FAQ: Waiver of Documentation

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

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

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

    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).

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

    To waive the requirement for documentation under 46.117(c)(1) 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.

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

    When the IRB waives documentation of consent under (c)(1), the subject must still be offered the opportunity to be linked to the research. ThisSigning the consent document is the easiest way to be linked to the research. The investigator can propose an alternative mechanism as a substitute.

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

    When the IRB waives documentation of consent under (c)(2) or under 50.109(c) of the FDA regs, 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
  6. 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