Carte Blanche: The Erosion of Medical Consent

Harriet Washington

feb 2021 · Penguin Random House Audio · Narrado por William DeMeritt

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Carte Blanche is the alarming tale of how the right of Americans to say "no" to risky medical research is eroding at a time when we are racing to produce a vaccine and treatments for Covid-19

This medical right that we have long taken for granted was first sacrificed on the altar of military expediency in 1990 when the Department of Defense asked for and received from the FDA a waiver that permitted it to force an experimental anthrax vaccine on the ranks of ground troops headed for the Persian Gulf. Since then, the military has pressed ahead to impose nonconsensual testing of the blood substitute PolyHeme in civilian urbanities, quietly enrolling more than 20,000 non-consenting subjects since 2005. Most Americans think that their right to give or withhold consent is protected by law, but the passing in 1996 of modifications to the Code of Federal Regulations, such as statute CFR 21 50.24, now permit investigators to conduct research wtih trauma victims without their consent or event their knowledge. More than a dozen studies since have used the 1996 loophole to recruit large numbers of subjects without their knowledge. The erosion of consent is the result of a U.S. medical-research system that has proven again and again that it cannot be trusted.

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HARRIET A. WASHINGTON is a science writer, editor and ethicist. She is the author of A Terrible Thing to Waste: Environmental Racism and the Assault on the American Mind; Infectious Madness: The Surprising Science of How We 'Catch' Mental Illness; and Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present, which won the National Book Critics Circle Award (Nonfiction). She has been a Research Fellow in Medical Ethics at Harvard Medical School, Visiting Fellow at the Harvard TH Chan School of Public Health, a visiting scholar At DePaul University College of Law, the Miriam Shearing Fellow at the University of Nevada's Black Mountain Institute and a senior resarch scholar at the National Center for Bioethics at Tuskegee University. She has also held fellowships at Stanford University, holds a MA in journalism from Columbia University and in 2016 was elected a Fellow at the New York Academy of Medicine. She lectures in bioethics at Columbia and is a newly elected member of the National Book Critics Circle.