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    California Pacific Medical Center
    Institutional Review Board (IRB)

    IRB Submission Requirements  |  For Full Committee Review  |  For Expedited Review  |  For Exempt Review  |  CPMC IRB List of Training Options

    IRB Submission Requirements

    Submit through IRBNet to:
    IRB Office
    2200 Webster Street, 5th Floor, PAC Campus,
    San Francisco, CA 94115
    (415) 600-3688 or (415) 600-3709

    The following research plans require IRB review and approval before the research begins:

    • plans that propose the use of living human subjects

    • the use of tissues or materials from living humans

    • the use of data on humans
    Important Instructions
    Each Of The Following Items Must be Completed In The Order Listed Below for Your IRBNet package.

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    For Full Committee Review

    New studies that involve more than minimal risk; use of new drugs, investigational devices, drug-sponsored studies; phase III studies, etc.

    1. Submit through IRBNet (collated, in the order listed) of the following:

      • CPMC - IRB Application Form with appropriate electronic signatures

      • Protocol Summary

      • Consent Form including California Experimental Subject’s Bill of Rights, HIPAA Authorization or Application to Waive Consent and HIPAA Authorization

      • HIPAA Compliance Application Form and/or the following HIPAA forms if applicable to the project:
        • Application for Tissue Use
        • Application for Chart Review
        • Recruitment documents (advertisements, etc.)

      • Complete Research Protocol

      • For NIH studies or other federally funded studies:
        • Complete grant packet
      • For Drug Studies:
        • Investigators Brochure (If this is unavailable, submit a summary of the preclinical/animal data and any relevant clinical data (or grant application)
        • Signed FDA 1572 Form
        • Package Insert (for studies of approved drugs)

      • For Device Studies:
        • FDA determination letter
        • Request for Investigational Device Use in a Patient Setting
      • Curriculum Vitae (signed & dated) of Principal Investigator (if first-time investigator)


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    For Expedited Review

    Refer to back of the expedited form for acceptable FEDERAL categories. Submissions qualifying for expedited review does not need full committee review but rather review by chair and one scientific merit review; internal review is usually completed within ten working days of submission (no specific due date deadline).

    Submit though IRBNet (collated, in the order listed) of the following:

    • CPMC - IRB Application Form with appropriate electronic signatures
      0Research Protocol or Protocol Summary

    • HIPAA Compliance Application Form

    • Curriculum Vitae (signed & dated) of Principal Investigator (if first-time investigator)

    • Include only if appropriate:
    • Consent Form including California Experimental Subject’s Bill of Rights, HIPAA Authorization or Application to Waive Consent and HIPAA Authorization Form

    • HIPAA Forms:
      • Application for Tissue Use
      • Application for Chart Review
    • Curriculum Vitae (signed & dated) of Principal Investigator (if first-time investigator)


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    For Exempt Review

    Submit through IRBNet (collated, in the order listed) of the following:

    • CPMC - IRB Application Form with appropriate electronic signatures

    • HIPAA Compliance Application Form

    • HIPAA Forms:
      • Include only if appropriate:
      • Application for Tissue Use
      • Application for Chart Review
    • Curriculum Vitae (signed & dated) of Principal Investigator (if first-time investigator)


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    CPMC IRB List of Training Options

    For Investigators and Key Personnel to Meet NIH 10/01/00 Training Requirement

    Training in the protection of the rights and welfare of human subjects in research is a requirement of the Federal Regulations. The Office of Human Research Protection (OHRP) requires that all IRB members, investigators, study coordinators and other research team members involved in human subject research or who handle subject identifiable research information have basic certification in human subject protection. This basic certification may be obtained from any one of the sites listed below. Only one certificate is necessary and must be submitted with all new study applications.

    Please note that this requirement applies to ALL research team members (principal investigators, co and sub investigators, study coordinators and other research team members.

    You may sign in and if you remember your ID and Password you may leave and reenter the site so that the training can be completed to accommodate your schedule.

    Once you have participated in one of the educational opportunities listed below, note the date you completed the training. Make sure that you print your certificate and submit to the IRB or NIH if needed.

    COURSE

    National Institutes of Health (NIH): Human Participant Protections Education for Research Teams

    On March 1, 2008, the NIH Office of Extramural Research on-line tutorial Protecting Human Research Participants (PHRP) replaced the NCI Human Participant Protections Education for Research Teams course. The NCI course is no longer available. The PHRP course updates the old course. It is an improved course that covers the same material. The PHRP course satisfies all the requirements met by the old course.

    Description: This computer-based training is intended for use by those involved in the design and conduct of research involving human participants, including but not limited to biomedical and behavioral researchers, nurses and data managers who are part of the research team. This tutorial presents common concepts, principles, and issues related to protection of human participants.

    Completion Time: Approximately two hours

    Cost: FREE



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