Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation
IRB: Ethics & Human Research 2014;36(3):9-15
7 Pages Posted: 13 May 2014
Date Written: May 11, 2014
Research biopsies involve nontrivial burdens, complication risk, and often have no clinical value for subjects. However, little is known about the motivations and consent quality for patients enrolling in such studies- especially outside the context of drug trials. This paper discusses the findings of 10 semi-structured interviews of patients, conducted months after they participated in biomarker studies involving nondiagnostic breast tumor biopsies. Subjects recalled being primarily motivated by altruism, and adequately understood the nontherapeutic nature of research biopsies. Many recalled burdens as modest to minimal. Nevertheless, subjects were generally disengaged from study objectives, and recounted being distracted by recent medical events during the consent process. In addition, two subjects described biopsies as very burdensome. The findings of this study suggest that, at least in recall, subjects are capable of distinguishing care and research procedures, and comprehending research burdens. However, subjects’ detachment from study objectives, and their emotional turmoil during consent, point to limitations in the consent process.
Keywords: Informed consent, clinical research, biopsy, oncology, therapeutic misconception, voluntariness, comprehension, motivation, research procedures
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