Single chapter.

I.-No research on the human embryo may be undertaken without authorisation. A research protocol conducted on a human embryo may only be authorised if :

1° The scientific relevance of the research is established;

2° The research, whether fundamental or applied, has a medical purpose or aims to improve knowledge of human biology;

3° Given the current state of scientific knowledge, this research cannot be carried out without using human embryos;

4° The project and the conditions for implementing the protocol respect the fundamental principles set out in Articles 16 to 16-8 of the Civil Code, the ethical principles set out in this Title and those set out in Title I of Book II of Part One of this Code.

II.Research may only be carried out on embryos conceived in vitro as part of medically assisted procreation which are no longer the subject of a parental project and which are proposed for research by the couple, the surviving member of the couple or the woman from whom they were conceived in application of 2° of II of Article L. 2141-4, the last paragraph of Article L. 2131-4 or the penultimate paragraph of Article L. 2141-3.

III.-Research protocols are authorised by the Agence de la biomédecine after it has verified that the conditions set out in I and II of this article have been met. The Agency's decision, together with the opinion of its Steering Committee, is communicated to the Ministers for Health and Research, who may jointly, within a period of one month, request a re-examination of the file on which the decision was based:

1° If there is any doubt about compliance with the principles mentioned in 4° of I or about the scientific relevance of an authorised protocol. The Agency will carry out this re-examination within a period of thirty days, during which the authorisation will be suspended. If the decision is confirmed, the protocol is deemed to have been validated;

2° In the interests of public health or scientific research, when the protocol has been refused. The Agency will carry out this re-examination within thirty days. If the decision is confirmed, the protocol is deemed to have been refused.

In the event of a breach of the legislative and regulatory requirements or those laid down in the authorisation, the Agency will suspend or withdraw authorisation for the research. The Agency will carry out inspections, including one or more experts with no links to the research team, under the conditions set out in Article L. 1418-2.

IV.- Embryos on which research has been carried out in application of this article may not be transferred for the purpose of gestation. Their in vitro development shall be terminated no later than the fourteenth day following their creation.

V.-Research may focus on the causes of infertility.