Have questions, suggestions, or concerns about research that involves human subjects? Use the IRB Staff Directory, Phone Tree, Office email address ("Ask the IRB" link), or suggestion box to contact us!
When a Principal Investigator (PI) is acting as a Sponsor-Investigator, additional consideration must be
given as to how compliance with FDA requirements will be maintained. The Columbia University FDA
Compliance Program for FDA-regulated Human Subjects Research outlines the institutional oversight of