Meeting rationale and objectives
A large outbreak of the Bundibugyo ebolavirus (BDBV) was first identified in the Ituri Province in the Democratic Republic of the Congo (DRC) in May 2026. This marked the DRC’s 17ème Ebola outbreak overall and only the third known outbreak of this virus since its identification in Uganda in 2007. There are currently no licensed vaccines or therapeutics for BDBV, though several trials are planned and underway.
DRC has been at the centre of major experimental Ebola vaccine, and therapeutic and diagnostic research over the past decade. Experience from the outbreak in North Kivu in 2018–20, the DRC-EB-001 trial of the Janssen two-dose vaccine, and more recent mpox vaccine trials has generated important lessons about rumour, mistrust, participant experience, protocol change, and the inclusion of vulnerable groups.
A growing body of social science research shows that social and behavioural science (SBS) and risk communication and community engagement (RCCE) can strengthen trial operations when they are integrated from the beginning. This includes improving design and implementation, reducing the risk of coercion or misunderstanding, supporting local ethical deliberation, and identifying contextual factors that may otherwise undermine feasibility, recruitment, retention, and trust.
Against this backdrop, the Multi-Hazard Research Network (MHRN) organised an online roundtable on 18 August 2026. The aim was to consolidate lessons learned from past SBS research in/on Ebola clinical trials and discuss current challenges with clinical trial design and rollout (see Annexe 1 for the agenda and participant list). The discussion brought together SBS researchers, trial implementers, RCCE specialists, and Ebola responders.
The roundtable had five objectives:
- Examine what did and did not work in community engagement, trust-building and communication during past Ebola trials and other relevant clinical trials;
- Consider how political-economic context and insecurity shape trust and implementation during an active health emergency overlapping with a humanitarian emergency;
- Surface ethical and design questions, including inclusion and exclusion criteria, the participation of pregnant and lactating women and young children, informed consent, placebo use, and the distribution of risks and benefits;
- Clarify the value of SBS for trial sponsors, funders, and regulators by identifying where it should inform trial design and rollout; et
- Map SBS capacity and possible support structures, including ways to connect DRC-based researchers more directly to trial design and implementation.
Thematic findings
The thematic findings are organised around these objectives, drawing on insights from the roundtable presentations, breakout group discussions, plenary discussions, and past SBS evidence (where applicable). This section is organised by objective. It begins by presenting information from the SBS evidence base and then from the roundtable deliberations.
Objective 1: Examine what did and did not work in community engagement, trust-building, and communication during past Ebola trials and other relevant clinical trials
Existing SBS evidence base
Involve communities as soon as possible. SBS research has shown the importance of involving communities in discussions around the ethics, logistics, and politics of clinical trial design as early as possible in the onset of a public health emergency.
- SBS Example 1: Evidence from scenario planning in Sierra Leone demonstrated the importance of engaging citizens in discussions around how to effectively deliver Covid-19 and Ebola vaccines before the vaccines arrived in their communities.
- SBS Example 2: During an Ebola vaccine trial in remote eastern DRC, trial managers had to adapt their approach to reporting serious adverse events.
Engage the wider population. SBS research has shown how community engagement efforts during vaccine trials can be expanded to focus on the wider population as well as the target groups and potential participants. Community engagement can include mass media approaches to sharing information about trials, and to raise awareness.
Reach vulnerable groups. Les spécialistes des sciences sociales ont également souligné l'importance de s'engager auprès des populations présentant des vulnérabilités spécifiques, qui peuvent être mal desservies ou considérées comme plus difficiles à atteindre, telles que les populations rurales, les personnes peu alphabétisées ou les populations en déplacement.
Communication mechanisms. Effective communication mechanisms should be put in place to respond to questions from community members who are included in or excluded from vaccination, and to answer questions about how vaccination is effective after exposure when this is not the case for other (more familiar) vaccines (e.g., measles). Community engagement can help people understand why a particular clinical trial approach is being taken and inform the approach itself. See Enria et coll. (2016).
Grounded ethics. In a public health emergency, trialists have to make difficult decisions around inclusion and exclusion criteria, and local deliberations (or ‘grounded ethics’) may offer important insights (see Annexe 3 and section on ‘grounded ethics’).
- SBS Example 3: During the Ebola vaccine trials in Sierra Leone (from 2015) and DRC (from 2019), different trials had different rules about the inclusion of pregnant women, and these rules also changed over time. Consultation with the public can offer insights into what is perceived to be acceptable and help manage mistrust that may be generated by shifting regulations.
