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Human Subjects Division (HSD)

Questions and Answers

| Clear Filter: "Consent, Assent and Waivers"
  • Confidential or Anonymous?

    Anonymity and confidentiality are not the same.

    Data

    When data are anonymous, they are not linked to the identity of individual subjects in any way that would make it possible to connect the information to the individual from whom it came. Anonymous data do NOT have direct identifiers like names, addresses, clinic or hospital number, Social Security Number, or insurance agency numbers.

    Data that are linked to subjects via a CODE are NOT anonymous.

    When data are confidential, there is a link between data and the individuals who provide it, but the link is obscured by coding or other procedures so that even someone who has access to the raw data cannot identify a subject without also having access to the link between the subject code and the subject\'s identity.

    Participation

    When participation is anonymous, it is impossible to know whether or not an individual participated in a study.

    When participation is confidential, the study participation of a specific individual is recorded, but cannot be known by anyone except the researcher and authorized research staff who have legitimate access to participation records.

  • May the investigator pre-sign the consent form?

    Except in very specific circumstances, approved on a case-by-case basis by reviewing Committee or subcommittee, consent forms should not be pre-signed.

  • What are the requirements for authorization when researchers wish to access patient information?

    The HIPAA regulations use the term \"authorization\" to describe the process through which a patient allows researchers to access protected health information (PHI). The information must include:

    • a description of the information to be used for research purposes;
    • who may use or disclose the information;
    • who may receive the information;
    • purpose of the use or disclosure;
    • expiration date or event (if the information will be kept indefinitely, the authorization states that there is no expiration date);
    • individual\'s signature and date;
    • right to revoke authorization;
    • right to refuse to sign authorization (if this happens, the individual may be excluded from the research and any treatment associated with the research);
    • if relevant, that the research subject\'s access rights are to be suspended while the clinical trial is in progress, and that the right to access PHI will be reinstated at the conclusion of the clinical trial.

    Blanket authorizations for research to be conducted in the future are not permitted. Each new use requires a specific authorization.

  • What is HIPAA?

    HIPAA is an acronym for the Health Insurance Portability and Accountability Act, passed by Congress in 1996. The purpose of the Act was to increase the ease with which people could transfer their health care information from one insurer or provider to the next. Congress, as part of HIPAA, required the development of privacy regulations to protect the confidentiality of individually identifiable health care information. The final (HIPAA) privacy rule was issued on August 14, 2002. As of April 14, 2003, The University of Washington is in compliance with the Privacy Rule.

  • What is Informed Consent?

    As it relates to the conduct of research within safe and ethical guidelines, informed consent is a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in the research described. In giving informed consent, research subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy; 21 CFR 50.20 and 50.251].

    There are a very few instances in which the requirement to obtain informed consent or in which written documentation of consent might be waived. These might include, for example:

    • Instances in which an investigational drug or device might be used in an emergency situation, the circumstances of which make obtaining informed consent impossible.
    • Research in which information about a potentially illegal activity is being collected and the informed consent could, in and of itself, pose a risk to participants of identification and arrest.
    • In cases where the requirement for informed consent or for written consent is waived, additional protections for research subjects are considered and typically included in the research procedures.
  • 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.
  • 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 kind of research and researchers are affected by the HIPAA regulations?

    Any kind of research conducted under the auspices of the UW and UW Medicine that creates or uses protected health information is subject to the HIPAA regulations. This includes such research activities as clinical trials, chart reviews, epidemiological studies, behavioral, and social science studies, as well as basic science research activities. It includes research that involves the provision of treatment as well as research that provides neither treatment nor diagnosis.

    All researchers, whether or not they are directly connected with UW Medicine, who wish to conduct research involving protected health information must complete HIPAA training before they will be allowed to have access to individually identifiable health information in any form.

  • What should my consent form contain?

    Guidance is available regarding consent, including sample forms, on the Consent, Assent and Waivers topic page.

  • Who is affected by HIPAA?

    All researchers (faculty, staff, or students) at the UW who access or create Protected Health Information (PHI) preceding or during the conduct of their research must comply with the HIPAA regulations.

  • Who should be listed on consent forms?

    The principal investigator should always be identified on the consent form. Also listed should be the name and phone number of the contact person for research subjects.

  • Who should sign as the investigator on the consent form?

    Consent forms should be signed by the person actually administering consent, at the time consent is administered. The person who administers consent, if that person is not the principal investigator, is acting as the agent of the principal investigator and must be able to represent the study with full knowledge and authority to prospective subjects; this person should be listed as an investigator in the Investigators' Information section of the consent form. The principal investigator is ultimately responsible for any defects in the consent process, and the chain of responsibility must be clear.