What does NCI CIRB Review?
The NCI CIRB may review the following type of studies, please see the NCI CIRB Participant's Area for more detailed information on eligible studies.
- Adult CIRB - Late Phase Emphasis - reviews NCI-sponsored adult phase 3 and large phase 2 studies
- Adult CIRB - Early Phase Emphasis - reviews NCI-sponsored adult phase 0, 1, and 2 studies
- Pediatric CIRB - reviews NCI-sponsored pediatric studies of all phases
What is the Role of the Emory IRB for NCI CIRB studies?
The Emory IRB facilitates meeting local Emory study requirements, such as:
- Clinical Trial Readiness Checklist
- Key Points Summary
- Required institutional consent language (e.g., Cost and Injury)
- HIPAA Review
- Education and Certification
- Any other local requirements
How to Get Started?
If you already have access to the Participant's Area and would like to start a study with the NCI CIRB:
Please review the General Guidance for NCI CIRB studies.
Study teams should contact Ashton Hughes, or Ameenah Lashleyto request access to the abbreviated eIRB Smartform template. Please include the PI's name, study title, coordinator, and if the study involves pediatric subjects.
Once you receive access to the abbreviated template, you will only be required to complete certain designated sections that pertain to CIRB studies. Once the requested sections are complete, please submit as per usual to trigger any necessary ancillary approvals.
To see which sections of the eIRB smartform need to be completed, please see this document.
Reporting events to CIRB
Once my study is enrolling, to whom do I report unanticipated problems involving risk to participants or others, serious adverse events, and/or noncompliance?
Please report all of the above to CIRB. You can find the requirements under the CIRB’s "CIRB Standard Operating Procedures" (under “CIRB STANDARD OPERATING PROCEDURES – UNANTICIPATED PROBLEMS AND SERIOUS OR CONTINUING NONCOMPLIANCE”). We recommend following the Emory IRB reporting guidelines if unsure, which are at least as strict and offer more detail. Check with your CIRB contact or at the CIRB helpdesk for more information about reporting mechanisms.
For questions about the NCI CIRB and the Emory IRB, please contact Rebecca Rousselle at email@example.com.
For questions after your study is submitted to CIRB, refer to CIRB contact page.