NIH requirements

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. 

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. 

Non-Exempt Human Subjects Collection Form (WORD)