Developing Legal Competences in Medical Students as Applied to Biomedical Research: Pedagogical Experience Based on the Standards of the Declaration of Helsinki


Cite item

Full Text

Abstract

The growing volume of biomedical research requires scientists and physicians to possess not only profound professional but also modern legal competences, given the dynamic development of legislation and the high level of responsibility for upholding human rights and freedoms. This article addresses the apparent contradiction between the objective need to develop legal competences in future medical professionals for the ethical and safe implementation of biomedical projects and their insufficient legal training within existing educational programs. The purpose of this study is to assess the level of medical students’ awareness of the legal and ethical principles that are keys in research involving humans and animals, as well as to analyze the development of their legal competences. In this regard, the article focuses on the standards of the Declaration of Helsinki, which serves as a global benchmark for ethical research practices and is integrated into Russian national legislation. The authors present the results of an anonymous online survey of 177 medical students majoring in General Medicine, Pediatrics and Dentistry. These results have shown that the respondents share key ethical values in scientific research but lack the legal knowledge necessary to develop their legal competences. This represents an important pedagogical challenge in this context and underscores the need to incorporate professionally oriented legal disciplines into medical educational programs. The materials and conclusions of this article may also be useful to researchers and practicing physicians in addressing pressing scientific challenges in biomedicine and healthcare.

About the authors

Anna D. Chestnikhina

Orel State University named after I.S. Turgenev

Email: romanova_orel@mail.ru
ORCID iD: 0000-0002-0632-5100
SPIN-code: 9494-5493

Research Fellow at the Laboratory of Molecular, Translational and Digital Cardioimmunology, Senior Lecturer at the Department of Public Health, Healthcare and Hygiene

95 Komsomolskaya St, Orel, 302026, Russian Federation

Daria O. Efremenko

Moscow University of the Ministry of Internal Affairs of Russia named after V.Y. Kikot

Email: darja.o.re-va@rambler.ru
ORCID iD: 0009-0006-1109-8850
SPIN-code: 7204-7732

Ph.D. in Leg. Sci., Deputy Head of the Philosophy Department

12 Academika Volgina St, Moscow, 117997, Russian Federation

Natalia A. Kabina

Orel State University named after I.S. Turgenev

Email: apt53boss@mail.ru
ORCID iD: 0009-0007-6915-9035
SPIN-code: 5103-2264

Research Fellow at the Laboratory of New Medical Technologies, Senior Lecturer at the Department of Pharmacology, Clinical Pharmacology and Pharmacy

95 Komsomolskaya St, Orel, 302026, Russian Federation

Maria O. Reviakina

Orel State University named after I.S. Turgenev

Author for correspondence.
Email: morevyakina@mail.ru
ORCID iD: 0000-0003-1593-5290
SPIN-code: 4921-7530

Ph.D. in Med. Sci., Leading Researcher of the Laboratory of Molecular, Translational and Digital Cardioimmunology, Associate Professor of the Department of Immunology and Specialized Clinical Disciplines

95 Komsomolskaya St, Orel, 302026, Russian Federation

Irina A. Snimshchikova

Orel State University named after I.S. Turgenev

Email: snimshikova@mail.ru
ORCID iD: 0000-0002-4258-963X
SPIN-code: 2728-3520

Dr. Med. Sci., Professor, Leading Researcher at the Laboratory of New Medical Technologies, Head of the Department of Immunology and Specialized Clinical Dis ciplines, Director of the Medical Institute

95 Komsomolskaya St, Orel, 302026, Russian Federation

Anna V. Konshina

National Medical Research Center of Traumatology and Orthopedics named after N.N. Priorov

Email: Astro.cito@ya.ru
ORCID iD: 0009-0000-0353-0849
SPIN-code: 6755-1368

Ph.D. in Biol. Sci., Associate Professor at the Department of Traumatology, Orthopedics and Related Disciplines, Head of the Department of Educational Activities

