Navigating ethical challenges of conducting randomized clinical trials on COVID-19

Abstract Background The contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material information, comprehension of disclosed information and voluntary consent to research participation. There is thus an urgent need to test, an...

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Main Author: Dan Kabonge Kaye
Format: Article
Language:English
Published: BMC 2022-01-01
Series:Philosophy, Ethics, and Humanities in Medicine
Subjects:
Online Access:https://doi.org/10.1186/s13010-022-00115-3
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author Dan Kabonge Kaye
author_facet Dan Kabonge Kaye
author_sort Dan Kabonge Kaye
collection DOAJ
description Abstract Background The contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material information, comprehension of disclosed information and voluntary consent to research participation. There is thus an urgent need to test, and an ethical imperative, to test, modify or refine medications or healthcare plans that could reduce patient morbidity, lower healthcare costs or strengthen healthcare systems. Methods Conceptual review. Discussion Although some allocation principles seem better than others, no single moral principle allocates interventions justly, necessitating combining the moral principles into multiprinciple allocation systems. The urgency notwithstanding, navigating ethical challenges related to conducting corona virus disease (COVID-19) clinical trials is mandatory, in order to safeguard the safety and welfare of research participants, ensure autonomy of participants, reduce possibilities for exploitation and ensure opportunities for research participation. The ethical challenges to can be categorized as challenges in allocation of resources for research; challenges of clinical equipoise in relation to the research questions; challenges of understanding disclosed information in potential participants; and challenges in obtaining informed consent. Conclusion To navigate these challenges, stakeholders need a delicate balance of moral principles during allocation of resources for research. Investigators need to apply information processing theories to aid decision-making about research participation or employ acceptable modifications to improve the informed consent process. Research and ethics committees should strengthen research review and oversight to ensure rigor, responsiveness and transparency.
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spelling doaj.art-4be073f362e24be8862887b16079ea822022-12-21T17:23:53ZengBMCPhilosophy, Ethics, and Humanities in Medicine1747-53412022-01-0117111110.1186/s13010-022-00115-3Navigating ethical challenges of conducting randomized clinical trials on COVID-19Dan Kabonge Kaye0College of Health Sciences, Department of Obstetrics and Gynecology, Makerere UniversityAbstract Background The contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material information, comprehension of disclosed information and voluntary consent to research participation. There is thus an urgent need to test, and an ethical imperative, to test, modify or refine medications or healthcare plans that could reduce patient morbidity, lower healthcare costs or strengthen healthcare systems. Methods Conceptual review. Discussion Although some allocation principles seem better than others, no single moral principle allocates interventions justly, necessitating combining the moral principles into multiprinciple allocation systems. The urgency notwithstanding, navigating ethical challenges related to conducting corona virus disease (COVID-19) clinical trials is mandatory, in order to safeguard the safety and welfare of research participants, ensure autonomy of participants, reduce possibilities for exploitation and ensure opportunities for research participation. The ethical challenges to can be categorized as challenges in allocation of resources for research; challenges of clinical equipoise in relation to the research questions; challenges of understanding disclosed information in potential participants; and challenges in obtaining informed consent. Conclusion To navigate these challenges, stakeholders need a delicate balance of moral principles during allocation of resources for research. Investigators need to apply information processing theories to aid decision-making about research participation or employ acceptable modifications to improve the informed consent process. Research and ethics committees should strengthen research review and oversight to ensure rigor, responsiveness and transparency.https://doi.org/10.1186/s13010-022-00115-3COVID-19Resource allocationClinical trials in emergency careEthical ChallengesInformed consentNavigating Ethical Challenges
spellingShingle Dan Kabonge Kaye
Navigating ethical challenges of conducting randomized clinical trials on COVID-19
Philosophy, Ethics, and Humanities in Medicine
COVID-19
Resource allocation
Clinical trials in emergency care
Ethical Challenges
Informed consent
Navigating Ethical Challenges
title Navigating ethical challenges of conducting randomized clinical trials on COVID-19
title_full Navigating ethical challenges of conducting randomized clinical trials on COVID-19
title_fullStr Navigating ethical challenges of conducting randomized clinical trials on COVID-19
title_full_unstemmed Navigating ethical challenges of conducting randomized clinical trials on COVID-19
title_short Navigating ethical challenges of conducting randomized clinical trials on COVID-19
title_sort navigating ethical challenges of conducting randomized clinical trials on covid 19
topic COVID-19
Resource allocation
Clinical trials in emergency care
Ethical Challenges
Informed consent
Navigating Ethical Challenges
url https://doi.org/10.1186/s13010-022-00115-3
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