Waiver of Informed Consent

Informed Consent may only be waived if the study involves no more than minimal risk and will not adversely affect the rights and welfare of the subjects. An approval of an IRB application that does not utilize informed consent will only be approved if the research cannot be practically carried out without the waiver. In historical research where information is obtained related to the causes of fatal motor vehicle accidents, for example, informed consent may be waived.

If the only paper document linking a subject to a specific study is the informed consent and the information sought is sensitive, subjects may agree to participate in the study after giving verbal consent without signing the document. This type of situation might arise where insurance, legal, employment or personal conflict issues would otherwise influence subjects not to participate if information is linked to them personally. This situation would only be approved if the study involves no more than minimal risk and will not adversely affect the rights and welfare of the subjects. If the procedures normally require written consent this would not override the need for permission to perform the procedures (eg. Surgical options, invasive procedures, genetic testing)

Let's Test Your Knowledge!

<<< Back