10 Priorova St, Moscow, 127299, Russian Federation

References

  1. Abbasi, M., Shirazi, M., Torkmandi, H., Homayoon, S., & Abdi, M. (2023). Impact of teaching, learning, and assessment of medical law on cognitive, affective and psychomotor skills of medical students: A systematic review. BMC Medical Education, 23(1), 703. https://doi.org/10.1186/s12909-023-04695-2
  2. Abreu, L.C.D., Pereira, V.X., Silva, R.P.M., Macedo Jr H., & Bezerra, I.M.P. (2017). The right to scientific information: One of the main elements of the unified health system. Journal of Human Growth and Development, 27(3), 258. https://doi.org/10.7322/jhgd.141485
  3. Arbel, E., Reese, A., Oh, K., & Mishra, A. (2024). Medical law and medical school curricula: A systematic review. Cureus, 16(2), e54377. https://doi.org/10.7759/cureus.54377
  4. Athalye-Jape, G. (2021). Systematic reviews of animal studies. In Patole, S. (Eds.), Principles and Practice of Systematic Reviews and Meta-Analysis (pp. 177–188). Cham : Springer. https://doi.org/10.1007/978-3-030-71921-0_17
  5. Ayman, A.A.R., & Ahmad, F.A. (2019). The role of researcher competencies in delivering successful research. Information and Knowledge Management, 9(1), 29-32. https://doi.org/10.7176/ikm/9-1-05
  6. Bompart, F. (2019). Healthy volunteers for clinical trials in resource-poor settings: National registries can address ethical and safety concerns. Cambridge Quarterly of Healthcare Ethics, 28(1), 134–143. https://doi.org/10.1017/s0963180118000476
  7. Chestnykhina, A.D., & Snimshchikova, I.A. (2022). Formation of the legal competence of the future doctor at the university. Global Problems of Modernity, 3(1), 24–30. (In Russ.). https://doi.org/10.26787/nydha-2713-2048-2022-3-1-24-30
  8. Ganeva, E.O., & Filatova, U.B. (2022). Animals as objects of civil rights: The legal regime of laboratory animals in Russia and abroad. Civil Law, (6), 23-26. (In Russ.). https://doi.org/10.18572/2070-2140-2022-6-23-26
  9. Gauthier, J. (2018a). References to human rights in codes of ethics for psychologists: Critical issues and recommendations. Part 1. RUDN Journal of Psychology and Pedagogics, 15(1), 7–21. https://doi.org/10.22363/2313-1683-2018-15-1-7-21
  10. Gauthier, J. (2018b). References to human rights in codes of ethics for psychologists: Critical issues and recommendations. Part II. RUDN Journal of Psychology and Pedagogics, 15(2), 131–146. https://doi.org/10.22363/2313-1683-2018-15-2-131-146
  11. Giordano, S. (2010). The 2008 Declaration of Helsinki: Some reflections. Journal of Medical Ethics, 36(10), 598–603. https://doi.org/10.1136/jme.2009.034132
  12. Guryleva, M.E. (2024). Ethical review of preclinical research. Kazan Medical Journal, 105(3), 459–466. (In Russ.). https://doi.org/10.17816/kmj631130
  13. Kapp, M.B. (2018). Teaching legal competencies through an individualized elective in medicine and law. Gerontology & Geriatrics Education, 39(4), 491–494. https://doi.org/10.1080/02701960.2016.1247072
  14. Kloop, R.A., & Rancourt, D.E. (2020). Managing emergent knowledge: Addressing the competency expectations of biomedical employers. Canadian Journal of Career Development, 19(2), 21–31. https://doi.org/10.82396/cjcd.v19i2.3159
  15. Krleža-Jerić, K., & Lemmens, T. (2009). 7th revision of the Declaration of Helsinki: Good news for the transparency of clinical trials. Croatian Medical Journal, 50(2), 105–110. https://doi.org/10.3325/cmj.2009.50.105
