ÌìÃÀÓ°ÊÓ´«Ã½

Research sponsored by National Cancer Institute (NCI) are eligible for review by the NCI CIRB. When planning to initiate a NCI sponsored cooperative group trial, consult  the  to see if the trial is listed on the menu of CIRB approved trials.  

Studies which involve any of the following are not eligible for submission to NCI CIRB:

1. Research involving prisoners
2. Planned emergency research
3. Single patient emergency use or compassionate use situations
4. Investigator-initiated research

USA may also require dual review by the USA IRB when the institution deems that the rights and welfare of subjects would be better served by local review.

Before you can submit to NCI CIRB, you must have access to the CIRB IRBManager. In order to gain access to IRBManager, you must first have a CTSU person ID, an active CTEP-IAM account, and listed on the CIRB roster for your site.

• To obtain or update IAM credentials, including the user name and password necessary to log into the CTSU website, visit the IAM registration page: 
• Once you receive an email with your CTSU log-on, you can be added to the CIRB Roster via the RUMS Roster. Contact your site RUMS administrator to update the roster.

Submitting to NCI CIRB

Steps	Create a New Project in IRBNet
Step 1: Investigator begins LOCAL processes for submission to USA IRB	Package 1: Upload the following items: USA IRB Part A Application IRB External Review Request Form (located in IRBNet) Sponsor Protocol   ICF with required USA Boilerplate language for NCI CIRB included PI must electronically sign package 1 for USA IRB local review All key personnel listed on Part A IRB application must have completed the required applicable human subjects training, ACRP (as applicable), and HIPPA for Research. Submit Package 1 for USA IRB administrative review and acknowledgment. Acknowledgment letter will be published in Package 1 NOTE:  Fees  IRB fees should be included in the study budget.  There is a one-time USA administrative review fee of $2000 for initial submissions. The contract agreement will include this fee to be paid to USA by the sponsor.
Step 2: Submission to NCI CIRB	Once the study team has received USA IRB acknowledgment in IRBNet confirming that IRB review can be ceded to the NCI CIRB, the USA principal investigator or designee must submit a Study-Specific Worksheet to the NCI CIRB to obtain approval to conduct the study at the ÌìÃÀÓ°ÊÓ´«Ã½.  NOTE:   Do not submit a Study-Specific Worksheet prior to receiving USA IRB acknowledgment that a study can be ceded to the NCI CIRB. Principal Investigator or designee completes the Study-Specific Worksheet which serves as the institution’s request to open a study overseen by NCI CIRB.  The Study-Specific Worksheet is completed and submitted online in the NCI CIRB's IRBManager system following the NCI CIRB Instruction Manual for Worksheet Completion in IRBManager (on the ). Questions about this process should be directed to the NCI CIRB Helpdesk. NOTE:  If someone other than the Principal Investigator submits the Study-Specific Worksheet, IRBManager will automatically generate an email to the Investigator requesting review, confirm intent to comply, and submission of the Worksheet in IRBManager.  The Investigator must click the SUBMIT button on the final page or the form will not be submitted. Once the NCI CIRB has approved the study for conduct at USA, the NCI CIRB is the IRB of record for the study and is responsible for local site issues as well as study-wide oversight.
Step 3: Review by NCI CIRB	What happens after you submit to the NCI CIRB? NCI CIRB will issue an approval letter through their IRBManager portal. NCI CIRB will contact the investigator/contact person directly with questions about the submission, and with determination of approval, modifications, or disapproval. Any questions that the PI/contact person may have regarding the NCI CIRB review process should be directed to NCI CIRB. Consent Documents: For NCI CIRB approved projects, the NCI CIRB document submitted to USA IRB in step 1 should be used for enrolling subjects.  The USA IRB is not the IRB of record for the protocol, and will not be USA stamped. NOTE:  Commencement of project should not begin until all approvals and the clinical trial agreement are in place.

The NCI CIRB is now the IRB of records for your study. You should refer to for their reporting requirements of continuing review, amendments, adverse events, protocol deviations, closure notifications, and any other submissions.

However, the USA IRB must still ensure adequate institutional oversight of research activities. Therefore, in addition to notifying NCI CIRB, investigators should notify the USA IRB of any of the following events:

• Change in PI or key personnel (NOTE: IRB Application Part A must be updated to reflect personnel changes)
• Change of study title
• Updated local recruitment/advertising materials
• Participant complaints
• Conflict of Interest (COI) updates
• Breaches of confidentiality/HIPAA Privacy or Security violations
• Protocol deviations that may represent a systematic problem requiring local evaluation by USA IRB to determine that sufficient local resources are available for safe conduct of the study
• Study holds or suspensions from NCI CIRB or Sponsor that are not built into the study design (eg: interim analysis or enrollment complete need not be reported
• Study Terminations from NCI CIRB or sponsor
• Any death of a participant outside of death as a result of natural disease progression
• Study Closure
• Completion of annual check-in form (more information below)

 

Annual Check-In: This is not the same as a continuing review. Therefore, it may occur at a different time than the continuing review required by NCI CIRB.

Project Personnel Updates:   USA IRB application Part A should be updated, as needed, (i.e., study personnel, PI change and submitted to USA IRB)

Monitoring of NCI CIRB Approval Protocols: NCI CIRB will arrange for monitoring ongoing research, as its policies and procedures require.  The USA IRB/ Office of Research Compliance and Assurance may monitor any CIRB approved protocol as part of its quality assurance program.

Record Keeping: Record keeping procedures for all files must be established, and CIRB documents, e-mail notifications, and other correspondence must be stored / filed as previously maintained through normal USA IRB approval.

The USA IRB local context consent language for NCI CIRB provides an outline of sections which may need to be included in your consent form.  All sections may not be applicable, rather they are dependent on the study to be conducted. 

Review the USA IRB Local Context Language for NCI CIRB to determine what specific USA language is required to be in the consent form. Generally, the HIPAA, Research Related Injury, Bill of Rights, ClinicalTrials.gov reporting, Reportable Income, and Source of Funding is required for the majority of studies.

NOTE: The NCI IRB does not permit HIPAA and GINA language to be a part of the consent document. Rather, these must be separate forms.

For questions concerning submission or reporting requirements of the USA IRB:

IRB Administrator
Office of Research Compliance and Assurance
irb@southalabama.edu
(251) 460-6308

 

For questions or concerns regarding submission or reporting requirements of the NCI CIRB: 

NCI CIRB Helpdesk
Telephone: 888-657-3711
Email:  ncicirbcontact@emmes.com

USA IRB SOP 1102: NCI CIRB