Members of the Bioethics and Deontology Committee:<\/h3>\n\n\n\nHead of the Committee<\/h4>\n
![\"Korzh](\"\/wp-content\/uploads\/2024\/09\/korz_irina.webp\")
<\/p>\n
Korzh Iryna<\/a>,<\/strong>
\nPhD, Senior Research Scientist of the Department of Conservative Treatment and Clinical Trials, Therapist<\/strong><\/p>\n<\/div>\n\nDeputy Head of the Committee<\/h4>\n
![\"Perfiliev](\"\/wp-content\/uploads\/2024\/11\/Perfiliev_OV.webp\")
<\/p>\n
Perfiliev Oleksandr<\/a>,<\/strong>
\nPhD, Senior Research Scientist of the Department of Spine Diseases and Injuries, Orthopedic Traumatologist<\/strong><\/p>\n<\/div>\n
\n\nSecretary of the Committee<\/h4>\n
Barsukova Olena,<\/strong>
\nLaboratory doctor of the Department of Laboratory Diagnostics and Immunology<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\nBuznytskyi Ruslan<\/a><\/div>\nAssociate Professor of the Department of Traumatology and Orthopedics, Physical and Rehabilitation Medicine, KhNMU, PhD, orthopedic traumatologist<\/div>\n<\/div>\n\nHrytsenko Anastasiia<\/div>\nMD of the Department of Pathology of the Spine and Joints of Childhood, orthopedic traumatologist<\/div>\n<\/div>\n\nZhyliaieva Nina<\/div>\nLawyer of the Kharkiv City Notary District, lawyer<\/div>\n<\/div>\n\nKutsenko Volodymyr<\/a><\/div>\nHead of the Department of Spine Diseases and Injuries, MD, orthopedic traumatologist<\/div>\n<\/div>\n\nLeontieva Fryda<\/a><\/div>\nHead of the Department of Laboratory Diagnostics and Immunology, Ph.<\/div>\n<\/div>\n\nMarushchak Oleksii<\/div>\nHead of the Department of Orthopedic Arthrology and Endoprosthetics, MD, orthopedic traumatologist<\/div>\n<\/div>\n\nMikhanovskyi Dmytro<\/a><\/div>\nDoctor of the emergency traumatology department with admission department, MD, orthopedic traumatologist<\/div>\n<\/div>\n\nMorozenko Dmytro<\/a><\/div>\nSenior Research Scientist of the Department of Laboratory Diagnostics and Immunology, Doctor of Veterinary Medicine<\/div>\n<\/div>\n\nBarsukova Olena<\/div>\nLaboratory doctor of the Department of Laboratory Diagnostics and Immunology<\/div>\n<\/div>\n\nStaude Volodymyr<\/div>\nHead of the Conservative Treatment and Clinical Trials Department, MD, orthopedic traumatologist<\/div>\n<\/div>\n\nFoklina Iryna<\/div>\nRadiologist at the OKL Clinical Hospital, Candidate of Medical Sciences.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\nThe Bioethics and Deontology Committee at the Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine was established by the order of the Director of the Institute \u2116 38 \u201co\u201d dated 21.05.2001, reorganized by the order \u2116 62 \u201co\u201d dated 01.04.2024. and functions as a public association without legal entity, guided by the Regulations on the Bioethics and Deontology Committee.(Orders<\/a> \u0442\u0430 Provisions<\/a>)<\/p>\nMeetings of the Bioethics and Deontology Committee are held on Mondays at 14:00 in the auditorium of the Institute as materials for bioethical expertise are accumulated<\/p>\n
Functions of the Committee on Bioethics and Deontology:<\/h4>\n\n- Ensuring expert evaluation of the compliance of scientific and clinical research conducted at the institute with the principles and norms of bioethics established by international agreements, national laws, and regulatory requirements.<\/li>\n<\/ul>\n
Main tasks of the Committee on Bioethics and Deontology:<\/h4>\n\n- Protection<\/strong> of the rights and safety of patients involved in clinical trials, as well as the rights and interests of researchers conducting the trials.<\/li>\n
- Protection<\/strong> of animals from cruelty in scientific experiments, as well as the safety of researchers and personnel involved in the experiments, and other people and the environment from the undesirable consequences of scientific research.<\/li>\n
- Protection<\/strong> of human rights and dignity in cases of using anatomical materials from deceased individuals in scientific experiments, as well as the rights and interests of researchers working with such materials.<\/li>\n<\/ul>\n
Materials Subject to Bioethical Review<\/h4>\n\n- Research projects at the planning stage and after completion.<\/li>\n