  16. Lapaeva, V.V. (2019). International regulation of relations of biomedicine: Interaction of law and morality. Law. Journal of the Higher School of Economics, (2), 22–44. (In Russ.). https://doi.org/10.17323/2072-8166.2019.2.22.44
  17. Logvinenko, T.I., Kanonir, T.N., Orel, E.A., & Kulikova, A.A. (2024). Ethical aspects of measuring intelligence: Towards competence and fairness. RUDN Journal of Psychology and Pedagogics, 21(2), 657–682. (In Russ.). https://doi.org/10.22363/2313-1683-2024-21-2-657-682
  18. Millum, J., Wendler, D., & Emanuel, E.J. (2013). The 50th anniversary of the Declaration of Helsinki: Progress but many remaining challenges. JAMA, 310(20), 2143–2144. https://doi.org/10.1001/jama.2013.281632
  19. Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: empirical studies on patient comprehension—systematic review. Trials, 22(1), 57. https://doi.org/10.1186/s13063-020-04969-w
  20. Pigeot, I., Foraita, R., Frömke, C., Haller, B., Hoffmann, V.S., & Zapf, A. (2019). Ethische Bewertung von Studien am Menschen außerhalb des regulatorischen Rahmens: nicht bindend, aber von großer Wichtigkeit. Bundesgesundheitsbl, 62(6), 722–728. https://doi.org/10.1007/s00103-019-02947-5
  21. Puzanova, Zh.V., Filippov, V.M., Simonova, M.A., & Grigorieva, N.A. (2024). Evidence-based pedagogy: Criteria for experimental research. RUDN Journal of Psychology and Pedagogics, 21(1), 313–327. (In Russ.). https://doi.org/10.22363/2313-1683-2024-21-1-313-327
  22. Rios, M.B., Perdiz, N.P., Gallardo, J.M., & Risk, M.R. (2024). Competency-based assessment of biomedical engineering students through the project-based learning process. In Lopez, N.M., & Tello, E. (Eds.). Advances in Bioengineering and Clinical Engineering. SABI 2022. IFMBE Proceedings (Vol 105., pp. 500–509). Cham: Springer. https://doi.org/10.1007/978-3-031-51723-5_62
  23. Roberts, R., & McCune, S. (2008). Animal studies in the development of medical countermeasures. Clinical Pharmacology & Therapeutics, 83(6), 918–920. https://doi.org/10.1038/clpt.2008.23
  24. Różyńska, J. (2021). Taking the principle of the primacy of the human being seriously. Medicine, Health Care and Philosophy, 24(4), 547–562. https://doi.org/10.1007/s11019-021-10043-2
  25. Schmidt, U., Frewer, A., & Sprumont, D. (Eds.). (2020). Ethical research: The declaration of Helsinki, and the past, present and future of human experimentation. New York, NY : Oxford University Press.
  26. Singh, H., & Fruman, D.A. (2020). Keys to successful implementation of a professional development program: Insights from UC Irvine’s GPS-BIOMED. In L. Infante Lara, L. Daniel, & R. Chalkley (Eds.), BEST. Implementing career development activities for biomedical research trainees (pp. 129–137). London: Academic Press. https://doi.org/10.1016/b978-0-12-820759-8.00009-7
  27. Van Howe, R.S., & Svoboda, J.S. (2008). Neonatal pain relief and the Helsinki Declaration. Journal of Law, Medicine & Ethics, 36(4), 803–823. https://doi.org/10.1111/j.1748-720x.2008.00339.x
  28. Weber, R.J., & Cobaugh, D.J. (2008). Developing and executing an effective research plan. American Journal of Health-System Pharmacy, 65(21), 2058–2065. https://doi.org/10.2146/ajhp070197
  29. World Medical Association (2025). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human participants. JAMA, 333(1), 71–74. https://doi.org/10.1001/jama.2024.21972

Supplementary files

Supplementary Files
Action
1. JATS XML