Who needs to submit an IRB application

Who needs to submit an IRB application?

All research projects, whether funded or unfunded, directed or co-directed by the University's faculty, students, or staff in which human subjects participate, are subject to the federal regulations governing such research. CUSM IRB uses the federal criteria at 45 CFR 46 to determine what requires IRB review. Therefore, the first question we ask is does the project meet the definition of human subject research.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The general rule is that if there is any element of research in an activity, that activity should undergo IRB review to ensure the protection of human subjects.

Human Subject: Living individuals about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR ยง 102(d)(1))

If your study meets the definition of human subjects research, you must submit an IRB application to CUSM IRB via email irb@cusm.org.

All human subjects research must receive prior approval from the IRB.