NO NO IRB REVIEW Non-Regulated Research Is the activity a systematic investigation?

NO NO YES YES NO IRB REVIEW Non-Regulated Research NO IRB REVIEW Non-Human Research Does research involve obtaining information about living individuals? Is the activity designed to develop or contribute to generalizable knowledge?

YES

Does activity involve interaction/intervention with individuals?

YES IRB REVIEW Human Subjects’ Research

NO

Is the information collected private?

IRB REVIEW Possible Human Research

NO

YES

NO IRB REVIEW Non-Human Research Is the information collected individually identifiable?

NO

YES

IRB REVIEW Human Subject’s Research

Systematic Investigation - Use of a clear plan, system or method to conduct a detailed examination or inquiry for facts.

Generalizable Knowledge - Knowledge that is universally or widely applicable

Private - behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 CFR 46.102(f)(2)]