INTEGRATING NEXT-GENERATION SEQUENCING INTO MEDICAL DIAGNOSTICS--A SNAPSHOT OF NORMATIVE CHALLENGES.

Abstract

Next-Generation Sequencing has been used as a diagnostic tool in an increasing manner. Compared to conventional medical interventions, NGS, as a medical intervention, has its own special characteristics. NGS allows us to obtain a multitude of additional findings. However, their correct interpretation requires molecular biological expertise and is still unknown at the time of the sampling. These factors, when applying NGS, lead to a dynamic process of informational interference with the patients' rights. The physician-patient relationship that becomes successive, is loosened by involving non-physician researchers in the validation of the findings and by the fact that genetic data also gives information about the relatives of the patient. Moreover, dealing with risk information lays the burden on the patients and strengthens their responsibility. These challenges increase in international translational medicine and they demand solutions for the protection of the patients' rights.