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.

Research:

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. 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 § 102(d)(1))

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

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

For new applications, please submit the following forms:

• Determination of Activity Form. Review the IRB Exempt & Expedited Review Categories to determine if your application fits any of the exempt and expedited categories listed.
• IRB Application
• Project Roster
• Any other supporting documents (e.g., consent form, recruitment materials, questionnaires, surveys, etc.)