Office of Responsible Research Practices
The Ohio State University

NCI Central IRB

The National Cancer Institutional (NCI) Central Institutional Review Board (CIRB) provides IRB review for select NCI-sponsored clinical trials conducted at Ohio State.  Eligible studies (determined by NCI) are listed on the NCI CIRB website.

Submission Instructions

Initial Review

Office of Responsible Research Practices (ORRP) staff will screen studies requesting NCI CIRB review to determine that the research is appropriate for submission to 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, COI disclosure) have been completed.  Ohio State investigators and/or their designees must submit the following materials for initial review using the Buck-IRB online system:

  • Buck-IRB application (choose “National Cancer Institute Central IRB (CIRB)” for Review Board), including the following as applicable
    • Requests of partial waviers of HIPAA research authorization for recruitment purposes
    • Information for review of radiologic procedures and treatments, such as non-clinical care X-rays, DEXA scans, CT scans, radiopharmaceuticals, and nuclear medicine procedures used for research purposes. (Note: Approval by the Ohio State Human Subject Radiation Committee (HSRC) is required prior to submission to CIRB. ORRP staff will facilitate HSRC review/approval on behalf of investigators.)
    • 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 included in the “Other comments” section of the Buck-IRB application:
      • # of co-investigators supporting the investigator’s research
      • # of research nurses/coordinators supporting the investigator’s research
      • # of actively accruing research studies for which the investigator is serving as PI
      • # of subjects currently receiving treatment on therapeutic studies where the investigator is acting as PI
      • Known conflicts of interest for which the investigator has a conflict management plan (CMP)
  • Proposed consent form (model downloaded from the Clinical Trials Support Unit (CTSU) with applicable radiation risk language and approved boilerplate language added – see below)
  • HIPAA research authorization form
  • Clinical Scientific Review Committee (CSRC) approval/acknowledgement letter
  • Institutional Biosafety Committee (IBC) approval letter, if applicable
  • Data collection form used to record Protected Health Information under the partial waiver of HIPAA research authorization, if applicable
  • Radiation dose calculations and risk language for consent form, if applicable

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.

Click here for a flowchart of the Ohio State institutional review process for new NCI CIRB studies.

Submissions after Initial Approval

After initial approval, investigators should submit subsequent study requests and documents according the chart below:

Ohio State review only Ohio State review first, then CIRB CIRB review only
  • add/remove co-investigators or key personnel
  • add/remove Ohio-State research locations
  • partial waiver of HIPAA authorization requests/changes
  • change of principal investigator
  • changes to radiation information
  • all other amendment requests
  • adverse event reports, protocol deviations, & unanticipated problems
  • continuing reviews
  • study closure notifications

Requests requiring Ohio State review are submitted in Buck-IRB, 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 on the CTSU website.

Study-specific model informed consent documents should be downloaded from the CTSU website and the 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 no longer permits HIPAA research authorization language to be embedded within the consent form. All CIRB studies must use a 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 CIRB-approved boilerplate language is revised, ORRP staff will notify all groups managing 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 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.

Additional Resources

Questions or Assistance