Waiver or Alteration of Informed Consent

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The CPHS/IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent provided the research meets all applicable regulations.

  • The research is no more than minimal risk;
  • The waiver or alteration will not adversely affect participants rights and welfare;
  • The research could not practicably be carried out without the waiver or alteration; and
  • Whenever appropriate, participants are provided with additional information after participation

A psychological study that uses deception is a common example of research that would require a waiver/alteration of informed consent. In such cases, researchers do not completely reveal the purpose/nature of the study during the consent process, since doing so might affect the results. The IRB commonly requires a debriefing procedure to be in place that fully discloses the purpose after the experimental session has taken place.

Research involving a so-called passive consent procedure requires a waiver/alteration of informed consent.