The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.

中文翻译：

---

种系基因组编辑研究：配子捐赠者在同意书中（不）被告知什么？

在人类中使用种系基因组编辑（GGE）的潜力引起了广泛关注，不仅因为它的科学可能性，也因为它引发的伦理、法律和社会挑战。伦理争论主要集中在使用 GGE 建立妊娠（即在临床环境中提供妊娠）的建议上，迄今为止，这在许多司法管辖区都是非法的。尽管 GGE 在研究中的使用（无法确定是否怀孕）受到的关注要少得多，尽管它也引发了严重的伦理和社会问题。在此，我们报告了一项广泛宣传的研究中使用的卵子和精子捐赠知情同意书的分析，该研究使用基因组编辑来纠正人类胚胎中致病的基因突变。重要的是，胚胎是使用专门为这些实验获得的卵子和精子创建的。分析表明，表格在解决各种问题方面存在缺陷，包括有关研究敏感性质的信息有限且可能具有误导性，缺乏对基因组测序的明确提及，以及表格的可读性较差。此外，卵子捐赠者 5,000 美元的高额补偿引发了人们对不当诱导参与研究的质疑。此外，由于鸡蛋的采购涉及严重的健康风险，因此可能会质疑是否应该进行需要这种程序的研究。如果继续进行此类实验，应告知捐助者所有相关方面，以便就参与做出明智的决定。