Please review all the steps, as well as the Special Guidance topics, before you begin planning your research. The federal regulations, university policies, and our IRB procedures do change from time to time, so this guide can be used each time you submit a new application or enter into a new phase of your research.
This Investigators’ Guide is divided into four steps:
Step One: Things to Do and Know Before you Prepare your IRB Application
Does my Project Require IRB Review?
The Types of IRB Review and the Review Categories
The CITI Training requirement
Step Two: How to Prepare and Submit your Application for IRB Review
A Line-by-Line Guide to the IRB Application form
Supporting Materials: Recruitment, Informed Consent, Study Instruments, Debriefing
How, Where, and When to Submit your Application
Step Three: The Review and Approval Processes
Possible Outcomes of Exempt, Expedited, or Full Board Reviews
Step Four: Your Ongoing Responsibilities After Your Protocol Has Been Approved
Revising/Amending an Approved Protocol
Continuing Review (“Renewing an approval”)
Closing Projects
For additional guidance, please contact the IRB Administrator, Carole Moran Krus, 216-397-1527, ckrus@jcu.edu