Participant Recruitment, Consent and Post-trial Access to Interventions

Abstract

AbstractHumanitarian emergencies, including public health crises such as epidemics, can overwhelm local resources and severely disrupt the functioning of communities and societies. Conducting research during or in the immediate aftermath of an emergency poses increased practical and ethical challenges, not least because the need to rapidly generate valuable knowledge must be constantly balanced with the principles of humanitarian assistance. This chapter provides an overview of key ethical considerations relevant to recruitment, consent and post-trial access to interventions in pandemic contexts, and proposes an “ethics in practice” approach. Research conducted during emergencies is unavoidably context – and time – sensitive, making generalized guidance difficult. The aim of this chapter is thus not to prescribe a checklist for decision-making, but to assist researchers and practitioners to reflect on and discern what constitutes ethical practice during exceptional times. In particular, public health emergencies highlight tensions that can arise between balancing the rights and interests of research participants with the health needs of the population. Careful consideration is also needed of the necessity of minimising risks and maximising benefits, including ensuring that recruitment processes are sensitive to potentially altered risk perceptions and impacts of increased vulnerability on power imbalances. The importance of establishing and maintaining trust is reviewed, particularly when asymmetries in knowledge and access to resources are heightened in complex and challenging pandemic contexts. The five case studies presented in this chapter invite readers to reflect on ethical challenges that research during public health emergencies presents, particularly in connection with processes for communicating with and recruiting participants which have been adapted in pandemic contexts; potential risks to research participants and study staff; and with the rights participants in control groups may have to access experimental products.