Genome Wide Association Studies (GWAS)
KUMC Policy Summary for Genome Wide Association Studies (GWAS)
The NIH GWAS policy is a data sharing policy implemented in 2008 for NIH-funded Genome-Wide Association studies, or GWAS. The NIH policy facilitates the sharing of large datasets containing coded, de-identified genotypic and phenotypic data obtained from NIH supported or conducted research. The NIH policy applies to data obtained prospectively as well as retrospectively from existing specimens. A key element of the NIH policy is the expectation that data from NIH-supported GWAS will be deposited into the NIH GWAS data repository, currently designated as the database of Genotypes and Phenotypes (dbGaP), at the National Center for Biotechnology Information (NCBI), within the National Library of Medicine (NLM).
The data submission portion of the KUMC policy applies to investigators who receive any NIH funding for genome-wide analysis of specimens. The GWAS policy has no threshold; therefore, any NIH funding for GWAS triggers requirements under the policy. The KUMC-generated data submitted for inclusion in the NIH GWAS data repository will be coded and de-identified by the submitting investigator from KUMC, but the investigator may retain the key to the code that would link to specific individuals. KUMC investigators may request submission of data and/or access to the NIH GWAS data repository through the IRB submission process.
A project is covered by the KUMC - GWAS policy, if:
- The PI will obtain NIH funds to conduct GWAS studies through a new application or continuing funding application submitted after 1/25/2008; or
- The PI has agreed to voluntarily submit genotype or phenotype data to the NIH GWAS registry; or
- The PI is applying to NIH to request access to the controlled portion of the dbGaP.
The following forms are available for use by investigators in planning to utilize GWAS data as previously described:
- Data Sharing Plan for GWAS studies at KUMC (fillable form - download to your desktop)
- Certificate to use GWAS data (fillable form - download to your desktop)
- Certificate to submit GWAS data (fillable form - download to your desktop)
Additionally, IRB Committee members have the following form to assist in their review of proposed GWAS projects: