Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?

A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial. to one or more interventions interventionsAn "intervention" is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies. (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. health-related biomedical or behavioral outcomes.A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life. Learn more

Answer the following four questions to determine if your study is a clinical trial:

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

Your study is considered to meet the NIH definition of a clinical trial even if:

  • Your study uses healthy participants, or does not include a comparison group (e.g., placebo or control)
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study utilizes a behavioral intervention
  • Your study uses an intervention for the purposes of understanding fundamental aspects of a phenomenon (See guidance and FAQs about Basic Experimental Studies with Humans (BESH)). 

Your study is NOT considered to meet the NIH definition of a clinical trial if:

  • Your study is intended solely to refine measures.
  • Your study involves secondary research with biological specimens or health information.


Decision Tool: Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?

To learn more about the considerations for each question, use the decision tool below:

Note for ancillary studies: When answering the following questions, take into account only the work being proposed in the ancillary study, not the work being done in the parent project.

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