NIH seeks input on proposed repository for genetic information

The National Institutes of Health (NIH) is seeking public input on a proposed new policy designed to facilitate the research community's access to data resulting from NIH-funded, genome-wide association studies.

NIH has published a Request for Information in the Federal Register today and will be accepting public comments until October 31.

Genome-wide association studies (GWAS) rely on the newly available research tools and technologies to rapidly and cost-effectively analyze genetic differences between people with specific illnesses, such as diabetes or heart disease, compared to healthy individuals. The differences may point to genetic risk factors for the development or progression of disease. Several NIH institutes recently launched, or are planning, GWAS initiatives with the expectation that the results will accelerate the development of better diagnostic tools and the design of new, safe and highly effective treatments.

"I predict that comprehensive, genomics-based health care will become the norm, with individualized preventive medicine and early detection of illnesses," said NIH Director Elias A. Zerhouni, M.D. "The NIH policies that give researchers rapid access to these findings will be an important step along that path."

As numerous GWAS programs get underway, NIH seeks to harmonize the policies by which the results will be made available to researchers. The proposed GWAS Policy calls-on NIH-funded GWAS investigators to quickly submit genetic data (genotypes) along with relevant health information (phenotypes) about individuals to a centralized NIH data repository. Data will be submitted in a form that protects the privacy and confidentiality of research participants. The data will be made freely available to all approved researchers to accelerate their studies.

The draft policy also proposes terms and conditions for investigators to access GWAS data for research purposes. Data will be released in a manner that preserves the privacy and confidentiality of research participants.

NIH encourages patenting of intellectual property that addresses public need, such as creating new treatments that can be brought to the clinic, but seeks to prevent premature or inappropriate patents that impede future research. Because publication credit is critical to academic promotion, the proposed NIH policy also defines a grace period during which GWAS data will be available for access, but principal investigators submitting the data would be the only ones allowed to publish analyses in scientific journals. The policy also asks that recipients of GWAS data acknowledge the submitting investigator in any published works.

"The NIH believes that the various and complex interests related to the submission of, and access to, GWAS data must be discussed with the public," said Elizabeth G. Nabel, M.D., director of National Heart, Lung, and Blood Institute and head of the NIH-wide team developing the policies. "Wide and rapid access to GWAS data may have implications for participants in studies, their families and communities, investigators, institutions and industry."

Some of the issues on which public consultation will be solicited include:

• Participant privacy concerns
• Potential risks and benefits for individual participants
• Professional recognition for the labor of investigators
• Intellectual property rights
• The development of a centralized NIH data repository

The NIH is soliciting comments on the proposed policy through: http://grants.nih.gov/grants/gwas/index.htm. Comments can also be submitted to [email protected]. A town hall meeting is also planned for early December 2006.