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

COMPASS-ELSI 2.0的建议建立在COMPASS-ELSI项目（以下简称COMPASS-ELSI 1.0）的结果之上。通过继续后者，COMPASS-ELSI 2.0一方面旨在巩固COMPASS-ELSI 1.0的开放问题，另一方面旨在研究基因组和表观基因组编辑的新方面，这些方面在第一个资助期内被发现与伦理和法律的辩论特别相关。除了COMPASS-ELSI 1.0项目组进行的研究外，一般的伦理和法律的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得到关注。然而，正如COMPASS-ELSI 1.0所揭示的那样，表观基因组编辑也具有很高的潜力。它可以在医学上开辟新的和独特的治疗可能性，并可以部分代表基因组编辑的侵入性和风险较小的治疗替代方案。在COMPASS-ELSI 1.0中开发的医学基因组和表观基因组编辑的法律的评估将得到扩展，特别是根据欧洲主要和次要法律以及其他国际法规评估生殖系干预。此外，疾病的概念需要在编辑程序的治疗和非治疗应用场景方面得到法律上的反映和调整，特别是表观基因组编辑。最后，将评估引入生殖医学法的方法，并提交具体的监管建议。COMPASS-ELSI 2.0伦理子项目填补了目前关于表观基因组编辑伦理评估的研究空白。重点关注作为用例的现实应用场景和对论点类型的分析，这包括评估胎儿中的表观基因组编辑与特殊道德地位和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论类型的评估。滑坡参数的有效性，只有当它是安全的参数，非同一性问题，和自然的参数进行了测试。评估这些参数类型是否也适用于表观基因组编辑的评估，例如，如果胎儿的表观基因组被修改，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的评估，并因此制定联合伦理和法律的建议。这些都将是有科学根据的，并且只以有效和健全的道德和法律的论点为基础。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。这延续了DFG之前的COMPASS-ELSI 1.0项目，为期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.