Letter to the Editor
Archives of Internal Medicine (to be published November 2008)
Participants in Phase 1 Oncology Research Trials are Vulnerable.
Dear Sir,
Seidenfeld, Horstmann, Emanuel and Grady[1] argue on the basis of empirical research they conducted that “the demographic and health status characteristics of phase 1 oncology trial participants are not those of a conventional vulnerable population and suggest little reason to assume that, as a group, they have a compromised ability to understand information or to make informed and voluntary decisions.”
The first part of this quotation may be true; the second part not necessarily so.
Seidenfeld et al. note that individuals are considered vulnerable in research if they are “relatively or (absolutely) incapable of protecting their own interests” and are thus presumed more likely to be misled, mistreated, or otherwise taken advantage of as research participants. They classify vulnerable populations in research into 3 broad categories. First, limited cognitive capacity may render individuals incapable of processing information or making rational decisions. Second, individuals’ capacity to make voluntary decisions may be compromised when they are in a dependent position and fear real or perceived repercussions, and third: individuals may be incapable of protecting their own interests because of a comparatively reduced ability to make rational or voluntary decisions. To the third group belong subjects who as a result of socio-demographic factors have a reduced ability to understand research information, as well as subjects who as a result of economic disadvantage may have difficulty to reject research participation because of severely circumscribed options for health care.
The concern with regard to the participation of patients in phase 1 oncology research trials is not so much whether participants count as being vulnerable on the basis of demographic and health status characteristics, but whether their consent is an expression of the so-called therapeutic misconception.[2] As a result of the therapeutic misconception the consent of the research subject falls below what counts as an informed, voluntary and well-considered decision. Falsely perceiving the participation in a phase 1 trial as promising a realistic chance of therapeutic benefits may be a result of the fostering of false hope. As Seidenfeld et al. rightly observe, patients with end-stage cancer may be swayed by a “unique” opportunity to receive a novel but unproved anticancer agent. They may misinterpret or disregard the unfavorable risks and benefits of participation.
So even if none of the 3 before mentioned categories may apply, participants in phase 1 oncology research trials nevertheless on the basis of the therapeutic misconception may qualify as being vulnerable, and as a result of that are in need of extra protection in these trials.
[1] Seidenfeld J, Horstmann E, Emanuel EJ, Grady C. Participants in phase 1 oncology research trials. Are they vulnerable? Arch Intern Med. 2008;168(1):16-20.
[2] Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception.
Glannon W. Phase I oncology trials: why the therapeutic misconception will not go away. J Med Ethics. 2006;32(5):252-255.
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