Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic
The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and...
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| Format: | Article |
| Language: | English |
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Sciendo
2021-12-01
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| Series: | Ethics & Bioethics (in Central Europe) |
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| Online Access: | https://doi.org/10.2478/ebce-2021-0018 |
| _version_ | 1818745008618995712 |
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| author | Jedličková Anetta |
| author_facet | Jedličková Anetta |
| author_sort | Jedličková Anetta |
| collection | DOAJ |
| description | The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations. |
| first_indexed | 2024-12-18T02:53:22Z |
| format | Article |
| id | doaj.art-4fa0c5dbf9ca41e1852fb061812cec2c |
| institution | Directory Open Access Journal |
| issn | 2453-7829 |
| language | English |
| last_indexed | 2024-12-18T02:53:22Z |
| publishDate | 2021-12-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Ethics & Bioethics (in Central Europe) |
| spelling | doaj.art-4fa0c5dbf9ca41e1852fb061812cec2c2022-12-21T21:23:25ZengSciendoEthics & Bioethics (in Central Europe)2453-78292021-12-01113-418119510.2478/ebce-2021-0018Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemicJedličková Anetta0Charles UniversityPrague (Czech Republic)The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.https://doi.org/10.2478/ebce-2021-0018clinical researchclinical trialscovid-19ethicsmedical ethicsregulatory adjustmentsresearch ethicsrisk management |
| spellingShingle | Jedličková Anetta Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic Ethics & Bioethics (in Central Europe) clinical research clinical trials covid-19 ethics medical ethics regulatory adjustments research ethics risk management |
| title | Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic |
| title_full | Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic |
| title_fullStr | Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic |
| title_full_unstemmed | Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic |
| title_short | Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic |
| title_sort | ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the covid 19 pandemic |
| topic | clinical research clinical trials covid-19 ethics medical ethics regulatory adjustments research ethics risk management |
| url | https://doi.org/10.2478/ebce-2021-0018 |
| work_keys_str_mv | AT jedlickovaanetta ethicalimplicationsofproceduralorprotocoladjustmentstoclinicalresearchinvolvingtheparticipationofhumansubjectsduringthecovid19pandemic |