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

这份关于COMPASS-ELSI 2.0的提案建立在COMPASS-ELSI项目(以下简称COMPASS-ELSI 1.0)成果的基础上。通过继续后者，COMPASS-ELSI 2.0一方面旨在巩固COMPASS-ELSI 1.0中尚未解决的问题，另一方面旨在研究基因组和表观基因组编辑的新方面，这些方面已被发现与第一个资助期的伦理和法律辩论特别相关。除了COMPASS-ELSI 1.0项目组进行的研究外，一般的伦理和法律话语主要集中在基因组编辑上，而表观基因组编辑几乎没有受到关注。然而，正如Compass-ELSI 1.0揭示的那样，表观基因组编辑也具有很高的潜力。它可能在医学上打开新的和独一无二的治疗可能性，并可能在一定程度上代表着一种侵入性更小、风险更低的治疗替代方案，而不是基因组编辑。将扩大COMPASS-ELSI 1.0中制定的对医学中基因组和表观基因组编辑的法律评估，特别是根据欧洲主要和次要法律并参照其他国际法规对生殖系干预措施的评估。此外，关于编辑程序的治疗性和非治疗性应用场景，特别是表观基因组编辑，疾病的概念需要在法律上得到反映和调整。最后，将对引入生殖医学法的方法进行评估，并提交具体的监管建议。COMPASS-ELSI 2.0的伦理子项目填补了目前在表观基因组编辑伦理评估方面的研究空白。将重点放在现实应用场景作为用例和对各种论点的分析上，这包括针对特殊道德地位对胎儿表观基因组编辑的评价和对父母同意的具体要求。它还包括对基因组编辑辩论中普遍存在的争辩类型的评估。测试了滑坡论点、只有当它是安全的论点、非同一性问题和自然性论点的有效性。评估这些论点类型是否也适用于表观基因组编辑的评估，例如，如果其表观基因组被修改，胎儿的身份是否会受到影响？跨学科项目COMPASS-ELS 2.0旨在指导与医学基因组编辑相比的表观基因组编辑的伦理和法律评估，并因此制定联合的伦理和法律建议。这些将是有科学依据的，而且只基于有效和健全的伦理和法律论点。它们包括对基因组编辑话语中使用的语言的考虑，并对所选措辞的含义敏感。这将把以前的DFG-项目COMPASS-ELSI 1.0再延长12个月。

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.