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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 4, 2019 No. KR DSM-64

About approval of Rules of carrying out medical researches, and also requirements to the research centers

According to Item 9 of article 180 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Rules of carrying out medical researches, and also requirements to the research centers according to appendix to this order.

2. To provide to department of science and human resources of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" the Ministries of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), and 3) of this Item.

3. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Abishev O. A.

4. This order becomes effective after ten calendar days after day of its first official publication.

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of May 4, 2019 No. KR DSM-64

Rules of carrying out medical researches, and also requirements to the research centers

Chapter 1. General provisions

1. Rules of carrying out medical researches, and also requirements to the research centers (further - Rules), are developed according to Item 9 of article 180 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for carrying out medical researches, and also establish requirements to the research centers.

2. In these rules the following terms and determinations are used:

1) the informed consent - the procedure of voluntary confirmation by the subject of research or its legal representative of consent to participation in specific research after receipt of information on all significant for adoption of the decision by it aspects of research;

2) biobank - specialized storage of biological materials for the scientific and medical purposes;

3) biological material - material samples, such as urine, the blood, fabrics, cages, DNA, RNA, squirrels and another who are brought together from the person;

4) bioethical examination - preliminary consideration of materials of medical research and issue of the reasonable conclusion of the Commission on bioethics from line items of the ethical acceptability, safety for participants and feasibility of this research;

5) genomic information - information on fragments or the complete nucleotide sequence of deoxyribonucleic, ribonucleic acid of the person and the related organisms;

6) the sponsor - physical person or legal entity, responsibility for its organization and (or) financing being the initiator of clinical trial and bearing.

7) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, control of quality of medical services;

8) the subject of research - the living person or the animal participating in medical research;

9) intervention research - research in which to subjects of research prospektivny purpose of one or several medical interventions in the form of preventive intervention, prescription of medicines, accomplishment of surgical interventions, behavioural therapy and others for the purpose of impact assessment of these interventions on indicators of the state of health is carried out;

10) not intervention research - research, with participation of the person as the subject of research which is conducted after approval to application of method and (or) means within the guaranteed amount of free medical care and (or) compulsory social medical insurance and is appointed within medical practice according to the instruction on medical application;

11) preclinical (not clinical) research - chemical, physical, biological, microbiological, pharmacological, toxicological and other pilot study or series of researches on studying of the examinee of method and (or) means by application of scientific evaluation methods for the purpose of studying of specific action and (or) receipt of proofs of safety for health of the person;

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