Answering the 4 Clinical Trial Questions for NIH-funded Basic Research Studies

Does the study involve human participants?

Federal regulations (45 CFR 46), define a human subject as a living individual about whom an investigator (whether professional or student) is conducting research:

• • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Are the participants prospectively assigned to an intervention?

Prospective assignment is not limited to random assignment to a manipulation or condition. "Prospectively assigned" means the experimental manipulation (intervention) is assigned per a predefined protocols.  The method of prospective assignment does not matter.  Neither does the number of conditions.

Is the study designed to evaluate the effective of the intervention on the participants?

Interventions are manipulations of the subject or their environment that are performed for research purposes. Interventions may include (but are not limited to): drugs/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/or diagnostic strategies.

Is the effect being evaluated a health-related biomedical or behavioral outcome?

Under the NIH definition of clinical trial, a health-related biomedical or behavioral outcomes has the potential for direct advancement of health.  Although basic science studies that produce fundamental knowledge about biological systems might eventually inform advances in health, they do not have the immediate intention of changing clinical practice but rather aim to understand fundamental aspects of phenomena without direct clinical applications. Therefore, for the purposes of the definition of a clinical trial, such studies do not have health-related biomedical or behavioral outcomes. Evaluations of the safety or efficacy of drugs, behavioral intervention, or medical devices have the potential for direct advancement of health and therefore are looking at health-related biomedical or behavioral outcomes. Likewise, studies comparing the relative effectiveness of two different behavioral therapies on a mental health condition would have health-related biomedical or behavioral outcomes.