The NIH defines Genome-Wide Association Studies (GWAS) as "any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition." Under the NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html), institutions must certify that plans for the submission of genotype and phenotype data from GWAS to the NIH meet the expectations of the policy.
In order for the institution to certify the plan, the PI should create a data sharing plan and provide a copy to the IRB for review. In addition, the consent form should include the appropriate GWAS language. See the sample consent form for an example of this language. The data sharing plan is expected to describe how the expectations of the policy will be met. Once the IRB reviews and approves the data sharing plan, UAB's Institutional Official, Dr. Marchase, will sign a GWAS Data Submission Certification. Please see the NIH GWAS web site at www.grants.nih.gov/grants/gwas for further guidance about such studies.
The data sharing plan should include: