Scientific progress in biomedicine takes place at unparalleled speed, and the applications of genome editing are now entering clinical practice. Genome editing is a breakthrough technology that can alter the genome of any organism including humans. Under the aegis of the project SYSNORM (Systems networks norms), researchers aimed to contribute to normative theory through research at the intersection of genomic science, philosophy, and ethics. In the first year of the project, researchers developed a novel foundational argument for dealing with comprehensive human data sets generated from high-throughput genome analyses. SYSNORM also worked on assessing the ethical implications of cutting-edge technologies such as organ-on-chip and organoid model systems. In the second year, the focus was on the emerging genome editing through CRISPR-Cas9 technology. SYSNORM obtained novel insight into the ethical and regulatory aspects of this breakthrough technology. Gene editing can be used for human gene therapies, in future including germ line gene therapy. The use of CRISPR/Cas9 for human germ line interventions influencing heritable traits in humans will have few consequences beyond the individual and their line of descendants. SYSNORM concluded that the potential disruptive effect of human germ line editing is small when compared to the global impact of using gene editing to influence ecosystems. The use of CRISPR-based alterations in wild animal populations, in combination with a gene drive, can be considered the most impactful application of genome editing. In this scenario, the genome alterations might rapidly spread through a wild animal or plant population enabling the reduction or elimination of disease vectors, pests, and invasive species. Therefore, the case of genome editing for ecosystem management requires global deliberations that take into account a diversity of value systems as well as effective modes of governance. Overall, SYSNORM activities contributed to the development of a blueprint for a normative model relevant for novel genomic technologies. Against the background of rapid technological progress, this project has addressed a broad range of issues of societal relevance, spanning from data sharing to the ethics of human germ line editing.
SYSNORM, network biomedince, data sharing, CRISPR/Cas9, germ line editing, gene drives