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Pediatric Central IRB PedCIRB Initiative

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					     UPDATE
Pediatric Central IRB

 PedCIRB Initiative

Barry Anderson, MD, PhD
National Cancer Institute
        Why a Central IRB?
  NCI developed a Central IRB model
  in consultation with OHRP because:
• IRBs are forced to “review too much, too
  quickly, with too little expertise”
• IRB reviews of large, multicenter clinical
  trials result in duplication of effort and
  inefficiency
• For Peds Oncology lack of expertise may
  compromise patient protection
                        Christian, M., NEJM (2000)
What does the PedCIRB do?
1.   COG pilot, phase 2 and phase 3 protocols submitted
     for PedCIRB review after CTEP approval

2.   Primary reviewer assigned and full Board review
     occurs (meet ~q2 weeks)

3.   Board votes to approve, approve with modifications,
     table, or disapprove

4.   NCI-CTEP signs off on PedCIRB approved version of
     protocol

5.   COG activates the protocol group-wide
     What does your IRB do?
1. CRA/IRB office downloads Facilitated Review
   Packet: CIRB's primary reviews, minutes,
   notification letters, and any other
   correspondence + application form

2. “Facilitated reviewer” or IRB subcommittee
   evaluates packet materials to consider local
   concerns and decide whether to accept CIRB
   Review, protocol and informed consent
      Modifications for local consent document permitted
 Meets OHRP requirement
"…an institution relying upon another
institution's IRB has a responsibility to
ensure that the particular characteristics of
its local research context are considered
through subsequent review by appropriate
designated institutional officials, such as
the Chairperson and/or other members of
its local IRB."
      What does your IRB do?
3. If CIRB review accepted, then CIRB is the IRB of
   record…
  •   initial, amendment and continuing reviews
  •   adverse event reviews
  •   DSMB report review

4. Your local IRB is responsible for…
  •   ongoing consideration of local context
  •   oversight of local performance for the protocol
  •   reviews local adverse events
       What do you NOT do?
1. Spend hours preparing protocol application
   forms for your IRB

2. Wait weeks/months for the next available Full
   Board Review slot on the IRB agenda

3. Hear complaints from the IRB chair that those
   *#!$@! COG protocols are too complicated and
   take up too much IRB time
 How does the local IRB stay
 in the loop about the study?
• Local IRB receives:
  –   Reports about adverse events;
  –   Changes to the protocol and consents;
  –   Continuations, suspensions, closures
  –   Final results
• NCI also posts on CIRB web site for local
  site review/download.
         Who is the PedCIRB?
• Bruce Gordon (Onc)     •   Eric Kodish (Onc/Ethics)
• Steve Davis (PICU)     •   Betsy Bickert (Pharm)
• John Sever (Peds ID)   •   Paul Colombani (Ped Surg)
• Stacey Berg (Onc)      •   Chris Fryer (Rad Onc)
• Ellen Brooks           •   John Holcenberg (Onc)
  (Ped Physiologist)     •   Jeff Krischer (Ped Epi)
• Gigi McMillan (Adv)    •   Ann McNeil (Onc Nurse)
• Catherine Woodman      •   Ceretta Washington (Adv)
  (Psychiatrist/Adv)     •   Octavio Zavala (Adv)
  Update on PedCIRB Activity
First Review of Protocols= Nov. 22, 2004

# Protocols Reviewed= 28

# Protocols Approved= 19

# Protocols Activated by COG= 10
      PedCIRB Approved and
         COG Activated
1. AALL0331- Std Pre-B ALL
2. AALL03B1- ALL Biology
3. AALL03N1- Adherence/Ethnic ALL
4. AAML0121- Amifostine MDS
5. ACNS0224- Topotecan/G-CSF BStm Glioma
6. ACNS0423- Rad/Temodar, CCNU
7. ANBL00B1- NBL Biology
8. ANBL0322- 14.18-IL2 Ab NBL Phase II
9. ANHL04B1- NHL Registry
10. ARST03P1- Infantile Fibrosarcoma
          PedCIRB Approved
1.   ACCL04C2- Electroaccupuncture
2.   ACNS0221- Phase II Conf Radrx Glioma
3.   ADVL0221- ET743 Phase II
4.   AHOD03P1- Lymph Predom Hodgkin’s*
5.   ANBL00P3- IVIG Opso-Myo NBL
6.   AOST0331- Osteosarc Phase III*
7.   ARAR0331- Nasopharyngeal Carcinoma*
8.   AREN0321- Renal Biology
9.   ARET0332- Unilateral Retinoblastoma*
            Enrolled COG Institutions &
           Participating COG Institutions
90                                      Participating
                                        Institutions
80                                      with at least 1
                                        Facilitated
70                                      Review

