Ken Kipnis, Nancy M.P. King and Robert M. Nelson (2006), 'Trials and Errors: Barriers to Oversight of Research Conducted under the Emergency Research Consent Waiver', IRB: Ethics & Human Research, 28, pp. 16-19

Despite the Nuremberg Code's assertion that "thevoluntary consent of the human subject isabsolutely essential," federal human research regulations permit both consent from legally authorized representatives (LARs) for incapacitated subjects, and waiver or alteration of informed consent for certain minimal risk research.1 In 1996, the regulations were amended to permit a limited category of research bearing more than minimal risk to go forward without informed consent from either incapacitated subjects or their LARs. Known as the "emergency research" (ER) waiver rule, the regulation was codified in Food and Drug Administration (FDA) regulations2 and adopted by the Department of Health and Human Services (DHHS).3