Which Funding Opportunity Announcement (FOA) Should I Use if My Human Subject Research Study is Delayed Onset?

The type of FOA you will need depends on whether you anticipate that your delayed onset human subject study will meet the definition of a clinical trial.

If it will, you will need to choose a funding opportunity that explicitly allows clinical trials (it will be designated ‘Clinical Trial Optional’ or ‘Clinical Trial Required’). Be sure to check the ‘Anticipated Clinical Trial’ box when completing your Delayed Onset Study record within the application.

If no clinical trial is involved, you will need to choose a funding opportunity designated as ‘Clinical Trial Optional’ or ‘Clinical Trial Not Allowed.’

When completing your application, follow the SF 424’s Delayed Onset Study instructions to complete the Delayed Onset Study Justification attachment. Be detailed about the information you need before you can develop definite plans for the involvement of human subjects, factors affecting the availability of the information, why that information is not currently available, and when the information is expected to become available during the course of the project.

Have other questions related to NIH clinical trial policies? Visit the clinical trials policy pages on grants.nih.gov for additional resources, and other frequently asked questions and their answers.

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