Boundaries Between Research, Surveillance and Monitored Emergency Use
Public Health Ethics Analysis Research Ethics in Epidemics and Pandemics: A Casebook(2024)
摘要
AbstractResponses to outbreaks, epidemics and pandemics involves a heterogeneous set of activities that aim to address threats to public health. In addition to research, non-research activities, such as prevention and control interventions, and surveillance, are conducted. The boundaries between research and non-research responses can rapidly blur during a public health emergency such as the COVID-19 pandemic. There may be common elements between these types of activities, and they may draw on the same resources and infrastructure. Non-research activities, such as surveillance and emergency non-research use of unproven interventions, and research activities must all be undertaken in an ethical manner as components of emergency response. However, care is needed to distinguish between non-research public health activities and research, because research often has considerations and requirements for its ethical conduct which are distinct from non-research public health activities. Research aims to produce generalizable knowledge, and mechanisms such as participant consent and independent ethics review aim to ensure that the rights and interests of research participants are respected. Ensuring that research and non-research activities are appropriately distinguished can additionally promote proper coordination of such activities, and increase trust and social accountability in pandemic responses. Consequently, it is important to distinguish between these different activities on the basis of their primary aim, and to consider whether their implementation is justifiable, based on their aims and the relevant ethical framework for each type of activity, and how they are coordinated as part of the larger collective activity of emergency response and management. Complex questions arise about how the different stakeholders involved in decision-making should make valid and justifiable decisions about whether the response activity is research or non-research. The cases in this chapter invite consideration about how such decisions should be made, and their implications, in the context of applications to conduct retrospective research into the outcomes of emergency uses of unproven interventions outside clinical trials, and of characterising antibody-testing initiatives and systematic data collection activities as surveillance or research.
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