- Dissertation (or initiative) studies at the planning stage and after completion.<\/li>\n
- Clinical trials of medicinal products (projects, significant amendments to trial protocols, annual and final reports, etc.).<\/li>\n
- Clinical trials of medical equipment and medical devices (projects, specialized evaluation of materials from completed studies).<\/li>\n
- Experimental studies involving animals.<\/li>\n
- Articles for publication in professional journals, other materials for printing.<\/li>\n<\/ol>\n
Procedure for Submitting Materials for Bioethical Expertise<\/h4>\n
At the stage of planning a scientific study<\/strong> (research project, dissertation, initiative study, etc.), the following documents must be submitted:<\/p>\n\n- An application from the Academic Council of the institute or<\/em> the responsible executor of the study, addressed to the head of the Committee on Bioethics and Deontology (sample application<\/a>).<\/li>\n
- A research project or an abstract-justification (design plan) of the dissertation or initiative study, specifying the objects and all methods of research and treatment.<\/li>\n
- A Patient or Parent Informed Consent Form if<\/em> non-standard research and treatment methods are used (patient form<\/a> or parent form<\/a>).<\/li>\n
- A contract for scientific and practical cooperation between the SI \u201cSytenko Institute of Spine and Joint Pathology NAMS of Ukraine\u201d and the cooperating institution if<\/em> a joint study is being conducted.<\/li>\n<\/ol>\n
For expert evaluation of a completed scientific study<\/strong>, the following documents must be submitted:<\/p>\n\n- An application from the Academic Council of the institute or<\/em> the responsible executor of the study, addressed to the head of the Committee on Bioethics and Deontology.<\/li>\n
- Materials of the completed study (research report, dissertation, article for publication, etc.).<\/li>\n<\/ol>\n
For expert evaluation of clinical trial materials<\/strong>, the list of documents is specified in the \u201cProcedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials…\u201d<\/em> (Order of the Ministry of Health of Ukraine No. 690 dated 23.09.2009, with all amendments).<\/p>\nThe Committee on Bioethics and Deontology has the right to request additional materials and information from researchers if necessary to fulfill its duties in conducting qualified bioethical expertise.<\/p>\n
Practical advice for responsible executors of biomedical researches and experts of the Bioethics and Deontology Committee<\/h4>\n\n- Plan of an oral presentation on scientific or dissertation research. <\/a><\/li>\n
- Plan of an oral presentation on clinical trial planning. <\/a><\/li>\n
- Key aspects of bioethical evaluation of materials of completed scientific research. <\/a><\/li>\n<\/ol>\n
Manuals and guidelines for experts of the Bioethics and Deontology Committee<\/h4>\n\n- Handbook for members of research ethics committees (Council of Europe, 2010).<\/a><\/li>\n
- General principles for organizing the activities of ethics committees at health care facilities where clinical trials of medicines are conducted (recommendations for experts): Manual \/ State Enterprise \u201cState Expert Center of the Ministry of Health of Ukraine\u201d, 2017.<\/a><\/li>\n
- Standard operating procedures (SOPs) for bioethics committees: Recommendations for ethics committees reviewing biomedical research (WHO, 2000).<\/a><\/li>\n
- International Ethical Guidelines for Health-related Research Involving Human Subjects. Geneva: Council for International Organizations for Medical Research (CIOMS), 2016.<\/a><\/li>\n
- Methodological recommendations for the removal of biological objects from deceased persons whose bodies are subject to forensic medical examination and pathological examination for scientific purposes (2018).<\/a><\/li>\n<\/ol>\n
Regulatory and legal framework of Ukraine for conducting bioethical expertise<\/h4>\n\n- The Law of Ukraine \u201cOn Medicinal Products\u201d (No. 124\/96-\u0412\u0420 of 04.04.1996, Articles 7, 8). https:\/\/zakon4.rada.gov.ua\/laws\/show\/123\/96-%D0%B2%D1%80<\/a><\/li>\n
