Data Sharing for Grants: Final Research Data

Note: For genome-wide association studies, also use the Data Sharing for Grants: Genome-Wide Association Studies SOP.

Purpose

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

Procedure

Applicants must share their final research data for some program announcements and request for applications, as well as for all applications that seek $500,000 or more in direct costs in any year of a grant.

Final research data are the recorded factual materials commonly accepted by the scientific community as necessary to document, support, and validate research findings.

Regardless of proposed budget amount, all applications that propose genome-wide association studies (GWAS) need a plan to share GWAS data. Read more in the Data Sharing for Grants: Genome-Wide Association Studies SOP.

Applicants

If your funding opportunity announcement or budget level would require data sharing as described above, follow these steps.

• Discuss your proposed data sharing plan with an NIAID program officer when requesting approval to accept assignment of the application. See the Big Grants SOP.
• Include a data sharing plan in your application stating how you will share your final data. If sharing is not possible, your plan must explain the reasons.
  • 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:
    • NIAID's Sample Data Sharing Plan.
    • NIAID's Sharing Data questions and answers.
    • NIH Data Sharing Policy site. Includes examples of data sharing at Data Sharing Workbook and Testimonials.
• You may request funds to prepare, document, and archive data in your budget.
• You will need to 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.
• Keep in mind 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 report.

Scientific Review Officers

• Remind reviewers to check that a data sharing plan is there.
• 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 data sharing plans should be a factor.
• Describe the reviewers' assessment of plans in an administrative note in the summary statement . If the plan is unacceptable or missing, flag it as a header in the summary statement.

Program Officers

• Oversee the NIH Data Sharing Policy and assess the appropriateness and adequacy of 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.
• 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 of Publications SOP

Sharing Model Organisms SOP

Trans NIAID Clinical Research Toolkit