The iterative informed consent model for the feedback of incidental findings in human health research using WGS procedures

Facing the upcoming application possibilities of genomic sequencing in human health research, to determine the appropriate ethical scope of genetic counselling for research participants becomes a most important challenge. In this thesis, an informed consent model for the disclosure of incidental findings in research using whole genome sequencing or whole exome sequencing will be presented. The design of an informed consent model is always based on a general informed consent theory. Thus, informed consent models can be defined as application of an ideal informed consent theory, containing general ethical principles, to a particular context. The aim of the thesis is to design and defend an inform model that determines the appropriate ethical scope of genetic counselling process for the disclosure of incidental findings –which I call the iterative feedback model due to the continuous informed consent process for the disclosure of incidental findings between counsellor and individual research participant. For this purpose, informed consent theories will be analysed and adapted to the case of human health research using whole genome/exome sequencing. Furthermore, relevant values of research ethics and characteristics of genomic data will be taken into consideration. The iterative model of informed consent is based on the traditional and on the dynamic consent models to ensure understanding and autonomous choice by research subjects.