In May 2001, an Ethics Commission consisting of 10 members was established at the institute by order of the director (No. 38 “o” dated May 21, 2001), following the order of the Ministry of Health of Ukraine.

The Head of the Ethics Commission was elected Igor KOTULSKYI (Candidate of Medical Sciences), Deputy Head – Vasyl MAKOLINETS (Doctor of Medicine), Secretary – Tamara GRASCHENKOVA (Candidate of Medical Sciences).

In 2005, the composition of the Ethics Commission was increased to 13 members due to the increase in the number of materials requiring bioethical expertise in accordance with the order of the Higher Attestation Commission of Ukraine No. 160 dated March 31, 2005.

In 2010, in accordance with the Regulations on Bioethics Committees in the System of the Academy of Medical Sciences of Ukraine, the Ethics Commission was renamed the Bioethics Committee, then in 2024 the Bioethics and Deontology Committee at the State Institution “Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine”.

During the existence of the Bioethics Committee, 7 rotations have been carried out in its composition (2004, 2007, 2010, 2012, 2015, 2020, 2024) with the total number of members varying from 10 to 15 people. The procedure for re-election of committee officials was carried out 4 times.

The Bioethics Committee performed an expert evaluation of 607 queries for the period 2001–2023, namely:

1. Scientific research projects – 103 (96 under the budget financing of the National Academy of Medical Sciences of Ukraine, 4 under the Cross-sectoral comprehensive program “Health of the Nation”, 1 under the State targeted social program “Youth of Ukraine”, 2 under the international grants Research Project Management Committee of North American Spine Society);
2. Scientific research reports – 73;
3. Dissertation researches planning – 23 doctoral and 88 candidate dissertations (including 7 PhD);
4. Completed dissertation researches – 22 doctoral and 82 candidate dissertations (including 5 PhD);
5. Experimental research projects according to contracts – 32;
6. Scientific publications (articles) – 33;
7. Clinical drug trials – 46 (including 19 international ones), and 60 substantial amendments, periodical and final reports on them;
8. Medical devices trials – 33, and 12 reports on them.

Additional materials for 4 research projects and 1 experimental study under the contract were also considered, as well as 2 reports on the work of the experimental biological clinic of the institute.

Bioethical expertise statistics for the period 2001–2023

Expertise of scientific researches (176 queries)

Expertise of experimental research projects (32 queries) and articles (33 queries)

Expertise of doctoral dissertations (45 queries)

Expertise of candidate dissertations (including PhD) (170 queries)

Expertise of clinical drug trials (106 queries)

Expertise of medical devices trials (45 queries)

Bioethics Committee meetings were held as materials for bioethical expertise are accumulated, after preliminary critical review by one or two experts, who reported their opinions at the meeting in the presence of the work performer.

In 2020–2021, Bioethics Committee meetings were held in a mixed format (offline and online) due to quarantine during the COVID-19 pandemic.

In 2022–2023, during the military actions in Ukraine and Kharkiv, Bioethics Committee meetings were held remotely (online) after the materials were reviewed by two experts.

During the entire period of Bioethics Committee work, there were no negative expert decisions, 4 candidate and 3 doctoral dissertations were recommended for reconsideration.

Reporting on the Bioethics Committee work was carried out in the such forms: annual letters to the Bioethics Committee at the Presidium of the National Academy of Medical Sciences of Ukraine (until 2017), oral presentations of the Head of the Bioethics Committee at the meeting of the Institute’s Scientific Council (2004, 2006, 2010, 2014, 2017, 2021), publications in the professional journal “Orthopedics, Traumatology and Prosthetics” (2009–2012).

