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 requesting $500,000 or more in direct costs in any year of a grant to share their data with the scientific community.

Procedure

Applicants must plan to share final research data when submitting any application that requests $500,000 or more in direct costs in any year as well as when responding to some program announcements and requests for applications.

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

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

Investigators

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

• Before you apply, discuss your proposed data sharing plan with an NIAID program officer when requesting our approval to accept assignment of an application requesting more than $500,000 or more in direct costs in any year. Read the Big Grants SOP for details on that policy.
• When you apply, 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 the Resource Sharing Plans section of the PHS 398 Research Plan form (electronic application) or the PHS 398 Resource Sharing Section (paper application).
  • Use these resources for writing a plan and finding more detailed information:
    • NIAID's Sample Data Sharing Plan—an example from a PI.
    • NIAID's Sharing Data questions and answers—covers general Q&As as well as questions from the extramural community.
    • NIH Sharing Policies and Related Guidance includes:
      • Data Sharing Policy site—provides background information, a workbook, and brochure.
      • 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.
      • 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.
• Ways to share data include publishing, making presentations, putting in an archive or online, or sending individual responses.
• 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 for a 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 FOA 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

• Work with PIs to develop acceptable data sharing plans 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).

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