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COMMENTS AND OPINIONS
Participants in Phase 1 Oncology Research Trials Are Vulnerable—Reply
Christine Grady, PhD, RN;
Justine Seidenfeld;
Elizabeth Horstmann, BA;
Ezekiel J. Emanuel, MD, PhD
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In reply
Our report on the characteristics of participants in phase 1 studies in the United States demonstrated that phase 1 participants as a group do not fit into groups conventionally considered vulnerable based on sociodemographic and health-related characteristics.1 Importantly, these findings do not preclude the possibility that individual phase 1 participants may be conventionally vulnerable, nor the possibility that phase 1 participants as a group are vulnerable in some other way.
The concept of vulnerability has a critical place in research ethics because of its power to designate certain groups that require additional protections above those required for all human participants. Unfortunately, vulnerability has been imprecisely defined, and an increasing number of groups are labeled vulnerable in research without a clear understanding of why. As a consequence, vulnerability has lost its power to guide the . . . [Full Text of this Article]
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Participants in Phase 1 Oncology Research Trials: Are They Vulnerable?
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