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Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic Cover

Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

Open Access
|Dec 2021

Abstract

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.

DOI: https://doi.org/10.2478/ebce-2021-0018 | Journal eISSN: 2453-7829 | Journal ISSN: 1338-5615
Language: English
Page range: 181 - 195
Published on: Dec 14, 2021
Published by: University of Prešov
In partnership with: Paradigm Publishing Services
Publication frequency: 2 issues per year

© 2021 Anetta Jedličková, published by University of Prešov
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.