How to Write a Human Subjects Grant Application

• Electronic applications. Part II Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan in the Grant Application Guide for your Grant Application Package.
• Paper applications. Part II Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan in the PHS 398.
• RFA or PA. If responding to a request for applications or program announcement, read the notice. If requirements differ from the application instructions, the RFA or PA takes precedence.
• NIAID Clinical Terms of Award
• PHS 2590 Non-Competing Grant Progress Report for noncompeting awards.

Tutorial Table of Contents

View the tutorial page-by-page, with illustrations.

• Are You Conducting Human Subjects Research?
  • Stay in Contact With Your Program Officer
  • Is Your Research Exempt?
  • Key Points to Remember About Human Subjects Exemptions
• Planning and Writing Your Research Application
  • Obtain a Federalwide Assurance
  • Avoid Conflicts of Interest
  • Know the Requirements for Investigator-Initiated Clinical Trials
  • Plan for Registering an IRB or IEC
  • IRB, IEC, and FWA Requirements for International Research
  • Guidance for Applicants on Enrolling Special Populations
  • Investigating Foreign Populations
  • Develop Your Human Subjects Research Plan
  • Designing Your Data and Safety Monitoring Plan
  • How Human Subjects Applications are Reviewed
  • What Happens If Reviewers Have Concerns?
• Before You Enroll Participants
  • We Must Have Approvals from All IRBs or IECs
  • We'll Discuss Data and Safety Monitoring With You
  • Meet Requirements for IND or IDE
  • Show Recombinant DNA Advisory Committee Approval
  • Document Training in Research Conduct
  • Include the Federalwide OHRP Assurance
  • Resolve Peer Review Concerns
• Maintaining Your Award
  • IRBs and IECs Have Ongoing Requirements
  • Amendments, Suspensions, Terminations, and Extensions
  • Report Data and Safety Monitoring Reviews
  • Report Adverse Events Promptly
  • Send the Inclusion Enrollment Form With Your Progress Report
  • Other Reporting Requirements
• Know Which NIAID Staff Can Help You
• Clinical Terms of Award Checklist
• More Human Subjects Links

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Translated Versions

• Translated Tutorials

Other Tutorials and Resources

• See our All About Grants page for more information on NIH grant application and review.
• Find answers to questions about application specifics in Quick Facts on Research Grant Applications.

Look It Up

See the Glossary for terms.