If I’m not sure whether NIH would consider my proposal a clinical trial, what should I do?

We have provided a tool to help you determine whether your human subjects research study meets the NIH definition of a clinical trial.

What is different about funding opportunity announcements (FOAs) that allow applications proposing clinical trials?

FOAs that accept clinical trials include specific review criteria to ensure that reviewers appropriately consider clinical trial-related information.

Why are Trainees or Fellows not allowed to lead an independent clinical trial?

In many disciplines, a fellow or trainee may not yet possess the skills or knowledge to independently lead a clinical trial (and to navigate all the components, complexities, and reporting requirements of clinical trials). In addition, neither fellowships nor training grants include sufficient research funds to support the majority, if not all types, of clinical trials.

What types of studies fall under the ‘Basic Experimental Studies with Humans Required’ FOAs?

Basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants” include studies that meet the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that fit within this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulated independent variables) and assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. See the Comparison of Funding Opportunity Types by Clinical Trial Allowability for additional guidance.

Note: Participation in funding opportunities for Basic Experimental Studies with Humans will vary by NIH Institute and Center (IC). Many ICs will continue to accept Basic Experimental Studies with Humans through existing FOAs that accept clinical trials. It is important to check with a Program Officer to determine the most appropriate FOA for your application.

What review criteria will be used to review applications submitted to the ‘Basic Experimental Studies with Humans Required’ FOAs?

Since these applications meet both the NIH definition of a clinical trial and the definition of basic research, they will be subject to the same review criteria as all ‘Clinical Trial Required’ FOA applications. See here for additional information.