Author granted license

Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International

Document Type


Publication Date





American Society of Law, Medicine & Ethics




In 1990, following Iraq's invasion of Kuwait, the Department of Defense (DOD) sought a waiver of the informed consent requirements of existing human experimentation regulations from the Food and Drug Administration (FDA). With this waiver, DOD could authorize military use of investigational drugs and vaccines on soldiers involved in the Gulf War without their informed consent. The basis of the waiver request was military expediency. In DOD's words: "In all peace time applications, we believe strongly in informed consent and ethical foundations... but military combat is different." DOD's rationale was that informed consent under combat conditions was "not feasible" because some troops might refuse to consent, and the military could not tolerate such refusals because of "military combat exigencies." 5 FDA granted the request and issued a new general regulation, Rule 23(d), which permits drug-by-drug waiver approval on the basis that consent is "not feasible" in a "specific military operation involving combat or the immediate threat of combat." 6

Link to Publisher Site Link to Publisher Site (BU Community Subscription)



To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.