National Cancer Institute Central Institutional Review Board (NCI CIRB)

National Cancer Institute eligible studies are sent to the NCI CIRB for IRB review.  

What is NCI CIRB?

NCI CIRB is the central institutional review board for the National Cancer Institute.  For more information, visit their website here: National Cancer Institute - Central IRB Website

What does NCI CIRB Review?

NCI CIRB is the IRB of record for many NCI-funded cooperative group studies. The NCI CIRB may review the following type of studies; please see the NCI CIRB Participant's Area for more detailed information on eligible studies.

  • Adult CIRB - Late Phase Emphasis - reviews NCI-sponsored adult phase 3 and large phase 2 studies
  • Adult CIRB - Early Phase Emphasis - reviews NCI-sponsored adult phase 0, 1, and 2 studies
  • Pediatric CIRB - reviews NCI-sponsored pediatric studies of all phases

What is the role of Emory IRB for NCI CIRB studies?

The Emory IRB, as with other external (XIRB) studies, verifies that local Emory study requirements are met, such as the below. We also still serve as the Privacy Board, thus grant partial HIPAA waivers.

  • Clinical Trial Readiness Checklist sign-off
  • Clinical Research Key Points Summary
  • Emory- or Georgia-specific consent language (e.g., costs to participants, injury coverage...)
  • HIPAA waivers and review of HIPAA authorization language
  • Education and Certification of investigators
  • Any other local requirements

Getting Started

If you have never used NCI CIRB before, you need access to their "Participant's Area."

Steps to Register with NCI CIRB

Step 1: Obtain access to NCI CIRB Participants Area

  • Complete the webform below to obtain an account to NCI CIRB’s IRBManager.
  • This information will be submitted to NCI CIRB by the Emory IRB.
  • Once NCI CIRB processes the request, a separate email with login information will be sent to the new personnel’s email address.

Step 2: Registering a PI for access to NCI CIRB studies

  • Complete the “Annual Principal Investigator Worksheet About Local Context” form via IRBManager.
  • While the form can be filled out by coordinators, the PI will need to submit the final form.
  • Once the CIRB has accepted the PI’s worksheet, contact the Emory IRB at wirb-l@listserv.cc.emory.edu to request that the PI role be given to the investigator in the CIRB database.

Submitting the form below will contact one of the Analyst Assistants on the IRB staff webpage who then requests your access to the NCI CIRB Participant's Area. The NCI requires the following information to gain access:

Personnel Name:*
Personnel Degree:*
Personnel Email:*
CTEP Person ID:*
Personnel Telephone*
Role*  PI Research Staff
Requester email:*

Note: This information will be submitted to NCI CIRB by the Emory IRB. Once NCI CIRB processes the request, a separate email with login information will be sent to the new personnel's email address.

Upon submission you will see a confirmation page,
if not, the IRB did not receive the request.

Accessing Participants Area

NCI will inform you whether CIRB will be the IRB of record for a given study. Studies and related materials approved by NCI CIRB are made available to participants on the NCI CIRB website.

To get started with the Emory IRB portion: 

  • Create a new study submission.  Use this template to provide only required information.   
  • NOte: If the study is under REMS, ask team to contact Margaret Huber and to fill REMS worksheet

 Beginning the NCI CIRB approval process

  • Studies are opened by a "Signatory Institution Principal Investigator" by submitting the Study-Specific Worksheet to the CIRB for review via IRBManager. 
  • Note, the "Study-Specific Worksheet" must include any deviations from Emory/NCI CIRB’s Boilerplate Language (i.e. "in case of injury" language, COI language... See our consent FAQ below). 
  • CIRB may email you to ask at which Emory/affiliated sites the study will open. Study team shall reply to CIRB with the correct site codes.

Processing the NCI CIRB approval

  • NCI CIRB emails PI/study team contact an approval letter, which includes additional instructions
  • The study team merges the CIRB-approved model consent with any applicable Emory boilerplate language (very limiited; most Emory language will be in the site-specific addendum).
  • Study team should add the following to the study submission:
    • NCI IRB approved consent
    • Site-Specific Consent-HIPAA Addendum (completed)
    • NCI CIRB approval letter for Emory site
    • NCI CIRB expiration date (via overall study approval letter)
  • Study team uploads the merged consent form, and the NCI CIRB approval letter for their eIRB submission, and the overall study approval letter (to show the CIRB expiration date) .

Processing Emory’s local acknowledgment 

Emory IRB will verify:

  • all study personnel have the required training (CITI, GCP, Key Concepts/Intro to Clinical Research)
  • all ancillary reviews have been completed (CTRC, Radiation Safety, COI, REMS review, etc.,)
  • the language in the consents is accurate (costs, injury coverage, etc.)
  • the study meets the criteria for a partial HIPAA waiver, if needed

Once the requirements have been verified, Emory will issue an acknowledgment letter and change the Status of the study to "Active" in eIRB.

