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TitleEthically Impossible
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Total Pages220
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Page 1

september 2011

“Ethically impossiblE”


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About the cover:
Detail taken from historical map

Author: Schrader; vivien St Martin, L.
Date: 1937
Short title: Mexique
Publisher: Librairie hachette, Paris
type: Atlas Map

Images copyright © 2000 by cartography Associates
David rumsey historical Map collection

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“EThically impoSSiblE” STD Research in Guatemala from 1946-1948


Writing after a thorough historical review of practices during this time
period, the president’s advisory committee on human Radiation Experi-
ments (the “Radiation Experiments committee”) reached a set of equivocal
conclusions. on one hand, the Radiation Experiments committee found
that, “as early as 1944 it was conventional for physicians and other biomed-
ical scientists to obtain consent from healthy subjects of research.”673
however, the committee also found that “physicians engaged in clinical
research [i.e., research on sick patients, not healthy volunteers] generally did
not obtain consent from patient-subjects” even when the experiment offered
no prospect of direct benefit to the patient.674 nonetheless, it was “common
for physicians to be concerned about risk in conducting research on patient-
subjects and, in the absence of a prospect of offsetting medical benefit, to
restrict research uses of patients to what were considered low- or minimal-
risk interventions.”675 Subsequent concerns that physician-investigators
underestimated risks to patient-subjects contributed to the establishment of
independent review mechanisms.

by mid-century, these early examples of informed consent and risk-assessment
practices, while not often phrased as such, were common for experiments
involving healthy subjects like prisoners, soldiers, and conscientious objec-
tors.676 in particular, the Terre haute researchers and their superiors—who
included some of the same individuals as the experiments in Guatemala—
carefully considered and adopted strict requirements for individual consent
and voluntariness for the research they conducted in 1943 and 1944.677 in
1946, VDRl researchers Drs. mahoney, cutler, Van Slyke, and blum also
recognized a need to use only “volunteers” as experimental subjects, and
then only after providing adequate information about risks for a prospective
participant to make an informed choice. Writing in the ����������


���������������������������� about their work with prisoners
at Terre haute, the doctors insisted that participants must possess “a thor-
ough understanding of the purpose underlying the study and the possible
risks involved.”678 other researchers engaged in intentional infection research
expressed similar sentiments.679 of course, it is impossible to know whether
these sentiments were largely intended to avert public disapproval.

The period between 1946 and 1948 was an especially important time in the
development of human research ethics. During these years, the nuremberg

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REViEWinG EThical STanDaRDS in conTEXT Vi


medical Tribunal considered charges against 23 physicians and bureaucrats
accused of complicity in concentration camp experiments, many of which
were geared to support the Third Reich’s war effort.680 a key witness for the
prosecution was Dr. andrew c. ivy, a leading u.S. medical researcher who
served as a vice president at the university of illinois and as former scien-
tific director of the naval medical Research institute in bethesda, maryland.
Dr. ivy was a consultant designated by the american medical association
to assist the prosecutors.681 around the time the trial began in 1946, Dr. ivy
prepared a report to articulate ethical and legal conventions, or “rules,” for
human experimentation. historians have argued that the preparation of this
report was prompted by the nazis’ defense lawyers’ surprisingly disconcerting
arguments regarding questionable conduct of human research in the united
States, particularly research conducted in prisons.682

The american medical association accepted the report of Dr. ivy and his
collaborator, Dr. leo alexander, and its house of Delegates adopted it in
December 1946. The �
� published
the statement in early January 1947.683 The rules emphasized voluntary and
informed consent, as well as avoidance of inappropriate risk. first:

“consent of the human subject must be obtained. all subjects
must have been volunteers in the absence of coercion in any
form. before volunteering the subjects have been informed of the
hazards, if any…”684

and, second:

“The experiment must be conducted…so as to avoid all unnecessary
physical and mental suffering and injury, and…there is no �����
reason to believe that death or disabling injury will occur, except
in such experiments as those on yellow fever where the experi-
menters serve as subjects along with non-scientific personnel.”685

in may 1947, Dr. ivy, describing his assessment of the nazi doctors’ medical
experiments in the newsletter of the federation of State medical boards,
concluded that the activities “were crimes because they were performed on
prisoners without their consent and in complete disregard for their human
rights. They were not conducted so as to avoid unnecessary pain and suffering,

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