Contact Information

Organization

THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

National Cancer Institute Central IRB (NCI CIRB) Initiative for Adult and Pediatric Human Research (Revised July 2007, November 2006)

• Overview of the CIRB Initiative
• How it Works - A Brief Synopsis
• Specific Procedures for UCSF Cancer Center PI Use of NCI CIRB
• CHR Review and Approval Procedures
• CIRB Responsibilities
• PI Responsibilities
• Request to Rely on NCI CIRB Form

Overview of the CIRB Initiative

The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI) in consultation with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The CIRB provides an innovative approach to the IRB review of adult and pediatric national multi-center cancer treatment trials that significantly speeds up IRB approval and yet maintains a high level of protection for the human research participants. Patients will be able to be enrolled in a much more timely fashion. For full details about this initiative, please see the NCI CIRB Initiative website.

In brief, however, the CIRB provides expert IRB review at the national level before the Cooperative Group distributes the protocol to local investigators. The CIRB is composed of individuals who represent a broad range of oncology disciplines and may include oncology physicians, nurses, patient representatives, pharmacists, ethicists and attorneys. Because UCSF has established a formal agreement with the NCI CIRB, investigators who wish to participate in the Cooperative Group Trials reviewed by the NCI CIRB may take advantage of these reviews.

• The Adult CIRB currently reviews all Phase 3 Cooperative Group Trials from the following relevant groups at UCSF: ACOSOG, CALGB, GOG, NSABP, RTOG and other cooperative groups opened through CTSU.
  
• The Pediatric CIRB reviews all NCI-approved COG Phase, 3 and Pilot protocols.

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How the CIRB Works - A Brief Synopsis

1. The Adult or Pediatric CIRB receives a completed application, protocol, informed consent form and related materials from the Cooperative Group via the NCI.



2. The full CIRB Board conducts initial review and approves the protocol.
   (Click on How it works - in detail for information on other review outcomes.)



3. After the protocol is activated by the Cooperative Group, all review documents are posted on the website for access by participating institutions.



4. A local investigator at a participating institution decides to join the clinical trial for a CIRB-approved protocol. The UCSF Cancer Center investigator downloads the application packet for facilitated review.



5. The CHR Chair and one other member (not the full committee) conduct a facilitated review, concentrating on local context issues.



6. The CHR notifies the CIRB Administrative Office of facilitated review acceptance via the website.



7. The CIRB becomes the IRB of Record for this protocol and is responsible for continuing review as well as review of subsequent amendments and serious adverse events (SAE) as notified by the Group.



8. The UCSF HRPP is responsible for review of local unanticipated problems and adverse events and is responsible for oversight of local conduct of the study.

   IMPORTANT NOTE: Please see simple CIRB flow diagram located at http://www.ncicirb.org/CIRB_Users_Guide.PDF for an overview of this process.

Related Links to CIRB Website:

• How it works - in detail
• Division of CIRB and Local Responsibilities
• Local context requirement (OHRP Guidance)
• CIRB Quickguide
• Contact the CIRB Initiative Operations Office

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Specific Procedures for UCSF Cancer Center PI Use of NCI CIRB

1. Each UCSF Participating Cooperative Group (CALGB, COG, ACOSOG, RTOG, NSABP and other CTSU groups must Register with the NCI CIRB through the CHR. Registration is needed in order to be able to access the full NCI CIRB website and to receive correspondence from the NCI CIRB. The CHR has already forwarded to the NCI CIRB many of the names of the Cooperative Group PIs as well as several of the names of the study coordinators and any other individuals who work the PI that need to receive correspondence from the CIRB. If any additional PIs or contacts need to be registered, pleased complete the linked NCI Contact form.
   
   At the time of this posting, the participating groups at UCSF are the ACOSOG, CALGB, the COG, the NSABP, RTOG and other CTSU groups.
   
   IMPORTANT NOTE: At this time, the VAMC is not participating in this initiative. It is hoped that the SFVAMC may pilot this project for the VAMC in the near future.



2. PI Reviews Listing of CIRB Approved Protocols. These are available at http://www.ncicirb.org/CIRB_Protocols.asp. Investigators may choose a new study or if s/he has a study active on the list they may transfer the study to CIRB.
   
   Note: Existing studies eligible for transfer must have current CHR approval with no reviews pending (e.g. no continuing reviews, modifications, local adverse events or protocol violations under CHR review) at the time of transfer request submission.
   
3. PI Downloads Protocol from NCI CIRB Website. If the PI is interested in participating in one or more of these protocols or transferring a CHR approved protocol to CIRB, he or she should download the protocol and consent documents.
   
   IMPORTANT NOTES:
   • Notify the Cancer Center Protocol Review Committee (CC PRC ) and obtain its approval for the study to occur at UCSF before forwarding documents to CHR.
   • Do not complete the CHR full committee application. The NCI-approved protocol will be the protocol that is submitted for facilitated review.



4. PI Makes NCI Consent Form UCSF-Specific. Click here for details
   
   IMPORTANT NOTE: The NCI allows local boilerplate additions to the informed consent.



5. PI Completes Request to Rely on NCI CIRB Form. This form provides basic information for the Human Research Protection Program office and database so that the HRPP can track the study, provide reports, and conduct on-site monitoring as needed.
   