 

Consent and HIPAA authorizations

NCI CIRB now has new consent form policy guidelines which can be accessed here and here.  The ability to modify the NCI CIRB master consent is severely limited.

Please note: 

  • CIRB now requires a stand-alone HIPAA authorization document separate from the consent form.  
  • CIRB no longer permits anything to be added/changed in the main consent form, other than injury coverage language. 
  • You must therefore also use our Site-Specific Consent-HIPAA Addendum
    • Use Emory's latest consent section table when modifying the main consent, and creating the Emory addendum.
  • You may also use our Withdrawal-Revocation Letter Template, at any time. It does not require IRB review or stamping.
  • CIRB does not review Assent forms. Use our usual Assent template for your CIRB studies, and submit with the above (see Consent Toolkit section of our website).
  • Do not submit these additional Emory-specific forms to NCI CIRB. Just upload in your local eIRB submission
  • Emory IRB will stamp the additional Emory-specific documents at initial review, but not re-stamp unless they change (e.g. due to change in PI).

After NCI CIRB Approval: upload the NCI-CIRB-approved consent form to your submission and other Emory offices (such as OCR) ALONG WITH the NCI CIRB approval letter with the consent form's version date, so that Emory offices can cross-check the two. 

Emory will NOT stamp your NCI-CIRB-approved consent form under the new model, so you do NOT need to use Emory's document stamping template for that.*  We will stamp the Site Information and HIPAA Authorization form described further below. We will also restamp older combination forms at amendment and renewal.

*For VA studies, the consent forms will continue to be stamped with Emory's date of acknowledgement.  For VA studies only, you should continue to put the main NCI CIRB consent forms on the document stamping template.

 

PI Changes

  • NCI CIRB has changed the process for requesting a change of PI.  A new separate Worksheet, the "3_5 - Change of PI Worksheet," allows multiple studies to be changed to a new PI as part of a single submission. Less administrative burden!
  • You will need to submit a separate revised Annual Principal Investigator Worksheet or revised Study-Specific worksheet for any affected study that has a change in the local context considerations. 
  • A revised Changing the PI on a Study Quickguide has also been posted to the NCI CIRB website to assist users in completing the new Change of PI worksheet.
  • If you have any questions regarding the use of a new Change of PI worksheet, please contact the CIRB Helpdesk or 1-888-657-3711.
  • Also, submit a modification in Emory's eIRB system to update the PI

Reportable New Information

Once my study is enrolling, to whom do I report unanticipated problems involving risk to participants or others, serious adverse events, and/or noncompliance? 

Please report all of the above to CIRB directly. You can find the requirements under the CIRB's "CIRB Standard Operating Procedures" (under CIRB STANDARD OPERATING PROCEDURES entitled UNANTICIPATED PROBLEMS AND SERIOUS OR CONTINUING NONCOMPLIANCE).

We recommend following the Emory IRB reporting guidelines if unsure, which are at least as strict and offer more detail.

Check with your CIRB contact or at the CIRB helpdesk for more information about reporting mechanisms.

Serious Compliance Events - Report to Emory as well!

The following events should be reported immediately to Emory IRB as well via email to Maria Davila and Shara Karlebach (IRB staff webpage) : 

  • Wrong drug
  • Wrong dose
  • Wrong side surgery
  • Potential HIPAA breach.

Questions?

For questions about the NCI CIRB and the Emory IRB, please first contact one of the analyst assistants listed on the IRB staff webpage.  If they are unavailable or unable to answer your question, you may contact Maria Davila at maria.davila@emory.edu or Rebecca Rousselle at rebecca.rousselle@emory.edu.

Modifications

NCI CIRB will notify the study team of any modifications to the overall study.

Modifications that require submission to NCI CIRB and Emory IRB

  • Changes to PI
  • Changes to consent forms IF using the older consent-HIPAA combined forms

Modifications that require review by Emory IRB only :

  • Changes to any study personnel (via study staff change request tool; will require a modification)
  • Changes to our local consent/ addendum

Modifications that do not require any notice to Emory IRB:

  • All other modifications

Submissions in eIRB

Depending on the state of your approved study, do the following:

Continuing Reviews

Step 1: Submit renewal documents to the appropriate cooperative group when requested

Step 2: Once approved by CIRB, upload the approval letter in the submission, so expiration dates can be updated in eIRB

  • NOTE: Emory IRB will not restamp any consent documents, except older consent-HIPAA combination forms.