Research: Intramural and Extramural

Jacquelyn Goldberg, JD

CIRB Review Board Administrator

Clinical Investigations Branch, CTEP

Division of Cancer Treatment & Diagnosis

The NCI’s Central IRB Initiative

June 26, 2007Clinical Trials Break Out Session

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Overview

• 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

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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 announcement– CIRB e-mail bi-monthly

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• 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?

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• 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?

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• 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

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• 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

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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

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Total studies presently on menu• Adult – 98• Pediatric – 46

– Total 144

Studies open to accrual• Adult – 64• Pediatric – 42

– Total 106

Current as of 05/10/2007

Studies available for facilitated review currently on CIRB menu

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1 Albert Einstein Cancer Research Center

2 Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

3 Cancer Center - University of Virginia, Health Sciences Center

4 Case Comprehensive Cancer Center

5 Yale Cancer Center

6 Comprehensive Cancer Center of Wake Forest University

7 Duke Comprehensive Cancer Center

8 Eppley Cancer Center

9 Fox Chase Cancer Center

10 Fred Hutchinson Cancer Research Center

11 Herbert Irving Comprehensive Cancer Center

12 Huntsman Cancer Institute

13 Indiana University Cancer Center

14 Jonsson Comprehensive Cancer Center

15 Kimmel Cancer Center

16 Lombardi Comprehensive Cancer Center

17 Mayo Clinic Cancer Center (Mayo Health System)

18 Norris Cotton Cancer Center

19 OHSU Cancer Institute

20 Siteman Cancer Center

21 The Cancer Institute of New Jersey

22 The Holden Comprehensive Cancer Center

23 The Sidney Kimmel Comprehensive Cancer Center

24 UAB Comprehensive Cancer Center

25 UCSF Comprehensive Cancer Center

26 UNC Lineberger Comprehensive Cancer Center

27 University of Colorado Cancer Center

28 University of Michigan Comprehensive Cancer Center

29 University of Pittsburgh Cancer Institute

30 University of Wisconsin Comprehensive Cancer Center

31 UNM Cancer Research & Treatment Center

32 USC/Norris Comprehensive Cancer Center

33 University of Arizona – Arizona Cancer Center

Current as of 05/10/2007

NCI Designated Cancer Centers

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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

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Contact the NCI CIRB

http://www.ncicirb.org

Email: ncicirbcontact@emmes.com

CIRB Toll-free Number: 888-657-3711

Fax Number: 301-560-6538

Mailing address:

NCI CIRB

C/O The EMMES Corporation

401 N. Washington Street, Suite 700

Rockville, MD 20850