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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">kulawr</journal-id><journal-title-group><journal-title xml:lang="en">Kutafin Law Review</journal-title><trans-title-group xml:lang="ru"><trans-title>Kutafin Law Review</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2713-0525</issn><issn pub-type="epub">2713-0533</issn><publisher><publisher-name>MSAL</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.17803/2313-5395.2022.1.19.175-190</article-id><article-id custom-type="elpub" pub-id-type="custom">kulawr-162</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ARTICLES</subject></subj-group></article-categories><title-group><article-title>Bioethical Aspects of Translational Medicine</article-title><trans-title-group xml:lang="ru"><trans-title></trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0032-0341</contrib-id><name-alternatives><name name-style="western" xml:lang="en"><surname>Khokhlov</surname><given-names>A. L.</given-names></name></name-alternatives><bio xml:lang="en"><p>Aleksandr L. Khokhlov, Dr. Sci. (Medicine), Professor, Corresponding Member of the Russian Academy of Sciences, Rector; Chairman of the Ethics Council (Ministry of Healthcare of the Russian Federation)</p><p>5 Revolyutsionnaya ulitsa, Yaroslavl 150000</p></bio><email xlink:type="simple">al460936@yandex.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2164-8290</contrib-id><name-alternatives><name name-style="western" xml:lang="en"><surname>Belousov</surname><given-names>D. Yu.</given-names></name></name-alternatives><bio xml:lang="en"><p>Dmitriy Yu. Belousov</p><p>142/2 Volgogradsky bulvar, Moscow 109439</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2139-6847</contrib-id><name-alternatives><name name-style="western" xml:lang="en"><surname>Kagramanyan</surname><given-names>I. N.</given-names></name></name-alternatives><bio xml:lang="en"><p>Igor N. Kagramanyan, Dr. Sci. (Medicine), Professor, Institute of Leadership and Healthcare Management</p><p>8/2 Тrubetskaya ulitsa, Moscow 119991</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8139-7932</contrib-id><name-alternatives><name name-style="western" xml:lang="en"><surname>Mokhov</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="en"><p>Aleksandr A. Mokhov, Dr. Sci. (Law), Professor, Head of the Department of Medical Law</p><p>9 Sadovaya-Kudrinskaya ultsa, Moscow 123995</p></bio><email xlink:type="simple">aamohov@msal.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0911-5002</contrib-id><name-alternatives><name name-style="western" xml:lang="en"><surname>Tsyzman</surname><given-names>L. G.</given-names></name></name-alternatives><bio xml:lang="en"><p>Lyubov G. Tsyzman, Expert</p><p>8/2 Petrovskiy bulvar, Moscow 2127051</p></bio><xref ref-type="aff" rid="aff-5"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2748-6923</contrib-id><name-alternatives><name name-style="western" xml:lang="en"><surname>Samarina</surname><given-names>E. I.</given-names></name></name-alternatives><bio xml:lang="en"><p>Elena I. Samarina, Postgraduate student, Department of Pharmacology</p><p>5 Revolyutsionnaya ulitsa, Yaroslavl, 150000</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff xml:lang="en" id="aff-1"><institution>Yaroslavl State Medical University</institution><country>Russian Federation</country></aff><aff xml:lang="en" id="aff-2"><institution>OOO “Tsentr farmakoekonomicheskikh issledovaniy” [Center for Pharmacoeconomic Research LLC]</institution><country>Russian Federation</country></aff><aff xml:lang="en" id="aff-3"><institution>I.M. Sechenov First Moscow State Medical University</institution><country>Russian Federation</country></aff><aff xml:lang="en" id="aff-4"><institution>Kutaﬁn Moscow State Law University (MSAL)</institution><country>Russian Federation</country></aff><aff xml:lang="en" id="aff-5"><institution>Center for Expert Evaluation of Medicinal Products (Ministry of Healthcare of the Russian Federation)</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2022</year></pub-date><pub-date pub-type="epub"><day>06</day><month>04</month><year>2022</year></pub-date><volume>9</volume><issue>1</issue><fpage>175</fpage><lpage>190</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Khokhlov A.L., Belousov D.Y., Kagramanyan I.N., Mokhov A.A., Tsyzman L.G., Samarina E.I., 2022</copyright-statement><copyright-year>2022</copyright-year><copyright-holder xml:lang="ru">Khokhlov A.L., Belousov D.Y., Kagramanyan I.N., Mokhov A.A., Tsyzman L.G., Samarina E.I.</copyright-holder><copyright-holder xml:lang="en">Khokhlov A.L., Belousov D.Y., Kagramanyan I.N., Mokhov A.A., Tsyzman L.G., Samarina E.I.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://kulawr.msal.ru/jour/article/view/162">https://kulawr.msal.ru/jour/article/view/162</self-uri><abstract><p>The development of modern medicine is associated with the dynamic translation (transfer) of basic medicine data to clinical research and further on to clinical practice. It is pointed out that research and development in the sphere of genetics and biotechnology, which are of particular significance during the COVID-19 pandemic, are of paramount importance in this regard. The concept of “translational distance” is analyzed as a measure of uncertainty, namely, the number and the size of logical leaps in course of transition from animal model trials to the first stages of human subject research. Translational research ethics has become a revolutionary, diverse, and distinct field of biomedical ethics. When studying the issue, special consideration is given to the critical blocks in translation as well as the characteristic features, types, and phases of translational research. It is emphasized that addressing the issue of minimizing irreducible uncertainty so that research participants could participate in research is a key component of ethical research. In view of the fact that the most important condition for the successful implementation of translational medicine is the adherence to the principles of bioethics when overcoming translational distances is analyzed taking into account the benefit-risk balance. As the development of translational medicine is significantly influenced by the legislation and the practice of its application, the national peculiarities of the attitude of different countries to the issues of ethics and the resolution thereof are studied, including the differences between the continental and the Anglo-Saxon legal families. Along with the formation of a general approach to the choice of a regulatory model in the sphere under consideration, the acceleration of circulation of the information related to science, research and technology, as well as the rapid obsolescence of innovations, should not be overlooked. At the same time, one should pay attention to the existing biological and other risks.