IRB reviews activities that meet the federal definitions of “research” and “human subject” (45 CFR 46.102):
Research: A systematic investigation, including research development, testing and evaluation, designed to develop of contribute to generalizable knowledge.
Human subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Intervention: includes physical procedures such as blood samples, x-rays; or the manipulation of the environment in order to stimulate certain types of behavior.
Interaction: includes interpersonal communication between the investigator and subject through surveys, interviews, administration of educational tests etc.
Identifiable: the identity of the subject is or may readily be ascertained by the investigator with the information obtained as part of the research.
Private information: a context in which an individual can reasonably expect that no observation or recording is taking place or information that is provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.
