12. Ethics and Legal Issue of Genetic Testing

摘要

The Expert Group, invited by European Commission’s Research Directorate-General, prepared 25 recommendations related to the use of genetic testing in health care systems and genetic testing as a method of research. This paper presents in detail the recommendations crucial for laboratory diagnostics and research. Genetic testing and genetic data, are a part of the spectrum of all health-care information, equally available to individuals and with identical high standards of quality and confidentiality. It is the individual’s right to specify the scope of privacy and confidentiality with regard to all health-care information, including data originating from genetic testing, as well as with regard to biological samples as data carriers. The national Ethics Commission gives the opinion on ethics of any testing, including genetic testing for research purposes, in line with the recommendations of competent bodies of the EU, and the Code of Ethics applicable in the Member State. Test subjects must give informed consent for current or future tests. The recommendations for using the existing and forming new “biological databanks”, cross-border exchange of samples, and samples of the deceased are also presented in the paper. The general public should be impartially informed in all forms possible, and public dialogue must take place within the general public on clinical applicability of genetic testing, on genetic screening and pharmacogenetics. Screen testing in the EU may differ between Member States, and it has to be verified and evaluated in regular intervals in each Member State within the framework of the public health-care system. Genetic counselling requires specifically trained experts and should be non-directed counselling with the objective of helping individuals or families to understand a genetic disease or to cope with it. Curricula at all levels of study programmes should include subjects regarding the progress and possibilities of genetic testing in medicine.