Main content

    PI Attestation - Research using Decedent Information

    Printer-friendly version: PI Attestation - Research using Decedent Information [MSWord 42KB]
    If you have problems using the Word document listed above, provide the Institutional Review Board (IRB) with the information below:

    If you have problems using the Word document, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, 5th Floor, P-Campus,
    San Francisco, CA 94115

    For questions and help, please call:
    Leigh Pruneau, PhD, RN, CIP., Human Research Protection Program Administrator at (415) 600-3688.

    This information must be provided and submitted to CPMC IRB prior to using or disclosing PHI to the researcher

    Please provide the following information

    • Principal Investigator:
    • Mailing Address:
    • Phone Number:
    • Fax Number:

    The signature, of the Chairman of the Department, acknowlegdes that this information has been reviewed and support its implementation.. Department Chair should provide signature/print name/date.

    PREPARATORY RESEARCH

    Principal Investigator should provide signature/date. By signing this document, the Principal Investigator (PI) is attesting to the following statements:

    1. The PI is requesting access to protected health information (PHI) for purposes of:
      • preparing a research design for assessing the feasibility of a specific research study.
      • for identifying patients for recruiting purpose.
      NOTE: The PI may not contact any individuals identified by the review prior to approval of the IRB of the research protocol.

    2. The PI is requesting access to only the minimum necessary protected health information.
    3. The PI will not remove the protected health information from the premises of California Pacific Medical Center in the course of the review.

    RESEARCH USING DECEDENT INFORMATION

    Department Chair should provide signature/date. The PI' signature attest to the following statements:

    1. The PI is requesting access to protected health information (PHI) for purposes of conducting research solely on decedents.
    2. The PI is requesting access to only the minimum necessary protected health information for purposes checked above.
    3. The PI will provide documentation to CPMC IRB of the death of each patient whose PHI I access, if required.
    4. Will the PI need identifiers of the deceased or their relatives, employers or household members? Yes/No.
      If NO, please sign and submit document.
      If YES, the PI should consider whether making an application to use or disclose a Limited Data Set, which must be accompanied by a Data Use Agreement, OR if protected health information (PHI) will be disclosed on decedent's relatives, employers or household members, then the research proposal must be submitted to the Institutional Review Board (IRB) for prospective review.