What is the GWAS policy?

The National Institutes of Health (NIH) Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) calls for investigators funded by the NIH for GWAS to: 1) share de-identified genetic (genotypic and phenotypic) data through a centralized NIH data repository; and, 2) submit documentation that describes how the institutions have considered the interests of the research participants, such as privacy and confidentiality. See also NIH Modifications to Genome-Wide Association Studies (GWAS) Data Access for the August 28, 2008 GWAS policy update.

Data Management
The policy defines how investigators may submit and request access to GWAS data for research purposes. Investigators using GWAS data from the NIH database are expected to continue to ensure the privacy and confidentiality of the individuals that participated in the original genetic association studies

Publication
The NIH policy allows investigators who submit GWAS data to the repository time to analyze and publish their results before additional investigators are permitted to submit manuscripts for publication using those data. Secondary investigators are expected to acknowledge the submitting investigator(s) in all publications utilizing GWAS data.

Intellectual Property
In the policy, the NIH encourages patents for downstream discoveries that would be necessary to develop products to meet public health needs, while discouraging obtaining a patent for early, pre-competitive information that may impede future research.

Why was the GWAS policy developed?

NIH Mission

The NIH mission is to uncover new knowledge that will lead to better health for everyone. The sharing of ideas, data, and research findings is encouraged by NIH as a primary mechanism for accomplishing this important public mission.

Data Sharing

Rapid advances in understanding the patterns of human genetic variation and maturing high-throughput, cost-effective methods for genotyping are providing powerful research tools for identifying genetic variants that contribute to health and disease. Consistent with the NIH mission to improve public health through research and the longstanding NIH policy to make available to the public the results of the research activities that it funds, the NIH has concluded that the full value of GWAS can best be realized if the genotype and phenotype datasets derived from GWAS are made available as rapidly as possible to a wide range of scientific investigators. The NIH recognizes that GWAS data release practices must be consistent with the informed consent provided by individual participants.

Related Resources

For additional information on Genome-Wide Association Studies (GWAS) please access the following NIH Websites:

• NIH Guide. Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data. October 19,2009. Notice Number: NOT-HG-10-006
• Implementation Guidance and Instructions for Applicants: Policy for Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies (GWAS)
• Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) - Federal Register Notice
• NIH Background Fact Sheet on GWAS Policy Update
• Genomic Data User Code of Conduct
• National Human Genome Research Institute (NHGRI)
• GWAS Overview (NHGRI)