Key publications:
- Doe-Anderson, J. et al. (2016) ‘Beating the odds: Successful establishment of a Phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak’, Communications sur les essais cliniques contemporains.
- Enria, L. et coll. (2016) ‘Power, fairness and trust: Understanding and engaging with vaccine trial participants and communities in the setting up of the EBOVAC-Salone vaccine trial in Sierra Leone’, Santé publique BMC, 16, p. 1140.
- Enria, L. et coll. (2026) ‘Mapping power in community engagement: Methodological reflections from health emergencies’, BMC Medical Research Methodology.
- James, M. (2025) ‘Rumor as ethical vernacular: Ebola and the politics of the womb in eastern Congo’, Anthropologie médicale trimestrielle, 39(3), p. e70015.
- Mansaray, A. et coll. (2024) ‘Engaging the public in decisions about emergency vaccine deployment strategies: Lessons from scenario-based discussions in Sierra Leone’, Santé publique mondiale, 19(1), p. 2334887.
Roundtable discussion
Support local needs. Rather than operating as a parallel ‘business’, trials can support existing local infrastructure, e.g., by addressing food and water shortages, and pay attention to staffing, salaries, recruitment networks and supply chains left behind (Trust discussion group; Plénier).
Understand community engagement as an iterative, continuous process. Experience over 10+ years of trials during outbreaks (Guinea 2015, DRC 2018–20) shows engagement must start at the political level, move to community leaders, and then to those actually eligible – not just the eligible group. In Guinea (2015), community and national-level resistance predicted disaster, but a humble, responsive approach led to success. This was repeated in DRC’s most difficult access areas via local representatives (Plénier). A humble, responsive approach offers a clear explanation for both eligible and ineligible people, explaining side effects, returning to update communities whenever messaging changed, and following up even in hard-to-access areas.
Be transparent about uncertainty and change. Problems arose historically when decisions (e.g., on inclusion/exclusion criteria) were presented as fixed and then reversed. Communities familiar with conflict and crisis are generally comfortable with uncertainty; the challenge is not whether it can be communicated but how – openly, and with explanation of what has been decided, why, and what remains unresolved (Trust discussion group; Plénier).
Co-design with prospective participants. Including prospective participants in discussions about trial design helps identify factors important for implementation, ethics and recruitment (Trust discussion group; Plénier).
Communicate across multiple strains, vaccines and trials. Differentiating between Ebola virus strains, and the simultaneous running of trials for different strains and up to four vaccine candidates, is a communication challenge that can be good for science but risks breaking trust if handled poorly (Trust discussion group; Plénier). Confusion may occur not only because there are multiple virus strains circulating, but also because clinical trials for other endemic diseases are taking place in parallel. In the case of the DRC, there is a parallel Mpox vaccine trial running in addition to field testing of the R21 malaria vaccine and a long-term Typhoid Conjugate Vaccine (TCV) trial. These are just the vaccine trials – multiple therapeutic trials are also running (e.g. against sleeping sickness). There is a need to coordinate between international partners and to tailor communication for communities.
Consider staff positionality and the ecology of trust. Trust may differ between local and international staff, but local is not a straightforward category – some health workers are already supported by international funding, and questions of who belongs and who benefits are fraught. A Sierra Leone example illustrates that very local staff (from the trial’s own town) built more trust than international funding or scientific authority, partly because, as one participant put it, if something goes wrong, you can leave, but they can’t. Local integration also means connecting trial teams with epidemiological/contact-tracing teams, historically often separate (Trust discussion group; Plénier).
Communicate about eligibility. In 2019, the greater challenge was often explaining why people could not take part or could not skip the line into a trial, rather than recruiting enough participants (Implementation discussion group).
Objective 2: Consider how political-economic context and insecurity shape trust and implementation during an active health emergency overlapping with a humanitarian emergency
Existing SBS evidence base
SBS research has demonstrated clearly that the historical and political-economic context of emergencies will shape the dynamics of vaccination.
- SBS Example 1: A study from 2024 on the recruitment of people living with HIV for an Ebola vaccine trial highlighted how the trial converged experiences of two major epidemics. The trial took place in a West African country where HIV is highly stigmatised (the study did not identify the country), but this local context was largely ignored and the clinical trialists did not conduct meaningful community engagement efforts. Rumours circulated about experimentation on people living with HIV, and participants also worried about disclosure of their status.
