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Waiver of Informed Consent Form

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Waiver of Informed Consent Form

Use this form if none of the required elements of consent are given. A waiver of informed consent completely waives the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include some or all of the required elements of informed consent provided all of the following are true:

  • The research involves no more than minimal risk
  • The waiver of informed consent will not adversely affect the rights and welfare of the subjects
  • It is not practicable to conduct the research without the waiver or alteration
  • Whenever appropriate, participants will be provided with additional pertinent information after their participation.

Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, or passive (opt-out) consent.

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research before granting a waiver of informed consent. Additionally, there are restrictions for when the IRB may waive the requirements for child assent and parental permission.