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The Ethical Use of Mandatory Research Biopsies

Overview
Journal Nat Rev Clin Oncol
Specialty Oncology
Date 2011 Aug 3
PMID 21808265
Citations 27
Authors
Erin M Olson
Nancy U Lin
Ian E Krop
Eric P Winer
Affiliations
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Abstract

Increasingly, clinical trials incorporate translational research questions aimed at identifying biomarkers of response or resistance to agents under investigation. Biomarker assays can require tissue samples to be collected through a research biopsy before therapy, during treatment, or at the time of tumor progression. Such biopsy samples will generally not provide a direct benefit to the patient and, given the risks associated with any surgical procedure, ethical concerns have been raised when the participant's enrollment on a clinical trial depends on their consent to undergo a research biopsy. In this Perspectives article, we present the rationale for mandatory research biopsies and offer suggestions for standardization to ensure that high-quality, patient-centered, clinical trials continue to be designed with scientific and ethical rigor.

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