Definition of Human Subjects Research

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR 46.102[d]). "Human subject" means 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" (45 CFR 46.102[f]).

The comparable FDA regulation (21 CFR 50) does not define "research" per se; rather, it defines "clinical investigation" as "any experiment that involves a test article and one or more human subjects..." (21 CFR 50.3[c]).

 

 What You Should Know about Human Research and the IRB

 IRB Jurisdiction

 PI Eligibility and Responsibilities

 Faculty Sponsor Eligibility and Responsibilities

 How to Submit Protocols

Pre-Review of New Studies

 Additional Reviews Required for Certain Human Studies

 Training

 Top Ten Reasons for Delays in IRB Approval