Abstract
Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority officials, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.
Highlights
Setting up for enteric human infection studies in Zambia It is evident that low- and middle-income countries (LMICs) carry the higher burden of infectious disease in comparison to high income countries[1,2,3]
The majority of human infection studies (HIS) studies have been conducted in high-income, non-endemic settings, which has raised calls to establish HIS models in LMICs so that the findings can be relevant to the population at risk[13]
The ownership of the whole process of considering what needs to be addressed as the country prepares for the conduct of HIS was enhanced with regulators identifying gaps in the legal and policy frameworks and determining how to address HIS applications and conduct
Summary
Setting up for enteric human infection studies in Zambia It is evident that low- and middle-income countries (LMICs) carry the higher burden of infectious disease in comparison to high income countries[1,2,3]. Most of these infectious diseases are preventable. The urgent need to address this health disparity has led to the introduction of human infection studies (HIS) in LMICs. HIS can accelerate the pace of vaccine discovery and testing by providing an early opportunity to evaluate efficacy, circumventing the difficulties, cost, time and unpredictability of large field trials[9]. The majority of HIS studies have been conducted in high-income, non-endemic settings, which has raised calls to establish HIS models in LMICs so that the findings can be relevant to the population at risk[13]
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