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Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt

The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, A...

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Autores principales: Marzouk, Diaa, Sharawy, Iman, Nakhla, Isabelle, El Hodhod, Mostafa, Gadallah, Hoda, El-Shalakany, Amr, Elwakil, Reda, Moussa, Mohammed M., Ismail, Alaa, Tash, Fathy M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596560/
https://www.ncbi.nlm.nih.gov/pubmed/34805197
http://dx.doi.org/10.3389/fmed.2021.715796
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author Marzouk, Diaa
Sharawy, Iman
Nakhla, Isabelle
El Hodhod, Mostafa
Gadallah, Hoda
El-Shalakany, Amr
Elwakil, Reda
Moussa, Mohammed M.
Ismail, Alaa
Tash, Fathy M.
author_facet Marzouk, Diaa
Sharawy, Iman
Nakhla, Isabelle
El Hodhod, Mostafa
Gadallah, Hoda
El-Shalakany, Amr
Elwakil, Reda
Moussa, Mohammed M.
Ismail, Alaa
Tash, Fathy M.
author_sort Marzouk, Diaa
collection PubMed
description The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, Ain Shams University Research Ethics Committee (FMASU REC). From April 10, 2020, until October 13, 2020, the FMASU REC reviewed 98 COVID-19 research protocols. This article addressed the question of how to face an overwhelming amount of research submitted to the REC while applying the required ethical principles. Ethical challenges included a new accelerated mode of review, online meetings, balance of risks vs. benefits, measures to mitigate risks, co-enrolment in different studies, protection of a vulnerable COVID-19 population, accelerated decisions, online research, how to handle informed consent during the pandemic, and justification of placebo arm.
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spelling pubmed-85965602021-11-18 Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt Marzouk, Diaa Sharawy, Iman Nakhla, Isabelle El Hodhod, Mostafa Gadallah, Hoda El-Shalakany, Amr Elwakil, Reda Moussa, Mohammed M. Ismail, Alaa Tash, Fathy M. Front Med (Lausanne) Medicine The COVID-19 pandemic resulted in an overwhelming increase in research studies submitted to research ethics committees (RECs) presenting many ethical challenges. This article aims to report the challenges encountered during review of COVID-19 research and the experience of the Faculty of Medicine, Ain Shams University Research Ethics Committee (FMASU REC). From April 10, 2020, until October 13, 2020, the FMASU REC reviewed 98 COVID-19 research protocols. This article addressed the question of how to face an overwhelming amount of research submitted to the REC while applying the required ethical principles. Ethical challenges included a new accelerated mode of review, online meetings, balance of risks vs. benefits, measures to mitigate risks, co-enrolment in different studies, protection of a vulnerable COVID-19 population, accelerated decisions, online research, how to handle informed consent during the pandemic, and justification of placebo arm. Frontiers Media S.A. 2021-11-02 /pmc/articles/PMC8596560/ /pubmed/34805197 http://dx.doi.org/10.3389/fmed.2021.715796 Text en Copyright © 2021 Marzouk, Sharawy, Nakhla, El Hodhod, Gadallah, El-Shalakany, Elwakil, Moussa, Ismail and Tash. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Marzouk, Diaa
Sharawy, Iman
Nakhla, Isabelle
El Hodhod, Mostafa
Gadallah, Hoda
El-Shalakany, Amr
Elwakil, Reda
Moussa, Mohammed M.
Ismail, Alaa
Tash, Fathy M.
Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt
title Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt
title_full Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt
title_fullStr Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt
title_full_unstemmed Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt
title_short Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt
title_sort challenges during review of covid-19 research proposals: experience of faculty of medicine, ain shams university research ethics committee, egypt
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596560/
https://www.ncbi.nlm.nih.gov/pubmed/34805197
http://dx.doi.org/10.3389/fmed.2021.715796
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