Genetic Research Agenda

Original Language Title: Ģenētiskās izpētes kārtība

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Cabinet of Ministers Regulations No. 692 Riga 2004 (august 10. 7. § 47) genetic research order Issued in accordance with human genome research of the law article 8 second paragraph 1. determines the procedure of genetic research. 2. Genetic research allowed to launch, if for a given genetic research program or project has received the following documents: genome research 2.1. Council assent;
2.2. Central Medical Ethics Committee's positive assessment of the compliance with ethical principles. 3. Submit a Genome Research Council and Central Committee of medical ethics in evaluation of genetic research program or project, the application shall state: 3.1 the purpose of the study, tasks and expected results;
3.2. research;
3.3. research performers and financial sources;
3.4. engaging in the study of gene donors and their selection. 4. Genetic research allowed only use hard-coded tissue samples, descriptions of DNA, descriptions of State of health and pedigree. 5. tissue samples and descriptions of State of health shall draw up a genome database the main processor (main controller), genome databases authorized processor (hereinafter authorised processor) or gene researcher, respecting the confidentiality of the identity of the gene donor, his tissue samples, descriptions of State of health and pedigree. 6. Description of State of health shall be drawn up and complements the main controller or authorized processor, based on the news, which provided a gene donor and the gene donor received from medical institutions. 7. Genetic Epidemiology of genetic research data receives the main controller and keep the single population genome database (hereinafter referred to as the genome data base). Genome database in digital form of the gene donor stored encoded DNA profiles, their comparative genetic studies populations of Latvia obtained genetic data, aggregate information about individual health risk groups and information on the mutual relationship between the structure of genes, gene products and inherited characteristics. 8. Genetic data relating to a particular gene donor, the Chief processor shall provide to the population register of the country of the genome to use the gene donor disease diagnosis, treatment and prevention, as well as epidemiological studies. 9. Genetic research can be performed independently and apart from the genome database only if the gene researchers have received the rule referred to in paragraph 3, the opinion and assessment of specific genetic research project and with the main controller in coordination by the order in which the genome database will include information about the gene donor's State of health, tissue samples and DNA profiles and they are available for genetic research. 10. Genome Database anonymously in coded form not allowed to keep such genetic research related data: 10.1 General scientific information that defines the relationship between genes, gene products and inherited characteristics;
10.2. the tissue samples and descriptions of State of health as a whole, if it has at least five gene donors of tissue samples and descriptions of State of health. 11. the Chief processor and authorised processor or gene researcher jointly develop a genetic research program or project implementation plan. The plan defines the tasks of each study participant, the participants in the financial or any other form of investment, the right to information and intellectual property arising in the course of the study, each participant's rights and obligations in the use of the results of the research and dissemination (including publication). 12. The main controller, the controller authorized and gene researcher is obliged to provide the joint program or project and the distribution of copyright protection under the copyright laws governing. The joint programme or project in industrial property rights protected by Patent law. 13. the provisions to be allocated to the national budget. Prime Minister i. Emsis Health Minister r. Muciņš