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DRAFTING THE INFORMED CONSENT FORM IN HUMAN RESEARCH: PRACTICAL ADVICE TO THE YOUNG RESEARCHER

https://doi.org/10.51922/1818-426X.2025.4.138

Abstract

Drafting the Informed Consent Form raises many questions among young researchers. Which types of biomedical research require to obtain informed consent, as well as how to draft the Informed Consent Form correctly are discussed in this article. The key elements of the Informed Consent Form are described, which allow to provide a potential participant with objective information about the researh, to ensure comprehension and voluntariness of participation. 

About the Authors

M. Yu. Revtovich
Educational Institution “Belarusian State Medical University”
Belarus


N. B. Halabarodzka
Educational Institution “Belarusian State Medical University”
Belarus


N. A. Trushel
Educational Institution “Belarusian State Medical University”
Belarus


References

1. Ob organizacii raboty Komiteta po biomedicinskoj etike uchrezhdeniya obrazovaniya “Belorusskij gosudarstvennyj medicinskij universitet”: prikaz ot 16 oktyabrya 2023 g. № 844. –URL: https://www.bsmu.by/upload/docs/universitet/nauka/2023/10-23/844.pdf (data obrashcheniya: 21.07.2025).

2. Ob obrashchenii lekarstvennyh sredstv: Zakon Respubliki Belarus’ ot 20 iyulya 2006 g. № 161-Z (v red. ot 14.10.2022 № 213-Z). Stat’ya 17. – URL: https://etalonline.by/document/?regnum=h10600161 (data obrashcheniya: 21.07.2025).

3. O klinicheskih issledovaniyah (ispytaniyah) lekarstvennyh preparatov: postanovlenie M-va zdravoohraneniya Resp. Belarus’ ot 6 noyabrya 2020 g. № 94 (izmeneniya i dopolneniya ot 22 avgusta 2022 g. № 88). – URL: https://pravo.by/document/?guid=3961&p0=W22036111 (data obrashcheniya: 21.07.2025).

4. Ob utverzhdenii Pravil nadlezhashchej klinicheskoj praktiki Evrazijskogo ekonomicheskogo soyuza: reshenie Soveta Evrazijskoj ekonomicheskoj komissii ot 03.11.2016 № 79. – URL: https://www.rceth.by/Documents/9es10rsN7920161103.rtf (data obrashcheniya: 21.07.2025).

5. Rabota komiteta po etike. Komitet po biomedicinskoj etike uchrezhdeniya obrazovaniya “Belorusskij gosudarstvennyj medicinskij universitet”. – URL: https://www.bsmu.by/universitet/nauchnaya-deyatelnost/rabota-komiteta-po-bioetike/ (data obrashcheniya: 21.07.2025).

6. Decision Tool: Am I Doing Human Subjects Research? (in compliance with 2018 Revised Common Rule requirements). US NIH. – URL: https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects/hs-decision (data obrashcheniya: 21.07.2025).

7. Mezhdunarodnye eticheskie rukovodyashchie principy dlya issledovanij v oblasti zdorov’ya s uchastiem lyudej, 4-e izdanie. Sovet mezhdunarodnyh nauchno-medicinskih organizacij (SMNMO). – Zheneva, 2016. – URL: https://cioms.ch/wp-content/uploads/2019/01/WEB-CIOMS-EthicalGuidelinesRussianLayout.pdf (data obrashcheniya: 21.07.2025).

8. Institutional Review Board Member Handbook / R. J. Amdur, E. A. Bankert. – 3rd Edition. – Jones & Bartlett Learning, 2011. – 218 p.

9. Rekomendacii po polucheniyu informirovannogo soglasiya na uchastie v nauchnom issledovanii: ucheb.-metod. posobie / N. V. Goloborod’ko, V. N. Sokol’chik, A. A. Aleksandrov. – Minsk: BelMAPO, 2020. – 36 s. – URL: https://drive.google.com/file/d/1cGU68PIe3gMuBVIjwdecMz3_XuBs4TDm/view (data obrashcheniya: 21.07.2025).

10. O zdravoohranenii: Zakon Respubliki Belarus’ ot 18 iyunya 1993 g. №2435-XII (s izmeneniyami i dopolneniyami). – URL: https://pravo.by/document/?guid=3871&p0=v19302435 (data obrashcheniya: 21.07.2025).

11. O Komitete po bioetike i Respublikanskom centre bioetiki: prikaz M-va zdravoohraneniya Resp. Belarus’ ot 17 iyunya 2024 g. № 853. – URL: https://etalonline.by/document/? regnum=u624e2809 (data obrashcheniya: 21.07.2025).

12. O zashchite personal’nyh dannyh: Zakon Respubliki Belarus’ 17 maya 2021 g. № 99-Z. – URL: https://etalonline.by/document/?regnum=h12100099 (data obrashcheniya: 21.07.2025).

13. Bel’montskij doklad “Eticheskie principy i rekomendacii o zashchite cheloveka pri provedenii issledovanij”. Nacional’naya komissiya po zashchite uchastnikov biomedicinskih i povedencheskih issledovanij SSHA, 1979. – URL: https://glori.kg/wpcontent/uploads/2017/08/Belmont-Report_RU.pdf (data obrashcheniya: 21.07.2025).

14. Hel’sinskaya deklaraciya Vsemirnoj Medicinskoj Associacii: Eticheskie principy provedeniya medicinskih issledovanij s uchastiem cheloveka v kachestve sub”ekta, 1964 (s izmeneniyami, v redakcii 2024). – URL: https://www.wma.net/policies-post/wma-declaration-of-helsinki/ (data obrashcheniya: 21.07.2025)


Review

For citations:


Revtovich M.Yu., Halabarodzka N.B., Trushel N.A. DRAFTING THE INFORMED CONSENT FORM IN HUMAN RESEARCH: PRACTICAL ADVICE TO THE YOUNG RESEARCHER. Medical Journal. 2025;(4):138-147. (In Russ.) https://doi.org/10.51922/1818-426X.2025.4.138

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ISSN 1818-426X (Print)