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Waiver of Documentation of Consent

Download a Waiver of Consent template

Description

Potential subjects or the parents of children who are subjects are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.

Situations when it is used

This process is often used in minimal risk research involving the administration of online or mailed surveys, telephone interviews, or when anonymous sensitive information is collected and you do not want any paperwork that links the subject to the research study.

Conditions for approval

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

  1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern , or

    (NOTE: The FDA has not adopted this category so it cannot be used if the research is subject to the FDA regulations at 21 CFR 50)

  2. That the research presents no more than minimal risk of harm to subjects (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Description

This waiver applies when the IRB determines that investigators need not obtain the subjects' informed consent to participate in research in special circumstances.

The IRB may approve research where investigators leave out or alter elements of informed consent, so long as the research meets all applicable regulations.

HHS regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations.

The FDA does not allow a waiver or alteration of the requirements for obtaining informed consent except in special circumstances.

Situations when it is used

The IRB often grants a waiver of consent for retrospective chart review studies.

On rare occasions, prospective collection of data through intervention or interaction with subjects may be granted a waiver of consent.Ìý With compelling reason, a waiver of consent may be granted for studies where secondary subjects may be involved and it would either be prohibitive or potentially dangerous to obtain a consent, as in the case where parent permission for a child to participate may be waived if consenting the parent could be detrimental to the child.

As another example, some research designs require that subjects be left unaware of the particular purpose of the research, because the subjects' responses might be biased if they know in advance what the investigators are seeking. Such research designs do not preclude offering potential subjects some information about the research and giving them the opportunity to decide whether to participate.

Additional provision for CHILDREN who are subjects

The IRB may waive the requirements for obtaining parental or guardian permission under the following provision:
  1. The IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and the following 2 additional criteria are also met:
  • an appropriate mechanism is in place to protect the children, and
  • the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child's age, maturity, status, and condition (45 CFR 46.408(c)). Note that an IRB may waive the requirement for obtaining parental or guardian permission under 45 CFR 46.408(c) even if the research involves more than minimal risk to the child subjects.

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