French Public Health Code
In forceI.-At the first medical examination referred to in the second paragraph of article R. 2122-1 or, failing that, during another medical consultation, any pregnant woman is informed by the doctor or midwife of the possibility of undergoing, at her request, one or more of the examinations referred to in I of article R. 2131-1.
Unless the pregnant woman objects, she will receive clear information tailored to her personal situation, covering the objectives of the examinations, the results likely to be obtained, the procedures, any constraints, risks or limitations and the fact that they are not compulsory.
The doctor or midwife will draw up a certificate, co-signed by the pregnant woman, certifying that she has been provided with the aforementioned information or that she did not wish to receive such information.
When the pregnant woman asks to have these examinations, her consent is obtained in writing. With regard to ultrasound examinations, the pregnant woman gives her written consent, before the first examination is carried out, for all ultrasound examinations covered by 1° of III of article R. 2131-1 to be carried out during the pregnancy. Consent may be revoked at any time in the same way.
II - In the event of a proven risk, the doctor, who may be a member of a multidisciplinary prenatal diagnosis centre, may, during a medical consultation tailored to the condition in question, inform the pregnant woman of the possibility of carrying out, at her request, one or more of the examinations mentioned in II of article R. 2131-1.
Unless the pregnant woman objects, she will receive clear information tailored to her personal situation, covering the objectives of the tests, the results that may be obtained, the procedures, any constraints, risks and limitations, and the fact that they are not compulsory. The doctor will also provide information on the characteristics of the condition being investigated, the means of detecting it, the possibilities for foetal medicine and, where appropriate, treatment or care from birth onwards. The doctor offers to provide the pregnant woman with the list of associations mentioned in III of article L. 2131-1.
The doctor draws up a certificate, co-signed by the pregnant woman, certifying that the aforementioned information has been provided to her or that she did not wish to receive such information.
When she requests to have these examinations, her consent is obtained in writing. With regard to ultrasound examinations, the pregnant woman gives her written consent, before the first examination is carried out, for all ultrasound examinations relating to the suspected condition and covered by 2° of III of article R. 2131-1 carried out during the pregnancy. Consent may be revoked at any time in the same way.
III - The certificate stating either the refusal to be informed or that clear and complete information has been provided and, where applicable, the written consent of the pregnant woman to undergo the examinations mentioned in I and II of article R. 2131-1 is collected on a form complying with the models laid down by order of the Minister for Health issued after consultation with the Agence de la biomédecine. The original of this certificate and, where applicable, of the written consent is kept in the medical record. A copy of this document and a copy of the certificate are given to the pregnant woman and to the practitioner carrying out the examinations.
