Data Sharing for Grants SOP: Final Research Data and GWAS

Purpose

To require NIH-supported investigators to share their data with the scientific community.

Procedure

NIH requires two types of data sharing from its supported investigators:

1. Final research data. Applicants seeking $500,000 or more in direct costs in any year of a grant must show how they will share final research data. For some program announcements and request for applications, data sharing may apply to smaller budget requests.
2. GWAS. All applications that are a genome-wide association studies (GWAS) have to include a plan to send data to NIH’s Database of Genotype and Phenotype (dbGaP).

Data Sharing

Applicants

• Discuss your proposed data sharing plan with an NIAID program officer when requesting approval to accept assignment of the application.
• Include a data sharing plan in your application stating how you will share your final data or explaining why data sharing is not possible.
  • Describe your plan -- or justify its absence -- in your Research Plan section.
    • 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).
    • The plan does not count toward the Research Plan page limit.
  • Here are some resources for writing a plan and links to more detailed information:
    • Our Sample Data Sharing Plan.
    • Sharing Data questions and answers.
    • NIH Data Sharing Policy site.
• You may request funds to prepare, document, and archive data in your budget.
• Remove individual identifiers, such as social security numbers, before sharing data. Data sharing plans must comply with the Health Insurance Portability and Accountability Act (HIPAA), a federal regulation that protects the privacy of living and deceased people.
• Ensure that data sharing starts no later than the time the main findings are accepted for publication.
• For noncompeting applications, document sharing in your annual progress reports.

Genome-Wide Association Studies

Applicants Planning to Submit Data

If your research qualifies as a genome-wide association study (GWAS), 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 the plan in Section K in the Resource Sharing Plans section of the PHS 398 Research Plan form. For sample plans, see NIH's Guidance for Developing Data-sharing Plans for GWAS. If sharing is not possible, your plan will 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 apply, 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 the following:
  • NIH's Genome-Wide Association Studies (GWAS) page.
  • Submitting Application for GWAS.

Applicants Planning to Access Data

If you will access GWAS data, submit a data access request that you and your institutional business official sign and 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 information, see NIH's Genome-Wide Association Studies (GWAS) page.

Scientific Review Officers

• Remind reviewers to check that the plan is there.
• Describe the reviewers' assessment of plans in an administrative note.
• Ensure that peer reviewers do not factor plans into their priority scores.

Program Officers

• Oversee the NIH data sharing policy and assess the appropriateness and adequacy of the investigators' proposed data sharing plans.
• Work with PIs in developing and adding 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 (see link below).
• Complete Program Officer Checklists for competing applications released for funding.

Grants Management Specialists

• Issue a restricted award if the program officer finds the data sharing plan unacceptable. This may be done at the end of the fiscal year only.
• Make the 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

Big Grants SOP

Grant Application, Electronic SOP

Grant Application, Paper SOP

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

Health Insurance Portability and Accountability Act

Public Access SOP

Sharing Model Organisms SOP

Trans NIAID Clinical Research Toolkit