The ethical use of mandatory research biopsies

Abstract

Recent clinical trials aim to identify biomarkers of response and resistance to the agents under investigation. This can require tissue samples that will not necessarily provide a direct benefit to the patient. Given the risks associated with any procedure, not every patient is willing to undergo a research biopsy. In this article, Olson et al. present the rationale to establish when research biopsies should be mandatory and to ensure that clinical trials are designed with scientific and ethical rigor. 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.