Nisker Jeff, White Angela, Tekpetey Francis, Feyles Valter
Department of Obstetrics and Gynaecology, Schulich School of Medicine & Dentistry, University of Western Ontario, London ON.
CIHR Strategic Training Initiative in Research in Reproductive Health Sciences (STIRRHS), University of Western Ontario, London ON.
J Obstet Gynaecol Can. 2006 Oct;28(10):903-908. doi: 10.1016/S1701-2163(16)32279-4.
To develop and investigate a consent process that satisfies the Assisted Human Reproduction (AHR) Act and the Canadian Institutes of Health Research (CIHR) Stem Cell Guidelines, furthers free and informed choice, and fosters embryo donation to human embryonic stem cell (hESC) research.
Consultations were undertaken with an hESC scientist, in vitro fertilization (IVF) team members, and the ethicist-author of the CIHR Guidelines to review the AHR Act, the CIHR Stem Cell Guidelines, the established consent process for embryo donation at University Hospital, London Health Sciences Centre, the characteristics of patients appropriate for contact, and strategies for sensitive recruitment. Invitation-to-participate packages were sent to patients.
Patients deemed appropriate for contact had indicated their intent to donate embryos to research, had embryos that had been cryopreserved for more than five years, had not received donor gametes, and had publicly listed addresses, with no suggestion of separation of the parties. Strategies developed to promote anonymity, confidentiality, and informed choice included a "firewall" between clinical and research teams and documents reiterating that, if embryos were donated, the woman would have to undergo additional IVF treatment to have a child. Of 40 couples contacted, only 22 agreed to donate embryos to the hESC study. One couple no longer wished to donate embryos to research, one package was returned as undeliverable, and no response was received from 16 couples.
The consent requirements of the AHR Act and the CIHR Stem Cell Guidelines should be met. Consider delaying the request for final consent until a significant time after IVF treatment to ensure that patients no longer want their embryos for reproductive purposes and are free from perceptions of coercion. A consent process promoting free and informed choice, sensitive recruitment, and donation of embryos for hESC research should be developed by the Canadian professional bodies.
制定并研究一种符合《人类辅助生殖法案》（AHR Act）和加拿大卫生研究院（CIHR）干细胞指南要求的同意程序，促进自由且知情的选择，并推动向人类胚胎干细胞（hESC）研究捐赠胚胎。
与一名hESC科学家、体外受精（IVF）团队成员以及CIHR指南的伦理学家作者进行了磋商，以审查《AHR法案》、CIHR干细胞指南、伦敦卫生科学中心大学医院既定的胚胎捐赠同意程序、适合联系的患者特征以及敏感招募策略。向患者发送了参与邀请包。
被认为适合联系的患者已表明其向研究捐赠胚胎的意向，拥有已冷冻保存五年以上的胚胎，未接受过捐赠配子，且公开列出了地址，无双方分离的迹象。为促进匿名性、保密性和知情选择而制定的策略包括临床团队与研究团队之间的“防火墙”，以及文件重申如果捐赠胚胎，女性将不得不接受额外的IVF治疗才能生育。在联系的40对夫妇中，只有22对同意向hESC研究捐赠胚胎。一对夫妇不再希望向研究捐赠胚胎，一个包裹因无法投递而被退回，16对夫妇未回复。
应满足《AHR法案》和CIHR干细胞指南的同意要求。考虑将最终同意的请求推迟到IVF治疗后的一段较长时间，以确保患者不再出于生殖目的需要其胚胎，且不存在受胁迫的感觉。加拿大专业机构应制定一种促进自由且知情选择、敏感招募以及为hESC研究捐赠胚胎的同意程序。
