The Local Commission on Bioethics (hereinafter — the Commission) at the Republican State Enterprise on the Right of Economic Management “Research Institute of Balneology and Medical Rehabilitation” of the Ministry of Health of the Republic of Kazakhstan (hereinafter — the Institute) is an independent expert body that conducts bioethical review of documents related to biomedical research at the stages of planning, implementation, and after completion, with the aim of ensuring safety and protecting the rights of participants in biomedical research.
The main purpose of the Commission is to conduct independent bioethical review of research to ensure safety, protection of health, and safeguarding the rights of research participants and researchers at the stages of planning, conduct, and completion of research.

Objectives of the Commission:

-review of research projects and studies involving both patients and healthy participants in accordance with national legislation, international ethical standards, and Standard Operating Procedures (SOPs);
-issuance of opinions for biomedical research planned at the Institute;
-bioethical monitoring of ongoing biomedical research for which the Commission has issued approval and authorization from the competent authority has been obtained;
-submission of an annual report on the Commission’s activities to the Central Bioethics Commission of the Republic of Kazakhstan in the prescribed manner.

For the initial review of research, the Local Bioethics Commission accepts an application for ethical review submitted in both electronic and hard-copy formats in two copies, the current version of the researcher’s curriculum vitae and/or other documents confirming the researcher’s qualifications; the study protocol and any subsequent amendments, as well as the informed consent form. Additionally, the Investigator’s Brochure, proof of payment for ethical review (for commercial studies), and other documents required for review may be requested.

The Local Bioethics Commission accepts the following types of submissions:

application for initial ethical review;
resubmission (with revisions);
application for protocol amendments and/or related documents;
notifications of serious adverse events, safety reports, and study progress reports (interim and final), etc.;
application for exemption from ethical review;
notification of study termination or suspension.
Applications for initial and resubmission review must be submitted no later than 14 calendar days prior to the Commission meeting. The Commission conducts the bioethical assessment of the study protocol and related materials within up to 30 calendar days and informs the applicant of its decision within 3 days after the meeting.
Notifications of serious adverse events and reactions must be submitted by the applicant within 7 calendar days after detection.

1. Ethics Committee Organization and SOP Development

1.1. Procedure for establishing a Local Bioethics Committee — SOP/001
1.2. Development, review, dissemination, and revision of SOPs — SOP/002
1.3. Procedure for ensuring confidentiality and managing conflicts of interest of Local Bioethics Committee members — SOP/003
1.4. Procedure for engaging independent consultants for ethical review — SOP/004
1.5. Procedure for training members of the Local Bioethics Committee — SOP/005

2. Initial Review Procedures

2.1. Application and research protocol submission process — SOP/006
2.2. Procedure for research assessment — SOP/007
2.3. Procedure for initial ethical review of the research protocol — SOP/008
2.4. Procedure for expedited ethical review of research applications — SOP/009
2.5. Ethical review of investigator-initiated / dissertation research — SOP/010
2.6. Procedure for exemption from ethical review — SOP/011
2.7. Procedure for review of research involving vulnerable populations — SOP/012

3. Protocol Amendments, Monitoring, and Study Closure

3.1. Procedure for review of resubmissions — SOP/013
3.2. Procedure for review of protocol amendments — SOP/014
3.3. Procedure for continuing review and study oversight — SOP/015
3.4. Procedure for review of final reports — SOP/016

4. Study Oversight and Monitoring

4.1. Procedure for review of protocol deviations and/or violations — SOP/017
4.2. Procedure for handling participant requests/complaints — SOP/018
4.3. Procedure for study suspension or termination — SOP/019

5. Monitoring and Assessment of Adverse Events

5.1. Procedure for review of Serious Adverse Events (SAEs) — SOP/020

6. Site Monitoring

6.1. Inspection of the research site — SOP/021

7. Meeting Agenda Preparation and Communication Reporting

7.1. Procedure for conducting Local Bioethics Committee meetings and decision-making — SOP/022
7.2. Extraordinary meeting procedure — SOP/023

8. Documentation

8.1. Procedure for record-keeping and document archiving of the Local Bioethics Committee — SOP/024

Contact information for the Secretariat of the Local Bioethics Commission
Chairperson of the Local Bioethics Commission: Baurzhan Madina Baurzhanqyzy
Secretary of the Local Bioethics Commission: Daniyarova Gulnur Daniyarqyzy
Address: Research Institute of Mechanisms and Methods of Medical Research, Ministry of Health of the Republic of Kazakhstan, Astana, Dostyk Street, 13/3, 3rd floor, office 504
📞 Contact information: Mobile: 8 7055965060
✉️ Email: research2026bmr@gmail.com

Cover letter

Application form for primary examination

Form for reporting violations and/or deviations from the study protocol

Final Research Report Form

Interim progress report

Study protocol structure

Application for amendments to the study protocol

Reporting of serious adverse events

Informed consent form