1. 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, 2007 Clinical Trials Break Out Session

2. 2 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

3. 3 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

4. 4 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 ?

5. 5 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 ?

6. 6 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

7. 7 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

8. 8 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

9. 9 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

10. 10 1Albert Einstein Cancer Research Center 2 Arthur G. James Cancer Hospital & Richard J. Solove Research Institute 3 Cancer Center - University of Virginia, Health Sciences Center 4Case Comprehensive Cancer Center 5Yale Cancer Center 6Comprehensive Cancer Center of Wake Forest University 7Duke Comprehensive Cancer Center 8Eppley Cancer Center 9Fox Chase Cancer Center 10Fred Hutchinson Cancer Research Center 11Herbert Irving Comprehensive Cancer Center 12Huntsman Cancer Institute 13Indiana University Cancer Center 14Jonsson Comprehensive Cancer Center 15Kimmel Cancer Center 16Lombardi Comprehensive Cancer Center 17Mayo Clinic Cancer Center (Mayo Health System) 18Norris Cotton Cancer Center 19OHSU Cancer Institute 20Siteman Cancer Center 21The Cancer Institute of New Jersey 22The Holden Comprehensive Cancer Center 23The Sidney Kimmel Comprehensive Cancer Center 24UAB Comprehensive Cancer Center 25UCSF Comprehensive Cancer Center 26UNC Lineberger Comprehensive Cancer Center 27University of Colorado Cancer Center 28University of Michigan Comprehensive Cancer Center 29University of Pittsburgh Cancer Institute 30University of Wisconsin Comprehensive Cancer Center 31UNM Cancer Research & Treatment Center 32USC/Norris Comprehensive Cancer Center 33University of Arizona – Arizona Cancer Center Current as of 05/10/2007 NCI Designated Cancer Centers

11. 11 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

12. 12 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