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 April 26, 2023 in the following composition:
1) | Shaimardanova Galiya Masugutovna | Chairman of the local Ethics Commission, MD, Professor, pathologist of the Department of Pathomorphology |
2) | Mensagieva Shynar Zharasovna | Secretary of the local Ethics Commission, specialist of the Department of Scientific and Innovative Management |
3) | Kolos Anatoly Ivanovich | MD, Professor, Thoracic surgeon, LEC expert |
4) | Askarov Manarbek Bapovich | MD, Professor, Director of the Institute of Fundamental and Applied Medicine, LEC expert |
5) | Bisenova Nelya Mikhailovna | Doctor of Biological Sciences, Professor, Head of the Microbiological laboratory, LEC expert |
6) | Pak Alexey Mikhailovich | PhD, Director of the Institute of Internal Medicine, pulmonologist-somnologist, LEC expert |
7) | Kozina Larisa Vladimirovna | Candidate of Medical Sciences, Head of the Central Research Laboratory, LEC expert |
8) | Almas Tolegenovich | PhD, Cardiac surgeon, LEC expert |
9) | Chumakova Elmira Kelsovna | Candidate of Medical Sciences, Head of the Department of Radiation Diagnostics, LEC expert |
10) | Kamnev Vladimir Gennadievich | senior specialist of the Legal Department, LEC expert |
11) | Gaypov Abdujappar Erkinovich | PhD, Assistant Professor at the Nazarbayev University Medical School, external expert of the LEC |
12) | Shayakhmetov Yerzhan Mukataevich | Director of the International Oncological Center of Tomotherapy "YMIT" LLP, surgeon of the highest category, external expert of the LEC |
12.07.2023 Batyrbek Nazgul Kairatovna was appointed secretary of the lke in connection with the signing of Mensagiev Shynar Zharasovna.
In 2023, 4 meetings were held, 10 applications were considered