FAQ: Waiver of Documentation

  1. What is the difference between a waiver of documentation of consent and a waiver of consent?

    When the IRB grants a waiver of consent, consent is not necessary for enrollment.

    When the IRB grants a waiver of documentation of consent, the investigator needs to obtain the subject’s consent but not the subject’s signature to document it. In this case, the investigator can document having obtained consent (e.g. on the verbal consent form or in the study chart).

  2. Can I record any individually identifiable private information and obtain a waiver of documentation of consent under 46.117(c)(1)(i)?

    In order to waive documentation under (c)(1)(i), all of the data collected must be anonymous which means recorded without any identifying information.

  3. If the study is FDA-regulated, can I obtain a waiver of documentation under 46.117(c)(1)(i)?

    The FDA regulations mandate that all subjects be identifiable in order to permit an audit of the source documents so there is no FDA equivalent to 46.117(c)(1)(i).

  4. Which research procedures can take place and still waive documentation of consent?

    To waive the requirement for documentation under 46.117(c)(1)(ii) or 56.109(c)(1), the procedures in the research must be limited to those that don't require written consent as part of clinical care. Examples include: Blood draw, Questionnaires, Chest X-ray, and DXA scan.

  5. Why does the IRB require that I have a consent form approved if I have obtained a waiver of documentation of consent?

    The IRB must ensure that the subject is provided with the necessary information to make an informed decision about study participation. The waiver of documentation is merely related to the requirement for a subject to sign, and thus document, their consent.

  6. When do I need to give the subject an information sheet?

    When the IRB waives documentation of consent under (c)(1) or under 50.109(c) of the FDA regulations, it can require the investigator to provide the subject an Information Sheet when the IRB decides that subjects should have some information to refer back to after completion of the study. The contents of the Information Sheet do not need to match those of a consent form but should contain at a minimum:

    • The title of the research
    • Contact information for the investigator
    • An explanation of the purpose of the research
    • A description of the procedures
  7. What if HIPAA applies to the research, can I still obtain a waiver of documentation of consent?

    HIPAA at 45 CFR 164.512 permits oral authorization instead of written authorization provided that the study meets the criteria for alteration or waiver of HIPAA. If the research involves individually identifiable health information, then the investigator must also do one of the following:

    • Request an alteration (sometimes referred to as a partial waiver) of Written Authorization, or
    • Obtain Written Authorization for use of PHI using a stand-alone HIPAA Authorization