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Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns

INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the exp...

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Autores principales: Sisk, Bryan A., Baldwin, Kari, Parsons, Meredith, DuBois, James M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8947496/
https://www.ncbi.nlm.nih.gov/pubmed/35324933
http://dx.doi.org/10.1371/journal.pone.0265252
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author Sisk, Bryan A.
Baldwin, Kari
Parsons, Meredith
DuBois, James M.
author_facet Sisk, Bryan A.
Baldwin, Kari
Parsons, Meredith
DuBois, James M.
author_sort Sisk, Bryan A.
collection PubMed
description INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND METHODS: We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. RESULTS: IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND CONCLUSIONS: This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises.
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spelling pubmed-89474962022-03-25 Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns Sisk, Bryan A. Baldwin, Kari Parsons, Meredith DuBois, James M. PLoS One Research Article INTRODUCTION: SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19. We must learn about these challenges from the experiences of researchers and Research Ethics Committee professionals responsible for these COVID-19 studies to prepare for the next emergency. MATERIALS AND METHODS: We conducted an online survey to identify the ethical, oversight, and regulatory challenges of conducting COVID-19 research during the early pandemic, and proposed solutions for overcoming these barriers. Using criterion-based, convenience sampling, we invited researchers who proposed or conducted COVID-19 research to complete an anonymous, online survey about their experiences. We administered a separate but related survey to Institutional Review Board (IRB) professionals who reviewed COVID-19 research studies. The surveys included open-ended and demographic items. We performed inductive content analysis on responses to open-ended survey questions. RESULTS: IRB professionals (n = 143) and researchers (n = 211) described 19 types of barriers to COVID-19 research, related to 5 overarching categories: policy and regulatory, biases and misperceptions, institutional and inter-institutional conflicts, risks of harm, and pressure of the pandemic. Researchers and IRB professionals described 8 categories of adaptations and solutions to these challenges: enacting technological solutions; developing protocol-based solutions; disposition and team management; establishing and communicating appropriate standards; national guidance and leadership; maintaining high standards; prioritizing studies before IRB review; and identifying and incorporating experts. DISCUSSION AND CONCLUSIONS: This inventory of challenges represents ongoing barriers to studying the current pandemic, and they represent a risk to research during future public health emergencies. Delays in studies of a pandemic during a pandemic threatens the health and safety of the public. We urge the development of a national working group to address these issues before the next public health emergency arises. Public Library of Science 2022-03-24 /pmc/articles/PMC8947496/ /pubmed/35324933 http://dx.doi.org/10.1371/journal.pone.0265252 Text en © 2022 Sisk et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Sisk, Bryan A.
Baldwin, Kari
Parsons, Meredith
DuBois, James M.
Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
title Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
title_full Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
title_fullStr Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
title_full_unstemmed Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
title_short Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
title_sort ethical, regulatory, and practical barriers to covid-19 research: a stakeholder-informed inventory of concerns
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8947496/
https://www.ncbi.nlm.nih.gov/pubmed/35324933
http://dx.doi.org/10.1371/journal.pone.0265252
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