60
50                                      Enrolled
                                        Institutions
40
30
20
10
0
     Jan    Mar   May    Jul   Sept
Total Facilitated Reviews Performed &
    Participating COG Institutions
100                                                       Participating
                                                          Institutions
90                                                        with at least 1
                                                          Facilitated
80                                                        Review
70
60                                                        Total
                                                          Facilitated
50                                                        Reviews
                                                          Performed
40
30
20
10
 0
      Jan       Mar       May       Jul       Sept
                                                         # protocols
      0     2    4    4    5    6   7     8    8     9
        4-7 Facilitated Reviews
•   Children’s Hospital Med Ctr of Akron
•   Children’s Medial Center Dayton
•   Connecticut Children's Med Ctr
•   Marshfield Clinic
•   SUNY Upstate Med Univ (Syracuse)
•   St. John Hospital and Med Ctr
•   University of New Mexico
       How do you sign-up?
1. Your IRB adds the PedCIRB to its
   institutional Federal Wide Assurance

2. Your institution signs an authorization
   agreement with the CIRB

   Note: This agreement allows, but does
   not require, the institution to use the
   central IRB as the IRB of record on any
   PedCIRB reviewed COG protocol.
Contact the PedCIRB
        www.ncicirb.org

  Email: pediatriccirb@ctisinc.com

CIRB Toll-free Number is 888-657-3711

              NCICIRB
              C/O CTIS Inc.
       One Research Court, Suite 200
           Rockville, MD 20850
       COG PedCIRB Participants
•   All Children's Health System, Inc.            •   Children's National Medical Center
•   Asheville Hematology-Oncology (Mission        •   Columbus Children's Hospital
    Health Inc. IRB)                              •   Connecticut Children's Medical Center
•   Atlantic Health System                            (CCMC)
•   Brooklyn Hospital Center                      •   Cook Children's Health Care System
•   CAMC Health Education and Research            •   Cottage Health System
    Institute                                     •   Covenant Children's Hospital
•   Cancer Center of Kansas (Via Christi Med      •   Dartmouth College
    Ctr IRB)                                      •   Driscoll Children's Hospital
•   Carillon Medical Center                       •   Eastern Virginia Medical School
•   Cedars-Sinai Medical Center                   •   Florida Hospital Cancer Institute
•   Children's Hospital and Health Center         •   Georgetown University
•   Children's Hospital and Regional Medical      •   Hackensack University Medical Center
    Center                                        •   Hope-A Women's Cancer Center (Mission
•   Children's Hospital Central California            Health Inc. IRB)
•   Children's Hospital Los Angeles               •   Inland Empire Hospital Services
•   Children's Hospital Medical Center of Akron       Association/ IRB Spokane
•   Children's Hospital of Austin                 •   Inova Health System
•   Children's Hospital of Omaha                  •   Joe DiMaggio Children's Hospital
•   Children's Hospital of Wisconsin, Inc.        •   Johns Hopkins University School of
•   Children's Medical Center                         Medicine
•   Children's Memorial Hospital
       COG PedCIRB Participants
•   Kaiser Foundation Research Institute           •   Oncology Care Associates, PLLC
•   Keesler Medical Center                         •   Palmetto Health Alliance
•   Lee Memorial Health System                     •   Penn State College of Medicine
•   Legacy Emanuel Hospital & Health Center        •   Phoenix Children's Hospital
    (Legacy Health System)                         •   Primary Children's Medical Center
•   LifeBridge Health, Inc.                        •   ProMedica Health System (Including Toledo
•   Maimonides Medical Center                          Children's Hospital)
•   Maine Children's Cancer Center                 •   Rockwood Cancer Treatment Center (IRB-
•   Maine Medical Center                               Spokane)
•   Marshall University                            •   Sacred Heart Health System, Inc.
•   Marshfield Clinic                              •   Scott & White Memorial Hospital
•   Mayo Foundation                                •   South Broward Hospital District
•   Medical City Dallas Hospital                   •   St. Francis Health System
•   Medical University of South Carolina           •   St. John Hospital and Medical Center
•   Memorial Health Services                       •   St. Joseph Regional Health Center
•   Memorial Health University Medical Center      •   St. Joseph's Health Care System
•   Mission Health Inc.                            •   St. Jude Midwest Affiliate (University of IL
•   Montefiore Medical Center                          College of Medicine IRB)
•   MSU-Kalamazoo Center for Medical Studies       •   St. Vincent Hospital
•   North Broward Hospital District                •   Sunrise Hospital and Medical Center LLC
•   North Texas Hospital for Children at Medical   •   SUNY Upstate Medical University
    City Dallas                                    •   University Hospitals of Cleveland
•   Ochsner Clinic Foundation (CCOP)
COG PedCIRB Participants
  •   University of Alabama at Birmingham (UAB)
  •   University of California, Davis
  •   University of Colorado Health Science Center &
      Colorado Multiple IRB
  •   University of Illinois at Chicago
  •   University of Nebraska Medical Center
  •   University of New Mexico Health Sciences Center
  •   University of North Carolina - Chapel Hill
  •   University of Texas Southwestern Medical Center
  •   University of Virginia
  •   Via Christi Regional Medical Center
  •   Wake Forest University Health Sciences
  •   Washington University Medical Center
  •   Wesley Medical Center, LLC
  •   William Beaumont Hospital (aka Beaumont CCOP)
  •   Yale University

				
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