Abstract

Since the beginning of the COVID-19 pandemic, numerous studies have been conducted to identify interventions that could contribute to alleviating the burden it has caused. The Institut national d'excellence en santé et en services sociaux (INESSS) has played a key role in informing the government of Québec regarding the evaluation of specific pandemic-related interventions. This process took place in a context characterized by a sense of urgency to assess and recommend potential interventions that could save lives and reduce the effects of the disease on populations and healthcare systems, which increased the pressure on the regulatory agencies leading these evaluations. While some of the interventions examined were considered promising, results from COVID-19 studies often led to uncertainty regarding their efficacy or safety. Regulatory agencies evaluating the value of promising interventions thus face challenges in deciding whether these should be made available to the population, particularly when assessing their benefit-risk balance. To shed light on these challenges, we identified underlying ethical considerations that can influence such an assessment. A rapid literature review was conducted in February 2021, to identify the main challenges associated with the benefit-risk balance assessment of promising interventions. To reinforce our understanding of the underlying ethical considerations, we initiated a discussion among various social actors involved in critical thinking surrounding the evaluation of promising interventions, including ethicists, clinicians and researchers involved in clinical or public health practice, as well as patients and citizens. This discussion allowed us to create a space for exchange and mutual understanding among these various actors who contributed equally to the identification of ethical considerations. The knowledge and perspectives stemming from the scientific literature and those consulted were integrated in a common reflection on these ethical considerations. This allowed patients and citizens, directly affected by the evaluation of pandemic-related interventions and the resulting social choices, to contribute to the identification of the relevant ethical considerations. It also allowed for reflection on the responsibilities of the various actors involved in the development, evaluation, and distribution of promising interventions in a setting of urgency and uncertainty, such as that brought about by the COVID-19 pandemic.

Highlights

  • The COVID-19 pandemic has seen an unprecedented mobilization of the scientific community and unparalleled efforts to develop interventions for reducing or countering its impact on individuals and on healthcare systems

  • We explore the ethical considerations that can facilitate such an assessment, focusing on contributions to the reflection by patients and citizens

  • Search for Publications For the purposes of this discussion, a strategy was developed in February 2021, in collaboration with an information specialist, to search for articles on the assessment of benefits and risks associated with promising interventions in a pandemic context, published in English or French since 2015 (Appendix A)

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Summary

INTRODUCTION

The COVID-19 pandemic has seen an unprecedented mobilization of the scientific community and unparalleled efforts to develop interventions for reducing or countering its impact on individuals and on healthcare systems. At the center of this situation lies the need to assess the balance between the benefits to the population (e.g., reducing strain on the healthcare system) and the risks to individuals (e.g., adverse events), in a setting of considerable uncertainty regarding the developing body of scientific evidence. It is in this context that the Institut national d’excellence en santé et en services sociaux (INESSS) conducted a reflection aiming to identify ethical considerations that could support the benefit-risk balance assessment of a promising intervention in the context of a pandemic.

METHODS
Literature Review
DISCUSSION
CONCLUSION
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