The Committee on Bioethics and Deontology 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 № 38 “o” dated 21.05.2001, reorganized by the order № 62 “o” dated 01.04.2024.
and functions as a public association without legal entity, guided by the Regulations on the Committee on Bioethics and Deontology.
(Orders та Provisions)

Meetings of the Committee on Bioethics and Deontology are held on Mondays at 14:00 in the auditorium of the Institute as materials for consideration are accumulated.

Functions of the Bioethics and Deontology Committee:

• Providing expert work on assessing the compliance of scientific and clinical trials conducted at the Institute with the principles and norms of bioethics established by international treaties and national laws and regulations.

The main tasks of the Bioethics and Deontology Committee:

• Protecting the rights and safety of patients involved in clinical trials, as well as the rights and interests of researchers conducting trials;
• Protection of animals from cruel treatment in scientific experiments, as well as the safety of researchers and personnel involved in the conduct of experiments, as well as other people and the environment from undesirable consequences of scientific research;
• Protection of human rights and dignity in the case of the use of anatomical materials of deceased persons in scientific experiments, as well as the rights and interests of researchers working with anatomical materials of deceased persons.

Materials subject to bioethical review

1. Research works at the planning stage and after their implementation
2. Dissertation (or initiative) research at the planning stage and after its completion
3. Clinical trials of medicinal products (projects, significant amendments to trial protocols, annual and final reports, etc.)
4. Clinical trials of medical equipment and medical devices (projects, specialized evaluation of the materials of the completed trials)
5. Experimental studies using animals
6. Articles for publication in professional journals, other materials for printing

Procedure for submitting materials for bioethical review

The following documents must be submitted at the planning stage of a research study (research, dissertation, initiative, etc.):

1. A statement of the Academic Council of the Institute or the responsible executor of the work addressed to the Chairman of the Bioethics Committee (sample statement);
2. Draft of the research project or abstract (plan-design) of the dissertation or initiative work with indication of the objects and all methods of research and treatment;
3. Informed Consent Form of the patient or the patient’s parents in case of application of non-standard methods of research and treatment (patient’s form or the form of the patient’s parents).
4. Agreement on Scientific and Practical Cooperation between the Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine and the co-executing institution in case of joint research.

1. Statement of the Academic Council of the institute or the responsible executor of the work addressed to the chairman of the bioethics committee (sample application);
2. A draft of a research project or an abstract of justification (plan-design) of a dissertation or initiative work, indicating the objects and all methods of research and treatment;
3. Form of Informed Consent of the patient or the patient’s parents in case of application of non-standard methods of research and treatment (patient form or form of the patient’s parents).
4. Agreement on scientific and practical cooperation between the Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine and the co-executing institution in case of joint research.

The following documents must be submitted for expert evaluation of the completed research:

1. A statement of the Academic Council of the Institute or the responsible executor of the work addressed to the chairman of the bioethics committee;
2. Materials of the completed research (research report, dissertation, article for publication, etc.).

For the expert evaluation of clinical trial materials, the list of documents is specified in the “Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials…” (Order of the Ministry of Health of Ukraine No. 690 of 23.09.2009, as amended).

The Committee on Bioethics and Deontology has the right to request additional materials and information from researchers if necessary to fulfill its responsibilities for a qualified bioethical review.

Practical advice for responsible executors of biomedical research and experts of the bioethics and deontology committee

1. A plan for constructing a research report and dissertation research.
2. Outline of a clinical trial planning report.
3. Key aspects of bioethical expertise of research materials.

Manuals and guidelines for experts of the bioethics and deontology committee

1. Handbook for members of research ethics committees (Council of Europe, 2010).
2. 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 “State Expert Center of the Ministry of Health of Ukraine”, 2017.
3. Standard operating procedures (SOPs) for bioethics committees: Recommendations for ethics committees reviewing biomedical research (WHO, 2000).
4. International Ethical Guidelines for Health-related Research Involving Human Subjects. Geneva: Council for International Organizations for Medical Research (CIOMS), 2016.
5. 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).

Regulatory and legal framework of Ukraine for conducting bioethical expertise

1. The Law of Ukraine “On Medicinal Products” (No. 124/96-ВР of 04.04.1996, Articles 7, 8). https://zakon4.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80
2. The Law of Ukraine “On Transplantation of Human Organs and Other Anatomical Materials” (No. 1007-XIV of July 16, 1999). https://zakon.rada.gov.ua/laws/show/2427-19
3. Instruction of the Ministry of Health of Ukraine “Instruction on the removal of anatomical formations, tissues, their components and fragments from a cadaveric donor” (No. 226 of 25.09.2000). URL: https://zakon.rada.gov.ua/laws/show/z0699-00
4. The Law of Ukraine “On the Protection of Animals from Cruelty” (No. 3447-IV of February 21, 2006, Articles 26, 31). https://zakon.rada.gov.ua/laws/show/3447-15
5. Order of the Ministry of Health of Ukraine “On Approval of Documents on Quality Assurance of Medicinal Products” (No. 95 of February 16, 2009). https://zakon5.rada.gov.ua/rada/show/v0095282-09
6. Order of the Ministry of Health of Ukraine “On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Clinical Trial Materials and the Model Regulations on Ethics Commissions” (No. 690 of 23.09.2009). https://zakon.rada.gov.ua/laws/show/z1010-09
7. The Law of Ukraine “On Personal Data Protection” (No. 2297-VI of June 1, 2010). https://zakon.rada.gov.ua/laws/show/2297-17
8. Order of the Ministry of Education, Youth and Sports of Ukraine “Procedure for Conducting Experiments and Animal Experiments by Scientific Institutions” (No. 249 of March 1, 2012). https://zakon.rada.gov.ua/laws/show/z0416-12
9. Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Technical Regulations on Medical Devices” (No. 753 of 02.10.2013). https://zakon2.rada.gov.ua/laws/show/753-2013-%D0%BF
10. Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Technical Regulations on Active Implantable Medical Devices” (No. 755 of 02.10.2013). https://zakon2.rada.gov.ua/laws/show/755-2013-%D0%BF

International regulatory framework for bioethical review

1. Helsinki Declaration of the World Medical Association “Ethical Principles for Medical Research Involving Human Subjects” (1964). https://zakon.rada.gov.ua/laws/show/990_005
2. 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
3. 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
4. Additional Protocol to the Convention on Human Rights and Biomedicine for Biomedical Research (2005).https://zakon.rada.gov.ua/laws/show/994_686
5. 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