Bioethics and toxicological-hygienic research

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Abstract

There are presented and discussed documents regulating the ethical component of working with experimental animals and humans when examining public health, including documents regulating the use of genomic samples in clinical trials of drugs and the study of other factors in the human environment.

Contribution:
Revazova Yu.A. — concept and collection of literary data, writing the text;
Zhukova V.V. — collection of literary data;
Ilyushina N.A. — collection of literary data, writing the text;
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Conflict of interest. The authors declare no conflict of interest.

Acknowledgement. The study had no sponsorship.

Received: January 16, 2024 / Accepted: February 9, 2024 / Published: March 15, 2024

About the authors

Yulia A. Revazova

Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing

Author for correspondence.
Email: revazova013@gmail.com
ORCID iD: 0000-0001-5067-5469

MD, PhD, DSci., Professor, Honoured Scientist of the Russian Federation, Chief researcher of the Dept. of genetic toxicology of the Institute of Hygiene, Toxicology of Pesticides and Chemical Safety of the Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing, Mytishchi, 141014, Russian Federation

https://www.scopus.com/authid/detail.uri?authorId=6602245454

e-mail: revazova013@gmail.com

Russian Federation

Valentina V. Zhukova

Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing

Email: Zhukovs.vv@fncg.ru
ORCID iD: 0009-0004-6830-2213

The scientific secretary of the Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing, Mytishchi, 141014, Russian Federation

e-mail: Zhukovs.vv@fncg.ru

Russian Federation

Nataliya A. Ilyushina

Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing

Email: Ilyushina-na@mail.ru
ORCID iD: 0000-0001-9122-9465

MD, PhD, DSci., head of the Dept. of genetic toxicology of the Institute of Hygiene, Toxicology of Pesticides and Chemical Safety of the Federal Scientific Center of Hygiene named after F.F. Erisman of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing, Mytishchi, 141014, Russian Federation

https://www.scopus.com/authid/detail.uri?authorId=6603049459

e-mail: Ilyushina-na@mail.ru

Russian Federation

References

  1. Bioethics and Global Challenges. Documents and Reflections [Bioetika i global’nye vyzovy. Dokumenty i razmyshleniya]. Moscow: Veche; 2020. (in Russian)
  2. Smith J.A., van den Broek F.A.R., Martorell J.C., Hackbarth H., Ruksenas O., Zeller W. Principles and practice in ethical review of animal experiments across Europe: Summary of the report of the FELASA Working Group on Ethical Evaluation of Animal Experiments. Lab. Anim. 2007; 41(2): 143–60. https://doi.org/10.1258/002367707780378212
  3. FELASA. Principles and procedures for ethical review of animal experimentation in Europe: summary report of the FELASA working group on the ethical assessment of animal experimentation. Available at: https://felasa.eu/Portals/1/Reports/Principles-practice-ethical-review_full%20report%20.pdf?ver=dcRnbLmZjGgX0YFSz7A0cw%3d%3d
  4. EUR-Lex. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0063
  5. Council of Europe. Annex A to the European Convention for the Conservation of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS No. 123). Guidelines for the care and maintenance of laboratory animals (Article No. 5 of the Convention). Available at: https://rm.coe.int/168007a67b
  6. National Research Council. Guide for the Care and Use of Laboratory Animals. Washington, DC: The National Academies Press; 2011. https://doi.org/10.17226/12910
  7. Chuchalin A.G., Grebenshchikova E.G., eds. Voluntary Informed Consent [Dobrovol’noe informirovannoe soglasie]. Moscow: Veche; 2022. (in Russian)
  8. Melent’ev A.V., Babanov S.A., Baykova A.G., Lavrent’eva N.E. Molecular and genetic features in various phenotypes of occupational bronchial asthma. Gigiena i Sanitaria (Hygiene and Sanitation, Russian journal). 2023; 102(3): 252–8. https://doi.org/10.47470/0016-9900-2023-102-3-252-258 https://elibrary.ru/lxjtks (in Russian)
  9. Kazitskaya A.S., Yadykina T.K., Gulyaeva O.N., Panev N.I., Zhukova A.G. Polymorphism of antioxidant defense enzyme genes as the risk for formation of chronic dust bronchitis in long-term labour experience coal mine workers. Gigiena i Sanitaria (Hygiene and Sanitation, Russian journal). 2023; 102(4): 345–50. https://doi.org/10.47470/0016-9900-2023-102-4-345-350 https://elibrary.ru/vdcjvh (in Russian)
  10. Ilyushina N.A., Demidova Yu.V., Makarova M.A., Ilyushin A.G., Egorova O.V., Bereznyak I.V., et al. Cytogenetic analysis in exfoliated buccal epithelial cells of the workers who come into contact with pesticides. Toksikologicheskiy vestnik. 2021; 29(4): 22–9. https://doi.org/10.36946/0869-7922-2021-29-4-22-29 https://elibrary.ru/pmosqh (in Russian)
  11. Chernyak Yu.I., Merinova A.P. Analysis of polymorphic loci of candidate genes in patients with occupational diseases. Gigiena i Sanitaria (Hygiene and Sanitation, Russian journal). 2023; 102(7): 689–94. https://doi.org/10.47470/0016-9900-2023-102-7-689-694 https://elibrary.ru/glwiya (in Russian)
  12. Shirinkina A.S., Dolgikh O.V. Features of immunological indicators in children with allergy modified by nickel contamination of biomedia and polymorphism of CPOX rs1131857 detoxification gene. Zdravookhranenie Rossiyskoy Federatsii. 2023; 67(6): 519–25. https://doi.org/10.47470/0044-197X-2023-67-6-519-525 https://elibrary.ru/zonxxj (in Russian)
  13. Bereza I.A., Amromina A.M., Shaikhova D.R., Shastin A.S., Gazimova V.G., Astakhova S.G., et al. Relationship of the superoxide dismutase 2 (SOD2) gene Ala16Val polymorphism with risk factors for the cardiovascular disease in iron and steel production employees. Gigiena i Sanitaria (Hygiene and Sanitation, Russian journal). 2023; 102(5): 457–61. https://doi.org/10.47470/0016-9900-2023-102-5-457-461 https://elibrary.ru/ppesvo (in Russian)
  14. International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guidance. Guideline on Genomic Sampling and Management of Genomic Data. E18; 2017. Available at: https://pharmadvisor.ru/document/tr3854/
  15. UN. Universal Declaration on the Human Genome and Human Rights. Available at: https://www.ohchr.org/en/instruments-mechanisms/instruments/universal-declaration-human-genome-and-human-rights

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Copyright (c) 2024 Revazova Y.A., Zhukova V.V., Ilyushina N.A.


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