The Local ethical commission of LLP “NROC” (hereinafter referred to as the Commission) is an independent expert body, which includes leading scientific experts, representatives of public organizations that protect the rights, safety and well-being of subjects and researchers, ethical and moral and legal assessment of clinical trial materials/ tests in cases of controversial issues arising at all stages of a clinical study/trial, as well as after their completion.

The main goal of the Commission is to protect the rights, dignity, safety and well-being of subjects (patients and volunteers) and researchers participating in clinical trials, biomedical experiments, as well as the moral, ethical and legal assessment of clinical trial materials.

The main tasks of the Commission are:

1. Ensuring safety and human rights at the stages of planning and conducting research;
2. Ethical and legal examination of materials from clinical studies carried out within the framework of scientific and technical programs, initiative (dissertation) works, scientific projects (including with the participation of international organizations), scientific publications;
3. Development of documents on issues of biological and medical ethics.

• Regulations on the local ethical commission
• Composition of the local ethics commission
• Schedule of meetings of the local ethics commission
• Calendar plan of the local ethical commission
• List of standard operating procedures for a clinical trial
• List of approved standard operating procedures
• List of documents for examination of a clinical trial
• List of documents for examination of clinical research work
• List of documents for examination of new technologies
• List of documents for examination of experimental research work

List of documents for examination.

1. Application addressed to the chairman of the Local Ethics Commission
2. Application form filled out by the researcher, according to the form in the appendix (download the application form)

- contact information of the researcher;

- design and methodology of the project;

- the number of study participants who must be recruited, both in the organization and in all places where the project is implemented (in cases where the project will be implemented in several centers);

- whether the researcher plans to recruit people from vulnerable populations (for example, children or people with cognitive problems);

- source of funding (eg granting agency, pharmaceutical company);

- a list of other LECs that the researcher contacted;

- all resources that are requested from the organization (for example, analysis of blood samples, office space, x-ray machine);

- a statement about the presence of any conflict of interest of the researcher.

3. A brief summary of the project (synopsis), presented in accessible language;
4. Clinical trial protocol (original or copy), signed by the sponsor or its authorized representative and the investigator;
5. Form of informed consent of research subjects in the state and Russian languages (download the form)
6. All questionnaires and other forms (individual registration cards) for data collection in the state and Russian languages;
7. Instructions (draft) for the medical use of a medicinal product, medical device or medical equipment;
8. Resume of the researcher(s), certificates of completion of training, incl. Good Clinical Practice/Good Laboratory Practice courses;
9. Investigator's Brochure on Clinical Trials;
10. Contract with sponsors and project budget (if applicable);
11. Insurance agreement for participants;
12. Other research documents

• Recruitment announcements
• Presentation of the conditions for the transfer of payments for the responsibility of the researcher (in cases if provided for in the protocol)
• Presentation of materials used to attract potential study participants
• Submission of a description of the conditions of insurance of study participants (in cases if provided for in the protocol)
• Provide a description of all compensation for participation in the study.
• Presentation of all significant previous decisions made by other ECs or authorities regarding the planned study
• Individual registration form, questionnaires designed to be completed by study participants

Documents are submitted in paper and electronic versions.

Forms of documents required for ethical examination

• Study protocol diagram
• Application form
• Forms of documents for examination of experimental research work

Contacts of the Secretariat of the Commission of the LLP “National Scientific Oncology Center”

Phone: 8 (7172) 70-29-59

Chairman of the Commission: Aida Fazylovna Shakirova, candidate of medical sciences, professor.

Deputy Chairman: Sagandykov Irlan Nigmetzhanovich, candidate of medical sciences,

Secretary of the Commission: Yessenbaeva Gulfairus Abdimazhitovna

e-mail: