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    Institutional Review Board (IRB) - Request For Discarded Biological Specimens For Research

    Printer-friendly version: Request For Discarded Biological Specimens For Research (MSWord 99KB )

    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.

    Policy Request For Discarded Biological Specimens For Research

    Use of human tissue and biological specimens collected for research procedures are subject to IRB review. This includes discarded or previously stored surgically removed tissue, tumors, blood, urine, cerebrospinal fluid etc. The type of IRB review required depends on how, when and for what purpose human tissue is acquired. If the tissue is to be used for genetic research and requires the maintenance of identifiers or links to identifiers, a full protocol application must be submitted in addition to this form.

    Provide the following information for the Request For Discarded Biological Specimens For Research

    • Title of Project:
    • Principal Investigator's name: The Principal Investigator must be a medical staff member or an employee of CPMC. He or she is considered the responsible party for legal and ethical performance of the project.
    • Sutter Affiliation:
    • Department:
    • Mailing Address:
    • Phone Number:
    • Fax Number:
    • E-mail address:
    • If you wish to designate a contact other than the PI to receive correspondence regarding this IRB submission, please include their information: Name of Contact and E-mail address


    1. Purpose of the Sample Collection (describe briefly):

    2. Are you receiving funding from any source to perform this research? (Yes /No). If yes, who is providing the funds?

    3. This is a request for:
      Body Fluid (Check all that apply) Obtained where? (Pathology, OR, Labs, outside CPMC, etc) Number of samples Samples requested over what period of time? Status
      Blood     
      CSF     
      Urine     
      Sputum     
      Other     

    4. If this is a request for TUMOR or TISSUE, please complete the following. Provide complete information for each type of specimen request.
      • Tissue/Tumor Type
      • Obtained where? (Pathology, OR, Labs, outside CPMC, etc)
      • Number of samples
      • Samples requested over what period of time?
      • Status: R=Retrospective (Samples which already exist or are currently stored);P=Prospective (Samples to be obtained in the future)
      • If you propose to use retrospective research samples (status category R), was informed consent initially obtained? Yes /No/Don’t know
      • If yes, what was the subject's understanding of how the samples would be used?
    5. Will biological specimens be released outside CPMC? Yes/No
      If yes, please specify who will receive the sample, for what purpose, and whether identifying information will be released. (Informed consent is required to release specimens with identifiers outside CPMC.)
    6. Will the samples be stored/banked for future use? Yes/No
      If yes,where will the tissue be stored?
      What future types of research would you anticipate using the samples for? Who will be responsible for distributing the tissue?

    7. HIPAA Privacy Rule Protections: The Health Insurance Portability & Accountability Act (HIPAA) privacy rules apply to private health information associated with specimens that are obtained, used and stored for research purposes.

      The following information is considered identifiable under the Privacy Rule regulations. Please check off whether any the following will be obtained and/ or maintained with the specimen. If any of these elements are checked off, under Privacy rule provisions it cannot be considered de-identified and authorization from the subject or a waiver of authorization granted by the IRB is required.

      These items may be included and considered a "limited data set.” Use of data under the provisions of a "limited data set" require the signing of a data use agreement by the recipient (this includes researchers) or a request for a waiver of authorization or authorization is required.
      • Patient/Subject name
      • Medical record numbers (or specimen #)
      • Address street location
      • Telephone number code
      • Fax Number
      • E-mail address
      • Social security' number
      • Health plan beneficiary numbers
      • Account numbers
      • Certificate/license numbers
      • Vehicle identification numbers and serial numbers
      • Medical device identifiers and serial numbers
      • Web URLs
      • Internet protocol (IP) address
      • Biometric identifiers (finger and voice prints)
      • Full face photographic images
      • Any unique identifying number, characteristic or code
    8. List all names of individual(s) who will be given access to private health information associated with the specimens, indicate whether CPMC medical staff or employee, and role with the study or project
    9. If links to identifiers (codes) are to be used, please describe the coding mechanism.
    10. Investigators are required to only obtain the minimum necessary data with the specimen in order to achieve the goals of the research. Please justify why the data you are obtaining with the specimen is the minimum necessary to achieve the goals of the research.
    11. Please describe the steps taken to assure privacy and confidentiality of subject data obtained with the specimen and to protect the identifiers from improper use or disclosure.
    12. You are required to destroy identifiers (or links) at the earliest possible time. Please describe your plans and specify when this will occur or provide justification for retaining the identifiers.


    Informed Consent Requirements for Identified or Linked Specimens

    PROSPECTIVELY Collected Samples: Informed consent must be obtained for all prospective specimen/tissue collections with identifiers or links to identifiers. This includes the future collection of left over/ discarded clinical specimens. Please submit an informed consent with this request and do not check off that you are requesting a waiver.

    RETROSPECTIVELY Collected Samples: A waiver of informed consent/HIPAA authorization may be considered only for research which involves the collection of identified or linked biological specimens and associated data when the specimen/tissue already exists (already being stored) at the time the research proposal is submitted and no results will be given back to a physician, patient or placed in the medical record.

    Principal Investigator's statement and acknowledgement that the information provided above is complete and correct

    I assure that the information I obtain as part of this research (including protected health information) will not be reuse or disclosed to any other person or entity other than those listed on this form, except as required by law or for authorized oversight of the research project. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entity, I will seek approval by CPMC IRB.

    Principal Investigator should provide signature/date.
    Your signature acknowledges that you have reviewed the attached protocol and support its implementation.