The IRB process is complex and often confusing. Even experienced investigators can struggle with their IRB applications. This step-by-step guide is here to help investigators through the different phases of the IRB review process. 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:
Does my Project Require IRB Review?
The Types of IRB Review and the Review Categories
The CITI Training requirement
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
Possible Outcomes of Exempt, Expedited, or Full Board Reviews
Revising your Application
Revising/Amending an Approved Protocol
Continuing Review (“Renewing an approval”)
For additional guidance, please contact the IRB Administrator, Carole Moran Krus, 216-397-1527, firstname.lastname@example.org