Non-Exempt Human Subject Studies (Not Clinical Trials)
Non-Exempt Human Subjects Guidelines
This page is meant to help researchers and staff prepare NIH applications that involve non-exempt human subjects studies that DO NOT meet the definition of a clinical trial. If you are unsure if your study constitutes a clinical trial, please complete the NIH questionnaire.
Guidelines and templates for the individual components that must be attached or filled out via text field are provided below.
- Conditions or Focus of Study (text field, required)
- Eligibility Criteria (text field, required)
- Inclusion of Individuals Across the Lifespan (attachment, required)
- Inclusion of Women and Minorities (attachment, required)
- Recruitment and Retention Plan (attachment, required)
- Study Timeline (attachment, required)
- Inclusion Enrollment Reports (text field, required)
- Protection of Human Subjects (attachment, required)
- Single IRB (sIRB) Plan (attachment, optional) Data and Safety Monitoring Plan (attachment, optional)
- Data and Safety Monitoring Plan (attachment, optional)
- Overall Structure of the Study Team (attachment, optional)
Download our Non-Exempt Human Subjects Collection Form
Our collection form helps you compile all documentation required for your non-exempt human subjects application, all in one Word document.