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Human Subjects Division (HSD)

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Consent, Assent and Waivers

Researchers are required to obtain the informed consent of all participants in human subjects research prior to enrolling those individuals in a study. The individual's consent must be voluntary and based upon adequate knowledge of the purpose, risks, and potential benefits of a research study. All potential participants should also be informed of their right to abstain from participation or to withdraw consent to participate at any time without reprisal. After ensuring that a person has understood the information, the researcher should then obtain the person's consent, preferably in writing.

In cases where individuals are unable to provide consent, either because they are minors or because they are physically or mentally incapable of making informed decisions, researchers are required to obtain "assent" or agreement to participate in a study from the individual. No individual should be enrolled in a study if they do not want to participate, even in cases where their legal guardian consents to their participation. When possible, an assent form should be used to document an individual’s assent.

The IRB may waive the requirement to obtain a subject's consent, or to obtain documentation of the consent, when specific regulatory criteria are met.

Related Questions And Answers

  • 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.

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