Data Sharing for Grants: Genome-Wide Association Studies

Note: For NIH's general data sharing policy, see the Data Sharing for Grants: Final Research Data SOP.

Purpose

To require NIH-supported investigators to share data from genome-wide association studies (GWAS) with the scientific community and to provide information to other investigators on how to prepare a data access request.

Procedure

Regardless of proposed budget amount, all GWAS applications must include a plan to send data to NIH’s Database of Genotype and Phenotype (dbGaP).

GWAS is defined as research to study variation across the entire human genome to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition.

In addition to the GWAS data sharing requirement, applicants must share any other final research data for some program announcements and requests for applications, as well as for all applications that seek $500,000 or more in direct costs in any year of a grant. Read more in the Data Sharing for Grants: Final Research Data SOP.

Applicants Who Plan to Conduct a GWAS

If your research qualifies as a genome-wide association study as defined above, follow these steps.

• Include a plan in your application to send your data to the Database of Genotype and Phenotype (dbGaP), housed at the National Center for Biotechnology Information in the National Library of Medicine.
• Put it in Section K of the Resource Sharing Plans section of the PHS 398 Research Plan form (for an electronic application) or the PHS 398 Resource Sharing Section (for a paper application).
  • For sample plans, see NIH's Guidance for Developing Data-sharing Plans for GWAS.
  • If sharing is not possible, your plan must explain the reasons.
• In your cover letter, state that you are proposing to conduct GWAS research or planning to access GWAS data in the NIH repository.
• Before you submit your application, your institutional review board will need to review your plan.
• When you submit the data, your institution will certify that your submissions meet NIH's and its own policies. For details, read NIH's Points to Consider for IRBs and Institutions.

For more information, see NIH's Genome-Wide Association Studies (GWAS) page and Submitting Application for GWAS.

Applicants Who Plan to Use GWAS Data

If you will access GWAS data, submit a data access request. Include the following:

• A description of how the proposed research will use the data. Put this in Section D of the Research Design and Methods section of the Research Plan.
• A Data Use Certification.
• Signatures of the investigator and institutional business official.

For more about the data access request, see NIH's Genome-Wide Association Studies (GWAS) page.

In your cover letter, state that you are planning to access GWAS data.

Scientific Review Officers

• See NIH's Implementation Guidance for NIH Extramural Staff.
• Remind reviewers to check that applicants provided a GWAS data sharing plan.
• Ask reviewers to check the acceptability of the plan.
• Ensure that reviewers do not factor the plan into their priority scores unless the funding opportunity announcement states that GWAS data sharing plans should be a factor.
• Describe the reviewers' assessment of plans in the summary statement under heading "Data Sharing Plan."
• If the plan is unacceptable or missing, flag it as a header in the summary statement.

Program Officers

• Oversee the NIH GWAS data sharing policy and assess the appropriateness and adequacy of investigators' proposed data sharing plans.
• Work with PIs in developing and adding GWAS data sharing plans to their applications.
• Make sure PIs comply with policy both on data sharing and HIPAA.
• Use data sharing language in the boilerplate for request for applications and program announcements.
• Complete Program Officer Checklists for competing applications released for funding.

Grants Management Specialists

• Issue a restricted award if the program officer finds the GWAS data sharing plan unacceptable. This may be done at the end of the fiscal year only.
• Make the GWAS data sharing plan a term of award if indicated by a program officer on the Program Officer Checklist.
• Confirm receipt of institutional certification.

Contacts

Applicants or grantees with questions should Contact Staff for Help.

Contact for NIAID Staff

Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Grant Application, Electronic SOP

Grant Application, Paper SOP

Grant Application Guide for your Grant Application Package (for electronic application)

Human Subjects Research Requirements SOP and other Human Subjects SOPs

Health Insurance Portability and Accountability Act

Public Access of Publications SOP

Sharing Model Organisms SOP

Trans NIAID Clinical Research Toolkit