Genetic screening is defined by article 3 (g) of the Law on Biomedical Research as a public health programme aimed at identifying certain genetic determinants in individuals, for which an early medical intervention could lead to the elimination or reduction of mortality, morbidity or disabilities associated with such determinants.  According to the first paragraph of article 54 genetic screenings are aimed at detecting a serious disease or health risk of the participating individual or in his descent, for the purpose of early treatment of a disease or to offer access to preventive measures.

The health authorities shall determine based on objective criteria, the relevance of the genetic screening in accordance with the diseases to be prevented or treated.  Likewise, they shall ensure a universal and equitable access of the screening to the population for which it is indicated, for the organization and planning of the program as well as the quality of the screening tests, diagnostic tests of a second level and the preventive and therapeutic services that are offered (article 54 (2)). 
For the undertaking of the screening, the psycho-social aspects and its integration into the health system shall be taken into account.  The specific program of screening shall also be evaluated by the ethics committee of the centre that performs it (article 54 (3)).  Appropriate procedures shall be established for the continuous follow-up and evaluation of the program (article 54 (4)).

The participation in a genetic screening has to be offered to all members of the population for which it is intended.  The previous written consent in the terms provided in articles 4 and 48 (3) of every person concerned is necessary (article 54 (5)).  Article 4 of the Law on Biomedical Research establishes the right to informed consent as a general principle which is elaborated regarding genetics in article 48 (see § 1 of this title).  According to the third paragraph of the latter there must be an explicit and written consent of the person interested in order to have access to a genetic screening.  The Research Ethics Committee has to determine the situations in which the consent may be expressed verbally.  In any case, when the screening includes non-curable diseases or the benefits are scarce or uncertain, the consent must always be in writing. 
Article 54 (6) specifies the content of the written information that has to be provided prior to this consent as the following:

1. The sought characteristics and objectives of the screening;
2. The voluntary nature of the participation;
3. The validity and reliability of the screening tests and of the diagnostic tests of a second level;
4. The possibility to obtain false positives and, in turn, the need to confirm or discard the diagnosis;
5. The time periods that will elapse between the different stages of the screening process;
6. The existing possibilities of treatment and prevention of the disease once it has been diagnosed;
7. The discomforts, risks and adverse events that could be derived from the diagnostic process, including those associated to the taking of samples and to the therapeutic or preventive measure.

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