French guidelines for genetic counselling: key points of decree 2008-321 of April 4, 2008
| The person is informed about the disease characteristics, detection techniques, genetic analysis sensitivity, prevention and treatment possibilities, genetic modality of the disease transmission and consequences for the other family members |
| Informed written consent is mandatory |
| Patient aged <18 years and adults under guardianship must agree with the genetic testing, whereas the informed written consent must be signed by the legal representative |
| The genetic counselling must be performed in an individual consultation |
| For asymptomatic high-risk relatives, the genetic counselling must be performed in an individual consultation. This presymptomatic diagnosis requires a multidisciplinary approach involving geneticists, pulmonologists, genetic counsellors, psychologists and nurses. This team is registered to the biomedical agency and follows their recommendations |
| Genetic testing can be prescribed in asymptomatic high-risk relatives aged <18 years or in adults under guardianship, only if he/she or his/her family can benefit from preventive or curative treatments |
| Genetic testing is performed under the responsibility of a physician allowed by Article R.1131-9, practicing in one of the institutions listed in Article R.1131-13. This physician is the only one authorised to sign the genetic results |
| The genetic testing can only be performed in biological laboratories of public health institutions, cancer centres, biological laboratories mentioned in Article L.6211-2 and in biological laboratories of the French blood bank centres authorised by Article R.11301-14 |
| The prescriber must inform directly the person who underwent the genetic testing in an individual consultation |
| The person who underwent the genetic testing can refuse to know the result |
Reproduced from [49] with permission.