NIH requirements

Delayed Onset Study Guidelines

This page will 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.

Guidelines and templates for the individual components on this form that must be attached or filled out via text field are provided below.

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

Complete the Collection Form for Delayed Onset Studies

Our collection form helps you easily compile all required documentation for delayed onset studies in one Word document.

Delayed Onset Studies Collection Form