From the Archive: Informed Consent and Medical Research

In our “From the Archive” series, we revisit articles from past issues of the journal. This installment of the series will focus on the nature of informed consent in medical research: here through a case of using radioactive plutonium on living hospital patients. In response to our readership poll, this article was chosen for its discussion of themes valuable to both medical anthropology and to science and technology studies. The article touches on issues pertinent to social studies of health, human subjects research, and the relationships between government, science, and public knowledge.

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Today in From the Archive, we will explore Sharon R. Kaufman’s article “The World War II Plutonium Experiments: Contested Stories and their Lessons for Medical Research and Informed Consent” (Culture, Medicine & Psychiatry June 1997. Volume 21 Issue 2, pages 161-197.) Kaufman opens her argument by asserting that “informed consent is shown to be an evolving process and discursive practice that cannot be understood apart from its historical and cultural embeddedness.” To address this point, she draws on the public response to medical research carried out on 18 patients across the United States who were injected with plutonium: a WWII-era experiment that illustrates the evolving nature of consent between the past and the present. Kaufman suggests that, rather than simply maligning this past research as unethical, we must consider how consent itself is not a static concept.

The author begins by explaining that this experiment, which operated between 1945-1947, only entered common public knowledge in 1993, when once-classified documents about the research were released. The release led to widespread outrage, as media outlets decried the federal government for sponsoring the secret project and endangering the lives of patients. Two central narratives emerged from the information release: a report penned by a journalist, and a report developed between 1994-1995 by a faculty committee at the University of California San Francisco (UCSF) where three of the patient experiments had formerly occurred. The faculty committee’s report aimed to develop a scientific and ethical account of the experiment to be made available to the public and the “university community.”

Though both reports drew information from numerous primary historical documents that described the case, Kaufman cautions us that both accounts are anachronistic, and each crafts a contemporary story consistent with the audience and the authorship of each piece. The journalist’s scathing report emphasized the vulnerability of individual citizens and the hazards of a government able to “harm and deceive,” whereas the committee report instead highlighted the ethics of scientific research and the methodology of the experiment, while paying less heed to the matter of government secrecy. The latter report concluded that the research did not meet either modern measures of informed consent or consent practices of the era in which the experiment was performed; the journalist’s report did not draw this distinction, instead suggesting that the experiment was unethical in both past and present because of the long-term effects of the research on participants or their families.

Kaufman writes that while both reports rightfully agreed that the experiment was “troubling” and that it had undeniable effects on research participants, they simultaneously direct us to a larger issue. Consent, she posits, is scarcely stable: it is situated within too many contexts to be defined in any single fashion. For instance, she notes that patients cannot always distinguish between “therapy” and “experiment” in medical research: thus meaning that the trust participants have in their clinicians’ recommendations for care, and informed consent for research on their illness, cannot always be separated. Likewise, high-risk experiments are not inherently unethical despite being potentially ‘unsuccessful,’ in whatever manner this is defined by researchers and participants. Thus there is no stable measure for informed consent which can be applied to all experiments, in all historical periods.

Kaufman also remarks that such discussions about the “elusive” nature of consent did not formally begin until 1966, the year that Henry Beecher published a landmark article on ethics in clinical research. This was historically much later than the era of the plutonium experiments in the 1940s, when “consent, however informal in character before the war, frequently took a back seat to the sense of urgency and necessity for human experimentation brought on by the war.” Today’s conversations about the autonomy of the patient, transparency surrounding the risks and aims of medical research, and the strengthening of informed consent arrive out of a “different” historical moment, the author states.

This leads Kaufman back to the two plutonium narratives published in the 1990s. She concludes that “as evocations of a moral stance, the narratives
challenge us to compare the past with the present and to reconsider the
idea of moral progress in human experimentation. They promote scrutiny
of contemporary ethical discourses about trust, risk, and the nature of the
physician/investigator-patient/subject relationship.” Kaufman’s article, in sum, invites us to consider the social and historical situatedness of consent in medical research. Rather than characterizing consent as stable across time, she presents a case that underscores how past experiments, contemporary perspectives, and current ethical standards intersect to create new narratives about the complexities of medical research.


 

To access the full article, click here: http://link.springer.com/article/10.1023/A%3A1005360928209

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