This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
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 are expected 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 (PAs) and requests for applications (RFAs).
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 the proposed budget level, all applications proposing research that generates large-scale genomic data must include a genomic data-sharing plan. Timing, scope, and conditions of sharing depend on the nature of the research. Read more about Genomic Data Sharing at NIAID.
Investigators
If your notice of funding opportunity (NOFO), budget level, or type of research would expect data sharing as described above, follow these steps:
- Before you apply, discuss your proposed data sharing plan with an NIAID program officer. If you are requesting $500,000 or more in direct costs in any year, you can discuss your plan when you request our approval to accept assignment of your application. 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 data. If sharing is not possible, your plan must explain the reasons. Describe your plan—or justify its absence—in an attachment to the PHS 398 Research Plan Form, unless the NOFO instructions say otherwise.
- 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, include data-sharing activities in your annual progress report.
Scientific Review Officers
- Remind reviewers to check for a data sharing plan and assess its acceptability.
- Ask reviewers to check the acceptability of the plan.
- Ensure that reviewers do not factor the plan into their overall impact scores unless the NOFO 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 principal investigators (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.
- Remind PIs to comply with policy both on data sharing and HIPAA.
- Use boilerplate sharing language in the NOFO templates for RFAs, PAs, and solicitations unless you have unique data sharing requirements.
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 read Contacting Program Officers and Grants Management Specialists.
- Contact for NIAID Staff.
- Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.
Links
NIAID
- Data Policy and Guidance
- Genomic Data Sharing (GDS) SOP
- NIAID Sample Data Sharing Plan—an example from a PI
- NIAID Genomic Data Sharing Plan Examples
- Program Officer Checklist SOP
- Sharing Model Organisms SOP
NIH
Resources on Scientific Data Sharing and writing a data sharing plan
- NIH Sharing Policies and Related Guidance
- Which Sharing Policies Apply to My Research?—tool for grant applicants and recipients
- NIH Institute and Center (IC) Data Sharing Policies—filter for NIAID specifics
- Writing a Data Management and Sharing Plan—includes Sample DMS Plans
- Data Management and Sharing (DMS) Policy
- Data Sharing Policy site—provides background information and guidance.
- 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.
Guidance on the NIH Genomic Data Sharing (GDS) policy