Disclosure of Individual Research Results and Incidental Findings in Biobank Research: Why We need an Evidence-based Approach

Abstract

Globally, genomic research is generating unprecedented advances in the understanding of the biology, pathogenetic mechanisms and prognostic markers of many cancers and is creating the possibility of precision (personalised) therapies. As more data are generated, it becomes increasingly necessary to determine the clinical significance of this data and to know when this data should be acted upon. The return of individual research results (IRRs) and incidental findings (IFs) from genomic research, in a well-informed and applicable manner, is becoming increasingly important and is already presenting practical challenges in Australian genetics clinics and familial clinics. This article argues for the need to develop an evidence-based approach to help frame ethical-legal responses to address these tensions – one that may offer flexible and defensible parameters to inform the management of disclosure of IRRs and IFs, safeguarding the health and wellbeing of tissue donors and allowing translational biobank genomic research to flourish.