Institutional Review Board
The Institutional Review Board (IRB) is a university-wide standing committee whose primary mission is to ensure the rights and welfare of all human participants in CUSM-affiliated research. The IRB has the authority to review, approve, disapprove, or require changes to all studies under their purview. Federal and state regulations, university policy, and the Belmont Report guide the IRB review process. All human subject research conducted at CUSM by faculty, staff, and students must have an approved IRB protocol before the study can be performed.
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.
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.
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.
- Any other supporting documents (e.g., consent form, recruitment materials, questionnaires, surveys, etc.)
Education & Training
Required Human Subjects Protection Training
Everyone conducting human subjects research listed on the Project Roster must complete the Collaborative Institutional Training Initiative (CITI) online course.
Questions about the IRB and CUSM policies and procedures regarding human subjects in research can be directed to IRB@cusm.org.