In 2022–2023, Barkov O. and Nikolchenko O. developed “Working program on the study discipline “Ethics and Bioethics” for higher education holders of the third degree of Doctor of Philosophy in the specialty 222 Medicine (specialization – Traumatology and Orthopedics)”

In previous years, the Bioethics Committee was headed by:

KOTULSKYI
Igor Volodymyrovych
(from 2001 to 2014),
PhD

BARKOV
Oleksandr Oleksandrovych
(from 2015 to 2024),
PhD

In different years, the following worked as members of the Bioethics Committee:

BARKOV Oleksandr Oleksandrovych (2012–2024, Head of the Committee from 2015 to 2024),
BUZNYTSKY Ruslan Igorovych (since 2015),
VOLOSHYN Mykyta Igorovych (2024-2025),
GOLOVINA Olga Oleksandrivna (2015–2024),
GRASHCHENKOVA Tamara Mykytivna (2001–2003, Secretary of the Committee),
GRECHYSHNIKOVA Svitlana Borysivna (2007–2010),
HRYTSENKO Anastasia Mykolaivna (since 2024),
GUZ Valeryia Mykhailivna (2004–2024),
DEMCHENKO Oleksandr Vasyliovych (2005–2012),
ZHYLІAEVA Nina Volodymyrivna (since 2024),
KATSALAP Yelyzaveta Serhiivna (2020–2024),
KLADCHENKO Lyudmyla Oleksandrivna (2001–2007),
KOVALENKO Oksana Pavlivna (2003–2004, Secretary of the Committee),
KOSTRIKOVA Eleonora Vasylivna (2001–2010),
KOTULSKYI Igor Volodymyrovych (2010–2024, Head of the Committee),
KRASNOBAY Vitaliy Volodymyrovych (2010–2015),
KUTSENKO Volodymyr Oleksandrovych (since 2005),
LEONІYEVA Frуda Solomonivna (since 2024),
LIZOGUB Mykola Vitaliyovych (2012–2024),
MAKOLINETS Vasyl Ivanovych (2001–2015, Deputy Head of the Сommittee),
MALYSHKINA Svitlana Volodymyrivna (2010–2015),
MARUSHCHAK Oleksii Polikarpovich (since 2024),
MATELENOK Yevhen Mykhailovych (2005–2010),
MITRYAEVA Natalia Anatoliivna (2001–2015),
MIKHANOVSKY Dmytro Oleksandrovych (since 2024),
MOROZENKO Dmytro Volodymyrovych (since 2015),
NIKOLCHENKO Olga Anatoliivna (2004 -2025, Secretary of the Committee),
NIKONOVA Olena Petrivna (2007–2015),
PERFILIEV Oleksandr Vyacheslavovych (since 2024, Deputy Head of the Сommittee),
PIDGAYSKA Olga Oleksiivna (2010–2024, Deputy Head of the Сommittee from 2015 to 2024),
POVELYCHENKO Olena Dmytrivna (since 2020, 2025 – Secretary of the Committee),
PUSTOVOYT Borys Anatoliyovych (2001–2012),
STAUDE Volodymyr Anatoliyovych (since 2015),
THANKUT Volodymyr Oleksiyovych (2001–2024),
FOKLINA Iryna Volodymyrivna (since 2024),
Shapilov Sergii Anatoliyovych (2004–2007).

Publications of the Bioethics and Deontology Committee (2 articles, 6 theses of Congresses and Scientific & practical conferences, 2 work reports):

