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 its 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.
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.edu.
All human subjects research must receive prior approval from the IRB.
Only the IRB can determine review requirements for human subjects research activity. Failure to obtain IRB review for human research activities violates federal and/or University policy and could result in the university revoking your research privileges, withholding your degree, terminating employment, loss of grant funding, inability to present or publish, or rejection of research paper/thesis/dissertation.
• The IRB will not review applications until all required documents are received and
completed.
• Non-Exempt applications may require additional review time and/or approval by the
IRB Committee.
• Contact the IRB with questions regarding application status or for assistance.
Complete and submit the following documents to IRB@cusm.edu:
IRB Application Form
Attach all additional study materials being used, including but not limited to: Consent
Forms, Recruitment Letters, Survey questions, Flyers, Social Media Posts, HIPAA Authorization
Form, and CITI Training Certificates
For new applications, please submit the following forms:
- IRB Application
- Any other supporting documents (e.g., consent form, recruitment materials, questionnaires, surveys, etc.)
- Sample Consent Form
- HIPAA Form When Needed
Review the IRB Exempt & Expedited Review Categories to determine if your application fits any of the exempt and expedited categories listed.
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.edu
CONTACT THE INSTITUTIONAL REVIEW BOARD
Questions about the IRB and CUSM policies and procedures regarding human subjects
in research can be directed to
IRB@cusm.edu
(909) 580-9661
