About Committee
Local Ethics Committee was established to carry out an independent assessment of studies on the subject of ethics, in order to comply with the rights to health, welfare and safety of research participants by using modern science and technology, as an expert institution of the Society.
The purpose of the Local Ethics Committee is protecting the rights and dignity of the person involved in biomedical research.
• Protection of the rights and interests of researchers.
• Protection of vertebrate animals.
The objectives
- conducting an independent examination of research documents;
- an independent assessment of safety and respect for human rights at the stages of planning and conducting the study;
- assessment of the conformity of the clinical research program with the standards of good clinical and scientific practice and qualifications of researchers and the technical equipment of the healthcare organization conducting this study;
- international and national ethical assessment of compliance in biomedical research;
- participation in the development of documents on biological and medical ethics.
The main functions:
- оrganization of ethical examination of projects of scientific and technical programs of applied and fundamental nature, regardless of the source of funding in healthcare;
- conducting a moral-ethical and legal examination of materials of preclinical (non-clinical), clinical studies as well as examination of master's and doctoral dissertations
- conducting a moral-ethical and legal examination of biomedical experiments using new medical technologies, medicines, biologically active food additives, medical equipment and medical devices, new tools and methods for the prevention, diagnosis and treatment of diseases during national and international studies;
- consideration of disputable issues that arose before, during and (or) after the completion of research and biomedical experiments;
- holding meetings, conferences, symposiums;
- interaction with other republican and international organizations in the field of science.
According to the activity of the Local Ethical Committee any research work related to the study of the effects of medicine and medical devices in humans is a clinical trial / experiment and it must comply with the following requirements:
- the planned research work must be acceptedd by the commission;
- any biomedical research / experiment involving a person as a subject of research can be carried out only after obtaining written informed consent of the subject or his legal representative;
- a person has the right to refuse research / experiment at any stage
- if the purpose of the planned scientific work is to study a new medical product or device, including the study of new indications, dosage regimens, routes of administration of registered drugs, or new methods of diagnosis and treatment, it is necessary to obtain permission from the Ministry of Health of the Republic of Kazakhstan;
- particular attention in planning the trial / experiment should be given to “vulnerable patients”.