National Cancer Institute (NCI) Central IRB (CIRB)
National Cancer Institute (NCI) Central IRB (CIRB) Heading link
UIC is a participating site in the National Cancer Institute (NCI) Central IRB (CIRB). NCI CIRB is the IRB of Record responsible for review of the study as well as review of local context issues for participating sites. Local policy, conflict of interest, HIPAA authorization, and ancillary committee approvals are still the responsibility of the relying IRB (UIC).
Through an MOU with Rush Medical Center and Cook County Health (Stroger), UIC OPRS will serve as the signatory institution and local coordinating center for UIC, Rush, and Cook County Health for NCI (CIRB) studies.
For research reviewed by NCI, the Cancer Center Protocol Review Committee (CC-PRC) typically provides review of scientific merit, resources and financial aspects of the study.
Local Principal Investigators are responsible for the following:
- Complete and submit the Annual Investigator Worksheet About Local Context and any other worksheets/forms required by the NCI CIRB for participation.
- Complete and submit the Study-Specific Worksheet About Local Context to open a study.
- Provide updates in a timely manner to the NCI CIRB whenever a Signatory Institution Principal Investigator is replaced. The CIRB requires submission and approval of the Annual Principal Investigator Worksheet About Local Context prior to finalizing the replacement Principal Investigator.
- Incorporating UIC/Rush/Cook County Health -approved boilerplate language into the NCI CIRB-approved model consent form. No changes may be made to either the CIRB-approved or local boilerplate language without prior approval by the NCI CIRB.
- Revising, monitoring and tracking all consents, assents and short forms as necessary to be in compliance with current CIRB approved protocol.
Submission Procedures: General Heading link
-
Submission Procedures: General
The following are standard requirements for UIC regardless of the type of submission:
- HIPAA Authorization
- Per the NCI CIRB, “Compliance with HIPAA regulations are considered an institutional requirement and remains the purview of the local institution”; therefore, UIC, Rush and Cook County Health utilize a stand-alone HIPAA authorization for research for CIRB studies. The CIRB does not approve the HIPAA Authorization language as it does not function as a Privacy Board.
- Rush and Cook County Health utilize a stand-alone HIPAA authorization for research and therefore, UIC will not act as the Privacy Board for these institutions and is not responsible for verifying that they are adhering to their institutions HIPAA authorization language.
- Each institution is responsible for ensuring that local requirements are assessed (e.g., training requirements for their investigators and research personnel and institutional specific registrations or reviews).
- Random independent spot audits will be conducted throughout the year to assure that the correct consent documents are being used.
- All submissions must be made via OPRS Live.
- HIPAA Authorization
-
Initial Registration of NCI CIRB Approved Protocols with UIC OPRS
NCI CIRB studies must be registered with the UIC OPRS via OPRS Live. When creating a new Initial Registration for a CIRB study, select “National Cancer Institute Central IRB (NCI CIRB)” as the External Review Agency.
- The local investigator is responsible for providing the following materials with the Initial Registration:
- UIC Registration Application for NCI CIRB Research Study
- Current NCI CIRB Approval Letter, which references the NCI CIRB approval period
- NCI CIRB Study-specific Worksheet
- NCI CIRB Initial Application
- Current NCI CIRB approved protocol document
- Current NCI CIRB approved consent documents, assents and short forms with local template language incorporated
- Local HIPAA authorization(s)
- UIC Appendix A1: Use of Drugs or Biologic Products in Research (as applicable)
- UIC Appendix P: Co-Investigators/Other Key Research Personnel (as applicable)
- UIC Cancer Center Protocol Review Committee (CC-PRC) Approval or Exemption Letter
- Other applicable internal review approvals (e.g., Radiation Safety, IBC, etc.)
- The investigator will receive an Acknowledgement letter which references the NCI CIRB approval period.
- The local investigator is responsible for providing the following materials with the Initial Registration:
-
Amendments
- UIC investigators should only submit Amendments that affect Local Research Personnel and/or Local Context Changes to the UIC OPRS. OPRS does not monitor CIRB specific amendments as individual amendments. Any changes made to the consent/assent documents due to CIRB specific amendments should be submitted at the time of Continuing Review.
- The local investigator is responsible for submitting amendments for personnel or other local context changes to the approved protocol by providing the following documents, as applicable:
- External IRB Form – Local Amendment to Previously Approved Research application
- Revised Appendix P
- Appendix Z (to add or remove funding)
- Appendix A1 (required if the Amendment involves changes to the Drugs or Biologics used for research purposes; this must be indicated in the OPRS Live CIRB Amendment Questionnaire to ensure review by the UIC Investigational Drug Service)
- Other UIC Appendices, as applicable
- The investigator will receive an Acknowledgement letter referencing the proposed local context changes.
-
Continuing Review
- The Continuing Review is submitted to the UIC OPRS after the project has been reviewed by the NCI CIRB. The local investigator is to submit the following:
- External IRB Continuing Review form
- Current NCI CIRB Approval letter, which references the NCI CIRB approval period
- Current NCI CIRB Continuing Review Application
- Current NCI CIRB approved protocol document
- Current NCI CIRB approved consent document, assents and short forms with local template language incorporated
- HIPAA authorization(s), as applicable.
- Appendix P with current personnel (Personnel can be removed; however, an amendment is required to add personnel.)
- The investigator will receive an Acknowledgement letter which references the NCI CIRB approval period.
- The Continuing Review is submitted to the UIC OPRS after the project has been reviewed by the NCI CIRB. The local investigator is to submit the following:
-
Unanticipated Problems or Other Events Requiring Prompt Reporting
- Events that require reporting and that involves the UIC study site (including Rush or Cook County Health) must be promptly reported to the NCI CIRB by the institutional investigator following the guidelines provided by the NCI CIRB.
- Investigators are also required to submit an External IRB Prompt Reporting to OPRS to UIC OPRS of the events as per the NCI CIRB requirements for reporting events to the local institution.
- The investigator will receive an Acknowledgement letter referencing the prompt report.
-
Study Closure
- Once enrollment and all study procedures have been completed, the local investigator is required to submit the following documents to the UIC OPRS:
- External IRB Closure at UIC form
- NCI CIRB Study Closure letter
- The investigator will receive an Acknowledgement letter indicating the closure of the research.
- Once enrollment and all study procedures have been completed, the local investigator is required to submit the following documents to the UIC OPRS: