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A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d)

Human Subject
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. 45 CFR 46.102(f)

Physical procedures and manipulations of the subject's environment performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private Information
Private information is information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

Definition of Human Research
Data from living individuals
Biological material from living individuals
Interaction or intervention with a living individual
Use of a non-FDA approved, drug, device or biological
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Chapter 2
Quick Links

Research in Humans

History of Rules About Research in Humans


Federal Mandate

Respect for Persons



Common Rule

IRB Mission



Chapter 2 Download (PDF)