Exempt Human Subject Studies (Exemption 4)

Exemption 4 Guidelines

This page is meant to help researchers and staff prepare NIH applications that involve Exempt Human Subjects Studies (Exemption 4). If you are unsure if your study constitutes a clinical trial, please complete the NIH questionnaire.

Guidelines and templates for the individual components on this form that must be attached or filled out via text field are provided below.

• Conditions or Focus of Study (text field, not required)
• Eligibility Criteria (text field, not required)
• Inclusion of Individuals Across the Lifespan (attachment, not required)
• Inclusion of Women and Minorities (attachment, not required)
• Recruitment and Retention Plan (attachment, not required)
• Study Timeline (attachment, not required)
• Inclusion Enrollment Reports (not required)
  • Planned Enrollment Report
  • Cumulative (Actual) Enrollment Report
• Protection of Human Subjects (attachment, required)
• Data and Safety Monitoring Plan (attachment, optional)
• Overall Structure of the Study Team (attachment, optional)
• Exemption 4 Justification (attachment, required)

Complete the Collection Form for Exemption 4

Our collection form helps you easily compile all required documentation for exemption 4 studies.

Exemption 4 Collection Form