Implementation Guidance and Instructions for Applicants: Policy for Sharing of Data Obtained in NIH-Supported or Conducted Genome-Wide Association Studies (GWAS)

Notice Number: NOT-OD-08-013

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

  • August 27, 2014 - See Notice NOT-OD-14-124.
  • September 27, 2013 - See Notice NOT-OD-13-119. Request for Information: Input on the Draft NIH Genomic Data Sharing Policy.
  • August 10, 2012 - See Notice NOT-OD-12-136. Notice of New Process for Requesting dbGaP Access to Aggregate Genomic Data for General Research Use Purposes.

Key Dates
Release Date: November 16, 2007

Other Relevant Notices

August 28, 2007 (NOT-OD-07-088) - 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)

This Notice provides guidance and instructions for applicants regarding implementation of the NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), which was released August 28, 2007 (NOT-OD-07-088).

Background

As part of the mission to discover new knowledge that will lead to better health for the public, the National Institutes of Health (NIH) are interested in advancing the use of data obtained through genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease.  After public consultation with representatives from the scientific and lay communities (http://grants.nih.gov/grants/gwas/index.htm), the NIH announced the final policy for the sharing of data obtained through NIH-supported or –conducted GWAS (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html). 

Policy Goals

The goal of the GWAS policy is to facilitate broad and consistent access to NIH-supported GWAS data in order to speed the translation of basic genetic research into therapies, products, and procedures that benefit the public health.  The NIH believes that the full value of GWAS to the public can be realized only if the resulting 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—these studies generally require significant resources; present challenges in analyzing the large datasets; and provide extraordinary opportunities for making comparisons across multiple studies.

Applicability

This NIH policy applies to:

  • Competing grant applications that include GWAS and are submitted to the NIH for the January 25, 2008 and subsequent due dates;
  • Proposals for contracts that include GWAS and are submitted to the NIH on or after January 25, 2008;
  • and NIH intramural research projects that include GWAS and are approved on or after January 25, 2008.
Instructions for Applicants

Applicants should state in the cover letter if they are proposing to conduct GWAS research, or plan to access GWAS data in the NIH repository as part of the proposed research.

Applicants Proposing GWAS

Applications and proposals that include GWAS, regardless of the requested costs, are expected to include as part of the Research Plan either a plan for submission of GWAS data to the NIH-designated GWAS data repository, or an appropriate explanation for why submission to the repository will not be possible.   This information should be included as part of the Research Plan of the application.  In the PHS 398 application, place this information in Section K. Resource Sharing; in the SF424 R&R it should be addressed in the PDF attachment of the PHS 398 Research Plan Component, Item 17 Resource Sharing Plan(s). Note, this is not part of the page limits for Sections 2 through 5 of the Research Plan.   These instructions apply to all applications proposing GWAS, including those submitted in response to a GWAS-specified Funding Opportunity Announcement (FOA).  However, when responding to existing FOAs for GWAS, applicants should pay particular attention to any additional instructions, especially those related to data sharing.

Applicants Intending to Access the NIH GWAS Data Repository

Applicants who plan to seek data from the NIH GWAS data repository for use in research will be expected to meet data security measures and to submit a data access request, including a Data Use Certification that is co-signed by the investigator and the designated Institutional Official.  In the Research Design and Methods section of the Research Plan, the applicants should briefly address plans for requesting access to data and state their intention to abide by the Data Use Certification.  The Design and Methods section of the Research Plan is Section D in the PHS 398 application, and item 5 in the PDF attachment of the PHS 398 Research Plan Component. Applicants who intend to access data in the NIH GWAS data repository for the research proposed may wish to secure that access prior to submitting their application for NIH support. 
These instructions will be included in a future version of the PHS 398 Grant Application and Grants.gov SF424 (R&R) Application Guide. 

Implementation Guidance

Implementation guidance is provided in a number of documents available at the following web site:   http://grants.nih.gov/grants/gwas/index.htm, including:
  • developing data sharing plans for applications and proposals that include GWAS;
  • peer review of  GWAS grant applications
  • submitting data to the NIH GWAS data repository;
  • requesting access to data in the NIH GWAS data repository;
  • oversight of the NIH GWAS initiative;
  • protections for research participants;
  • points to consider for Institutional Review Boards and institutions in their review of data submission plans and institutional certifications; and
  • frequently asked questions and answers.

Inquiries

For questions or further information, contact:

Laura Lyman Rodriguez, Ph.D.
Special Advisor to the Director
National Human Genome Research Institute
31 Center Drive, Room 4B09
Bethesda, MD 20892
Phone: 301-496-0844

Stephanie Y. Burrows, Ph.D.
Scientific Program Specialist
Office of Science and Technology
National Heart, Lung, and Blood Institute
31 Center Drive, Room 5A07
Bethesda, MD 20892-2482
Phone: 301-496-9899
Email inquiries should be directed to GWAS@nih.gov

Additional information and detailed implementation guidance related to the NIH GWAS Policy will be provided at http://grants.nih.gov/grants/gwas/index.htm.

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