Ethics committee
The Ethics Committee of JSC ‘Republican Scientific Center for Neurosurgery’ is a standing advisory body of the system of ethical review of the Company carrying out its activities basing on the principles of humanism and respect for human dignity, recognition of the autonomy of the individual, and equality of all its members.
The Committee was established to conduct ethical and legal review of biomedical projects involving human subjects as testees, research onanimals, for the prevention and resolution of moral-ethical problems arising in the field of research and clinical practice, as well as to monitor compliance with the rights of patients, doctors, middle and junior medical staff in the implementation of diagnostic procedures, patient care, and research .
In its work the Committee is guided by the Constitution of the Republic of Kazakhstan; regulations in the area of healthcare, the Code of the Republic of Kazakhstan № 193-IV « On people's health and the health care system’ dd. September 18, 2009;the Decree of the Minister of Healthcare of the Republic of Kazakhstan № 697 ‘On approval of the Rules of biomedical experiments , pre-clinical (non-clinical ) and clinical research’dd. November 12, 2009; theState Standards of the Republic of Kazakhstan ‘Proper Laboratory Practice’, ‘Proper Clinical Practice’ approved by the Decree № 575 of the Chairman of the Committee for Technical Regulation and Metrology of the Ministry of Industry and Trade of the Republic of Kazakhstan dd. December 29, 2006, the Declaration of Helsinki of the World Medical Association ‘Guidelines for physicians in biomedical research involving human subjects’, the International Standards for conducting clinical trials ICN Harmonized Tripartite Guideline for Good Clinical Practice (ICN GCP);the Convention on Human Rights and Biomedicine, recommendations by the World health Organization,the Ethics Committee conducting biomedical research, the European Convention for the protection of Vertebrate Animals used for experimental and other scientific purposes, other normative legal acts of the Republic of Kazakhstan, orders and directives of the Company and the given Regulations of the Ethics Committee (hereinafter – Regulations) .
The main objectives of the Commission
Conduction of qualitative ethical and legalexamination of materials of preclinical trials (studies), medical and biological experiments and clinical studies with the use of new technologies, medicines, food supplements, medical equipment and health care products, new methods of treatment and evaluation of patients for compliance with ethical principles and national legislation;
Assessment of the scientific validity of the pre-clinical trials (studies), medical and biological experiments and clinical studies and the perceived effectiveness and safety of the studied technologies and medicines;
Regular supervision of the study after obtaining permission to conduct and the execution og the decisions of the Commission;
Control over the observance of ethical norms and rules governing the relationship between the medical staff, patients and their families in clinical practice;
Providing advice to the participants of trials (studies), medical staff, patients and their families with a view of preventing and resolving ethical and legal conflicts;
Studying international and domestic experience in the legal and ethical regulation of biomedical research and health care practice;
Providing training to the Committee members and researchers of the Company in ethics and ethical review.
