Strengthening the ethics of clinical research for participants in Ebola-affected countries

November 14, 2018
UN / Sylvain Liechti

Heavily informed by the 2014-2016 Ebola outbreak in West Africa, this project aims to support the ethical conduct of research in Ebola-affected countries.

The project will develop, pilot, and publish an open-access, multilingual “Primer on clinical research and research participation for potential participants in Ebola-affected country contexts”, for use in workshops with individuals and communities considering or already involved in Ebola Virus Disease (EVD) research in EVD-affected countries.

The challenge

Humanitarian and emergency responses to outbreaks of highly infectious and dangerous agents like Ebola are typically comprised of rapid and top-down deployment of biomedical interventions and strict regulatory and enforcement measures (such as medical quarantines, travel restrictions, and government controls on sociocultural practices). Scientific research can also play a key role in helping to understand the nature of outbreaks and to better inform the control and prevention of further transmission. However, as observed during the 2014-2016 Ebola outbreak in West Africa, the efficacy and ethical soundness of such activities are challenged by public health emergencies when the local context is often rife with fear, confusion, and misinformation.

Key to overcoming such challenging environments is the development and use of respectful, culturally tailored, and accessible communications strategies that empower local stakeholders to become knowledgeable and active change agents in emergency response activities.

The project

Building on past work undertaken in Guinea, Sierra Leone, and Liberia during the Ebola epidemic in 2014, this project aims to address the challenges of conducting research under emergency contexts and on populations with limited literacy and with low socio-economic status. A multidisciplinary team of Canadian and African researchers will work with researchers, ethicists, Ebola survivor groups, and civil society leaders to develop and field-test a suite of culturally-adapted, multilingual, and open-access communications tools to support the ethical conduct of research during outbreaks in low-resource settings.

This “ethics primer” toolbox will be developed using a participatory research approach through community consultations and community piloting of resources and prototypes and will be shared with an extensive network of project partners in academia, civil society, patient advocacy groups, and ethics oversight bodies in the Democratic Republic of the Congo, Guinea, and Sierra Leone.

The impact

With an emphasis on context and participant-appropriate strategies, the “Primer on Clinical Research Ethics and Research Participation” would be the first of its kind: a pragmatic, evidence-based suite of participant-informed, multilingual resources aimed at equipping individuals and communities in sub-Saharan Africa with more background knowledge, strategies, and tools to participate in scientific research undertaken in emergency settings.

In addition, this research aims to:

  • Characterize the communications challenges and barriers that hinder individual and community understanding of research and ethical conduct of research, particularly in Ebola-affected settings;
  • Develop, pilot, and disseminate an open-access suite of multilingual, accessible, and adaptable learning tools on research and research participation specifically geared to limited-literacy adults; and
  • Support researchers, research participants, ethicists, regulators, and civil society in understanding, discussing, preparing for, and navigating the ethical conduct of research in EVD-affected contexts.