title: International regulatory landscape and integration of corrective genome editing into in vitro fertilization.
abstract: Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.
authors.forename: Motoko
authors.initials: M
authors.lastname: Araki
authors.affiliation: Office of Health and Safety, Hokkaido University, Sapporo 060-0808, Japan. tishii@general.hokudai.ac.jp.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ishii
mesh_terms: D000818:Animals; D005307:Fertilization in Vitro / Q000009:adverse effects* / Q000592:standards / Q000639:trends; D030342:Genetic Diseases, Inborn / Q000235:genetics / Q000517:prevention & control / Q000628:therapy*; D005818:Genetic Engineering / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D015894:Genome, Human; D023281:Genomics / Q000379:methods / Q000639:trends; D014943:Global Health; D006291:Health Policy / Q000639:trends; D006801:Humans; D057905:Stem Cell Research / Q000331:legislation & jurisprudence; D052416:Targeted Gene Repair / Q000009:adverse effects* / Q000941:ethics / Q000592:standards / Q000639:trends; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence / Q000592:standards