The right of a patient to consent to diagnostic procedures is one of the basic patient rights in Spain. This guiding principle is elaborated in article 48 of the Law on Biomedical Research. According to this article the express and specific written consent is necessary for the undertaking of a genetic analysis. 

Article 47 of the Law elaborates the content of the information that has to be provided prior to the consent.  It stipulates that, notwithstanding what is provided by the legislation on the protection of data of a personal nature, the person must receive the following written information before he consents to the analysis:

1. Purpose of the genetic analysis for which he is consenting;
2. Place of the undertaking of the analysis and the destination of the biological sample at the end of it, whether it is the disassociation of the identifying data of the sample, its destruction or other destinations, for which the consent of the subject must be requested in the terms provided in this Law;
3. Persons who will have access to the results of the analysis when those are not going to undergo a process of disassociation or anonimisation;
4. A warning about the possibility of unexpected findings and its possible importance for the subject, and also about his possibility to take a position in relation to receiving this information;
5. A warning about the possible implications that the received information can have for his family members and the appropriateness of the subject to transmit the information to family members;
6. The promise to provide genetic counseling, once the results of the analysis are obtained and evaluated.

Top