A research study in which one or more human subjects are 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 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.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
Your human subjects study may meet
the NIH definition of a clinical trial.
- Why Changes to Clinical Trial Policies?
- Good Clinical Practice Training
- Clinical Trial-specific Funding Opportunities
- Clinical Trial-Specific Review Criteria
- New Human Subject and Clinical Trial Information Form
- Single IRB Policy for Multi-site Research
- Clinical Trials Protocol Template
- Clinicaltrials.gov Registration and Reporting
- Human Subjects System
Credit: Lydia Polimeni, National Institutes of Health