NCI Central IRB
The National Cancer Institutional (NCI) Central Institutional Review Board (CIRB) provides IRB review for select NCI-sponsored clinical trials conducted at The Ohio State University. Eligible studies (determined by NCI) are listed on the NCI CIRB website.
Studies submitted for NCI CIRB review will be screened by Office of Responsible Research Practices (ORRP) staff 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:
- Research protocol
- Proposed consent form (model downloaded from the CIRB website with approved template language added – see below)
- HIPAA research authorization form (Note: Partial waivers of authorization for recruitment purposes, if applicable, are requested in the Buck-IRB system.)
- Radiation Pre-Submission Worksheet, as applicable (for review of radiologic procedures, e.g., non-clinical care X-rays, DEXA scans, CT scans, or nuclear medicine procedures used for research purposes. Note: Approval by the Ohio State Human Subject Radiation Committee is required prior to submission to CIRB.)
Following screening, Ohio State authorization to submit to NCI CIRB will be sent to investigators by ORRP staff. Once authorization is received, the Study-Specific Worksheet about Local Context form can be submitted to CIRB for approval via NCI’s IRB Manager. The NCI CIRB approval letter will be sent directly to the PI/research staff by CIRB.
Submissions after Initial Approval
After initial approval, investigators should submit all subsequent study requests and documents directly to NCI CIRB, following CIRB guidelines. These may include the following:
- Amendments (excluding personnel changes – see below)
- Adverse event reports, protocol violations, and/or unanticipated problems involving risks to subjects or others that occur in Ohio State research
- Continuing reviews
- Closure notifications
Note: Changes in PI, co-investigators, or key personnel must be entered into the Buck-IRB system. Changes in personnel are not submitted to NCI CIRB, with the exception of PI changes, which must receive Ohio State authorization before the change is submitted to CIRB. An approved Annual Principal Investigator Worksheet about Local Context form must be on file at CIRB for all principal investigators before CIRB submission, or the form completed using NCI’s IRB Manager.
NCI CIRB will provide documentation of amendment and continuing review approval through website postings. Continuing review approval dates can also be found on the NCI CIRB website.
Approved Consent Template Language
Study-specific model informed consent documents should be downloaded from the NCI CIRB website and the template language below added to the specified sections. Note: The template language should also be added to the appropriate sections of new or revised consent documents downloaded after amendment or continuing review approvals.
- Costs section: “You will be responsible for any co-pays, co-insurance, and/or deductibles as required by your insurance company.”
- Confidentiality section: “If this study is related to your medical care, your study-related information may be placed in your permanent hospital, clinic, or physician’s office records. Authorized Ohio State University staff not involved in the study may be aware that you are participating in a research study and have access to your information.”
- Injury section: “If you suffer an injury from participating in this study, you should notify the researcher or study doctor immediately, who will determine if you should obtain medical treatment at The Ohio State University Wexner Medical Center. The cost for this treatment will be billed to you or your medical or hospital insurance. The Ohio State University has no funds set aside for the payment of health care expenses for this study.”
- Contacts section: “For questions about your rights as a participant in this study or to discuss other study-related concerns or complaints with someone who is not part of the research team, you may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 1-800-678-6251.”
- PI name and contact information should also be added to the appropriate sections of the model form.
- Add to the signature line:
I have explained the research to the participant or his/her representative before requesting the signature(s) above. There are no blanks in this document. A copy of this form has been given to the participant or his/her representative.
|Printed name of person obtaining consent||Signature of person obtaining consent|
|Date and time||AM/PM|
Questions or Assistance
Quality Improvement Specialist
The Ohio State University
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210
Phone: 614-292-9832 | Fax: 614-688-0366 | Email: firstname.lastname@example.org