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The Vulnerability of the Very Sick

Published online by Cambridge University Press:  01 January 2021

Jerry Menikoff
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Extract

Suppose that someone has a serious illness. The illness will likely lead to significant disabilities, and may even cause death. Existing treatments are unsatisfactory. The patient learns about a clinical trial, in which some allegedly promising new treatment for that illness is being tested.

Such seriously ill patients for whom existing treatments are unsatisfactory have sometimes been categorized as medically vulnerable in the literature. Should these patients indeed be considered vulnerable subjects and be provided with special protections? And if the answer is yes, then what are those special protections? This article explores the possible answers to these questions.

The federal regulations for the protection of research subjects have several provisions addressing the concept of vulnerability. The three subparts Subparts B (pregnant women, fetuses, and neonates), C (prisoners), and D (children) deal with specific categories of vulnerable subjects, but do relatively little to address broader issues relating to vulnerability that might apply to a category such as the medically vulnerable. The Common Rule (Subpart A) is the only section containing general discussions of vulnerability.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 1 , Spring 2009 , pp. 51 - 58
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

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Exploitation is a concept that does not have a single clear meaning. In its own way, it may be as unclear as the concepts of vulnerability or undue influence, and no doubt there is some degree of overlap among these concepts that would require extended analysis to tease out. One of the best discussions of what exploitation should mean is Alan Wertheimer's Exploitation (1996). Wertheimer concludes that it should refer to circumstances in which one party takes unfair advantage of another party. Under his view, it is not necessary that the exploited party be made worse off by the transaction, nor does the party's consent negate the existence of exploitation. That understanding of the term is consistent with its use in this article. Our society might consider it unfair to reap huge benefits in terms of additional medical knowledge when the subjects are offered participation in studies that intentionally minimize their likelihood of obtaining substantial net health benefits. That the subjects are slightly better off than if they were not able to enroll in these studies, and that they consented to participate, does not alter the ability to characterize what happens as being exploitive.Google Scholar
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