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. 2024 Mar;27(1):49-70.
doi: 10.1007/s11019-023-10184-6. Epub 2023 Dec 28.

The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic

Mariana Barosa  1   2 , Euzebiusz Jamrozik  3   4   5 , Vinay Prasad  6
Affiliations

The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic

Mariana Barosa et al. Med Health Care Philos. 2024 Mar.

Abstract

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise-i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention-has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions.

Keywords: Medical research ethics; Non-pharmaceutical interventions; Pandemic; Public health emergency; Public health research ethics.

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Conflict of interest statement

V.P. receives research funding from Arnold Ventures through a grant made to UCSF, and royalties for books and writing from Johns Hopkins Press, MedPage, and the Free Press. He declares consultancy roles with UnitedHealthcare and OptumRX; He hosts the podcasts, Plenary Session, VPZD, Sensible Medicine, writes the newsletters, Sensible Medicine, the Drug Development Letter and VP's Observations and Thoughts, and runs the YouTube channel Vinay Prasad MD MPH, which collectively earn revenue on the platforms: Patreon, YouTube and Substack.

Figures

Fig. 1
Fig. 1
Equipoise in situations of uncertainty and/or disagreement
Fig. 2
Fig. 2
Comparison between proposed public health policymaking reform (a suggestion) and status quo
Fig. 3
Fig. 3
Examples of Non-Pharmaceutical Interventions employed during the COVID-19 pandemic
See this image and copyright information in PMC

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