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| THE HUMAN RESEARCH PROTECTION PROGRAM |
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THE COMMITTEE ON HUMAN RESEARCH CANCER CENTER PROTOCOL REVIEW COMMITTEE (CCPRC) Cancer-Related Applications All UCSF cancer-related clinical protocols must undergo the following review process in the order listed: 1) Submit new protocols to the applicable program’s Site or Modality Committee for review and approval. A Site Committee has been established for each site-specific research program to enhance integration of laboratory and clinical research and to develop new studies. These committees meet monthly and are chaired by the Program Co-Leader of each site-specific research program. The Site Committee assesses the scientific validity of protocols, prioritization of protocols within the programs and the feasibility of protocols based on the available patient resources. List of Site Committees and Chairs 2) Following Site or Modality Committee approval, submit new protocols to the Clinical Research Support Service (CRSS) for review by the Cancer Center’s Protocol Review Committee (PRC). The protocol must be accompanied by an approved Protocol Review Committee (PRC) Application Form and a consent form. Other supporting documents should be submitted as applicable, e.g., Investigator’s Brochure, letters of support, etc. The PRC meets monthly, and concentrates primarily on scientific questions, the validity of the study design, and the biostatistical methods employed. The review outcome may be approved, contingently approved, or disapproved. Non-peer reviewed protocols (e.g., industry and investigator-initiated/institutional protocols) and standard of care protocols must go to full committee. Protocols requiring full committee review must be submitted to the CRSS no later than the ten business days prior to the upcoming PRC meeting. Previously peer-reviewed protocols (cooperative group or other NCI protocols) receive expedited review, and may be submitted to the PRC at any time, with an anticipated turn-around time of ten business days from date of submission. Non-therapeutic protocols (excluding quality of life studies) are generally exempt from PRC review; however, they should still be submitted to the PRC, which will issue a memorandum to the principal investigator stating that the PRC has granted permission for the protocol to be submitted to the Committee on Human Research (CHR). Quality of life studies may undergo expedited or full committee review. Investigators seeking more information on PRC should:
3) After PRC full approval or contingent approval, submit new protocols to CHR for review and approval. The Committee on Human Research (CHR) will not review a non-peer reviewed cancer-related protocol until the protocol has completed a PRC review and received either contingent approval or full approval from the PRC. Peer-reviewed cancer-related protocols may be submitted to CHR simultaneously with submission to the PRC. CHR will not issue full approval until the protocol has all contingencies removed and has obtained full PRC approval. No protocol should be submitted to CHR without prior submission to the PRC. 4) Protocol modifications should also be submitted to the PRC, and may or may not require PRC re-review. The Protocol Review Committee needs to review all modifications to a protocol. If the modifications require PRC Chair review, an approval will be issued. If the modifications do not require PRC Chair review, no correspondence will be issued.
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