What is a “waiver” of informed consent? How is it different from a waiver of documentation of informed consent?
A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters 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, studies that require deception or passive (opt-out) consent. PLEASE NOTE: The IRB will take into consideration the risks an
