Genomewide Association Studies Data Sharing: National Institutes of Health Policy Process.

Genomewide association studies (GWAS) are becoming an important part of the human genetics research landscape. As the technological and analytical tools have been developed, many of the National Institutes of Health (NIH) centers and institutes have launched projects to find genes or sets of genes that contribute to a variety of human disorders. Massive data sets are required to perform comprehensive genotype-phenotype analyses. GWAS projects that have been launched by the NIH include the Genetic Association Information Network (GAIN) (http://www.fnih.org/GAIN/GAIN_home.shtml) and the Genes and Environment Initiative (GEI) (http://www.gei.nih.gov). Because the NIH is the steward of the public’s investment in biomedical research, the NIH created a mechanism (i.e., a data repository) and related policy to maximize data sharing among the scientific community. The draft policy includes the following major elements: data management (i.e., protection of research subjects, data submission procedures, and data access principles), scientific publication, and intellectual property. The draft policy is available at http://grants2.nih.gov/grants/gwas/.