NIH requirements

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.

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