Can any of the required elements be waived by the IRB?
A. Yes. If there is a compelling reason to waive one or more elements, then the IRB may do so (45 CFR 46.116(d)). In the context of minimal risk survey research on mundane topics, where potential subjects might refuse to participate rather than listen to a lengthy informed consent process, an investigator might wish to minimize respondent time burden by requesting a waiver of one or more elements in the oral consent process and offering instead to provide the information in response to a subject’s question. For example, some IRBs have agreed to waive the required “explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights” if it is available to any subject requesting it. Importantly, it is the investigator’s responsibility to request waivers of consent or any specific elements of consent, and the investigator’s rationale for a waiver may or may not be compelling to the IRB. The Federal regulations (45 CFR 46.116(d)) state that IRB
