Requirements Of The Genome Database The Main Controller And Genome Database For Authorised Processor

Original Language Title: Prasības genoma datu bāzes galvenajam apstrādātājam un genoma datu bāzes autorizētajam apstrādātājam

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/92354

 
Cabinet of Ministers Regulations No. 693 Riga 2004 (august 10. 8. § 47) genome database of the main processor and the genome database for authorised processor released in accordance with human genome research of the law article 4, first subparagraph, and article 6 1. determined the genome database of the main controller (hereinafter referred to as the main processor) and the genome database for authorized suppliers (hereinafter authorized processor) sliding.
2. On the main controller may authorise the national scientific institutions, if it is able to carry out the human genome research tasks required by law and comply with the following requirements: 2.1. the institution has a genome database and supplement appropriate research equipment and data-processing equipment: 2.1.1. at least 1000 samples for closed refrigerating equipment for the storage of the tissue sample, minus to minus 70 ° C 180 ° C; 2.1.2. automatic DNA nucleotide sequence detection equipment with data processing and the power of not less than 100 analyses per day; 2.1.3. automatic genotipēšan (DNA polymorphisms or mutations) with appropriate software; 2.1.4. fragments of DNA chemical synthesis and purification of products equipment detection and nucleotide sequence of genotipēšan; 2.2. personnel is genome database and supplement the necessary scientific qualifications and experience in genetic research: research 2.2.1 at least half the staff is a PhD in biology, chemistry or medicine; 2.2.2. at least 60% of the research staff has at least five years of experience in DNS structure and molecular genetics research, including work with recombinant DNA; 2.3. the staff is genome database and reload the experience necessary for scientific research management and coordination (including international cooperation): 2.3.1. experience of the Latvian Council of science scientific cooperation project management and coordination; 2.3.2. the participation of the European Union's scientific and technological development framework programme projects and other international research cooperation projects in molecular genetics, genetic engineering and Biomedicine;
2.4. the premises meet the safety considerations (for example, you might get some laboratory space, with a total area of at least 200 m2, separate facilities for the tissue sample, description of State of health, research results and other documentation, equipped with safety features, fire and burglar alarm), and is certified by the State fire and rescue service; 2.5. the genome database is to ensure the processing of personal data according to the laws and requirements regarding the protection of personal data, also the minimum personal data processing system of technical and organisational requirements, and the data State Inspectorate's opinion.
3. the Chief processor may authorize natural or legal persons to be authorized, if the controller is to ensure the achievement of the following requirements: 3.1. blood sampling, description of State of health and genealogical data creation: 3.1.1. blood sampling corresponds to the Cabinet on 19 February 2002, the Regulation No 77 "provisions concerning minimum requirements for medical institutions and their departments ' requirements; 3.1.2. the medical people are certified and registered in the field of treatment of regulatory laws in the order; 3.2. tissue samples with the genetic research and related documents and information material for temporary storage is a separate room, and the Latvian National Archive Fund of the opinion of the supervisory authority.
Prime Minister i. Emsis Health Minister r. Muciņš Editorial Note: regulations shall enter into force with the 14 august 2004.