Local Bioethics Commission
Local Bioethics Commission
Local Bioethics Commission (hereinafter – LBC) of NJSC "Astana Medical University" is an advisory body that protects the rights, safety and well-being of subjects and researchers, as well as ethical and moral and legal assessment of scientific research materials, the objects of which are humans or animals.
Basic goals:
The main purpose of the Committee is to monitor and organize advice on ethical standards in the conduct of scientific research;
Main goals:
Protection of health, rights and interests of persons participating in clinical research, biomedical experiments, ensuring their safety;
Protection of the rights of animals that are the objects of a scientific experiment;
Ethics counseling and advocacy for bona fide researchers pursuing good clinical and laboratory practice;
Implementation of ethical and moral and 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;
Consideration of ethical issues, feasibility and possibility of conducting scientific experiments on animals, the degree of validity and minimization of harm to animals
Chairman of Local Bioethics Commission –PhD Kamalbekova Gulnara Maratovna
Secretary of Local Bioethics Commission – Nuran Aruzhan Musilimovna, specialist in the Department of scientific development
Contacts: lkb@amu.kz
LBC members are representatives of different specialties. The LBC decision is issued NOT by the secretary, and directly members of the LBC, the secretary prepares and issues a documented decision of the LBC in the form of an extract.
List of documents to be submitted to the LKB MUA (in electronic version):
A detailed inventory of documents (dates and version numbers) in electronic form is attached to the dossier.
The electronic version is sent in one archived email to: lkb@amu.kz , named by last name and within the framework of which the work is performed (for example, Akhmetov A.A. Doctoral student.zip or Akhmetova A., The Project of the Ministry of Health РК.гаг .). Each document in the archive folder must be correctly named (for example, the Statement of A.A. Akhmetov, the Protocol of A.A. Akhmetov, the questionnaire of A.A. Akhmetov, etc.). After checking the electronic version, if there are any comments, correct it within 2 working days and send the full corrected a package of documents, i.e. not only the corrected version.
NB! Documents sent to the mail that do not comply with the above recommendations will not be checked.
NB! Researchers must submit documents BEFORE STARTING the study. Project managers and principal investigators must submit documents at least 10 working days in advance of the deadline for submitting documents to the competition.
List of documents for research with human participation as a research subject without intervention (prospective):
1. Statement addressed to the Chairman of the Local Bioethics Committee
2. Application for primary examination (Appendix 1)
3. Annotation of research work (for dissertation candidates)
4. Research protocol (Appendix 2) and accompanying documents:
§ Information for the participant
§ Forms of informed consent (for research involving minors - relevant documents with information and an informed consent form for a parent (legal representative), for a teenager 14-17 years old and (if available) adapted information for a child over 10 years old)
§ Questionnaires, questionnaires, scales, etc., intended to be filled out by the doctor-researcher (if any)
§ Diaries, questionnaires, questionnaires, etc. to be filled out by patients participating in the study (if any)
§ Study participant card (if applicable)
§ Case registration forms
§ Research budget, its rationale
§ Research contracts
§ Resume of the researcher (CV) and his supervisor (in the case of dissertation research) (Appendix 3)
5. Investigator Certificates in Good Clinical Practice (GCP) and / or Research Management - if any; if they are not there, then the applicant must receive them at the appropriate educational institution (without a certificate, work will not be considered).
List of documents for research with human participation as a research subject without intervention (retrospective):
1. Statement addressed to the Chairman of the Local Bioethics Committee
2. Application for primary examination (Appendix 1)
3. Annotation of research work (for dissertation candidates)
4. Research protocol (Appendix 2) and accompanying documents:
§ Information for the organization
§ Informed consent forms for the organization
§ Study participant card (if applicable)
§ Case registration forms
§ Resume of the researcher (CV) and his supervisor (in the case of dissertation research) (Appendix 3)
5. Investigator Certificates in Good Clinical Practice (GCP) and / or Research Management - if any; if they are not there, then the applicant must receive them at the appropriate educational institution (without a certificate, work will not be considered).
List of documents for research with human participation as a subject of research with intervention:
1. Statement addressed to the Chairman of the Local Bioethics Committee
2. Application forms for primary examination (Appendix 1)
3. Annotation of research work (for dissertation candidates)
4. Research protocol (Appendix 2) and accompanying documents:
§ Information for the participant
§ Forms of informed consent (for research involving minors - relevant documents with information and an informed consent form for a parent (legal representative), for a teenager 14-17 years old and (if available) adapted information for a child over 10 years old)
§ Questionnaires, questionnaires, scales, etc., intended to be filled out by the doctor-researcher (if any)
§ Diaries, questionnaires, questionnaires, etc. to be filled out by patients participating in the study (if any)
§ Study participant card (if applicable)
§ Case registration forms
§ Research budget, its rationale
§ Research contracts
§ Resume of the researcher (CV) and his supervisor (in the case of dissertation research) (Appendix 3)
§ Investigator Brochures (Appendix 4)
5. Investigator Certificates in Good Clinical Practice (GCP) and / or Research Management - if any; if they are not there, then the applicant must receive them at the appropriate educational institution (without a certificate, work will not be considered).
List of documents for research with laboratory animals as a research subject:
1. Statement addressed to the Chairman of the Local Bioethics Committee
2. Application forms for primary examination (Appendix 1)
3. Resume of the researcher (CV) and his supervisor (in the case of dissertation research) (Appendix 3)
4. Annotation of research work (for dissertation candidates)
5. Research protocol (Appendix 2) and accompanying documents:
Certificate on the state of production facilities for preclinical studies
Information about the equipment and apparatus available in the organization for conducting preclinical studies
Information about laboratory animals and conditions of their keeping
List of methods used in preclinical studies
List of standard operating procedures
Guarantee obligation
6. Investigator's Certificates of Good Laboratory Practice (GLP) - if any; if they are not there, then the applicant must receive them at the appropriate educational institution (without a certificate, work will not be considered).
