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The ethical use of mandatory research biopsies.

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.

SUBMITTER: Olson EM

PROVIDER: S-EPMC3632075 | biostudies-other | 2011 Aug

REPOSITORIES: biostudies-other

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The ethical use of mandatory research biopsies.

Olson Erin M EM Lin Nancy U NU Krop Ian E IE Winer Eric P EP

Nature reviews. Clinical oncology 20110802 10

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 ...[more]

PMID: 21808265

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