RESUMO
Los test genéticos directos al consumidor tienen por objeto conocer la predisposición a padecer enfermedades comunes de origen multifactorial. Tal y como se ofrecen constituyen un reclamo cuya calidad y utilidad no ha sido probada, ya que, en muchos casos, no predicen el desarrollo de la enfermedad ni su gravedad. Objeciones tales como la falta de información y de consejo genético, el impacto en el individuo y en su familia, la agresiva publicidad y el riesgo de estigmatización justifican la adopción de cautelas y el sometimiento a unos estrictos estándares éticos y jurídicos
Direct-to-consumer genetic testing aim to meet the predisposition to common diseases of multifactorial origin. These tests are offered as a form of claim whose quality and usefulness has not been tested, since in many cases do not predict the development of the disease or its severity. Objections such as lack of information and genetic counselling, the impact on the individual and his family, aggressive advertising and the risk of stigmatization justify the need to take precautionary measures and to be subject to strict ethical and legal standards
Assuntos
Humanos , Testes Genéticos/ética , Doenças Genéticas Inatas/diagnóstico , Defesa do Consumidor/ética , Aconselhamento Genético/ética , Valor Preditivo dos Testes , Informação de Saúde ao Consumidor/ética , Autoadministração/ética , Publicidade Direta ao Consumidor/éticaRESUMO
This paper examines from a practical perspective, the content of the information sheet to the participant in a clinical trial in which pharmacogenetic studies are conducted and/or pharmacogenomics, and scope of informed consent. The text is accompanied by a guide of questions to assess the fit of a participant information sheet on the regulation of clinical trials, biological samples and protection of personal data.
