生殖象基因編輯之倫理法律分析：以中國基因編輯嬰兒為例

Ethical Legal Analysis of Germline Gene Editing: An Example of Gene Editing Baby in China

本文以2018年11月中國科學家進行胚胎基因編輯並宣稱已誕生能預防HIV感染之雙胞胎嬰兒為例，探討進行人類生殖系基因編輯所涉倫理法律問題。首先回顧該案相關科學事實、分析胚胎基因編輯所涉人體試驗及研究倫理問題、概述國際醫學會之基因編輯倫理規範與聲明，並以本國相關法律規範為參照、檢視該胚胎基因編輯案例在我國將涉及之法律責任，最後提出合乎倫理之生殖系基因編輯條件。作者藉此案例回顧與倫理法律分析指出，在CRISPR-Cas9基因編輯技術日漸廣泛使用時，相關國際學會指引對於人類生殖系基因編輯之規範有逐漸考慮放寬之趨勢，然而在未能確保生殖系基因編輯對人類胚胎之影響及下一世代可能的長遠衝擊時，生殖系基因編輯是違背研究倫理，而我國法令對此亦明確禁止。未來若能確保安全性前提之下，其可能開放之條件應僅限於重大殘疾且無其他替代療法之遺傳疾病的治療，並須經嚴謹之臨床試驗審查程序、落實知情同意以保障受試者權益。 This paper examines the ethical legal issues involving germ-line gene editing. The Chinese twin baby gene editing case was taken as an example to analyze the medical facts, research ethics and integrity issues, professional guidelines on gene editing, and the possible legal liabilities as investigated according to the laws and regulations in Taiwan. The authors maintain that despite certain international guidelines on germ-line gene editing have been considering to relax recently, specific purpose for treating serious hereditary disease without alternative therapy based on sound clinical evidences and prudent ethics review process for safeguarding transparency and human subject protection are essential for conducting germ-line gene editing research. However, before the premise of safety can be assured, any germ-line gene intervention should be deemed unethical, and it is also against the law of this country.