The Huron IRB system is now live.
For details on navigating the IRB process at Ohio State, visit our transition page for the latest information.
The National Cancer Institutional (NCI) Central Institutional Review Board (CIRB) provides IRB review for select NCI-sponsored clinical trials conducted at Ohio State.
Submission Instructions
Initial Review Submissions
Office of Responsible Research Practices (ORRP) staff screen studies requesting NCI CIRB review to determine that the research is appropriate for submission to NCI CIRB and to confirm that the necessary NCI and institutional requirements (e.g., approved NCI Annual Principal Investigator Worksheet about Local Context form, CITI training, and COI disclosures) have been completed. Ohio State investigators must submit the following materials for initial review using Huron IRB system:
- External IRB application using the Huron IRB system (choose “National Cancer Institute Central IRB (CIRB)” for Review Board), including the following as applicable:
- Research protocol and External IRB Site Supplement
- If the study PI does not have an approved Annual Principal Investigator Worksheet About Local Context on file with NCI CIRB, the following information should be provided using the “Add Comment” feature in the Huron IRB system:
- number of co-investigators supporting the investigator’s research
- number of research nurses/coordinators supporting the investigator’s research
- number of actively accruing research studies for which the investigator is serving as PI
- number of research participants currently receiving treatment on therapeutic studies where the investigator is acting as PI
- known conflicts of interest for which the investigator or the research staff has a conflict management plan (CMP) related to any NCI CIRB studies
- Proposed consent form (model downloaded from the Cancer Trials Support Unit (CTSU) with applicable radiation risk language and approved boilerplate language added)
- HIPAA research authorization form
- Clinical Scientific Review Committee (CSRC) approval/acknowledgment letter
- Institutional Biosafety Committee (IBC) approval letter, if applicable
- Data collection form(s) used to record Protected Health Information under any requested waivers of HIPAA research authorization, and the applicable HRP-510 protocol appendix.
- Human Subject Radiation Committee (HSRC) approval (research radiation exposure studies), HRP-510 Appendix O – Radiation, radiation dose calculations, and risk language for consent form
Notes
Following screening, ORRP staff will provide Ohio State authorization to submit to NCI CIRB. Once authorization is received, the study team can submit the Study-Specific Worksheet about Local Context form to CIRB for approval via NCI’s IRB Manager. The NCI CIRB approval letter will be sent directly to the PI/research staff by NCI CIRB.
Institutional Review Process for New NCI CIRB Studies
- Study team receives sponsor documents
- Study team prepares submission for CSRC review and inserts boilerplate language
- Study team submits using the Huron IRB system
- ORRP reviews COI/CITI, annual PI worksheet and/or Privacy board review if applicable
- ORRP grants authorization to cede
- Study team completes study-specific worksheet
- NCI CIRB approves study-specific worksheet
- Study team opens study at Ohio State
Submissions after Initial Approval
After initial approval, investigators should submit subsequent study requests and documents:
Ohio State Review Only
- add/remove co-investigators or key personnel
- add/remove Ohio-State research locations
- waiver of HIPAA authorization requests/changes
Ohio State Review First, then CIRB
- change of principal investigator
- changes to radiation information
- revisions to the Ohio State institutional consent language
CIRB Review Only
- all other amendment requests
- adverse event reports, protocol deviations, & unanticipated problems
- continuing reviews
- study closure notifications
Notes
Requests requiring Ohio State review are submitted in the Huron IRB system, while requests requiring NCI CIRB review are submitted via the NCI’s IRB Manager. Submissions requiring both Ohio State and NCI CIRB review may not be submitted to the latter until ORRP staff have authorized the amendment to proceed.
NCI CIRB will provide documentation of amendment and continuing review approval through website postings. Continuing review approval dates can also be found at CTSU.
Approved Consent Boilerplate Language
Study-specific model informed consent documents should be downloaded from CTSU and the NCI CIRB-approved boilerplate language added to the specified sections. The language must be copied verbatim, and no other changes may be made to the consent form, with the exception of radiation risk language required by Ohio State’s HSRC (if applicable). Refer to the NCI CIRB Guidelines for Permitted Boilerplate Language Additions for more information.
Additional Instructions
- NCI CIRB does not permit HIPAA research authorization language to be embedded within the consent form. All NCI CIRB studies must use an Ohio State-approved stand-alone HIPAA research authorization form.
- When a sponsor sends a revised model consent form, always insert the most recently approved boilerplate language.
- If Ohio State's NCI CIRB-approved boilerplate language is revised, ORRP staff will notify all groups managing NCI CIRB studies and will indicate whether re-consent is necessary. Typically, revisions to boilerplate language should be implemented concurrently with the next sponsor amendment.
- Changes to study team contact information in the consent form (phone number, PI name) do not require review by either ORRP or NCI CIRB.
- For whom to contact with questions about participant rights, study teams should insert ORRP’s contact information (1-800-678-6251) in the blanks provided; no other changes to the text may be made.