- The Law of Ukraine \u201cOn Transplantation of Human Organs and Other Anatomical Materials\u201d (No. 1007-XIV of July 16, 1999). https:\/\/zakon.rada.gov.ua\/laws\/show\/2427-19<\/a><\/li>\n
- The Law of Ukraine \u201cOn the Protection of Animals from Cruelty\u201d (No. 3447-IV of February 21, 2006, Articles 26, 31). https:\/\/zakon.rada.gov.ua\/laws\/show\/3447-15<\/a><\/li>\n
- Order of the Ministry of Health of Ukraine \u201cOn Approval of Documents on Quality Assurance of Medicinal Products\u201d (No. 95 of February 16, 2009). https:\/\/zakon5.rada.gov.ua\/rada\/show\/v0095282-09<\/a><\/li>\n
- Order of the Ministry of Health of Ukraine \u201cOn Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Clinical Trial Materials and the Model Regulations on Ethics Commissions\u201d (No. 690 of 23.09.2009). https:\/\/zakon.rada.gov.ua\/laws\/show\/z1010-09<\/a><\/li>\n
- The Law of Ukraine \u201cOn Personal Data Protection\u201d (No. 2297-VI of June 1, 2010). https:\/\/zakon.rada.gov.ua\/laws\/show\/2297-17<\/a><\/li>\n
- Order of the Ministry of Education, Youth and Sports of Ukraine \u201cProcedure for Conducting Experiments and Animal Experiments by Scientific Institutions\u201d (No. 249 of March 1, 2012). https:\/\/zakon.rada.gov.ua\/laws\/show\/z0416-12<\/a><\/li>\n
- Resolution of the Cabinet of Ministers of Ukraine \u201cOn Approval of the Technical Regulations on Medical Devices\u201d (No. 753 of 02.10.2013). https:\/\/zakon2.rada.gov.ua\/laws\/show\/753-2013-%D0%BF<\/a><\/li>\n
- Resolution of the Cabinet of Ministers of Ukraine \u201cOn Approval of the Technical Regulations on Active Implantable Medical Devices\u201d (No. 755 of 02.10.2013). https:\/\/zakon2.rada.gov.ua\/laws\/show\/755-2013-%D0%BF<\/a><\/li>\n<\/ol>\n
International regulatory framework for bioethical review<\/h4>\n\n- Helsinki Declaration of the World Medical Association \u201cEthical Principles for Medical Research Involving Human Subjects\u201d (1964). 10th Edition (2024) https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki\/<\/a><\/li>\n
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Council of Europe, 1997). https:\/\/zakon.rada.gov.ua\/laws\/show\/994_334<\/a><\/li>\n
- Additional Protocol to the Convention on Human Rights and Biomedicine on Transplantation of Organs and Tissues of Human Origin (2002). https:\/\/zakon.rada.gov.ua\/laws\/show\/994_684<\/a><\/li>\n
- Additional Protocol to the Convention on Human Rights and Biomedicine for Biomedical Research (2005).https:\/\/zakon.rada.gov.ua\/laws\/show\/994_686<\/a><\/li>\n
- European Convention for the Protection of Vertebrate Animals Used for Research and Other Scientific Purposes (1986). https:\/\/zakon.rada.gov.ua\/laws\/show\/994_137<\/a><\/li>\n<\/ol>\n
Reports<\/h4>\n\n- Report on the work of the Bioethics and Deontology Committee at the State Institution “Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine” for 2024<\/a><\/li>\n
- Report on the work of the Bioethics and Deontology Committee at the State Institution “Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine” for 2025<\/a><\/li>\n<\/ul>\n<\/div>\n
<\/p>","protected":false},"excerpt":{"rendered":"
Members of the Bioethics and Deontology Committee: Head of the Committee Korzh Iryna, PhD, Senior Research Scientist of the Department of Conservative Treatment and Clinical Trials, Therapist Deputy Head of the Committee Perfiliev Oleksandr, PhD, Senior Research Scientist of the Department of Spine Diseases and Injuries, Orthopedic Traumatologist Secretary of the Committee Barsukova Olena, Laboratory […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1700,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-department.php","meta":{"footnotes":""},"class_list":["post-2192","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/2192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/comments?post=2192"}],"version-history":[{"count":37,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/2192\/revisions"}],"predecessor-version":[{"id":9219,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/2192\/revisions\/9219"}],"up":[{"embeddable":true,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/1700"}],"wp:attachment":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/media?parent=2192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Head of the Committee<\/h4>\n
