Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-26T08:25:01.298Z Has data issue: false hasContentIssue false
  • English
  • Français

The Vulnerability of the Very Sick

Published online by Cambridge University Press:  01 January 2021

Jerry Menikoff
Get access Rights & Permissions [Opens in a new window]

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

National Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in Research Involving Human Participants, Vol. I, Bethesda, 2001; Kipnis, K., “Vulnerability in Research Subjects: A Bioethical Taxonomy,” in Ethical and Policy Issues in Research Involving Human Participants, Vol. II, National Bioethics Advisory Commission, Bethesda, 2001.Google Scholar
45 CFR Part 46, Subparts B, C, and D.Google Scholar
45 CFR §§ 46.107(a), 111(a)(3), and 111(b).Google Scholar
45 CFR § 46.111(a)(3).Google Scholar
In contrast, the Belmont Report did specifically note that the “very sick,” due to “their dependent status and their frequently compromised capacity to consent,” and the ease at manipulating them, merited special protections. Department of Health, Education and Welfare, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 44 Federal Register 23,192 (1979).Google Scholar
45 CFR § 46.111(a)(3).Google Scholar
45 CFR § 46.111(b).Google Scholar
45 CFR § 46.107(a).Google Scholar
Levine, C., “The Limitations of “Vulnerability' as a Protection for Human Research Participants,” American Journal of Bioethics 4, no. 3 (2004): 44–49.CrossRefGoogle Scholar
See NBAC, supra note 1, at 85.Google Scholar
Id., at 87.Google Scholar
Id., at 89.Google Scholar
The word “enlightened” is from the Nuremberg Code. Trials of War Criminals before the Nurenberg Military Tribunals under Control Council Law No. 10 (1949).Google Scholar
45 CFR § 46.111(a)(3).Google Scholar
45 CFR § 46.116.Google Scholar
Id.Google Scholar
Id.Google Scholar
45 CFR § 46.102(c).Google Scholar
Luebbert, R., “IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies,” Journal of Empirical Research on Human Research Ethics 3, no. 1 (2008): 15–34, at 16.CrossRefGoogle Scholar
Pereira, J., “The Frequency and Clinical Course of Cognitive Impairment in Patients with Terminal Cancer,” Cancer 79, no. 4 (1997): 835–842; Schaeffer, M. H., “The Impact of Disease Severity on the Informed Consent Process in Clinical Research,” American Journal of Medicine 100, no. 3 (1996): 261–268; Raymont, V., “Prevalence of Mental Incapacity in Medical Inpatients and Associated Risk Factors,” The Lancet 364, no. 9443 (2004): 1421–1427.3.0.CO;2-#>CrossRefGoogle Scholar
See Luebbert, , supra note 19.Google Scholar
See Department of Health, Education and Welfare, supra note 5.Google Scholar
Resnik, D., “Oncology Consent Forms: Failure to Disclose Off-Site Treatment Availability,” IRB: Ethics & Human Research 30, no. 6 (2008): 7–11.Google Scholar
See National Bioethics Advisory Commission, supra note 1, at 88.Google Scholar
Id., at 88.Google Scholar
Note that this category has a significant overlap with the category of patients described by the NBAC report as being medically vulnerable, which is “potential participants who have serious health conditions for which there are no satisfactory standard treatments.”27. See NBAC, supra note 1, at 90. See also Appelbaum, P. S. Roth, L. H. Lidz, C. W. Benson, P. Winslade, W., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report 17, no. 2 (1987): 20–24.CrossRefGoogle Scholar
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
Hawkins, J. S. Emanuel, E., “Clarifying Confusions about Coercion,” Hastings Center Report 35, no. 5 (2005): 16–19; see Kipnis, , supra note 1, at G-8.CrossRefGoogle Scholar
This assumes that the design elements which lead to the reduction in benefits, or the increase in risks, contribute toward answering the research question.Google Scholar
45 CFR § 46.111(a)(2).Google Scholar
Menikoff, J. Richards, E., What the Doctor Didn't Say: The Hidden Truth about Medical Research (New York: Oxford University Press, 2006): at 56.
See supra note 28.Google Scholar
45 CFR § 46.111(a)(1).Google Scholar
See Kipnis, , supra note 1. The issues being raised here might interact in a complicated way with other types of vulnerability. For example, the subjects might be economically vulnerable, and obtaining the new treatment outside of the study might be much more expensive than participating in the study.Google Scholar
Addicott, C., “Regulating Research on the Terminally Ill: A Proposal for Heightened Safeguards,” Journal of Contemporary Health Law & Policy 15, no. 2 (1999): 479–524.Google Scholar
The NBAC reports suggests that one way of minimizing the likelihood of an IRB encountering the lopsided designs discussed here is to have representatives of the vulnerable population play an active role in the design of the study. See NBAC, supra note 1, at 91.Google Scholar
See Kipnis, , supra note 1.Google Scholar