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Human Subjects Division (HSD)

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Use of Identifiable Specimens/Data

Research that involves the review of identifiable biological data and/or specimens belonging to human subjects but not direct interaction with subjects is referred to as the "Use of Identifiable Data/Specimens."

Research using medical records, protected health information (PHI), employment data, study records, pathology specimens, or data and/or specimens from a repository are all included in this category.

For more information on why review of identifiable biological data and/or specimens is considered human subjects research, and considerations to take into account, please read the SOP Human Subjects Research

To apply for IRB review of research using identifiable biological data and/or specimens, please use the "APPLICATION: Specimen or Data Use, Identifiable (PDF)."

Related Questions And Answers

  • What is PHI?

    Protected Health Information is any information pertaining to:

    • the past, present, or future physical or mental health or condition of an individual;
    • the provision of health care to an individual; or
    • the past, present, or future payment for the provision of health care to an individual.

    PHI may be information that is recorded electronically, on paper, or orally. PHI may concern living people or dead people (referred to in the law as "decedents"). PHI does NOT include de-identified information or biological tissue with no accompanying information, such as an accession number or code number that may be linked to an identifier.

  • What is needed to request a "Waiver of HIPAA Authorization?"

    The UW IRB Committees use specific criteria in reviewing requests for a waiver of HIPAA authorization for research. In completing the Human Subjects Review Application (UW 13-11), researchers should explain how:

    • The use or disclosure of protected health information involves no more than minimal risk to the privacy, safety, and welfare of the individual;
    • The research could not practicably be conducted without the waiver or alteration;
    • The research could not practicably be conducted without access to the protected health information;
    • There is an adequate plan to protect the identifiers from improper use or disclosure;
    • There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
    • There are adequate written assurances that the protected health information will not be re-used or disclosed to a third party except as required by law, for authorized oversight of the research, or as permitted by an authorization signed by the research subject

    In requesting this waiver, researchers should also provide the following information:

    • Detailed information about the types of protected health information that will be used, including how it will be used, who will have access to it, and when it will be destroyed;
    • What risks are posed by the use of the data, and how they have been minimized
    • The justification for access to the data and why they are necessary to conduct the research.