Spanish legislation

Law 14/2006; 27th May 2006. BOE nº 126

Embryo research

CHAPTER IV

Research using human gametes and pre-embryonic cells

Article 14. Use of gametes for scientific research.

1. Individual gametes can be used for research purposes.

2. Gametes used for research purposes or experimentation cannot subsequently be implanted into a woman or be used to create pre-embryos for reproductive purposes.

Article 15. Use of pre-embryos for scientific research.

1. Research or experimentation using pre-embryos that were created for reproduction purposes, but are subsequently no longer required for such purposes is considered ethically acceptable only if the following apply:

a) Written consent of the couple, or woman alone when applicable, after they have undergone a detailed explanation of the aims of the investigation and its implications. In all cases, the written consent provided must specify the couple’s relinquishment or woman’s alone when applicable, of all legal and financial claims over the results that could arise directly or indirectly from the investigations being carried out.

b) The pre-embryo must not have been developing in vitro for more than 14 days after fertilisation. Time spent in cryopreservation state need not be counted.

c) Investigation projects related to development and employing of assisted fertilisation techniques must be carried out in authorised centres. In all cases, projects are to be carried out by qualified scientific teams and kept under the control of the competent health authorities.

d) Research or experimentation must be carried out following a correctly presented project plan. The plan must be approved by the competent health authorities, and if the investigation is related to embryonic development or makes use of assisted reproduction techniques, it must be authorised beforehand by the Comisión Nacional de Reproducción Humana Asistida (National Committee of Assisted Human Reproduction). If the research or experimentation is related to the obtention, development and use of cell lines from embryonic stem cells, the competent authority must approve the project, before the investigation can proceed.

e) In the case of pre-embryos being transferred to another research centre, the relationship between the research teams and centres involved in the transfer, and their common interest of whichever nature must be specified in the aforementioned project plan. In these cases the established confidentiality regulations regarding the origin of the embryo must be maintained, alongside the donors freely given consent to use the cells and the relinquishment of all legal and financial claim over the results

2. Once the investigation has been completed, the health authority that approved the research must transfer the results to the Comisión Nacional de Reproducción Humana Asistida (National Committee of Assisted Human Reproduction) or when applicable, the competent authority that approved the investigation.

Article 16. Conservation and use of pre-embryos in research

1. Surplus pre-embryos that have been cryopreserved and for which consent has been given by the donors, or woman alone if applicable, for them to be used for research purposes, are to be stored in corresponding assisted reproduction centres.

2. Before definitive use of the pre-embryo in an investigation can proceed, the written consent of the couple, or woman alone if applicable, from which the pre-embryo has been obtained is required. This is necessary in all instances, whether the embryo is being used following a specific project plan devised by the assisted reproduction centre where it was obtained, or whether it is being used following a specific project plan after its transferral to a different centre. In all cases, the individuals from which the pre-embryo originates must have undergone a detailed explanation and must understand the aims of the research, its stages and duration, the specificity of its restriction to a basic scope or its extension to a wider scope of clinical use, as well as the possible outcomes of the investigation. If written consent has not been given to use a pre-embryo in a specific investigation, it should be requested in all cases before any research starts, unless consent has not been renewed according to the provisions of clause 11.6

CHAPTER V Health centres and biomedical teams.

Article 17.Calification and authorisation of assisted reproduction centres.

Every centre or department that performs assisted reproduction techniques or related reproduction methods will be considered a health establishment and service. Gamete and embryo banks fall under this category. These centres are governed by regulations laid out in the General Health Act 14/1986, 25 April or regulations set by Public Administrations with command over health matters, and they must be authorised to practice assisted reproduction techniques by the competent corresponding authorities.

Article 18. Operating conditions of assisted reproduction centres and teams.

1. Biomedical teams that work in these centres and health departments must be appropriately qualified to carry out assisted reproduction techniques, complementary procedures and related scientific actions, and for this purpose they must use the necessary equipment and methods, which will be established by Royal Decree. Biomedical teams will work in an interdisciplinary manner and the director of the centre or health service where they work will be the person held in direct responsibility for their actions.

2. Biomedical teams and the directors of the centres or health services where they work are held to the same legal regulations for malpractice. This includes violating the preservation of the donors’ confidentiality of identity and carrying out malpractice with assisted reproduction techniques or the corresponding biological material. Malpractice also encompasses causing avoidable injury to the interests of the donors or recipients, or transmitting a congenital or hereditary illness to the pre-embryo through omission of information and disregard for previous investigations.

3. Medical teams will compile a medical history file, guarded by the correct data protection and confidentiality measures of all the donors and recipients health information, as well as their signed consent forms regarding donation and assisted reproduction techniques respectively. The information contained in the medical files, except for the identity of the donors, must be accessible, if requested, to the female recipient and her partner, and also the child born using assisted reproduction techniques or his/her legal representatives when he/she comes of age.

4. Biomedical teams must carry out all obligatory tests on donors and recipients, as according to regulations and they must fulfil information protocols regarding the position of the donors and the activity of the assisted reproduction centres.