Epidemiology and Genetics Research Program Division of Cancer Control and Population Sciences October 19 , 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:

• Reminder: Deadline To Comment on NIH Proposed Policy on Data Sharing in Genome-Wide Association Studies – Oct. 31
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Reminder: Deadline To Comment on NIH Proposed Policy on Data Sharing in Genome-Wide Association Studies – Oct. 31

A reminder that October 31 is the deadline to submit comments on the National Institutes of Health's (NIH) proposed policy for sharing data obtained in Genome-Wide Association Studies that are supported or conducted by the Institutes. You can readily submit your comments through the online form on NIH's Web site. You also may submit comments by e-mail to GWAS@nih.gov or by postal mail to NIH GWAS RFI Comments, National Institutes of Health, Office of Extramural Research, 6705 Rockledge Drive, Room 350, Bethesda, MD 20892-7963.

The Request for Information about the draft policy was announced in the NIH Guide ForGrants and Contracts and The Federal Register on August 30.

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.

The policy is proposed to apply to active research applications identified by applicants or NIH staff as GWAS as explained in the NIH GUIDE Notice NOT-OD-06-071.

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 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:

1. What are the potential benefits and risks associated with wide sharing of phenotypic and genotypic data where identifying information has been removed?
2. 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?
3. What are the advantages and disadvantages of the proposed:
   1. centralized NIH data repository?
   2. approach to data submission?
   3. approach to scientific publication?
   4. approach to intellectual property?
4. 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 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.

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