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Table 1 Summary of suggested substantive and procedural legal requirements of germline therapies

From: Human germline editing in the era of CRISPR-Cas: risk and uncertainty, inter-generational responsibility, therapeutic legitimacy

Substantive requirements Treatment of, or prevention against, certain serious, hitherto incurable hereditary diseases.
Diseases to be defined in an abstract way or identified in a list which could be of an exhaustive (i.e. static) or only exemplary (i.e. dynamic) character
Interventions for other, e.g. enhancement or eugenic, purposes to be explicitly prohibited
Acceptable risk of the intervention
Unambiguous cure or prevention of the hereditary disease and unequivocal overall advantage for the embryo’s and its offspring’s health
No negative side effects such as a higher susceptibility of the genome edited embryo, or the resulting born human being and its descendants, to other kinds of diseases
Dependence of the permissibility of germline interventions on necessity
Preclinical scientific testing and evaluation using in vitro animal and human (e.g. stem cell) models as well as in vivo animal models
Procedural requirements Drawing up, and updating, list of diseases by legislator or, on the basis of legislatively delegated powers, of an administrative authority and/or of a special committee composed of relevant stakeholders (e.g. scientists, ethicists, lawyers, medical doctors, patient groups)
Consent of the (future) parents of the embryo
Consent of the mother who will have to carry the genetically modified embryo
Thorough information about the risks by a medical doctor
Establishment of international body in form of “trustee” or “custodian” for the purposes of consent of future generations
Participation in the decision-making process of other institutions such as an ethics committee or a judge