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
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 firstname.lastname@example.org 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:
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. The 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.
NCI CIRB limits changes to consent forms. Please review the NCI CIRB's Guidelines for Permitted Boilerplate Language Additions and Boilerplate language Q & A for more information.
- CIRB requires a stand-alone HIPAA authorization document separate from the consent form.
- CIRB does not allow changes in the main consent form, other than injury coverage language.
- You must therefore use Emory's 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 them 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.
The Emory IRB will NOT stamp your NCI-CIRB-approved consent forms, but 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.
- 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.
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 Emory consent form language in the main consent form (not just in the Emory addendum)
- Updates to drugs or devices used
Modifications that require review by Emory IRB only:
- Changes to study staff that require immediate access to eIRB (other staff changes are reported at CR)
- Changes to research sites
- Changes in financial interests on the part of any study team members (if determined to be a COI, an update to the main consent form will need to be submitted to NCI CIRB)
- Changes to Emory consent form language in the main consent form (not just in the Emory addendum)
- Changes to our local consent/addendum
- changes to the Clinical Research Key Points (CRKP) Summary
- All other modifications
No other changes need to be submitted locally to us at this time (subject to change).
Ancillary Review Changes: It is the responsibility of the Emory Principal Investigator to notify ancillary review committees if changes are made to approved research that may impact the reviews of these committees. Examples include, but are not limited to, changes relevant to radiation, conflict of interest, and biosafety review.
How to Submit to Emory IRB in eIRB
Depending on the state of your approved study, do the following:
- "Active" status- submit via 'Create Site Modification" (for Emory-specific information changes) or "Update Study Details" (for study-wide changes). You can find more information here.
- "External IRB" status- you need to submit an "Update" to the submission. You can find more information about this process here.
Step 1: Submit renewal documents to the appropriate cooperative group when requested
Step 2: Once your site has received continuing review approval from the NCI CIRB, next steps depend on whether you are the PI or a Co-I/Coordinator...
If you are the PI, select "Report Continuing Review Data" on the left menu in the study workspace in eIRB to update the Emory IRB, and submit the documents listed below.
If you are not the PI, submit the below items via "Log Comment" and select that you want to notify the IRB Coordinator.
Please submit the following to the Emory IRB:
- The renewal approval letter from the reviewing IRB.
- Updates to local study team members (that have not already been reported)
- This must be done via a simultaneous study update (see Modifications section above)
- A summary of all internal Reportable New Information (RNIs) submitted to the reviewing IRB since the last review, if any (and if not already reported promptly).
- RNIs include but are not limited to unanticipated problems that increase risk of harm to others, noncompliance, breaches of confidentiality, wrong site surgeries, wrong drug administered, wrong patient, fabrication of data and falsification of data.
- In the summary, provide the outcome of the reviewing IRB's review (e.g. "Noncompliance," "Serious noncompliance," "Unanticipated Problem"...)
- Note: The reviewing IRB may call these submissions something different, e.g. "Reportable Events"
- Upload a copy of the report(s) submitted to the reviewing IRB.
- attach the completed CR workbook.
- NOTE: The Emory IRB will not restamp any consent documents except older consent-HIPAA combination forms.
You must report reportable events/new information to the NCI CIRB according to the NCI CIRB's policies and procedures. 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).
Check with your CIRB contact or at the CIRB helpdesk for more information about reporting mechanisms.
Report egregious reportable events promptly to Emory office of Compliance, Risk Management Office, and Emory IRB IN ADDITION to the NCI CIRB.
Examples of egregious reportable events:
- the wrong side surgery
- the wrong drug, wrong patient
- fabrication or falsification of data
- HIPAA privacy matter (report any inadvertent data disclosure and we will help determine further actions)
How to report to Emory IRB: Click on "Report New Information" on the left menu of the study workspace in eIRB.
- Egregious events (reported promptly): Upload a copy of the report(s) made to the reviewing IRB, and any correspondence from the reviewing IRB (but do not delay to wait for their determination).
- Events reported to the External IRB in the past approval period: Submit to the Emory IRB at the time of continuing review. Click Report Continuing Review Data on the left menu. Under question 4, attach the filled CR workbook.
See our submissions guidance table here.