- SBS Example 2: During the Uganda outbreak of Ebola (Sudan virus disease) in 2022, rumours emerged around how the outbreak had been planned to displace artisanal gold miners from Mubende District, where the outbreak originated. Memories of such rumours persist, and they may affect perceptions of future clinical trials.
- SBS Example 3: Research on an Ebola vaccine trial during the Covid-19 pandemic in Goma, DRC, raised key issues related to both local and global political anxieties and also personal experiences. Trial participants’ narratives linked foreign-led vaccine research to wider conversations around resource extraction, whilst the Covid-19 pandemic resurfaced critiques of Western biomedical colonialism. The authors of the study suggested that when trials are conducted with meaningful community engagement, they can themselves provide an opportunity to address vaccine anxieties.
Key publications:
- James, M., Kasereka, J.G. and Lees, S. (2021) ‘The politics of the second vaccine: Debates surrounding Ebola vaccine trials in eastern Democratic Republic of the Congo’, Journal des affaires humanitaires, 3(3), pp. 4–13.
- Kelly, A.H. (2018) ‘Ebola vaccines, evidentiary charisma and the rise of global health emergency research’, Économie et société, 47(1), pp. 135–161.
- Street, A. and Kelly, A.H. (2025) ‘Tolerable tests: Regulating diagnostic innovation in a global health emergency, lessons from Ebola’, Science, Technology, & Human Values, 50(4), pp. 744–771.
Roundtable discussion
Context shapes trials and response, and vice versa. Trials in DRC unfold within active insecurity and a pre-existing humanitarian emergency, and cannot be understood separately from the political economy the response itself creates.
Insecurity constrains access and delivery. Non-state armed groups, security-driven limits on group size, blocked roads, and displacement make some areas unsafe for trials, complicate follow-up, and – combined with non-specific symptoms that could indicate malaria or Ebola – complicate diagnosis and containment (Kavunga presentation).
Trials become entangled in ‘Ebola business’ politics. Multiple trials during the 2018–20 outbreak generated mistrust and concerns about people profiting from crisis in eastern DRC. These concerns sit within fractious state–society relations, colonial and post-colonial histories of medical violence, and ongoing conflict. However, they are also a legitimate political critique of the deeply unequal political economy that large aid inflows create. The roughly US$1.4 billion 2018–20 Ebola response generated job kickback schemes and inflated rental contracts that became sources of profit-making (James presentation).
Trial set-up interacts with local political economies. Addressing perceptions of ‘Ebola business’ perceptions require attention to how trials become embedded in local political, social, economic and material infrastructures – staffing, salaries, recruitment processes and networks, supply chains, and service provision left over after trials end (Trust discussion group).
Defining local is itself a site of power struggle. Who counts as local, and who gets access to employment and cash injections from the new Ebola business, is fraught and cannot be treated as self-evident, particularly where existing international actors (e.g., non-governmental organisations (NGOs) already subsidising healthcare workers) shape the local ecology of trust that a new trial enters (Trust discussion group; Plénier).
Conflict disrupts the local leadership structures trials rely on. The World Health Organization (WHO) pre-established protocols developed for Bunia need to be adapted with local communities. In Ituri, community leaders have left the area due to conflict, leaving no clear structure to route engagement through local leaders or representatives (Implementation discussion group).
Material infrastructure left behind by trials cuts both ways. Food provision and water stations can build trust if integrated with existing community trust infrastructure, or they can be read as an outside business operating in parallel if they are not (Plénier).
Objective 3: Surface ethical and design questions, including inclusion and exclusion criteria, the participation of pregnant and lactating women and young children, informed consent, placebo use, and the distribution of risks and benefits
Existing SBS evidence base
SBS evidence highlights how complex clinical trial participation can be, and how even in an atmosphere of mistrust, participants take part in trials because of altruism, curiosity and hope, health-seeking and beliefs about vaccines, and expectations linked to participation.
- SBS Example 1: A study of participants in the EBOVAC trial in Sierra Leone makes the case for thinking about ‘grounded ethics’ that considers context and participant decision-making (Tengbeh et coll. 2018).
SBS research during the 10ème Ebola outbreak in DRC looked at the inclusion of pregnant women in vaccine trials, after having previously been excluded. Pregnant women weighed the benefits and potential risk, seeing it as ‘acceptable risk.’
