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Resources for NIH's Human Subjects and Clinical Trials Updates

Delayed Onset Studies

This page is meant to help researchers and staff prepare NIH applications that involve Delayed Onset Studies. Delayed onset studies are those studies for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset Studies.

Our template 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 Delayed Onset 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 Delayed Onset Studies Only.

  • Study Title (600 characters max) 
  • Is a Clinical Trial Anticipated? Yes/No (if YES, verify FOA allows clinical trials here)
  • Delayed Onset Justification (attachment, required)
    • Note: Only 1 justification is required for multiple delayed onset studies within a single application