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COMMENTS AND OPINIONS
Participants in Phase 1 Oncology Research Trials Are Vulnerable
Ron Berghmans, PhD
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Seidenfeld et al1(p16) argue on the basis of empirical research they conducted that "[t]he 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 al1(p17) 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 . . . [Full Text of this Article]
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RELATED ARTICLE
Participants in Phase 1 Oncology Research Trials: Are They Vulnerable?
Justine Seidenfeld, Elizabeth Horstmann, Ezekiel J. Emanuel, and Christine Grady
Arch Intern Med. 2008;168(1):16-20.
ABSTRACT
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RELATED LETTER
Participants in Phase 1 Oncology Research Trials Are Vulnerable—Reply
Christine Grady, Justine Seidenfeld, Elizabeth Horstmann, and Ezekiel J. Emanuel
Arch Intern Med. 2008;168(20):2288.
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