Importance: With the increase in trials assessing comparative effectiveness of approved products and alternative care strategies, guidance is needed to ensure ethical oversight is fit for purpose for the risks, burdens, and constraints on choice this research presents.
Observations: US regulations governing human research emerged in response to horrific research abuses, reinforcing the view that research holds greater risks, uncertainties, and potential for abuse than clinical care, and thus protections and oversight are required for research, but not for care. The research oversight system established by these regulations has been effective, with most clinical research reviewed in advance for possible risk and burdens and for threats to autonomy and justice.
Many policies were put in place during the COVID-19 pandemic in the United States to manage the negative impact of the coronavirus. Limiting severe illness and death was one important objective of these policies, but it is widely acknowledged by public health ethicists that pandemic policies needed to consider other factors. Drawing on semi-structured interviews with 38 people across 17 states who participated in the state-level COVID-19 pandemic policy process, we examine how those actors recounted their engagement with four different objectives over the course of the pandemic: protecting public health with respect to COVID-19 (which we refer to as pathogen-focused disease prevention), protecting the economy, promoting the public's broader health and wellbeing, and preserving and restoring individual freedoms.
View Article and Find Full Text PDF