Spanish Regulations. ETS 164, October 1997 Convention on Human Rights and Biomedecine (Oviedo Convention)
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1 Spanish Regulations ETS 164, October 1997 Convention on Human Rights and Biomedecine (Oviedo Convention) Royal Decree 2132/2004, requirements and procedures for the development of research projects for the establishment of embryonic stem cells ( IVF surplus embryos) (BOE 30 octubre) Law 14/2006, Assisted Reproduction Tecniques Law 14/2007, Biomedical Research
2 Convention on Human Rights and Biomedecine (Oviedo Convention) Article 13 Interventions on the human genome An intervention seeking to modify the human genome may only be undertaken for preventive,diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants Article 18 Research on embryos in vitro 1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2 The creation of human embryos for research purposes is prohibited.
3 Law 14/2006 Assisted Reproduction Tecniques Clinical ART Research in human embryos Possible options for use of supernumerary cryopreserved human embryos - Use for the couple or patient - Donation to other couplesor single women - Donation for research - Discard
4 Law 14/2006 Assisted Reproduction Tecniques Chapter IV Article 15 Research with human gametes and embryos Requirements o Informed consent o Development <14 days o Authorised centers o Qualified personel o Project authorised by competent authorities + CNRHA (or Guarantees Commission) o Follow up
5 Law 14/2006 Assisted Reproduction Tecniques Chapter III Article 13. Therapeutic techniques in the preembryo 1. Therapeutic techniques with the aim of treating a disease and preventing transmission. 2. Requirements a) Informed consent b) Well diagnosed diseases with a severe or very severe prognosis and adequate chances of success. c) No modification of non pathologic traits (avoid eugenics) d) Authorised centers, skilled professionals. 3. Authorisation by competent authority and National Commission for ART IN CONTRADICTION WITH OVIEDO CONVENTION
6 Couples choices regarding the fate of cryopreserved embryos stored for >2 years Luna et al, 2009
7 Distribution of responses in relation to the origin of gametes Luna et al, 2009
8 National Commission for Assisted Reproduction The National Comission for ART is a permanent and consultive collegiate body dependent on the Ministry of Health with the aim of giving advice about the use of ART techniques, including related scientific activities. AIMS Development and follow-up of ART techniques Guidelines Gamete donors and patients Genetic diseases for PGD Authorisation and certification of ART centres Services and SOPs Results Evaluation of authorised research projects Legislation update Experimental techniques authorisation Research (infertility, gamete and embryo) project authorisation Donor compensation
9 Invasive Procedures Embryos and hesc Genetic Tests & Biobanks Law on Biomedical Research Spanish Committee on Bioethics Groups & Centers Promotion of Biomedical Research Networks Professional Career
10 Law 14/2007, Biomedical Research Ø Ø Ø Allows SCNT and other techniques for hesc derivation No generation of human embryos solely for research purposes allowed (Oviedo Convention).Definition of embryo National Guarantees Commission created for the control of embryo and hesc research.
11 National Guarantees Commission Review and approval needed for Research with human embryos intended for hesc derivation and for other uses except for research related to ART Research with hesc and hips Research in oocyte activation for SCNT Research with human samples that aim to obtain pluripotent stem cells
12 National Guarantees Commission Review and approval needed for Research involving cells from embryonic/fetal origin Research with pluripotent stem cells from other countries - NAS Paris April 2016
13 Germline Genome Editing No research projects involving germline genome editing submitted for review and authorisation to the Spanish National Commission for Assisted Reproduction.
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