The Local Ethics Commission (LEC) of the Kazakhstan-Russian Medical University is a collegial body that independently assesses whether proposals for conducting health-related research comply with recognised ethical standards in the Republic of Kazakhstan.

The LEC protects the rights, safety and well-being of research participants and researchers and provides an ethical, moral and legal assessment of scientific research materials involving humans or animals.

The LEC operates according to the principles of objectivity and independence from political, administrative, institutional, collegial, financial and economic influence.

The primary purpose of the LEC is to review and ensure compliance with ethical standards in health-related research.

• Assess whether documents for health-related research, including research involving animals, comply with the ethical standards established by the legislation of the Republic of Kazakhstan;
• Review issues concerning compliance with ethical standards during the planning and conduct of health-related research;
• Independently assess the scientific value of a health-related research project and review its ethical acceptability;
• Assess the scientific validity, expected effectiveness and safety, including risks, of health-related research;
• Promote bioethical principles in health-related research and further study issues arising from their application and the development of relevant technologies;
• Review research for compliance with applicable legal requirements, including respect for human dignity, privacy, life and health, access to information, and civil rights relating to receiving or refusing medical care and providing informed consent.

Chair of the LEC: Arystan Oskarovich Seidalin, Doctor of Medical Sciences, Professor and Vice-Rector for Scientific and Clinical Affairs.

Secretary of the LEC: Urnisyam Alimzhanovna Kuvatbayeva, Master of Healthcare.

Contact email: u.kuvatbaeva@medkrmu.kz

Members of the LEC include representatives of the University’s academic staff, students and members of the public. Decisions are made by the members of the LEC rather than by the secretary; the secretary prepares and issues the documented decision as an extract from the minutes.

The dossier must include a detailed inventory of documents indicating dates and version numbers, submitted as one paper copy and in electronic form.

The electronic version must be sent as a single archived file to u.kuvatbaeva@medkrmu.kz. The file name must include the applicant’s surname and the programme or status under which the work is being completed. Each document in the archive must have a clear and accurate file name.

If comments are issued after the electronic review, they must be addressed within three working days and the complete revised set of documents must be resubmitted, not only the corrected file. Once the electronic version has been accepted, one signed paper copy must be submitted in a folder with dividers to Room 804, 51/53 Abylai Khan Avenue, Almaty, at a time agreed in advance with the secretary.

Important: documents that do not comply with these requirements will not be reviewed. Documents must be submitted in both Kazakh and Russian. Researchers must submit documents before the study begins. Project leaders and principal investigators must submit documents at least 10 working days before the competition application deadline.

• Application addressed to the Chair of the LEC;
• Application for initial review (Appendix 1);
• Research abstract for dissertation applicants;
• Research protocol (Appendix 2) and accompanying documents:

1. Information for the organisation;
2. Informed consent forms for the organisation;
3. Participant card, where applicable;
4. Case report forms;
5. Curriculum vitae (CV) of the researcher and, for dissertation research, the academic supervisor.

• Application addressed to the Chair of the LEC;
• Initial review application forms;
• Research abstract for dissertation applicants;
• Research protocol (Appendix 2) and accompanying documents:

1. Participant information sheet;
2. Informed consent form with information for the patient or healthy volunteer, provided in Kazakh and Russian;
3. For research involving minors, appropriate information and consent documents for a parent or legal representative, for adolescents aged 14–17, and, where applicable, age-adapted information for children aged 10 years and older;
4. Document guaranteeing protection of the rights of patient participants if their health is harmed during the study;
5. Materials, including advertising materials, used to inform and recruit participants, together with instructions for medicines and devices, where applicable;
6. Questionnaires, surveys, scales and similar instruments to be completed by the investigator;
7. Diaries, questionnaires, surveys and similar instruments to be completed by patient participants;
8. Participant card, where applicable;
9. Case report forms;
10. Research budget and justification;
11. Research agreements;
12. Curriculum vitae (CV) of the researcher and, for dissertation research, the academic supervisor;
13. Investigator’s brochure.

• Application addressed to the Chair of the LEC;
• Initial review application forms;
• Curriculum vitae (CV) of the researcher and, for dissertation research, the academic supervisor (Appendix 3);
• Research abstract for dissertation applicants;
• Research protocol (Appendix 2) and accompanying documents:

1. Statement on the condition of facilities used for preclinical studies;
2. Information on equipment and instruments available for preclinical studies;
3. Information on laboratory animals and their housing conditions;
4. List of methods used in preclinical studies;
5. List of standard operating procedures;
6. Letter of guarantee.