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Waiver of the Requirements to Obtain Informed Consent

Studies can be conducted without obtaining informed consent (or parental consent) or using a consent process that includes altered elements  but only if the HSRO grants a waiver of the informed consent requirement.

In order for an IRB to waive or alter consent, the IRB must find and document all of the following points:

  • The research involves no more than minimal risk to the subjects;
  • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format*;
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation, and
  • The research could not practicably be carried out without the requested waiver or alteration.

* This new criterion is that the IRB must determine that the research could not practicably be carried out without using the information or biospecimens in an identifiable form. The purpose of this additional criterion is that if the research could be done using non-identifiable information, then that is what should be done. In these cases, researchers shouldn’t be using identifiable information because it increases the risk of breaches of privacy or confidentiality.

In each case, all of the points must be evident for a waiver. The IRB will consider whether a waiver is appropriate and may not grant one if they feel it is not in the best interest of the subjects.


Sometimes, particularly in behavioral research, investigators plan to withhold information about the real purpose of the research or even give subjects false information about some aspect of the research.  This means that the subject's consent may not be fully informed.  When the IRB reviews research involving incomplete disclosure or outright deception it must decide whether the information to be withheld would influence the decision of prospective subjects about participating in the research.

The IRB will consider the risks to which subjects will be exposed and then decide whether to waive or alter consent requirements.  To receive a waiver of consent requirements, the study must present no more than minimal risk and the waiver must not adversely affect the rights and welfare of subjects, and must be essential to the ability to carry out the research.

Whenever appropriate, subjects should be given additional pertinent information after they have participated in such a study. The IRB will determine if a debriefing form is necessary and will guide the Investigator in what information should be disclosed.