Waiver of the Consent Requirement

While the federal regulations state “Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject’s legally authorized representative,” there may be circumstances where studies can be conducted without obtaining informed consent or by using a consent process that omits or alters the required elements.

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 HSRO 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.

In order to waive or alter consent, the HSRO 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.

The HSRO 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 HSRO will determine if a debriefing form is necessary and will guide the Investigator in what information should be disclosed.