title: 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.
authors.affiliation: Dana-Farber Cancer Institute, Harvard Medical School, 450 Brookline Avenue, Boston, MA 02215, USA.
authors.forename: Erin M
authors.initials: EM
authors.lastname: Olson
authors.forename: Nancy U
authors.initials: NU
authors.lastname: Lin
authors.forename: Ian E
authors.initials: IE
authors.lastname: Krop
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
mesh_terms: D035843:Biomedical Research; D001706:Biopsy / Q000379:methods; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*