</p></abstract><kwd-group xml:lang="en"><kwd>translational research</kwd><kwd>translational distance</kwd><kwd>translational blocks</kwd><kwd>bioethics</kwd></kwd-group><funding-group><funding-statement xml:lang="en">The research was carried out within the framework of the strategic academic leadership program “Priority-2030”.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Ashikhmin, Ya.I., (2015). Translational medicine: a new hope or an insidious plot of the pharmaceutical industry? Pharmacogenetics and Pharmacogenomics, 1, pp. 40–44. Available at: https://clck.ru/VPtJe [Accessed 21.03.2022] (In Russ.).</mixed-citation><mixed-citation xml:lang="en">Ashikhmin, Ya.I., (2015). Translational medicine: a new hope or an insidious plot of the pharmaceutical industry? Pharmacogenetics and Pharmacogenomics, 1, pp. 40–44. Available at: https://clck.ru/VPtJe [Accessed 21.03.2022] (In Russ.).</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Baker, H.B., McQuilling, J.P., and King, N.M., (2016). Ethical considerations in tissue engineering research: Case studies in translation. Methods, 99, pp. 135–144, doi: 10.1016/j.ymeth.2015.08.010.</mixed-citation><mixed-citation xml:lang="en">Baker, H.B., McQuilling, J.P., and King, N.M., (2016). Ethical considerations in tissue engineering research: Case studies in translation. Methods, 99, pp. 135–144, doi: 10.1016/j.ymeth.2015.08.010.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Emanuel, E.J., Wendler, D., and Grady, C., (2000). What makes clinical research ethical? The Journal of the American Medical Association, 283(20), pp. 2701–2711, doi: 10.1001/jama.283.20.2701. PMID: 10819955.</mixed-citation><mixed-citation xml:lang="en">Emanuel, E.J., Wendler, D., and Grady, C., (2000). What makes clinical research ethical? The Journal of the American Medical Association, 283(20), pp. 2701–2711, doi: 10.1001/jama.283.20.2701. PMID: 10819955.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Esch, M.B., King, T.L., and Shuler, M.L., (2011). The role of body-on-a-chip devices in drug and toxicity studies. Annual Review of Biomedical Engineering. 15 (13), pp. 55–72, doi: 10.1146/annurev-bioeng-071910-124629. PMID: 21513459.</mixed-citation><mixed-citation xml:lang="en">Esch, M.B., King, T.L., and Shuler, M.L., (2011). The role of body-on-a-chip devices in drug and toxicity studies. Annual Review of Biomedical Engineering. 15 (13), pp. 55–72, doi: 10.1146/annurev-bioeng-071910-124629. PMID: 21513459.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Joffe, S. and Miller, F.G., (2008). Bench to bedside: mapping the moral terrain of clinical research. The Hastings Center Report, 38(2), pp. 30–42, doi: 10.1353/hcr.2008.0019. PMID: 18457227.</mixed-citation><mixed-citation xml:lang="en">Joffe, S. and Miller, F.G., (2008). Bench to bedside: mapping the moral terrain of clinical research. The Hastings Center Report, 38(2), pp. 30–42, doi: 10.1353/hcr.2008.0019. PMID: 18457227.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Khokhlov, A.L., et al., eds., (2021). Ethical review of biomedical research: guidelines for ethics committees. Moscow: OKI Publishing House (In Russ.).</mixed-citation><mixed-citation xml:lang="en">Khokhlov, A.L., et al., eds., (2021). Ethical review of biomedical research: guidelines for ethics committees. Moscow: OKI Publishing House (In Russ.).</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Kimmelman, J., (2009). Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation. Cambridge University Press.</mixed-citation><mixed-citation xml:lang="en">Kimmelman, J., (2009). Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation. Cambridge University Press.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Seals, D.R., (2013). Translational physiology: from molecules to public health. Journal of Phisiology, 591(14), pp. 3457–3469, doi: 10.1113/jphysiol.2013.253195.</mixed-citation><mixed-citation xml:lang="en">Seals, D.R., (2013). Translational physiology: from molecules to public health. Journal of Phisiology, 591(14), pp. 3457–3469, doi: 10.1113/jphysiol.2013.253195.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Sychev, D.A., (2016). Pharmacogenetics and pharmacogenomics: translational research is on the rise. Pharmacogenetics and Pharmacogenomics, 2, p. 3. Available at: https://clck.ru/VPt2g [Accessed 21.03.2022] (In Russ.).</mixed-citation><mixed-citation xml:lang="en">Sychev, D.A., (2016). Pharmacogenetics and pharmacogenomics: translational research is on the rise. Pharmacogenetics and Pharmacogenomics, 2, p. 3. Available at: https://clck.ru/VPt2g [Accessed 21.03.2022] (In Russ.).</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">The Belmont report: ethical principles and guidelines for the protection of human subjects of research. (1978). Available at: https://clck.ru/VTGxS [Accessed 21.03.2022].</mixed-citation><mixed-citation xml:lang="en">The Belmont report: ethical principles and guidelines for the protection of human subjects of research. (1978). Available at: https://clck.ru/VTGxS [Accessed 21.03.2022].</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