Key publications:
- James, M. (2025) ‘Rumor as ethical vernacular: Ebola and the politics of the womb in eastern Congo’, Anthropologie médicale trimestrielle, 39(3), p. e70015.
- Schwartz, D.A. (2020) ‘Being pregnant during the Kivu Ebola virus outbreak in DR Congo: The rVSV-ZEBOV vaccine and its accessibility by mothers and infants during humanitarian crises and in conflict areas’, Vaccins, 8(1), p. 38.
Roundtable discussion
Inclusion, exclusion, and the participation of pregnant and lactating women and young children
During the 2018–20 outbreak, pregnant women were initially excluded from Ebola trials, then included after a policy reversal. This created confusion and revealed a degree of scientific uncertainty around acceptable risk. It also fed rumours that the vaccine would exterminate or sterilise the population and put those already pregnant in danger (James presentation). More recently, an mpox trial intended to recruit children over 12, but on the ground children under 5 were suffering the most from mpox, requiring the protocol to be changed – an example of the recruitment problems that arise when local communities are not included in design decisions (Implementation discussion group). Inclusion and exclusion criteria can also be operationally constrained by access to health structures, and overcoming these barriers can be costly.
Informed consent
There is currently no confirmed mechanism for sharing or harmonising consent processes and ethical review materials across concurrent, multi-site trials (Kindombe; Ethics discussion group; Plénier). Consent processes and community-facing information have historically been weak: the 2018–20 outbreak showed consent processes were often inadequate, especially confusing when vaccine availability differed between outbreaks or trial phases – a between-trial issue requiring earlier vaccines/trials to be explained to communities in relation to new ones (Ethics discussion group).
Placebo use
Frontline healthcare workers raised concerns about being randomised to placebo arms, given their occupational exposure – they’re on the frontline, anytime they’re getting the disease, how are they getting placebos? (Design discussion group; see paper on placebo use). In plenary, participants discussed that while scientific rigour requires certain design choices (placebo control groups, blinding), consent is the mechanism through which communities exercise agency over what they do not control directly: participants are not told who receives product versus placebo, but they consent to the study knowing this, and can refuse.
Distribution of risks and benefits, and multiple concurrent trials
Ethical debate over multiple vaccines in one epidemic. Introducing a second vaccine during the 2018–20 outbreak sparked debate – the then Minister of Health opposed it, fearing confusion, while ethicists argued existing effective treatment should not be withheld, though a second vaccine might help with supply. The second trial’s start became entangled in national political tensions, with accusations that the trial team was prioritising pharmaceutical business interests over citizens’ wellbeing (James presentation).
Between-trial ethics is under-addressed. Individual trials receive ethics approval, but there is no clear framework for when multiple trials run simultaneously, over time, or alongside the broader health system. This creates risks around recruitment and consent overlap, and the danger that uncoordinated trials undermine each other’s data validity (Ethics discussion group).
Defining trial itself is contested. It is not always clear where legitimate research ends and exploitative experimentation begins (Ethics discussion group).
Without proactive frameworks, unresolved ethical questions get settled politically rather than on principle, this is particularly true of decisions about competing trials (Ethics discussion group).
Local researcher involvement in design remains limited. Participants questioned how much local researchers have actually been involved in trial design, and noted that when trials start, the first priority is typically outbreak response – with research a secondary concern (Design discussion group).
Objective 4: Clarify the value of SBS for trial sponsors, funders and regulators by identifying where it should inform trial design and rollout
Existing SBS evidence base
There is evidence of SBS contributions to clinical trial design and rollout, and evidence of how those contributions strengthened trials and community perceptions of trials. SBS should be embedded across Ebola clinical trials and not only for community engagement but to understand the wider context of trials and identify challenges as they emerge (see panel recommendations in Kindombe et coll. 2026).
Key publications and tools:
- Kindombe, E.L. et coll. (2026) ‘Embedding social and behavioural science across and beyond Ebola clinical trials: A critical research priority’, The Lancet Santé mondiale.
- WHO Good Participatory Practice for rials of (re-)emerging pathogens (GPP-EP): Global guidelines for people involved in the design and implementation of prevention and treatment trials in the context of (re-) emerging pathogens. The guidelines specifically address how to engage stakeholders in the design, conduct and conclusion of trials.
