The ethical use of mandatory research biopsies

Nat Rev Clin Oncol. 2011 Aug 2;8(10):620-5. doi: 10.1038/nrclinonc.2011.114.

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.

Publication types

  • Review

MeSH terms

  • Biomedical Research*
  • Biopsy / methods
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / standards*
  • Humans
  • Informed Consent / ethics*