Institutional Review Board
The Institutional Review Board (IRB) is a committee that reviews protocols involving research with human beings. The IRB is essential for ensuring that humans participating in research as subjects are protected from physical, emotional and mental harm to the extent they agreed when entering a study.
IRB review is conducted by performing a risk-benefit analysis and applying HHS regulations at 45 CFR 46, which implement the National Research Act of 1974.
Please plan on at least a month between the time an application is submitted and the time an application is considered for review.
Various factors pertaining to a study can lead to decisions taking more than a month, so please consider this in your study planning. Forms to submit to the IRB are available on IRBNet.
The KCU Institutional Review Board may review protocols of external organizations, provided it has adequate expertise, subject to the following fee schedule:
Initial Review $1,500.00
- Protocol (with all amendments and subject hand-outs included in initial packet)
- Investigator Drug Brochure or Equivalent
- Consent Forms: Up to three; after three, $50 per consent form
- Recruitment Materials
- Annual Review $400
- Final Report at Closeout $100
- Revised IDB $100
- Protocol Deviations No Charge
- Protocol Violations No Charge
Modifications (Eligible for Expedited Review)
- Recruitment Materials $200 per review
- Consent Form $200 per sponsor request
- Protocol Amendment $200 per amendment
- Subject-provided Materials $200 per item
Modifications Requiring Full Board $200 Per Review
- Any modification that does not meet expedited review (i.e. does not change risk/benefit ratio)
The KCU Institutional Review Board reviews external studies in accordance with KCU’s policies, procedures, and standard operating procedures, unless negotiated otherwise.