Local Bioethics Committee (hereinafter referred to as the “Committee”) of the National Research Oncology Center LLP (hereinafter referred to as “NROC”) is an independent expert body responsible for protecting the rights of research participants, conducting bioethical reviews of documents related to biomedical research at the planning, implementation, and post-completion stages. The Committee’s activities are aimed at ensuring the safety and protection of the rights of participants in biomedical research. In its work, the Committee is guided by the laws and regulatory legal acts of the Republic of Kazakhstan, as well as international guidelines and standards.
The primary objective of the Committee is to protect the rights, dignity, safety, and well-being of research participants (patients and volunteers) and investigators involved in clinical studies and biomedical research. The Committee also provides ethical and legal review of clinical research materials.
- To ensure the safety and protection of human rights during the planning and conduct of research studies.
- To conduct ethical and legal reviews of clinical research materials carried out within the framework of scientific and technical programs, investigator-initiated (including dissertation) studies, research projects (including those involving international organizations), and scientific publications.
- To develop documents related to biological and medical ethics.
- Regulations on the Local Bioethics Committee
- Composition of the Local Bioethics Committee
- Independent Experts of the Local Bioethics Committee
- Schedule of Meetings of the Local Bioethics Committee
- Annual Work Plan of the Local Bioethics Commission
- Annual Reports of the Committee
- List of Approved Standard Operating Procedures
- List of Approved Standard Operating Procedures for Clinical Research
- List of Documents for the Expert Review of a Clinical Research of a Medicinal Product.
- List of Documents for the Expert Review of a Clinical Research Study
- List of Documents Required for the Expert Review of New Technologies
- List of Documents Required for the Expert Review of Experimental Research Projects
- List of Documents Required for the Expert Review of Manuscripts
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Application addressed to the Chairperson of the Local Bioethics Committee (download form);
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Application form completed by the investigator in accordance with the prescribed template (download form);
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Project summary (synopsis) written in clear and accessible language;
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Clinical study protocol (original or copy) signed by the sponsor or its authorized representative and the investigator (download form);
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Informed Consent Form for study participants in the Kazakh and Russian languages (download form);
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All questionnaires and other data collection forms (Individual Case Report Forms) in the Kazakh and Russian languages;
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Instructions for Use (draft) of the medicinal product, medical device, or medical equipment;
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Curriculum Vitae (CV) of the investigator(s), including certificates of training completion, including Good Clinical Practice/Good Laboratory Practice (GLP) courses (download form);
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Investigator’s Brochure for the clinical trial (download form);
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Contract with the sponsor(s) and project budget (if applicable);
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Participant insurance agreement;
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Other study-related documents.
- Application form for amendments to the study protocol (download form);
- Review of external, multicenter, international, and clinical studies is conducted in accordance with the fee schedule approved by the Order of the Chairman of the Management Board of the LLP National Research Oncology Center. .
Documents must be submitted in both hard-copy and electronic formats.
Chairperson of the Committee, PhD, Associate Professor (Docent)
Deputy Chairperson, Candidate of Medical Sciences
Secretary of the Committee, Leading Specialist of the Scientific Management Department