Notice Number: NOT-OD-07-013

Key Dates
Release Date: October 20, 2006

Update: The following update relating to this announcement has been issued:

• August 28, 2007 - See Notice (NOT-OD-07-088) Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS).
• October20, 2006 (NOT-OD-07-012) - Extended Comment Period for the Proposed Policy for Sharing of Data Obtained in
  NIH Supported or Conducted Genome-Wide Association Studies (GWAS).

Issued by
National Institutes of Health (NIH), ( http://www.nih.gov )

The purpose of this notice is to announce that the National Institutes of Health (NIH) will hold a Town Hall meeting on Thursday, December 14, 2006, from approximately 10am to 2pm, near the NIH main campus, to continue the dialog concerning the proposed policy for sharing of data obtained in NIH supported or conducted Genome-Wide Association Studies (GWAS).

This draft policy is proposed to apply to active research applications identified by applicants or NIH staff as GWAS per NOT-OD-06-071 .

Background
Consistent with both the NIH mission to improve public health through research and its longstanding legislative mandate to make available to the public the results of the research activities that it supports and conducts, the NIH believes that the full value of GWAS to the public can be realized only if the genotype and phenotype datasets are made available as rapidly as possible to a wide range of scientific investigators. Rapid and broad data access is particularly important for GWAS because of the significant resources involved; the challenges of analyzing large datasets; and the extraordinary opportunities for making comparisons across multiple studies.

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. 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 1 ) and other recent NIH discussions. 2

The comments received as part of the Comment Period for the Proposed Policy for Sharing of Data obtained in NIH supported or conducted Genome-Wide Association Studies (GWAS ) NOT-OD-07-012 ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-012.html ) will contribute to the Town Hall Meeting discussions. All of the comments received during the comment period and Town Hall Meeting will help inform the development of the proposed policy.

Participation
All individuals who wish to attend the Town Hall Meeting should register through the meeting's website which will be available at http://grants.nih.gov/grants/gwas/index.htm , on or about November 3, 2006. A detailed meeting agenda will be posted on this Web site along with any relevant information. Participants are responsible for their own travel and other expenses associated with participating in this meeting .

Inquiry

Questions concerning this notice and the town hall meeting should be directed to GWAS@nih.gov .

Endnotes

1 The 2003 NIH Data Sharing Policy applies to investigators seeking $500,000 or more in direct costs in any year (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm ).

2 Request for Information on Modifications to the NHLBI Policy for Distribution of Data from Clinical Trials and Epidemiology Studies ( http://www.nhlbi.nih.gov/funding/policies/rfi-genome.htm ), 2006