Data Sharing for Grants: Genome-Wide Association Studies (GWAS)

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 enable investigators to access GWAS data.

Procedure

Regardless of the proposed budget amount, all GWAS applications must include a plan to send data to NIH’s Database of Genotype and Phenotype (dbGaP) housed at the National Center for Biotechnology Information in the National Library of Medicine.

GWAS are studies of the variation across the 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 other final research data for applications that seek $500,000 or more in direct costs in any year of the grant as well as for some program announcements and requests for applications. Read more in the Data Sharing for Grants: Final Research Data SOP.

Investigators Who Plan to Conduct a GWAS

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

• Create a plan in your application to send your data to the Database of Genotype and Phenotype (dbGaP).
  • If sharing is not possible, your plan must explain the reasons.
  • We strongly advise that you contact your program officer to assess the viability of your plan.
• Ways to share data include publishing, making presentations, putting in an archive or online, or responding to requests individually.
• Describe your plan—or justify its absence—in the Resource Sharing Plans section of the PHS 398 Research Plan form (electronic application) or the PHS 398 Resource Sharing Section (paper application).
• For more information on writing a plan, see the following resources:
  • Key Elements to Consider in Preparing a Data Sharing Plan Under NIH Extramural Support—outlines the essential parts of a plan, regardless of the data being shared.
  • For sample plans:
    • NIH's Guidance for Developing Data Sharing Plans for GWAS—sample plans for different scenarios, e.g., existing specimens and data, specimens or data not yet collected.
    • Example Plan Addressing Key Elements for a Data Sharing Plan Under NIH Extramural Support—provides a template you can modify as appropriate for the data you plan to share.
• 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).

Investigators Who Plan to Use GWAS Data

If you plan to access GWAS in the controlled-access portions of the database, take the following actions:

• We recommend getting required approvals before applying, so you will be ready if you get funded.
  • To apply, go to the eRA Commons and apply using the SF 424 form. Follow NIH’s Request Procedures (PDF) on dbGaP Authorized Access.
  • Complete a Data Use Certification, which has the terms for using the dataset, cosigned by you and your institutional official.
• In the Approach section of your application's Research Strategy, describe how your proposed research will use the data and comply with your Data Use Certification.
• In your cover letter, state that you are planning to access GWAS data.

Scientific Review Officers

• 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 overall impact 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.
• If the plan is unacceptable or missing, flag it as a header in the summary statement.
• If you plan to access data:
  • See NIH's Implementation Guidance for NIH Extramural Staff.
  • You must get permission to access data in dbGaP. Follow the instructions in Requesting Access to Data in the NIH GWAS Data Repository.

Program Officers

• Work with PIs to develop an acceptable GWAS data sharing plan for their application.
• After review, assess the appropriateness and adequacy of investigators' proposed data sharing plan. Complete Program Officer Checklists for competing applications released for funding.
• Make sure PIs comply with policy both on data sharing and HIPAA.
• Use sharing language in the boilerplate for RFAs, PAs, and solicitations (see link below).
• If you plan to access data:
  • See NIH's Implementation Guidance for NIH Extramural Staff.
  • You must get permission to access data in dbGaP. Follow the instructions in Requesting Access to Data in the NIH GWAS Data Repository.

Grants Management Specialists

• Issue a restricted award if the program officer finds the sharing plan unacceptable (done at the end of the fiscal year only).
• Remove a restriction after receiving a revised sharing plan that is acceptable to program staff.

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

NIAID

Sharing Data questions and answers

What Resources Do You Need to Share? in the Strategy for NIH Funding

Application portal

Grant Application, Electronic SOP

Grant Application, Paper SOP

Program Officer Checklist SOP

Public Access of Publications SOP

Sharing Model Organisms SOP

Trans NIAID Clinical Research Toolkit

Other

SF 424 Application Guide for your grant application package (for electronic application)

Submission Guidelines and Templates for Publications in the NIH Guide

Health Insurance Portability and Accountability Act