Local Bioethics Committee
The Local Bioethics Committee of the LLP “Scientific Research Institute for Biological Safety Problems” is an independent expert body that conducts bioethical review of scientific studies performed at the Institute and/or submitted for review in the established procedure.
The Committee assesses compliance with bioethical principles and biological safety requirements, and ensures the protection of the rights, safety and well-being of research participants, personnel, animals, the environment and society.
A specific feature of the Committee’s work is the integration of bioethical review and biological risk assessment, which is particularly important for studies involving microorganisms, viruses, biological agents, biological materials and laboratory animals.
Main areas of activity
The Committee carries out:
– bioethical review of scientific studies;
– assessment of the risk-benefit ratio;
– assessment of compliance with biological safety requirements;
– review of studies using biological materials, microorganisms, viruses and laboratory animals;
– review of study protocols and accompanying documents;
– review of changes and amendments to study protocols;
– monitoring of approved studies;
– review of reports on violations, deviations and biological incidents;
– review of final reports on completed studies;
– issuance of opinions and bioethical approval certificates within the competence of the Committee.
Biosafety and specialized review
The Committee pays special attention to biological safety issues when reviewing studies related to:
– pathogenic biological agents;
– microorganisms and viruses;
– biological materials;
– laboratory animals;
– housing and handling conditions for laboratory animals;
– biosafety levels of laboratories;
– protection of personnel, animals, the environment and third parties;
– potential dual-use risks.
Where necessary, the Committee engages independent experts and specialists in relevant areas, including biosafety, veterinary medicine, microbiology, virology, laboratory diagnostics, preclinical studies and work with laboratory animals.
International standards and scientific publications
The Committee’s activities are organized taking into account national requirements and internationally recognized principles of bioethics, good research practice, protection of research participants and humane treatment of laboratory animals.
Bioethical approval may be required for:
– publication of scientific results in international scientific journals;
– participation in international research projects;
– submission of applications for international grants;
– presentation of research results in dissertation, reporting and registration materials.
The Committee prepares documents required to confirm bioethical review of a study, including:
– LBC opinion;
– bioethical approval certificate;
– bioethical approval number;
– information for the “Ethical Approval” section in scientific publications.
Specific features of LBC activities
Specific features of LBC activities include:
– integration of bioethical review and biosafety assessment;
– review of studies involving biological agents and laboratory animals;
– application of approved standard operating procedures;
– consideration of risks to research participants, personnel, animals, the environment and society;
– engagement of independent experts when specialized issues are reviewed;
– documentation of decisions, opinions and follow-up monitoring of approved studies.
LBC documents
This page contains open documents of the Local Bioethics Committee intended to inform applicants and ensure the procedure for submitting materials for bioethical review.
- Open regulatory documents of the LBC
The package contains the order on establishment of the LBC, the Regulations on the LBC, the composition of the LBC and the register of open documents.
Download package: Open regulatory documents of the LBC
- Standard operating procedures of the LBC
The package contains approved standard operating procedures of the LBC regulating the organization of the Committee’s work, submission and review of applications, conduct of bioethical review, decision-making, monitoring of approved studies, review of amendments, violations, reports and archiving of documents.
Download package: Standard operating procedures of the LBC
- Documents and forms for applicants
The package contains instructions for applicants, the application form, the study protocol template, forms, guidance notes and other documents required for submission of materials for bioethical review.
Download package: Documents and forms for applicants
Submission of an application
To undergo bioethical review, the applicant shall:
– prepare an application for bioethical review;
– prepare the study protocol;
– attach the documents required for the relevant type of study;
– where necessary, attach the informed consent form, information on laboratory animals, biological materials, pathogenic biological agents and biosafety measures;
– submit the set of documents to the LBC Secretary;
– wait for registration of the application and notification of the further review procedure.
Submission, registration, administrative review, expert review, decision-making and notification of the applicant are carried out in accordance with the approved standard operating procedures of the LBC.
Contact information
Secretary of the Local Bioethics Committee:
Kurmasheva Alina Kairzhanovna
E-mail: a.kurmasheva@biosafety.kz