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Normative framework of informed consent in clinical research in Germany, Poland, and Russia

BACKGROUND: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the...

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Autores principales: Orzechowski, Marcin, Woniak, Katarzyna, Timmermann, Cristian, Steger, Florian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088727/
https://www.ncbi.nlm.nih.gov/pubmed/33933040
http://dx.doi.org/10.1186/s12910-021-00622-6
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author Orzechowski, Marcin
Woniak, Katarzyna
Timmermann, Cristian
Steger, Florian
author_facet Orzechowski, Marcin
Woniak, Katarzyna
Timmermann, Cristian
Steger, Florian
author_sort Orzechowski, Marcin
collection PubMed
description BACKGROUND: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. METHODS: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. RESULTS: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. CONCLUSIONS: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable.
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spelling pubmed-80887272021-05-04 Normative framework of informed consent in clinical research in Germany, Poland, and Russia Orzechowski, Marcin Woniak, Katarzyna Timmermann, Cristian Steger, Florian BMC Med Ethics Research BACKGROUND: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. METHODS: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. RESULTS: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. CONCLUSIONS: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable. BioMed Central 2021-05-01 /pmc/articles/PMC8088727/ /pubmed/33933040 http://dx.doi.org/10.1186/s12910-021-00622-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Orzechowski, Marcin
Woniak, Katarzyna
Timmermann, Cristian
Steger, Florian
Normative framework of informed consent in clinical research in Germany, Poland, and Russia
title Normative framework of informed consent in clinical research in Germany, Poland, and Russia
title_full Normative framework of informed consent in clinical research in Germany, Poland, and Russia
title_fullStr Normative framework of informed consent in clinical research in Germany, Poland, and Russia
title_full_unstemmed Normative framework of informed consent in clinical research in Germany, Poland, and Russia
title_short Normative framework of informed consent in clinical research in Germany, Poland, and Russia
title_sort normative framework of informed consent in clinical research in germany, poland, and russia
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088727/
https://www.ncbi.nlm.nih.gov/pubmed/33933040
http://dx.doi.org/10.1186/s12910-021-00622-6
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