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Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
August 31, 2006 |
EGRP NEWS FLASH
From the Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
This News Flash brings you news about:
 NIH Seeks Comment on Data Sharing for Genome-Wide Association Studies – By
Oct. 31, 2006
A Request for Information was announced in the NIH GUIDE FOR GRANTS
AND CONTRACTS and THE FEDERAL REGISTER yesterday, August 30, 2006, seeking
comments on a proposed policy for sharing of data obtained in NIH supported
or conducted Genome-Wide Association Studies (GWAS). A GWAS is currently
defined 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. Responses must be received by October 31, 2006, to ensure
that comments can be considered in developing new policies.
The draft policy is proposed to apply to active research applications
identified by applicants or NIH staff as GWAS as explained in NIH GUIDE NOT-OD-06-071.
You can readily submit your comments through the online
form on the
NIH Web site.
Or, you may submit comments by e-mail to GWAS@nih.gov or send them by
mail to NIH GWAS RFI Comments, National Institutes of Health, Office
of Extramural Research, 6705 Rockledge Drive, Room 350, Bethesda, MD
20892-7963.
The proposed policy addresses: (1) data sharing procedures, (2) data
access principles, (3) intellectual property, and (4) issues regarding
the protection of research participants through all phases of GWAS. Many
of the principles contained in the policy reflect and extend existing
NIH polices (e.g., the 2003 data sharing policy) and other recent NIH
discussions. (See End Notes 1 and 2, respectively,
below.)
The goal of the proposed policy is to advance science for the benefit
of the public through the creation of a centralized NIH GWAS data repository.
Maximizing the availability of resources facilitates research and enables
medical science to better address the health needs of people based on
their individual genetic information. NIH is seeking public input and
advice on the overall concept of the proposed policy and specific feedback
on the following questions:
- What are the potential benefits and risks associated with wide
sharing of phenotypic and genotypic data where identifying information
has been removed?
- In addition to removing personal identifying information, what
protections are needed to minimize risks to research participants whose
phenotypic and genotypic data are included in a centralized NIH data
repository and shared with qualified investigators for research purposes?
- What are the advantages and disadvantages of the proposed:
- centralized NIH data repository?
- approach to data submission?
- approach to scientific publication?
- approach to intellectual property?
- What specific
resources may investigators and institutions need to meet the goals
of this proposed policy?
Please refer to NIH GUIDE NOT-OD-06-094 to read the complete text of the Request for Information and the
proposed policy.
End Notes
(1) The 2003 NIH
Data Sharing Policy applies to investigators
seeking $500,000 or more in direct costs in any year.
(2) Request
for Information on Modifications to the NHLBI Policy
for Distribution of Data from Clinical Trials and Epidemiology
Studies, 2006:
Genome-Wide Association Studies: Design and Analysis Colloquium,
Oct. 2006
Yale Continuing Medical Education is hosting "Genome-Wide Association
Studies: Design and Analysis - An International Colloquium" in
New Haven, Conn., October 26-27, 2006. EGRP is not a sponsor of the meeting.
We thought some of you might be interested and had not received word
about it. Colloquium
Web site.
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