Clinical trials allowed or not? Don’t let a simple mistake cost you a grant

March/April 2023 | Volume 22 Number 2

Photo courtesy of Magaly Blas Remember to review all requirements, especially those around clinical trials, to make sure you’re applying to the correct funding opportunity notice.

When you submit an application that includes a clinical trial as part of your project, make sure you apply to the correct notice of funding opportunity (NOFO)—the one designated “clinical trial required or optional.” If, by accident, you submit to a NOFO where clinical trials are not allowed, your application will be returned without review. In the past, reviewers could simply label these as “misclassified” and still enter the application into the review process, but in 2018, NIH revised its procedures. Now, these applications are automatically disqualified.

To avoid such a mistake, you should review all requirements to make sure you’re applying to the correct funding opportunity notice. NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” More details are available on grants.nih.gov: 

• Clinical Trial Requirements: Includes a precise definition of a clinical trial and its review criteria.
• Comparison of Funding Opportunity Announcement Types by Clinical Trial Allowability [PDF]: Gives further detail about the differences between study types.
• Decision Tool: Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial: Helps you steer your application to the appropriate NOFO.

The revised process has improved NIH's ability to identify clinical trials, uniformly apply review criteria, and ensure appropriate data collection and reporting. NIH terminology has also changed; the term, "Funding Opportunity Announcement" (FOA) has been phased out and "Notice of Funding Opportunity" (NOFO) is now the preferred term. To avoid any errors, simply take the time to double check your application before sending.

Updated April 7, 2023

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