Local Ethics Committee
The Local Bioethics Committee (LEC) at HemCenter LLP has been operating since 2019.
The LEC is an independent expert body of HemCenter LLP, composed of leading specialists in healthcare and science, representatives of medical and humanitarian professions, public organizations, and legal experts. The committee safeguards the rights, safety, and well-being of research participants and investigators and provides ethical and legal evaluation of clinical and scientific research materials at all stages — from planning to completion.
In its activities, the LEC adheres to the principles of respect for human dignity, recognition of personal autonomy, justice, beneficence, and non-maleficence towards clinical research participants, as well as to competence, collegiality, objectivity, and independence from political, administrative, departmental, collegial, or financial-economic influences.
The LEC is guided by:
- The Constitution of the Republic of Kazakhstan
- The Code of the Republic of Kazakhstan “On Public Health and the Healthcare System”
- Laws of the Republic of Kazakhstan
- The European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (1986)
- The Convention on Human Rights and Biomedicine (1997)
- The Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects (1964 and subsequent revisions)
- Good Clinical Practice (GCP) standards
- This Regulation and other sectoral legal documents, as well as the Standard Operating Procedures of the Center
Main Tasks of the LEC:
- Objective, independent assessment of risks and benefits, and the safety of clinical research involving new technologies, medicines, dietary supplements, medical devices, and new treatment methods, ensuring compliance with humanitarian and ethical principles and legal norms at both the planning and implementation stages.
- Evaluation of compliance of the clinical trial program with Good Clinical Practice (GCP) standards, as well as the qualifications of investigators and the technical readiness of the healthcare organization conducting the research.
- Assessment of compliance with international and national ethical norms in biomedical research.
- Participation in the development of bioethics-related documents at both local and national levels.
Chair of the LEC: Dr. Sci. (Med.), Professor, Department of Internal Medicine, Non-profit Joint Stock Company “Karaganda Medical University” Ludmila Gennadyevna Turgunova