   MPORTANT NOTE: This form requests information about other related committee approvals that are needed. If Radiation Safety and/or Biosafety Approvals are needed, these approvals must be in place before final CHR approval can be granted. Also, Key Personnel must complete the online Human Subjects Protection Training at https://www.researchonline.ucsf.edu/.



6. PI Forwards Five Collated Copies of the Following Information to the CHR Office at Box 0962 or to 3333 California St., Suite 315.

• Cover letter (optional – to point out any changes made to the local consent form)

• Request to Rely on NCI CIRB Form.
• For transfer studies only, 5 copies of the CHR Study Close-out Reporting Form.
1. Check “Study was started but closed prior to completion” and indicate “transfer study to Central IRB” below in Section B
2. Answer rest of questions to indicate study status at time of transfer

• NCI CIRB Facilitated Review Packet (including Approved Protocol) downloaded from CIRB website.

1. For initial submissions to the CHR, download the “Local IRB Facilitated Review Packet”



2. For amendments, download the current amendment documents (including the CIRB approval letter for the amendment).
   
   For UCSF-only local context change to consent forms and/or study contacts, prepare a cover letter describing the changes, and submit along with the “Notice of Intent to Rely” form, and revised consent form, with ‘modification’ checked. If a consent form change is related to an Adverse Event report, also submit the report for reference.



3. For renewals, download the current continuing review documents (Correspondence / CIRB Continuing Review Approval letter, Protocol, Informed Consent, Support Documents – e.g. DMC report or study summary, CIRB approval letter for the continuing review).

• NCI CIRB Approved Consent and Recruitment Documents with UCSF-Specific Changes Incorporated.

IMPORTANT NOTES:

• For renewal and modifications including protocol amendments, submit only the track changes version of the protocol (i.e., not both the track change and the clean copy)
• Check the Facilitate Review packet to be sure the most recent CIRB approval letter is included.
• If a renewal or modification is pending with CIRB at the time the UCSF investigator wishes to join the study, wait for CIRB approval of the pending item before submitting the application to the CHR.

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CHR Review and Approval Procedures

• The CHR Chair Conducts Facilitated Review of the Study. A designated CHR Chair or Vice Chair with a background in oncology and another voting member of the CHR conduct a “Facilitated Review” of the study. “Facilitated Review” involves the following:
  
  • After confirming that CC PRC approval is in place, review the submitted materials (as described above).
  
  
  
  • Determine if there are any local context issues that must be addressed by the CHR.
  
  
  
  • Determine if the CIRB approval is acceptable to the CHR.
  
  
  
  • Decide whether to accept the CIRB review or conduct a separate CHR full committee review.



• The CHR Notifies PI of Acceptance or Rejection of CIRB Approval.
  • For new and transfer studies, the local investigator and the CHR receive a registration email from the CIRB, indicating the CIRB has become the IRB of record for the study at the local institution. The CHR also issues a local facilitated review approval letter.

    Barring unforeseen circumstances, the notification by email from CIRB should occur within ten working days of receipt of the submission materials. The UCSF PI will also be able to view a copy of the Summary Sheet for the study on Research Online.

    IMPORTANT NOTE: The PI may begin enrolling patients as soon as the CIRB registration email notification is received.
    
• For renewal and modification submissions, the CHR issues a local facilitated review approval letter. The UCSF PI will also be able to view a copy of the Summary Sheet for the study on Research Online.
  
  The CHR Notifies the CIRB Administrative Office Each Time It Initially Accepts CIRB Review. The CHR will work with the CIRB office to ensure that all necessary paperwork is completed in a timely fashion.
  

  IMPORTANT NOTE: The date of initial approval at UCSF will be the date that the NCI CIRB issues the registration email for the study. The date of expiration of the study will be the NCI CIRB study expiration date. Therefore, it is in the best interests of the investigator to submit the paperwork to the CHR as soon as possible after the NCI CIRB approves a study. Approvals are valid for 365 days from the date of the NCI CIRB approval, not the UCSF approval, and then must be renewed.
  

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CIRB Responsibilities

• Perform initial reviews of new research studies, discuss issues with the lead organization and Study Chair, and make final decision of approval or disapproval of the study.



• Maintain and make accessible to designated IRBs the CIRB review materials.



• Carry out continuing reviews, and reviews of submitted serious adverse events, protocol amendments, DSMB reports and any other documents submitted by the lead organization or Study Chair.



• Notify each local institution of any new materials and any changes in the study approval status.



• Additional responsibilities are available on the NCI CIRB website.

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PI Responsibilities

• Assume ultimate responsibility for all aspects of the study. Please refer to the HRPP website for Researchers and Staff for full details of these responsibilities.



• Maintain a copy of the CHR Facilitated Approval in his or her study file in case the UCSF Human Research Protection Program, the UCSF Audit Services, the federal government, or the funding agency audits the study.



• Review CIRB website regularly to keep current with all information including amendments to CIRB-approved studies. UCSF requires facilitated review of study amendments.



• Track study expiration dates to prevent study approvals from expiring. UCSF requires facilitated review if renewals as well.



• Submit internal (on-site) Adverse Event, Protocol Violations and Incident Reports to both UCSF and CIRB.



• Submit renewal and modification materials to both UCSF and CIRB in a timely manner so that approvals and facilitated reviews will be kept in synch.



• Notify CIRB and/or UCSF CHR if any parts of this process are unclear. In this way, improvements and revisions can be made to ensure that process will be both efficient and effective.