Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat

Authors

George J. Annas, Boston University School of LawFollow

Author granted license

Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International

Document Type

Article

Publication Date

1998

ISSN

0098-8588

Publisher

American Society of Law, Medicine & Ethics

Language

en-US

Abstract

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

Recommended Citation

George J. Annas, Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat , in 24 American Journal of Law & Medicine 245 (1998).
Available at: https://scholarship.law.bu.edu/faculty_scholarship/1314