The Institutional Review Board uses the following definitions to determine what constitutes human subject research:
Health and Human Services Common Rule Definitions:
- Research 45 CFR 46.102(d) defines research as a systematic investigation, including research development, and testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subject 45 CFR 102(f) defines a human subject as an individual about whom an investigator conducting research obtains data through intervention or interaction with individual or identifiable private information.
- Intervention or Interaction includes physical procedures performed on an individual, manipulation, communication or interpersonal contact with an individual or manipulation of an individual's environment.
- Private Information includes information that an individual can reasonably expect will not be made public, and information about behavior that an individual can reasonably expect will not be observed or recorded.
- Identifiable means that the identity of the individual is or may be readily ascertained by the investigator or associated with the information.
Food and Drug Administration (FDA) Definitions:
- Research 21 CFR 50.3(c) defines research as an experiment that involves a test article and one or more human subjects.
- Human Subject 21 CFR 50.3(e) defines human subject as an individual who is or becomes a participant in research, either as a recipient of a test article or as a control.
- Test Article 21 CFR 50.3(j) defines test article as any drug (including a biological product) for human use, medical device for human use, human food additive, color, adaptive electronic product, or any other article subject to regulation under the jurisdiction of the FDA.
Process for Determining Whether an Activity Constitutes Human Subject Research
Investigators are responsible for determining what constitutes research with human subjects in accordance with the above definitions. When there is a question, the IRB Office is to be contacted for consultation. Investigators who wish to obtain a determination about whether an activity is human subject research may contact the IRB by phone or email, or may submit an application for review.