Protection, Health Seeking, or a Laissez-passer: Participants' Decision-making in an EVD Vaccine Trial in the Eastern Democratic Republic of the Congo

"...highlights the importance of understanding social, political, and economic contexts for ethical debates about clinical research..."

Discussion of public attitudes towards biomedical interventions is often framed in terms of "hesitancy" and "acceptance". In this framing, a supposed lack of scientific knowledge explains hesitancy: the cure is better "communication" or "public engagement". This idea of "knowledge deficit" has been widely critiqued. This article examines why people in the eastern Democratic Republic of the Congo (DRC) did decide to volunteer for a trial of a second Ebola virus disease (EVD) vaccine in North Kivu, despite a climate of distrust towards external intervention and controversy surrounding vaccine research.

The DRC-EB-001 EVD vaccine trial took place in Goma between November 14 2019 and February 9 2021, with a 5-month suspension of dose 2 in April 2020 to prevent potential COVID-19 transmission in the vaccination centre. This article is based on ethnographic observation, interviews, and focus groups with trial participants conducted between September 2020 and April 2021. Amidst existing distrust towards protracted foreign intervention and the central state, as well as rumours (e.g., that vaccine trials were a profitable part of EVD business), 20,000 people nonetheless volunteered for a second experimental vaccine that had sparked intense political controversy about the ethics of Western biomedical research in Africa. The research sought to understand why.

The study revealed that there were three key motivations for participating in the EVD vaccine trial:

1. Protection: Even though there were few EVD cases recorded in Goma, trial participants wanted to protect themselves from the ongoing epidemic and potential future Ebola outbreaks. Nonetheless, even though they decided to participate, many were concerned about the rumours circulating about the trial and expressed anxiety about potential side effects of the experimental vaccine.
2. Access to free healthcare offered by the trial: Participants described the advantage of having access to health advice through the trial's toll-free number and the importance of the vaccination card to access free treatment. However, these notions of exchange also led to frustration among participants who were disappointed that the trial only provided healthcare for one month after vaccination.
3. Laissez-passer: Many believed that the vaccine cards given to participants by the trial were (or would soon be) necessary to travel internationally, just like a yellow fever certificate.

Drawing on these participant narratives, the researchers make these points:

• Participation in vaccine trials may be understood to have advantages that have not been considered by the trial, because they go beyond medical considerations and are specific to a particular social setting. In fact, citizens in Goma critiqued the fact that the trial was only based in quartiers populaires on the periphery of the city rather than the affluent centre, where potential participants might be less interested in free health care.
• Despite an assumed relationship between rumours and "vaccine hesitancy", some rumours and subjective assessments may in fact encourage participation. For instance, the widespread belief that the vaccination card would soon be essential, or was already essential, in order to cross borders and travel in the province encouraged people to participate.
• Material objects associated with trial participation - such as vaccine cards given to participants - can hold social and political meaning beyond the confines of the vaccine clinic and influence decisions surrounding participation. The cards could represent a sense of belonging and rights claims based on the personal risk taken when participating for the greater good.

Thus, "Trial teams need to recognise the specific ways that clinical protocols interact with the political economy, because this shapes how and why people decision to volunteer. Rather than a means of ensuring participation, community engagement activities are an opportunity to explore the grey area between clinical trial protocols and participants' shared understandings...and investigate the blurred line between the hopes that become invested in participation, and beliefs or rumours that could be characterised as a different form of 'misconception.'"

In conclusion: "To better understand why people volunteer in clinical trials, it is necessary to examine how medical research becomes entangled in specific political economies. Trial participants' narratives provides an insight into how international bioethical debates interact with, but may also stand apart from, the situated social and economic realities driving decision-making around clinical trials on the ground. This reemphasizes the need for ethical approaches that focus on political, social, and economic context..."