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