P20.06B / B - Incidental findings in genetic testing: a comparison between US and european guidelines and a bioethical reflection

Next-Generation Sequencing (NGS) use in biomedical diagnosis and research makes now possible a deeper genetic and genomic analysis at a reduced cost. However, the analysis of evidence that is based on such big data can result in the generation of knowledge that is not relevant to the clinical question posed because some genes are associated with multiple medical conditions. These kind of information are commonly referred to as "incidental findings" and their management pose new ethical issues and dilemmas, especially regarding their disclosure to patients as well as the role of the different clinical figures involved. In this work we aim to analyze different recommendations and guidelines, referring in particular to USA and Europe. Numerous discussions have been conducted in order to reach a consensus on how to handle such findings in line with the legal and cultural particularities of individual states and general bio-ethical principles and different guidelines have been published. These reports mainly focus on the pros and cons of NGS technology and potential benefits and risks for reporting of incidental findings.We want to compare these various statements and try to figure out how patient’s will could be better included in the decision making and the disclosure process, in order to respect its autonomy. We also point out the need for continued debate, research, and discussion among all stakeholders to improve our understanding of the effect that different policies have on patients, providers, laboratories, and societies.