National Cancer Institute Central Institutional Review Board (NCI CIRB)

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

Please click on the frequently-asked questions below for information about NCI CIRB.


 

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 all NCI CIRB (National Cancer Institute) eligible studies. See http://www.irb.emory.edu/forms/external-irbs/cirb.html.  Please also see What umbrella agreements and MOUs are in place?.

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, facilitates meeting local Emory study requirements, such as:

  • Clinical Trial Readiness Checklist
  • Key Points Summary
  • Required institutional consent language (e.g., Cost and Injury)
  • HIPAA Review
  • Education and Certification
  • Any other local requirements

How do I get started?

Contact one of the Analyst Assistants on the IRB staff webpage to get 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.

NEW SECTION! What do I need to know about consent and HIPAA authorization documents?

NCI CIRB now has new consent form policy guidelines which can be accessed here and here.  Study teams will now be required to use NCI CIRB's template and plug only certain Emory-specific provisions into the appropriate places.

Use Emory's new guidance form to add the correct Emory-specific provisions to the CIRB template for your study.

Once the Emory consent form has been approved by the NCI CIRB, you will give the NCI CIRB approved consent form to your Emory IRB analyst assistant and other Emory offices (such as OCR) AS WELL AS 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 consent form, so you do NOT need to use Emory's document stamping template for your CIRB consent form.*  You can put the consent form on a regular Word document.

*Please be aware that 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 consent forms on the document stamping template.

Please note: 

  • CIRB now requires a stand-alone HIPAA authorization document separate from the consent form.  
  • There are certain sections that we have included in our Emory-specific NCI consent templates in the past.  Because those sections are no longer allowed, you will now need to include them in a separate Site Information Sheet which you'll provide to the subjects during the consent process.

Given the above, Emory has created a Site Information and HIPAA Authorization Form for you to use for your studies.  This form will NOT go to NCI CIRB but should be included in your local CIRB submission through eIRB for your analyst assistant to check and stamp.  You will notice that the template above already has the document stamping tool at the top.  Once initially stamped, the form does not need to be re-stamped at any point unless something within the HIPAA Authorization portion changes.  Remember that there must be some process for revocation.  You have the option to use the Emory research revocation letter, but it is not required as long as the HIPAA Authorization section of the above-mentioned form contains language telling subjects to write to a certain address and revoke their authorization (language that's already included on our template).  If you choose to use a revocation form, it will be reviewed and stamped by Emory IRB along with the Site Information and HIPAA Authorization Form as a LOCAL document.  It should not be included on your Study-Specific Worksheet to NCI CIRB.

I already have access to the Participants' Area. How do I start a study with NCI CIRB?

Please review the General Guidance for NCI CIRB studies.

Study teams should contact one of the Analyst Assistants on the IRB staff webpage to request access to the abbreviated eIRB Smartform template. Please include the PI's name, study title, coordinator, and if the study involves pediatric subjects.

Once you receive access to the abbreviated template, you will only be required to complete certain designated sections that pertain to CIRB studies.  Once the requested sections are complete, please submit as per usual to trigger any necessary ancillary approvals.

To see which sections of the eIRB smartform need to be completed, please see this document.

NEW SECTION! How do I handle a change in PI?

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. This modification aims to reduce the need for individual Worksheet submissions for each affected study, thus reducing the administrative burden on local site staff as well as the CIRB’s review process.

The removal of study specificity will require staff 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 new Change of PI worksheet, please contact the CIRB Helpdesk or 1-888-657-3711.

Who are my NCI CIRB contacts?

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. 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.

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.