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INTRODUCTION HEADER

Sharing research data supports the mission of the National Institutes of Health (NIH) and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. To set forth expectations that ensure the broad and responsible sharing of genomic research data, 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 (e.g., grants, contracts, and intramural 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. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Supplemental Information to the GDS Policy (available at http://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 submission and sharing of data from such projects.

More information on the NIH GDS Policy is available at http://gds.nih.gov/03policy2.html. Questions about the Policy can be e-mailed to GDS@mail.nih.gov.

 
IN THE SPOTLIGHT HEADER

NIH has developed new FAQs (available at http://gds.nih.gov/13faqs.html) to address questions on consent for broad sharing of genomic data for studies that are subject to the GDS Policy and the conditions for requesting an exception to the expectations to share genomic data.

NIH has also issued a Position on the Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy in the NIH Guide for Grants and Contracts (available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-086.html). NIH is now allowing investigators to request permission to transfer controlled-access genomic data and other associated data obtained from dbGaP to public or private cloud systems for storage and analysis, provided that the cloud computing systems meet the data use and security standards outlined in the NIH Security Best Practices for controlled-access data subject to the NIH GDS Policy (available at http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=dbgap_2b_security_procedures.pdf) as well as the institution's own IT security requirements and policies. Investigators who wish to use cloud computing will need to request to use such systems in their Data Access Request. Accordingly, NIH has revised the model Data Use Certification Agreement to include a new addendum for data security terms and best practices (found on the final page of the agreement, available at http://gds.nih.gov/pdf/Model_DUC.pdf).

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