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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 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 should my consent form contain?

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

  • 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.