<\/p>\n
Korzh Iryna<\/a>,<\/strong> Perfiliev Oleksandr<\/a>,<\/strong> Barsukova Olena,<\/strong> The Bioethics and Deontology Committee at the Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine was established by the order of the Director of the Institute \u2116 38 \u201co\u201d dated 21.05.2001, reorganized by the order \u2116 62 \u201co\u201d dated 01.04.2024. and functions as a public association without legal entity, guided by the Regulations on the Bioethics and Deontology Committee.(Orders<\/a> \u0442\u0430 Provisions<\/a>)<\/p>\n Meetings of the Bioethics and Deontology Committee are held on Mondays at 14:00 in the auditorium of the Institute as materials for bioethical expertise are accumulated<\/p>\n At the stage of planning a scientific study<\/strong> (research project, dissertation, initiative study, etc.), the following documents must be submitted:<\/p>\n For expert evaluation of a completed scientific study<\/strong>, the following documents must be submitted:<\/p>\n For expert evaluation of clinical trial materials<\/strong>, the list of documents is specified in the \u201cProcedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials…\u201d<\/em> (Order of the Ministry of Health of Ukraine No. 690 dated 23.09.2009, with all amendments).<\/p>\n The Committee on Bioethics and Deontology has the right to request additional materials and information from researchers if necessary to fulfill its duties in conducting qualified bioethical expertise.<\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" Members of the Bioethics and Deontology Committee: Head of the Committee Korzh Iryna, PhD, Senior Research Scientist of the Department of Conservative Treatment and Clinical Trials, Therapist Deputy Head of the Committee Perfiliev Oleksandr, PhD, Senior Research Scientist of the Department of Spine Diseases and Injuries, Orthopedic Traumatologist Secretary of the Committee Barsukova Olena, Laboratory […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1700,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-department.php","meta":{"footnotes":""},"class_list":["post-2192","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/2192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/comments?post=2192"}],"version-history":[{"count":37,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/2192\/revisions"}],"predecessor-version":[{"id":9219,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/2192\/revisions\/9219"}],"up":[{"embeddable":true,"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/pages\/1700"}],"wp:attachment":[{"href":"https:\/\/sytenko.org.ua\/en\/wp-json\/wp\/v2\/media?parent=2192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nPhD, Senior Research Scientist of the Department of Conservative Treatment and Clinical Trials, Therapist<\/strong><\/p>\n<\/div>\nDeputy Head of the Committee<\/h4>\n
<\/p>\n
\nPhD, Senior Research Scientist of the Department of Spine Diseases and Injuries, Orthopedic Traumatologist<\/strong><\/p>\n<\/div>\n
\nSecretary of the Committee<\/h4>\n
\nLaboratory doctor of the Department of Laboratory Diagnostics and Immunology<\/strong><\/p>\n<\/div>\n<\/div>\nFunctions of the Committee on Bioethics and Deontology:<\/h4>\n
\n
Main tasks of the Committee on Bioethics and Deontology:<\/h4>\n
\n
Materials Subject to Bioethical Review<\/h4>\n
\n
Procedure for Submitting Materials for Bioethical Expertise<\/h4>\n
\n
\n
Practical advice for responsible executors of biomedical researches and experts of the Bioethics and Deontology Committee<\/h4>\n
\n
Manuals and guidelines for experts of the Bioethics and Deontology Committee<\/h4>\n
\n
Regulatory and legal framework of Ukraine for conducting bioethical expertise<\/h4>\n
\n
International regulatory framework for bioethical review<\/h4>\n
\n
Reports<\/h4>\n
\n