Rules On The Genome Database Of The Main Processor And Authorised Processor Requirements And Procedures For The Consideration Of National Scientific Institutions In Compliance With The Genome Database Of The Main Processor Requirements

Original Language Title: Noteikumi par genoma datu bāzes galvenajam apstrādātājam un autorizētajam apstrādātājam izvirzītajām prasībām un kārtību, kādā izvērtējama valsts zinātnisko institūciju atbilstība genoma datu bāzes galvenajam apstrādātājam izvirzītajām prasībām

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Cabinet of Ministers Regulations No. 134 in Riga in 2006 (February 14. 9. § 42) the rules on the genome database of the main controller and the controller authorized the requirements and procedures for the consideration of national scientific institutions in compliance with the genome database of the main processor requirements Issued under the human genome research of the law article 4, first subparagraph, and article 6 1. determined the genome database of the main controller (further-the main controller) and genome database in the apstr be authorized (hereinafter authorized processor) the requirements and procedure for adoption in which the State scientific institutions examined (hereinafter the institution) to a main processor requirements. 2. On the main controller can empower the institution, 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 tissue samples from a 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. compliance with the rules of the institution 2. the requirements referred to in paragraph 1 evaluate the health statistics and medical technologies State Agency (hereinafter the Agency). 4. An institution wishing to qualify for the Cabinet the authority to create and to supplement the regular uniform national genomic database, fill out and submit to the Agency an application accompanied by: 4.1. information on compliance with this provision of the body 2.1., 2.2. and 2.3. the requirements referred to in subparagraph;
4.2. national fire and rescue service's opinion on compliance with the rules referred to in point 2.4;
4.3. Public opinion on compliance with the inspection rules referred to in point 2.5. 5. the Agency shall, within three working days after submission of the institution and the rules referred to in paragraph 4, the KUMU document receipt check is submitted all the required documents. If it is found that not all submitted that rule 4 of the acts referred to in the paragraph, the Agency shall forthwith request the missing doc file. If the body of the request 30dien dispatch failed to submit the missing documents, the Agency shall assess the conformity of this provision, the institution referred to in paragraph 2 above requirements and send the application back to the institution. 6. a decision on the conformity of the institution whether or not the main charger for izvirzāmaj processing requirements, the Agency shall adopt, within 30 days after receipt of the application for the institution. The time required for the missing document away, are not counted in the decision in due time. The agency within three working days after the decision in writing and shall inform the institution of the Ministry of health. 7. If a decision on the conformity of the institution 2 of these provisions with the requirements of the Agency, the Ministry of Health's decision within 30 days, submit to the Cabinet. 8. the Chief processor may authorize natural or legal persons to be authorized, if the controller is to ensure the achievement of the following requirements: 8.1 the blood sampling, description of State of health and genealogical data creation: 8.1.1. blood sampling for regulations concerning minimum requirements for medical institutions and their departments;
8.1.2. treatment is certified and registered in the field of treatment of regulatory laws in the order;
8.2. the tissue samples and genetic research related papers and information materials in the temporary storage is a separate room, and the Latvian National Archive Fund of the opinion of the supervisory authority. 9. Be declared unenforceable in the Cabinet of 10 august 2004, Regulation No 693 "requirements of the genome database the main controller and genome database for authorised processor" (Latvian journal, 2004, nr. 128). Prime Minister a. Halloween Health Minister g. Smith