Ceding Review to an Institutional Review Board Other than COMIRB
The External IRB team works within the Clinical Research Administration Office here at CU Anschutz Medical Campus. Our work involves managing all protocol documents and information related to human subject research protocols submitted to commercial IRBs (i.e. Western IRB, Advarra, NCI Cenral IRB, etc.) and non-commercial IRBs (i.e. Academic institutions). We are required to sign off on a number of items before you can submit your application to an external IRB.
All protocols using an external IRB must be submitted through the HSR portal by filling out the Protocol Assessment Form.
- Log into InfoEd and create a new protocol shell in the human subjects module with the study’s title, our faculty member listed as PI, primary contact and sub-investigators. This will generate a protocol number. You need this, even though you won’t be using COMIRB as your IRB.
- Using the COMIRB protocol number generated in InfoEd, submit your request through the HSR Portal. In the Protocol Assessment Form (PAF) there is a space to request reliance on an external IRB.
- We will then begin our internal reviews. If we don’t have a standing agreement with the IRB (like we do with WIRB and ADVARRA), we’ll also reach out to the external IRB and obtain permission.
For all submitted protocols, our external IRB team:
- reviews education and training requirements for study personnel;
- confirms that the University’s conflict of interest reporting requirements have been met;
- for commercial IRBs, verifies that consent language meets University standards (Consent Template)
- checks that all necessary documents have been received; and
- conducts other reviews as required by protocol type.
Join us at CTSA30: External IRB Oversight - UCD Requirements and Processes, where we discuss this process in depth.