Abstract
BackgroundThe 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.MethodsConceptual review.DiscussionAlthough 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.ConclusionTo 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.
Highlights
Challenges in priority setting for the research agenda on CVID‐19 There are profound gaps in current knowledge about COVID-19 and yet the disease has severe health, social, and economic consequences, making it an imperative to conduct scientifically rigorous clinical research evaluating potential prevention, mitigating therapies, and supportive treatment options [1, 6]
While risk factors for complications of COVID-19 include older age, cardiovascular disease, chronic lung disease, hypertension, diabetes and obesity [4, 5], it is unclear whether other comorbidities confer increased risk of complications, the evidence of worse clinical outcomes notwithstanding
While there are no proven therapies for COVID-19, immunomodulating therapies such as glucocorticoids, convalescent plasma, and anticytokine therapy promise some benefit
Summary
Some allocation principles seem better than others, no single moral principle allocates interventions justly, necessitating combining the moral principles into multiprinciple allocation systems. 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
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