- Triaging Community Feedback: A Participatory Approach: Not trial specific, but discusses practical methodological tools for collecting and prioritising community concerns through feedback mechanisms to inform emergency operations. This tool can be useful as a way to track rumours and concerns surrounding a trial and determining, with affected communities, how to prioritise and address them.
Roundtable discussion
A recurring theme across all three presentations was that SBS is typically brought in only after trial design is finalised, when it could instead inform decisions from the outset. Several strands of discussion point to where SBS evidence adds value for sponsors, funders and regulators.
Design-stage integration is important. Rumours, hesitancy and mid-trial disruption are more likely when eligibility, placebo use and protocol changes are not discussed with prospective participants in advance. Co-construction of protocols adapted to local realities was identified as a concrete opportunity (Kavunga presentation).
SBS clarifies decision-making that trialists might otherwise miss. Participant motivations for joining trials (e.g., protection, health-seeking, belief in future benefits) often go beyond medical reasoning and are shaped by local context; taking these seriously matters for bioethics and for anticipating recruitment and retention challenges (see Annexe 3 for underlying literature).
A dedicated SBS/implementation science platform could support sponsors and regulators directly, for example by enabling iterative, shared consent review across concurrent trials – addressing a coordination gap sponsors and regulators currently have no mechanism to resolve (Kindombe presentation).
This is not a one-off investment. Resourcing implications are ongoing; coordination requires dedicated resourcing and iterative review as new studies come online at different points in time (Kindombe presentation).
Rigour matters as much as inclusion. In closing remarks, Professor Clare Chandler (Foreign, Commonwealth & Development Office (FCDO)) emphasised that gathering SBS insights is clearly important but must be done with depth and rigour rather than anecdotally – a challenge given the many languages and communities involved – while noting that the field does not need to start from scratch given the existing evidence base (see Annexe 3).
Ethics between studies is a sponsor- or regulator-level question, not only a trial-level one. Chandler highlighted that ethics must be considered between studies and not just within them, underscoring that this work is sensitive, high-stakes and ongoing rather than a one-off exercise.
Objective 5: Map SBS capacity and possible support structures, including ways to connect DRC-based researchers more directly to trial design and implementation
Professor Kindombe’s proposed integrated SBS and implementation science learning platform aims to institutionalise SBS within DRC’s health system and could support iterative, shared consent review across trials. The protocol has already received ethics committee clearance and a small amount of initial funding from the Congolese government to begin activities while awaiting additional resources.
MHRN will offer a help desk function for clinical trialists encountering and anticipating SBS-related challenges in trial design and rollout, directly responding to the roundtable’s call for accessible support structures.
However, inter-trial coordination remains an open, under-resourced gap. No known mechanism currently exists to coordinate or share consent processes across trials and studies so that people are not repeatedly taken through similar ethics review processes. Participants flagged this as a good idea that would need to be iterative and resourced, given that trials do not all start consent processes at the same time. They asked whether this might sit within the vision for the Institut National de Recherche Biomédicale (INRB) platform (Plénier).
Connecting DRC-based researchers to trial design remains limited in practice. Participants raised open questions about how much local researchers have been involved in the design of current trials, pointing to a need for clearer pathways connecting DRC-based researchers into trial design and SBS conversations, not only implementation (Design discussion group).
Local capacity building was identified as a standing opportunity. Building local research capacity and an ethics/community engagement centre was raised as an opportunity alongside engaging local ambassadors and diversifying communication channels (Kavunga).
Coordination among those working with communities is itself a capacity need. In closing, Professor Chandler flagged Professor Kindombe’s proposed platform as an important initiative to track and encouraged updates on next steps. He underscored that those working with communities also need to coordinate with one another.
Annexe 1: Roundtable agenda and participant list
| 14:00-14:05 | Introduction to MHRN.
Professor Hayley MacGregor, Research Fellow at the Institute of Development Studies (IDS), and Director of MHRN. |
| 14:05-14:10 | Opening and introduction to the roundtable.
Dr Luisa Enria (LSHTM) and Dr Megan Schmidt-Sane (IDS/CWRU) |
| 14:10-14:20 | Overview of trials, opening remarks and discussion of challenges and opportunities with new Ebola clinical trial(s) in DRC.
Professor Hugo Kavunga, Institut National de Recherche Biomédicale (INRB) |
| 14:20-14:30 | The politics of medical research: Ethnographic insights from past Ebola trials in eastern DRC.
