|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 firstname.lastname@example.org.
A town hall meeting is also planned for early December 2006.
The Office of the Director, the central office at NIH, is responsible for
setting policy for NIH, which includes 27 Institutes and Centers. This involves
planning, managing, and coordinating the programs and activities of all NIH
components. The Office of the Director also includes program offices which
are responsible for stimulating specific areas of research throughout NIH.
Additional information is available at http://www.nih.gov/icd/od/.
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U.S. Department of Health and Human Services. It is the primary federal
agency for conducting and supporting basic, clinical and translational medical
research, and it investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit www.nih.gov.