MSU HRPP Manual Section 2-2-F-i

2-2-F-i, U.S. Department of Health and Human Services,  National Institutes of Health Definition of a Clinical Trial

Several NIH policy notices provide additional requirements applicable to clinical trials.

NIH defines a clinical trial as a research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Research
1See Common Rule definition of research at 45 CFR 46.102(d). See HRPP Manual 4-3, Determination of Human Subject Research, for more information about the definition of research.

Human Subject
2See Common Rule definition of human subject at 45 CFR 46.102(f). See HRPP Manual 4-3, Determination of Human Subject Research, for more information about the definition of human subject.

Prospectively Assigned
3The 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.

Intervention
4An 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.

Health-related biomedical or behavioral outcome
5Health-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.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 2-20-2017.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 2-2-F-i, U.S. Department of Health and Human Services, National Institutes of Health Definition of a Clinical Trial.