Dr Myfanwy James, London School of Economics (LSE). |
| 14:30-14:40 | Integrating social and behavioural sciences into Ebola clinical trials
Professor Esaie Kindombe, Institut National de Recherche Biomédicale (INRB) |
| 14:40-15:00 | Small group discussion on key emergent challenges in Ebola trial design and rollout
Groups: 1. Trust: How does the historical, social, political and economic context of the region shape (mis)trust in the state, researchers, institutions and the products being tested? What are current efforts/ challenges to building participants’ and communities’ trust in the context of the current outbreak, its response and a complex landscape of scientific research? 2. Implementation: What challenges exist around recruitment and retention into different therapeutic/ vaccine/ diagnostic trials? How can these be addressed? What are opportunities/ challenges for community engagement and communication (including around multiple trials) 3. Design: What challenges/ opportunities exist for co-production of trial design with affected populations? What aspects of local social, political and economic realities might affect the effectiveness of different trial designs? What considerations need to be made for equitable participation and around exclusion/ inclusion criteria? 4. Ethics: What key ethical questions are emerging from establishing trials in the context of this outbreak? What are specific challenges around use of placebos, randomisation, and the rollout of different trials (e.g. of different vaccines)? |
| 15:00-15:30 | Plenary discussion.
Moderated by Dr Luisa Enria and Dr Megan Schmidt-Sane Discussant: Professor Clare Chandler, FCDO |
List of participants
| Habtamu Wondiye Bekele | Africa Centres for Disease Control and Prevention (Africa CDC) |
| Oluwatoyosi Olawande | Centre de contrôle et de prévention des maladies d'Afrique |
| Helen Smith | Anthrologica Ltd |
| Juliette Bedford | Anthrologica Ltd |
| Soha Karam | Anthrologica Ltd |
| Parc Sung Joon | Bernhard Nocht Institute for Tropical Medicine (BNITM) |
| Christine Chimanuka | Université Catholique de Bukavu (UCB) |
| Ghislain Bisimwa | UCB |
| Marie-Rose Bashwira | UCB |
| Moussa Douno | Centre d’Excellence Africain pour la Prévention et le Contrôle des Maladies Transmissibles, Université Gamal Abdel Nasser de Conakry |
| Adrienne Keen | Coalition for Epidemic Preparedness Innovations (CEPI) |
| Isabel Foster | CEPI |
| Rachel James | Collective Service/International Federation of Red Cross and Red Crescent Societies (IFRC) |
| Gillian McKay | Elrha |
| Cathy Roth | Foreign, Commonwealth & Development Office, UK Government (FCDO) |
| Clare Chandler | FCDO |
| Jade Siu | FCDO |
| James Bunn | FCDO |
| Nel Druce | FCDO |
| Claas Kirchhelle | Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Christophe Vogel | Université de Gand |
| Winters Muttamba | Institute for Clinical and Economic Review (ICER) |
| Wilber Sabiiti | ICER, Makerere University and University of St. Andrew’s |
| Hayley MacGregor | Institut d'études sur le développement (IDS) |
| Tina Nelis | IDS |
| Megan Schmidt-Sane | IDS/Case Western Reserve University (CWRU) |
| Abdou Sebushishe | International Medical Corps (IMC) |
| Jennifer Majer | IMC |
| Lauren Bellhouse | IMC |
| Meaghan Sydlowski | IMC |
| Suha Khan | IMC |
| Josephine Bayigga | Infectious Diseases Institute (IDI) |
| Esaie Kindombe Luzolo | Institut National de Recherche Biomédicale (INRB) |
| Hugo Kavunga | INRB |
| Lina Karenzi | INRB |
| Jules Villa | Institut Pasteur |
| Myfanwy James | London School of Economics and Political Science (LSE) |
| Diane Duclos | The London School of Hygiene & Tropical Medicine (LSHTM) |
| Kasonia Kambale | LSHTM |
| Luisa Enria | LSHTM |
| Emilie Phillips | Medicins Sans Frontieres (MSF) |
| Giulia Scarpa | Médecins Sans Frontières |
| Pascale Lissouba | Médecins Sans Frontières |
| Anne Kelly | University of Oxford |
| Kate McNeil | University of Oxford |
| Sassy Molyneux | University of Oxford |
| Gonzalo Domingo | PATH |
| Stephanie Zobrist | PATH |
| Waly Diouf | Université Cheikh Anta Diop de Dakar |
| Anu Puri | UNICEF |
| Jean-Benoit Falisse | University of Edinburgh |
| Yasemin Inac | Vrije Universiteit Brussels |
| Abdourahamane Diallo | OMS |
| Reena Doshi | OMS |
Annexe 2: Detailed roundtable proceedings
Key findings from presentations
Three presentations anchored the roundtable. Across all three, a shared framing point recurred: social and behavioural science (SBS) is typically brought in only after clinical trialists have finalised trial design, and presenters agreed it needs a seat at the trial design table from the outset.