1. Kotulsky І.V., Nikolchenko О.А. (2010). The phenomenon of bioethics and questions of medical ethics. Orthopedics, Traumatology and Prosthetics, (2), 102–106. https://doi.org/10.15674/0030-598720102101-106 [rus]
2. Kotulsky І.V., Nikolchenko О.А., Demiyanenko H.M. (2011). Randomized clinical trials from the standpoint of bioethics. Orthopedics, Traumatology and Prosthetics, (2), 114–116. https://doi.org/10.15674/0030-598720112114-116 [ukr]
3. Kotulsky І.V., Nikolchenko О.А. Problematic issues of medical ethics in the field of orthopedics: experience of the Bioethics Committee at the Sytenko Institute of Spine and Joint Pathology. Proceedings of the II International Symposium “Bioethics – the way to world standards”. Kharkiv, 2005. 157–158. [ukr]
4. Kotulsky І.V., Nikolchenko О.А. Bioethical expertise of research in the orthopedic and traumatology field: work experience of the local Bioethics Committee. Proceedings ІІІ National Congresses on Bioethics. Kyiv, 2007. 151–152. [ukr]
5. Nikolchenko О.А., Malyshkina S.V., Kotulsky І.V. Basic ethical principles of using animals in experimental orthopedics and traumatology. Scientific and practical conference “Modern research in orthopedics and traumatology” (first scientific readings dedicated to the memory of Academician O. O. Korzh). Kharkiv, 2011. 42–44. [rus]
6. Kotulsky І.V., Nikolchenko О.А., Barkov O.О., Pidgayska O.O., Lyzogub M.V. Work experience of LEK in the field of orthopedics and traumatology. Proceedings V National Congresses on Bioethics. Kyiv, 2013. 176. [rus]
7. Korol Ye.М., Morozenko D.V. The problem of euthanasia in humane and veterinary medicine. Proceedings Scientific and practical conference with international participation «Youth Pharmacy Science». Kharkiv: NUPh, 2021. 472–473. [ukr]
8. Sheremet N.M., Morozenko D.V. Classification of pain in animals. Proceedings Scientific and practical distance conference with international participation “Modern achievements and prospects for the development of veterinary medicine, pharmacy and animal biology”. Kharkiv: NUPh, 2023.79–80. [ukr]
9. Kotulsky І.V., Nikolchenko О.А. (2011). Report on the work of the Bioethics Committee at the State Institution “Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine” for 2009–2010. Orthopedics, Traumatology and Prosthetics, (3), 125. [ukr]
10. Kotulsky І.V., Nikolchenko О.А. (2013). Report on the work of the Bioethics Committee at the State Institution “Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine” for 2011–2012. Orthopedics, Traumatology and Prosthetics, (3), 116–117. [ukr]

Committee members participated in scientific forums and seminars on bioethics in Ukraine:

• seven National Congresses on Bioethics (2001, 2004, 2007, 2010, 2013, 2016, 2019);
• Ukrainian-American Seminar on Bioethics (Kyiv, 2001, Kotulsky І.V.);
• ІІ International symposium “Bioethics – the way to world standards” (Kharkiv, 2005, Kotulsky І.V., Nikolchenko О.А.);
• Seminar on Ethical review of biomedical research using animals (Kyiv, 2010, Nikolchenko О.А.);
• ІІ Ukrainian Congress on Medical Law, Bioethics and Social Policy (Kyiv, 2011, Nikolchenko О.А.);
• Course of lectures at the seminar “Good Clinical Practice (GCP). Legal and Regulatory Requirements and Ethical Aspects of Clinical Trials Conducting”, Kharkiv (Makolinets V.I., 2010; Kotulsky І.V., Nikolchenko О.А., 2013; Barkov O.О., Pidgayska O.O., 2014; Korzh І.V., 2017);
• Lecture-webinar of the National Academy of Medical Sciences of Ukraine for young scientists “Biostatistical model as an element of the design of the “Research Protocol” at the stage of bioethical expertise”, Kyiv, 2020 (Katsalap Ye.S., Povelychenko O.D.);
• Online course of AO according to the PEER (Program for Education and Excellence in Research) training program of the first level of complexity “Principles of Clinical Research in compliance with GCP and ethical requirements” (State Institution “Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine” under the auspices of the association “AO Foundation” in Switzerland, Kharkiv, 2021 (Hrytsenko A.M., Katsalap Ye.S., Nikolchenko О.А., Povelychenko O.D.);
• Scientific and practical seminar for the World Day for the Protection of Laboratory Animals “Bioethical aspects of the use of laboratory animals in experiments: national and international experience”, Kharkiv, 2023 (Morozenko D.V., Nikolchenko О.А.).

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