Explore UAB

Colleges & Schools

Office of Research

NCI Central IRB

The ​National Cancer Institute Central IRB provides IRB review for select NCI-sponsored clinical trials conducted at UAB. Eligible studies (determined by NCI) are listed on the NCI CIRB​ website. 

Application Instructions

Initial Review

Studies submitted for NCI CIRB review will be initially reviewed and approved by National Cancer Institutional (NCI) Central Institutional Review Board (CIRB) to confirm that the necessary NCI and institutional requirements have been completed. UAB investigators and/or their research staff may access the Cancer Trials Support Unit (CTSU) website ctsu.org to obtain the NCI CIRB-approved documents.
 
UAB investigators and/or their research staff must submit the following materials, as applicable, for initial review in IRAP:
  • Institution Review Form Relying on an External IRB (Note: all research personnel listed on the Institutional Review Form Relying on an External IRB​ form are to be listed on the Responsible Personnel List (RPL) on file with OSP)
  • Protocol Oversight Review Form and/or Protocol Review Committee Approval
  • Proposed consent form(s) (model downloaded from the CIRB website with UAB approved template language added - see below)
  • Radiation Safety Approval
  • Infection Control Approval
  • Release of Drugs for Human Research Use
  • Release of Pathology
  • Form FDA 1572

Following review, investigators will receive authorization to submit to NCI IRB. Once authorization is received, the Study-Specific Worksheet About Local Context may be submitted to NCI CIRB to open the study. The NCI CIRB approval letter will be sent directly to the investigator/research staff by CIRB.

Submissions after Initial Approval
 
Continuing Reviews:The investigator/research staff must submit continuing review information for each study in IRAP. The continuing review submission must contain the following information:
  • NCI CIRB Approval Date
  • NCI CIRB Expiration Date
  • Number of consent forms renewed
  • NCI CIRB Approval Letter (attachment)
  • Current version of UAB consent form(s) for the protocol (attachment)
Changes in Study Personnel: Investigator/Research staff must provide any changes in study personnel by amendment in IRAP. All research personnel are to be listed on the Responsible Personnel List (RPL) on file with OSP.
 
Change in Funding: Changes in funding may include: new funding, continuing with new OSP numbers, funding ending, or additional funding received. The investigator/research staff must provide any changes in funding, along with the applicable OSP number(s), by amendment in IRAP.
 
Reportable Problems that Occur Locally: The investigator/research staff must submit the Problem Report for any reportable problems that occur locally to:
  • UAB IRB (see POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB, PRO106 UAB Procedure to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB); and
  • NCI CIRB.
Study Closure: The investigator/research staff must submit study closure information for each study by amendment in IRAP. The amendment submission must contain the following informatio
  • Study Closure date: Date of Closure
  • Reason for closure/termination

Approved Boilerplate Language 

Study-specific model informed consent documents should be downloaded from the NCI CIRB website and the NCI-approved boilerplate language added to the specified sections. Note: The boilerplate language should also be added to the appropriate sections of new or revised consent documents downloaded after amendment or continuing review approvals.