The Local Bioethics Commission of the Republican state enterprise on the right of economic management «Kazakh Center for Dermatology and Infectious Diseases» of the Ministry of Health of the Republic of Kazakhstan (hereinafter referred to as the LCB) is an independent expert authority and functions in accordance with the legislation of the Republic of Kazakhstan to conduct an independent bioethical examination of documents related to biomedical research at the planning stage, during and after completion in order to ensure the safety and protection of the rights of participants in biomedical research.

The LCB is guided by the Constitution of the Republic of Kazakhstan, the laws of the Republic of Kazakhstan, acts of the President and the Government of the Republic of Kazakhstan, the Order of the Minister of Health of the Republic of Kazakhstan dated December 21, 2020 № KR DSM-310/2020 «On approval of the rules for biomedical research and requirements for research centers», the Standard of Good Clinical Practice (GCP), the order of the acting Minister of Health of the Republic of Kazakhstan dated February 4, 2021 № KR DSM-15 "On approval of appropriate pharmaceutical practices, rules for conducting clinical trials of medicines and medical devices, clinical and laboratory tests of medical devices for diagnostics outside a living organism (in vitro) and requirements for clinical databases and the provision of public services for the issuance of permits for clinical research and (or) testing of pharmacological and medicinal products, medical devices", By Order of the Minister of Health of the Republic of Kazakhstan dated December 11, 2020 № KR DSM-248/2020, by Order of the Minister of Health of the Republic of Kazakhstan dated December 9, 2020 № KR DSM-243/2020 "On approval of the Rules for Issuing and Validity of the certificate of compliance with the requirements of Bioethical commissions", by Order of the Minister of Health of the Republic of Kazakhstan dated October 23, 2020 № KR DSM-151/2020 "On approval of the Regulations on the Central Commission on Bioethics", the Helsinki Declaration of the World Medical Association, The Convention on Human Rights and Biomedicine (1997) and the Regulation on the Bioethics Commission of the RSE at the "Kazakh Scientific Center of Dermatology and Infectious Diseases" of the Ministry of Health of the Republic of Kazakhstan. 

LKB tasks

Main tasks:

• Protection of the rights and welfare of peeople participating in clinical trials, biomedical experiments, ensuring guarantees of their safety;
• Protection of the rights and interests of the researchers;
• Protection of the rights of animals that are objects of scientific experiments;
• Advising on ethics issues and protecting bona fide researchers implementing good clinical and laboratory practice;
• Implementation of ethical and moral-legal assessment of planned, ongoing and completed clinical and experimental studies;
• Consideration of controversial issues that arose before, during, or after the completion of clinical and experimental studies; 

Chairman of the LCB - Candidate of Medical Sciences, Utegenova Aliya Kaziyevna - Specialist of the Department of Clinical Monitoring of the KSCDID

Deputy Chairman - Candidate of Biological Sciences, Dzisyuk N.V. - specialist of laboratory of KSCDID.

LKB Secretary - M.M.N., Magay Alyona Vladimirovna - Quality Manager of laboratory of KSCDID Contacts: lab2@kncdiz.kz +7 (727) 277-98-43

LKB members:

• Dzhusupgalieva M.Kh. - Candidate of Biological Sciences, specialist-methodologist of the Department of Information and Analytical Monitoring and Strategic Development of KSCDID,
• Kipshakbayev R.K.- PhD, Associate Professor of Caspian International School of Medicine, Caspian University,
• Amanzholov N.H. - President of the "Central Asian Association of PLHIV", Turdaliev B.S. - doctoral student at KazNMU named after S.Asfendiyarov,
• Balgimbayeva A.S.- chief researcher of the Laboratory of Antibiotics LLP "Scientific and Production Center of Microbiology and Virology",
• Makymbaeva M.B. - Legal Adviser of the Department of Personnel Management, Public Procurement and Legal Support

Schedule of meetings of the Local Bioethics Commission of the Republican state enterprise on the right of economic management

KSCDID of the MoH of RK

List of documents to be submitted to the LCB KSCDID (in paper and electronic versions):

A detailed inventory of documents (dates and version numbers) in paper (1 copy) and electronic form is attached to the dossier.

