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View Article... - Novel Tech Ethics

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LAW AND ETHICS CRYOPRESERVED HUMAN EMBRYOS IN CANADA AND THEIR AVAILABILITY FOR RESEARCH Françoise Baylis, PhD, 1,2 Brenda Beagan, PhD, 3,4 Josephine Johnston, LLB, MBHL, 5 Natalie Ram 6 1 Department of Bioethics, Dalhousie University, Halifax NS 2 Department of Philosophy, Dalhousie University, Halifax NS 3 School of Occupational Therapy, Dalhousie University, Halifax NS 4 Department of Sociology and Social Anthropology, Dalhousie University, Halifax NS 5 The Hastings Center, Garrison NY 6 Princeton University, Princeton NJ Abstract Objective: To determine the number of cryopreserved human embryos at all Canadian in vitro fertilization (IVF) clinics, the number of these embryos that have been donated to research, and the consent processes regarding the disposition of embryos no longer required for reproductive purposes. Methods: A questionnaire was mailed to 24 fertility clinics identified as conducting IVF and cryopreservation, inviting completion of the questionnaire by telephone. Thirteen clinics (response rate 54%) completed the survey. Results: As of August 2003, all 13 clinics cryopreserve embryos not required for intrauterine transfer; in total, 15 615 embryos are currently in storage in these clinics. Nine clinics specifically offer patients the option of donating embryos to research; in total, 299 embryos have been allocated for research, about 2% of all embryos stored by these 13 clinics. All 9 clinics routinely seek consent for research use of embryos, with 7 clinics currently using such embryos for research to improve clinic practices. Conclusion: The results highlight the difficulties of gathering accurate data on assisted human reproduction and related research in a context where there is no legislation governing these practices. Nonetheless, the data suggest there are very few cryopreserved embryos in Canada available for research and that even fewer of these may be potentially eligible for research due to incomplete or inadequate consent processes. Key Words Cryopreservation; human embryo, research; cell research, embryos; stem cells; Canada; data collection; legislation; informed consent Competing interests: None declared. Received on October 22, 2003 Revised and accepted on November 8, 2003 Résumé Objectif : Déterminer le nombre d’embryons humains cryoconservés que comptent toutes les cliniques canadiennes de fécondation in vitro (FIV), la quantité de ces embryons qui a été donnée pour la recherche et le processus d'obtention du consentement en matière d’élimination des embryons dont on ne fera pas usage à des fins de reproduction. Méthodes : Nous avons envoyé un questionnaire par la poste à 24 cliniques de fertilité où se pratique la FIV et la cryoconservation d’embryons, et nous avons communiqué avec chacune d’elles par téléphone afin de les inviter à remplir ce questionnaire. Treize de ces cliniques ont renvoyé le sondage dûment rempli (taux de réponse : 54 %). Résultats : En août 2003, chacune des 13 cliniques procédait à la cryoconservation d’embryons non destinés à un transfert intrautérin; en tout, 15 615 embryons étaient conservés dans ces cliniques. Neuf cliniques offrent directement à leurs patientes la possibilité de faire don d’embryons pour la recherche; au total, 299 embryons ont été affectés à la recherche, soit environ 2% de tous les embryons conservés dans ces 13 cliniques. Chacune des 9 cliniques obtient systématiquement un consentement pour l'utilisation des embryons à des fins de recherche et 7 cliniques utilisent actuellement de tels embryons pour la recherche afin d'améliorer les pratiques cliniques. Conclusion : Ces résultats illustrent la difficulté de recueillir des données exactes sur la procréation assistée et sur la recherche qui y est liée, en l'absence de législation gouvernant ces pratiques. Ces données indiquent cependant qu’il existe, au Canada, très peu d’embryons cryoconservés disponibles à des fins de recherche et qu’un nombre encore moindre d’entre eux peuvent être utilisés dans ce but en raison d'un processus d’obtention du consentement incomplet ou inadéquat. INTRODUCTION J Obstet Gynaecol Can 2003;25(12):1026–31. In 1987, for the first time in Canada, research involving human embryos for both reproductive and non-reproductive purposes was explicitly permitted in the Medical Research Council (MRC) of Canada’s Guidelines on Research Involving Human Subjects. 1 These guidelines recognized a number of legitimate reasons for proceeding with embryo research, including understanding and correcting problems in human infertility and development, reducing neonatal death and birth defects in children, and assessing and improving the safety and efficacy of such procedures as in vitro (IVF) fertilization and embryo freezing. The MRC research guidelines identified local Research Ethics Boards (REBs) as the appropriate forum in which to determine the 1026 JOGC DECEMBER 2003

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