Research Ethics and Integrity Challenges During Pandemics: The Research Foundation of the PREPARED Code

Abstract

Abstract Crises and public health emergencies can have devastating and wide-ranging impacts across healthcare, social, cultural, economic and political contexts. Against this backdrop, many research ethics and research integrity challenges can be exacerbated, and new ones can emerge as researchers and other stakeholders find themselves in testing and unstable environments. Learning from these challenges, to prepare for similar future crises, requires a broad perspective and encompassing vision. It also requires careful identification and analysis of challenges to ensure that guidance for future crises has real-world applicability. A risk-based approach to ethics code development begins with the identification of ethics risks or challenges, which itself requires extensive research. This chapter describes the research foundation upon which the PREPARED Code was built. It presents an overview of the results of an in-depth review of published literature in nine languages, additional scoping reviews on Ebola and avian flu, investigations into the challenges experienced by groups who were disadvantaged during the COVID-19 pandemic, an analysis of the human rights challenges in the context of sudden global crises, an investigation into how one pharmaceutical company overcame governance challenges to produce a vaccine in record time, and an analysis of pandemic research ethics guidance documents. Together the findings from these activities constituted a strong foundation for the development of the PREPARED Code.

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