The electronic version is sent as one archived letter to the e-mail lab2@kncdiz.kz. After checking the electronic version, if there are comments, correct it within 3 working days and send the full corrected package of documents, i.e. not only the corrected version. After the electronic version is accepted, submit the paper version of the documents in 1 copy to the address of Raiymbek, 60, having previously agreed on a meeting with the secretary. The documents must be signed, must be provided in a folder, divided by separators, in the order of the list below.

NB! Researchers need to submit documents before STARTING the study. Project managers and principal researchers must submit documents AT LEAST 10 working days before the deadline for submitting documents.

LIST OF DOCUMENTS FOR RESEARCH WITH THE PARTICIPATION OF A PERSON AS A SUBJECT OF RESEARCH WITHOUT INTERVENTION (PROSPECTIVE):

• Statement addressed to the Chairman of the LEK;
• Application for primary examination;
• Research abstract (for dissertants and applications for the competition).
• RESEARCH PROTOCOL AND ACCOMPANYING DOCUMENTS:
• Information for the participant;
• Informed consent with information for the patient/healthy volunteer, provided in Kazakh and Russian;
• For studies involving minors – relevant documents with information and an informed consent form for a parent (legal representative), for a teenager aged 14-17 years and (if available) adapted information for a child above 10 years of age);
• Questionnaires, surveys, scales, etc., intended for filling out by a research doctor (if any);
• Diaries, questionnaires, surveys, etc., to be filled out by patients participating in the study (if any);
• Research participant card (if any);
• Case registration forms;
• Research budget, its justification;
• Research contracts.

LIST OF DOCUMENTS FOR RESEARCH WITH THE PARTICIPATION OF A PERSON AS A SUBJECT OF RESEARCH WITHOUT INTERVENTION (RETROSPECTIVE):

• Statement addressed to the Chairman of the LEK;
• Application for primary examination;
• Research abstract (for dissertants);
• Research protocol and accompanying documents:
• Information for the organization;
• Informed consent forms for the organization;
• Research participant card (if any);
• Case registration forms;
• Summary of the research (CV) and its supervisor (in the case of dissertation research).

List of documents submitted for biotic examination in the LCB of interventional clinical trial materials

The sponsor or the head of the study for the bioethical examination of the materials of the interventional clinical trial submits the following documents to the LCB:

1. An application for a clinical trial with a cover letter in any form;
2. clinical trial protocol (original or copy) signed by the sponsor or his authorized representative and researcher;
3. synopsis of the protocol of clinical research for international studies in the state and Russian languages;
4. the researcher's brochure;
5. instruction (or project) on the medical use of a medicinal product, a medical device;
6. information for the subject of the study about the clinical trial in the state and Russian languages;
7. the form of informed consent of the subjects of the study in the state and Russian languages;
8. a researcher's resume confirming his/her qualifications and a certificate of completion of good clinical practice courses;
9. information about clinical databases;
10. a power of attorney issued by a sponsor with clearly defined delegated authority, if the applicant of the clinical trial is not a sponsor;
11. information concerning the recruitment of research subjects (informational and promotional materials that will be used to attract research subjects to clinical research (if available) in the state and Russian languages);
12. a copy (or draft) of the sponsor's civil liability insurance contract for causing harm to the health and life of the subjects of the study;
13. a document defining the conditions for payment of remuneration or compensation to research subjects for participation in a clinical trial (if this is provided for by the protocol of the clinical trial). Information concerning the terms of payment or compensation to the subjects of the study or their legal representative for participation in a clinical trial is provided in a cover letter with a link to the relevant document that provides for this.

List of documents submitted for biotic examination in the LCB of non-interventional research materials

The sponsor or the head of the study submits the following documents to obtain the conclusion of the bioethical examination of the materials of the non-interventional study:

1. an application for a clinical trial with a cover letter in any form;
2. a researcher's resume confirming his qualifications and a certificate of completion of GCP courses;
3. a copy of the registration certificate for medicines;
4. a copy of the instructions for medical use (approved version);
5. a copy of the General Characteristics of the medicinal product for medical use (hereinafter referred to as OHLP) (approved version);
6. clinical trial protocol signed by the sponsor or an authorized representative of the sponsor;
7. information for the subjects of the study or their legal representative about the clinical trial in the state and Russian languages (if required by the protocol);
8. the form of informed consent of the subject of the study in the state and Russian languages (if required by the protocol);
9. a sample of an individual registration form on paper (if required by the protocol).