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美國科學院公開聲明:中國兩名基因編輯嬰兒是否合規(guī)有待確認

2018/11/27
導讀
在第二屆全球基因編輯峰會召開之際,來自南方科技大學學者賀建奎率先利用基因編輯技術編輯一對雙胞胎的基因,引發(fā)全球關注和廣泛討論。

賀建奎將自己推送至輿論的風口浪尖


撰文 | 葉水送 

 

  


在第二屆全球基因編輯峰會召開之際,來自南方科技大學學者賀建奎率先利用基因編輯技術編輯一對雙胞胎的基因,引發(fā)全球關注和廣泛討論。

 

為此美國科學院、工程院以及醫(yī)學院也在第一時間發(fā)表了一份聲明。聲明如下:

 

在第二屆人類基因組編輯國際峰會召開前夕,我們得知中國一對胚胎基因組被編輯的雙胞胎已經(jīng)出生。領導這項研究的科學家賀建奎將于本周三在峰會上發(fā)表演講。


遺傳性基因編輯的臨床試驗標準一直是許多研究小組爭論和討論的主題。大量的研究為可遺傳性基因編輯臨床試驗提供了指導。2017年,由美國國家科學學院、工程院以及醫(yī)學院聯(lián)合發(fā)布的一份報告得出的結論是,(人類胚胎的基因修飾)臨床試驗只有在臨床前被同行評議后權衡潛在風險與獲益、因醫(yī)學難題且無其他手段替代,以及在最大透明度和嚴格監(jiān)督的條件下,才可能被允許。報告還指出,應謹慎從事這類研究并廣泛征求公眾意見。它還制定了一個包括10個建議標準的管理框架。2018年,第二份報告由英國納菲爾德生物倫理委員會(Nuffield Council on Bioethics)獨立調查完成,它規(guī)定了允許可遺傳性基因組編輯干預的情況。中國兩名基因編輯嬰兒出生的臨床方案是否符合這些指導原則還有待確認。

 

我們希望,本次峰會對話將進一步增進全世界對人類基因組編輯問題的認識。我們的目標是幫助并確保人類基因組編輯研究以負責任的態(tài)度進行,從而造福所有人。


聲明原文如下


Statement from the Organizing Committee on Reported Human Embryo Genome Editing


HONG KONG -- On the eve of the Second International Summit on Human Genome Editing, we were informed of the birth of twins in China whose embryonic genomes had been edited. The researcher who led the work, He Jainkui, is scheduled to speak at the summit on Wednesday.

The criteria under which heritable genome-editing clinical trials could be deemed permissible have been the subject of much debate and discussion by many research groups.  Numerous studies have provided guidance for the conduct of heritable genome-editing clinical trials. One such study, a 2017 report by the U.S. National Academies of Sciences, Engineering, and Medicine, concluded that clinical trials might be permitted after peer-reviewed preclinical research further clarifies the potential risks and benefits, only for compelling medical reasons in the absence of reasonable alternatives, and with maximum transparency and strict oversight.  The report noted that such research should be approached with caution and with broad public input.  It specified a regulatory framework that included ten recommended criteria and structures. A second major report, released in 2018, which was the result of an independent inquiry by the Nuffield Council on Bioethics in the U.K., also specifies “circumstances in which heritable genome editing interventions should be permitted.”  Whether the clinical protocols that resulted in the births in China conformed with the guidance in these studies remains to be determined.

We hope that the dialogue at our summit further advances the world’s understanding of the issues surrounding human genome editing.  Our goal is to help ensure that human genome editing research be pursued responsibly, for the benefit of all society. 

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