LЕС NNMC
Local Ethics Commission
The Local Ethics Commission is an advisory body established to protect the rights and safety of patients and researchers, monitor compliance with the rules of humanism, morality and biomedical ethics when conducting clinical trials at the local level.
The Local Ethics Commission operates in accordance with national legislation: The Constitution of the Republic of Kazakhstan, laws of the Republic of Kazakhstan, acts of the President and the Government of the Republic of Kazakhstan, standards of good pharmaceutical practice in accordance with subparagraph 9) of Article 10 of the Code, rules for conducting biomedical research and requirements for research centers in accordance with paragraph 10 of Article 227 of the Code, the use of new methods of diagnosis, treatment and medical rehabilitation in accordance with paragraph 11 of Article 227 of the Code, conducting clinical trials of medicines and medical devices, requirements for clinical databases in accordance with paragraph 6 of Article 238 of the Code. In its work, the Ethics Commission also takes into account international ethics guidelines (the Council of Europe Convention on Human Rights and Biomedicine) in its assessments, recommendations and decisions, develops its own standard working procedures based on Recommendations to ethics Committees (Geneva, WHO, 2000 and the Forum of Ethics Committees of the CIS Member States (CCESG) and strives to comply with international safeguards requirements for all research participants.
The purpose and objectives of the LЕC
The purpose of the Ethics Commission (hereinafter referred to as the LCE) is to conduct an independent examination and supervision of biomedical research involving people as subjects in order to ensure respect and protection of the dignity, fundamental rights, safety and well—being of research participants.
The main tasks of the Commission are:
• Independent assessment of safety and human rights at the stages of planning and conducting the study;
• Ensuring the confidentiality and security of information related to the study;
• Conducting an independent examination, review of research documents;
• Assessment of compliance of the biomedical research program with the standards of good clinical and scientific practice, as well as the qualifications of researchers and the technical equipment of the healthcare organization conducting this research;
• Assessment of compliance with international and national ethical standards, rules and procedures of NSCMD JSC during clinical trials;
• Comparison of relative risks and benefits for patients;
• Participation in the development of documents on biological and medical ethics
The experts of the Local Ethics Commission were approved by the decision of the Scientific Council of JSC NNMC dated February 23, 2026 in the following composition:
1) | G.M. Shaimardanova | Chair of the Commission. Head of the Electron Microscopy Sector |
2) | N.M. Bissenova | Deputy Chair of the Commission. Head of the Microbiological Laboratory |
3) | N.K. Batyrbek | Executive Secretary. Specialist of the Department of Scientific and Innovation Management |
4) | G.S. Dosatayeva | Head of the Postgraduate Education Department; |
5) | A.M. Ganina | Head of the Cell Transplantation Technologies Department |
6) | O.N. Lukin | Head of the Sector of Biomedical Research Scientific Strategies |
7) | A.K. Atabayeva | Head of the Records Management Department |
8) | L.V. Kozina | Head of the Central Research Laboratory |
9) | A. Tolegenuly | Director of the Heart Institute |
10) | D.K. Sovetov | Lawyer |
11) | A.E. Gaipov | Professor at the Nazarbayev University School of Medicine, external expert. |
Local Ethics Commission of the National Scientific Medical Center (NSMC) is an independent expert body under the authorized authority.
The Commission protects the rights, safety, and well-being of research participants and investigators, and provides ethical and moral-legal evaluation of scientific research materials involving humans and animals.
In its activities, the Commission is guided by:
Laws and regulatory legal acts of the Republic of Kazakhstan:
Constitution of the Republic of Kazakhstan;
Code of the Republic of Kazakhstan dated July 7, 2020 “On Public Health and the Healthcare System”;
Order of the Minister of Health of the Republic of Kazakhstan dated December 21, 2020 No. KR DSM-310/220 “On approval of the Rules for conducting biomedical research and requirements for research centers”;
Order of the Minister of Health of the Republic of Kazakhstan dated December 11, 2020 No. DSM-248/2020 “On approval of the Rules for conducting clinical trials of medicinal products and medical devices, clinical and laboratory testing of medical devices, preclinical in vitro diagnostic studies, requirements for clinical sites, and provision of the public service ‘Issuance of permission to conduct clinical trials and/or testing of pharmacological and medicinal products and medical devices’”;
Good Laboratory Practice (GLP) Standard, Appendix 1 to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated February 4, 2021 No. DSM-15 “On approval of Good Pharmaceutical Practices”;
Good Clinical Practice (GCP) Standard, Appendix 2 to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated February 4, 2021 No. DSM-15 “On approval of Good Pharmaceutical Practices”.
International guidelines:
World Medical Association Declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects”;
WHO Operational Guidelines for Ethics Committees that Review Biomedical Research (TDR/PRD/ETHICS/2000.1);
CIOMS “International Ethical Guidelines for Health-related Research Involving Humans”;
Report of the CIOMS Working Group VI “Management of Safety Information from Clinical Trials”;
CIOMS “International Ethical Guidelines for Epidemiological Studies”;
CIOMS “International Guidelines for Ethical Review of Epidemiological Studies”;
ICH GCP Good Clinical Practice;
Convention on Human Rights and Biomedicine (1997);
European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (1986).