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Jacquelyn Goldberg, JD CIRB Review Board Administrator Clinical Investigations Branch, CTEP Division of Cancer Treatment & Diagnosis. The NCI’s Central IRB Initiative. June 26, 2007 Clinical Trials Break Out Session. Overview.

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The NCI’s Central IRB Initiative

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Jacquelyn Goldberg, JD

CIRB Review Board Administrator

Clinical Investigations Branch, CTEP

Division of Cancer Treatment & Diagnosis

The NCI’s Central IRB Initiative

June 26, 2007

Clinical Trials Break Out Session


CIRB Initiative is a program which enables IRB review to take place quickly at the local site while maintaining a high degree of human subject protection

2 Central Boards exist (adult and peds)

All phase adult 3 Cooperative Group trials and all COG trials receive review and approval prior to being made available to investigators for patient enrollment

how does the nci cirb model work
How does the NCI CIRB model work?

NCI/CTEP approves pending CIRB approval

CIRB approves protocol

NCI sends Group final approval

Local investigator is notified of protocol via

Routine Group activation


CIRB e-mail bi-monthly

If the local investigator decides to open protocol,

OPTION 1: Investigator or CRA downloads the completed application, protocol and consent from the CIRB website and submits documents to local IRB; (LIRB then downloads confidential documents)

OPTION 2: PI/CRA downloads all the documents and submits them to the LIRB

How does the NCI CIRB model work?

Local chair/subcommittee reviews for local concerns and decides whether to approve (“facilitated review”)

If LIRB accepts, they notify CIRB.

The CIRB becomes the IRB of record. It handles amendments, continuing reviews, adverse events etc.

If LIRB does not accept, LIRB can decide to review the protocol themselves as per their own local procedures.

How does the NCI CIRB model work?

CIRB and LIRB share regulatory responsibilities

The CIRB’s primary function is initial and continuing review of protocols

The local institution’s primary function is consideration of local context and oversight of local performance

CIRB review occurs BEFORE the protocol is distributed nationally;  Board has authority to make changes in the protocol (unlike local Boards which can only accept or reject these trials)

Extricates Board review process from local institutional politics

Protocols are reviewed by sophisticated patient advocates and cancer experts

Benefits to Research Participants

benefits to local investigators cras
Benefits to Local Investigators/CRAs

No advance preparation for IRB review at the local site—no IRB application to complete, just download the IRB packet from the CIRB website

No waiting for the next meeting of the full board, therefore investigators can enroll patients sooner

CIRB becomes IRB of record, no need to submit continuing reviews, amendments or AE reports (except for AEs at local site) to the LIRB or the CIRB

Total studies presently on menu

Adult – 98

Pediatric – 46

Total 144

Studies open to accrual

Adult – 64

Pediatric – 42

Total 106

Studies available for facilitated review currently on CIRB menu

Current as of 05/10/2007


NCI Designated Cancer Centers

Current as of 05/10/2007

nci cirb initiative 6 easy steps to join
NCI CIRB Initiative: 6 Easy Steps to Join

Modify institution’s FWA to include the CIRB and sign authorization agreement

Create a local IRB SOP for utilizing the CIRB

Determine the composition of the LIRB subcommittee

Notify local investigators of the new process

Copy the CIRB on the notification (which will show that the process is complete)

Provide CIRB with contact information for LIRB and PI to establish website access and facilitate communication

contact the nci cirb
Contact the NCI CIRB


CIRB Toll-free Number: 888-657-3711

Fax Number: 301-560-6538

Mailing address:


C/O The EMMES Corporation

401 N. Washington Street, Suite 700

Rockville, MD 20850