Do I need anything more than IRB approval for my NIH-funded study that involves large-scale genomic data analyses?
The National Institutes of Health (NIH) issued a Genomic Data Sharing Policy in 2008 that was updated as of January 25, 2015.
This NIH Policy requires the submission of large-scale genomic data as well as relevant associated data to an NIH-designated data repository and applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. The policy defines large-scale data as including genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. Further, the policy clarifies that its requirements apply irrespective of NIH funding level or funding mechanism (e.g., grant, contract, cooperative agreement, or intramural support). If you are an investigator who is required or voluntarily wishes to submit data to an NIH repository, you are required to obtain institutional certification before any data are sent to an NIH repository. For more information about how the UW-Madison addresses this NIH policy and to obtain certification to send samples to an NIH repository, please see NIH Genomic Data Sharing Policy for Human Data Guidance.