.nih.gov/index.html
GDS Policy: https://gds.nih.gov/PDF/NIH_GDS_Policy.pdf
https://gds.nih.gov/PDF/Supplemental_Info_GDS_Policy.pdf provides examples of genomic research
projects that are subject to the Policy and the timeline for data submission and sharing
Data Sharing Plan Required Elements:
https://gds.nih.gov/pdf/GDS_Policy_Guidance_Grant_App_Contract_Proposals.pdf
FAQ:
https://gds.nih.gov/13faqs_gds.html#b1
QUESTIONS?
Genomic program administrators assigned to each NIH institute: http://gds.nih.gov/pdf/IC_GPAs.pdf
9/22/15
Questions about the Policy can also be e-mailed to: mailto:%20GDS@mail.nih.gov
9/22/15
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