When relying on an external or centralized IRB of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of record. In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail. However the Principal Investigator will also be required to continue to follow all University of Iowa institutional policies as well as state and local laws governing human subjects research. The HawkIRB application is designed to capture the majority of the information necessary to identify the Human Research Protection Program review requirements and various institutional policies.
If you are interested in pursuing human subjects research utilizing an External IRB model, please review the "Final SOP for General External IRB" for specific information on the process and contact the Human Subjects Office at email@example.com . We will help you determine which model may work best for your proposal (Lead IRB of record, relying IRB, commercial IRB models, etc.)
The NCI CIRB is an institutional review board (IRB) that reviews federally funded oncology research under the purview of the National Cancer Institute (NCI.) Only approved clinical trials listed on the Clinical Trials Support Unit (CTSU) website can be submitted to the NCI CIRB for review. The UI Human Subjects Office reserves the right to retain any project that would have research components requiring institutional IRB review.
All NCI CIRB researchers should review the following process guidelines outlined in the UI/HSO NCI CIRB Standard Operating Procedures.
- Only new project submissions not previously reviewed by IRB-01 as of July 2016 can be submitted to the NCI CIRB. All federally funded oncology projects with current University of Iowa IRB approval will remain under IRB-01 review until the conclusion of the study.
- Register at ctsu.org. Once you complete the CTSU registration you will be sent a confirmation email with a CTEP ID. Forward this email to Marian Andersen to update the NCI Roster. After confirmation that you have been added to the NCI Roster, you will need to notify the UI External IRB Coordinator.
- Once you are registered, you can log into ctsu.org to see if the trial is listed on the menu of CIRB-approved trials. Only the trials listed on ctsu.org can be reviewed by the NCI-CIRB.
- All principal investigators are required to complete an Annual PI Worksheet. This document must be reviewed and approved by the HSO before submitting it to NCI CIRB. PIs should complete the worksheet and upload it to his/her profile in HawkIRB. Refer to the UI Instructions for assistance in completing this document.
- If your trial is listed on the site, you can start your application in HawkIRB. All Human Research Protection Committee approvals must be in place prior to submission to NCI CIRB.
- Follow the submission steps outlined in the UI NCI CIRB SOP to ensure all required attachments are uploaded with the application.
- After the HSO has reviewed your application and determined all UI requirements are met, an approval memo will be sent to the PI and contact person. You may now submit your project to the NCI-CIRB (IRB Manager) for review.
- PIs must submit his/her Annual PI Worksheet to the NCI CIRB for approval. If this step has not already been completed, see Step 4 under HSO Submission Process above.
- For new projects the PI must submit the Study-Specific Worksheet to the NCI CIRB to obtain approval to conduct the study at the University of Iowa. Note: Do not submit a Study Specific Worksheet before receiving approval in HawkIRB.
- The Study-Specific Worksheet and materials will be reviewed by the NCI-CIRB per its standard operating procedures.
- Once the NCI-CIRB has approved the study, the UI PI and study team will be responsible for monitoring the NCI-CIRB website for amendments and other IRB actions. Any reportable events must be reported to the NCI CIRB following the NCI CIRB instructional manual for Worksheet Completion in IRBManager. The study team must comply with all other NCI CIRB requirements as described in the NCI CIRB Standard Operating Procedures document and/or the Handbook for Local Institutions.
- Modifications of an NCI-CIRB approved project can be managed in the HawkIRB system by initiating a Mod Form and answering all applicable committee questions. All applicable committee reviews are the responsibility of the PI.
- Continuing reviews to NCI projects can be initiated by either the PI or HSO in HawkIRB.
Contact NCI-CIRB with any questions regarding NCI-CIRB procedures or forms.
Mail: C/O EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, MD 20850
Contact the University of Iowa's External IRB Coordinator in the Human Subjects Office with questions regarding the HawkIRB application process or UI requirements.
Mail: 105 HLHS, Human Subjects Office
600 Newton Rd, University of Iowa, Iowa City, IA 52242