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)
- 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.