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Resources for NIH's Human Subjects and Clinical Trials Updates

Non-Exempt Human Subject Studies (Not Clinical Trials)

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.

Our Protocol Summary is meant to help researchers and staff collect relevant required information that will be input into NIH’s PHS Human Subjects and Clinical Trials Information Form. 

Complete the collection form for Non-Exempt Human Subjects Studies here

For other types of studies, please see "What Do I Need to Know?" for links to additional collection forms.

Guidelines and templates for the individual components on this form that must be attached or filled out via text field are provided below. Note: These requirements apply to Non-Exempt Human Subject Studies (Non-Clinical Trials) Only.