COMParative ASSessment of Genome and Epigenome Editing in Medicine: Ethical, Legal and Social Implications 2.0 (COMPASS-ELSI 2.0)

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This proposal for COMPASS-ELSI 2.0 builds on the results of the COMPASS-ELSI project (hereafter COMPASS-ELSI 1.0). By continuing the latter, COMPASS-ELSI 2.0 on the one hand aims at consolidating open issues from COMPASS-ELSI 1.0, and on the other hand aims at studying new aspects of genome and epigenome editing that have been detected as particularly relevant for the ethical and legal debate during the first funding period. Apart from research conducted by the COMPASS-ELSI 1.0 project group, the general ethical and legal discourse has primarily concentrated on genome editing, whereas epigenome editing has gained little attention. However, as COMPASS-ELSI 1.0 revealed, also epigenome editing does possess high potential. It could open new and exclusive therapeutic possibilities in medicine and could partially represent a less invasive and less risky therapeutic alternative to genome editing. The legal assessment of genome and epigenome editing in medicine developed in COMPASS-ELSI 1.0 will be extended, especially regarding the evaluation of germline interventions according to European primary and secondary law and in the light of other international regulations. Furthermore, the concept of disease needs to be legally reflected and readjusted with regards to therapeutic and non-therapeutic application scenarios of the editing procedures, especially epigenome editing. Finally, approaches for the introduction of a reproductive medicine law will be evaluated and a concrete regulatory proposal will be submitted.The ethical subproject of COMPASS-ELSI 2.0 closes the current research gap on the ethical evaluation of epigenome editing. Focusing on realistic application scenarios as use cases and on the analysis of types of arguments this includes the evaluation of epigenome editing in fetuses with respect to a special moral status and specific requirements for parental consent. It also includes the evaluation of argumentative types prevalent in the debate on genome editing. The validity of slippery slope arguments, only-when-it-is-safe arguments, the non-identity problem, and naturalness arguments is tested. It is evaluated whether these argument types are also applicable to an assessment of epigenome editing, e.g., is the identity of the fetus affected if its epigenome is modified?The interdisciplinary project COMPASS-ELS 2.0 aims at guiding the ethical and legal assessment of epigenome editing in comparison to genome editing in medicine and formulates therefore joint ethical and legal recommendations. These will be scientifically well-founded and based only on valid and sound ethical and legal arguments. They include considerations about the language employed in genome editing discourse and are sensitive to implications of the chosen wording. This continues the previous DFG-project COMPASS-ELSI 1.0 for an additional period of 12 months.