Professor Hugo Kavunga (INRB): Overview of Trials, Challenges and Opportunities with New Ebola Trials in DRC
- Trials depend not just on lab science but on promptness of response, operational access, community buy-in, and ethics.
- Operational challenges: Non-state armed groups and insecurity make some areas unsafe for trials.
- Community buy-in: Trials cannot proceed without community trust, but who exactly can we engage?
- Ethics: The foundation for equity and respect – risks/benefits must be explained transparently. Unexplained gaps get filled by rumours, which undermine trial success.
- Insecurity and limited access (non-state armed groups, blocked roads, displacement, security-driven limits on group size).
- Non-specific symptoms (fever/pain could be malaria or Ebola) complicate diagnosis and containment.
- Rumours and mistrust (fear of exploitation; difficulty maintaining follow-up given blocked roads).
- Social/linguistic fragmentation – need for local staff who speak local languages.
- Cultural customs (e.g., burial practices).
- Pressure for data under unstable conditions.
- Engage with local ambassadors and use different communication channels.
- Find ways to improve visible community benefits.
- Consider co-construction of protocols adapted to local realities; building local research capacity and an ethics/community centre.
Dr. Myfanwy James (LSE): The Politics of Medical Research: Ethnographic Insights from Past Ebola Trials in Eastern DRC
- The politics of trials. Trials get caught up in broader political deliberations. Multiple trials during the country’s 10ème Ebola outbreak (2018–20) generated mistrust and concerns about ‘Ebola business‘ and people profiting from crisis in eastern DRC.
- These concerns need to be situated in fractious state-society relations, colonial and post-colonial histories of medical violence, and ongoing violent conflict. However, the idea of Ebola as a business is also a political critique of humanitarian response and the deeply unequal political economy it has formed in the area (compounded by insecurity, election disruption, and the political economy created by large aid inflows).
- During the 2018–20 epidemic, US$1.4 billion Ebola response created a political economy with job kick-back schemes and inflated rental contracts that did become a source of profit-making for many.
- Multiple vaccines in one epidemic. Introducing a second vaccine during the 2018–20 outbreak in eastern DRC sparked ethical debate – the then Minister of Heath opposed it fearing confusion.
- Meanwhile, ethicists argued that existing effective treatment should not be withheld, but at the same time, that a second vaccine might have advantages in the context of supply concerns. The start of the second trial became entangled in national political tensions with accusations that the trial team were prioritising pharmaceutical business interests over citizens’ wellbeing.
- Shifting inclusion/exclusion criteria: Challenges arise when vaccines have different eligibility requirements, or when eligibility evolves over time. For instance, during the 2018–20 outbreak, pregnant women were initially excluded from Ebola trials, then included after a policy reversal. This created confusion and revealed a degree of scientific uncertainty around ‘acceptable risk.‘ The reversal also fed also rumours that the vaccine would exterminate or sterilise the population and put those who were already pregnant in danger.
- Conclusions: Historical and political context is crucial for understanding mistrust, however decisions made by trial and response teams are also crucial. There is a need for public discussion around eligibility and protocol design before the start of a trial. Key questions include: Why are there different trials and interventions? What decisions have been made around eligibility and protocol design, and why?
Professor Esaie Kindombe Luzolo (INRB): Integrating SBS into Ebola Clinical Trials
- Contexte : Limited access to health services and no vaccine yet available in Ituri; treatment, vaccine, and diagnostic assessments are ongoing. Biomedical progress alone isn’t enough – needs integration with SBS. There is currently no confirmed way to share or harmonise consent processes and ethical review materials across concurrent trials.
- Aim: An integrated SBS and implementation science learning platform to support Ebola clinical trials and institutionalise SBS within DRC’s health system. An INRB platform could potentially support iterative, shared consent review across trials.
- Resourcing implications. Any such coordination would require dedicated resourcing and iterative review as new studies come online at different points in time – this isn’t a one-time setup but an ongoing commitment. This SBS protocol has already received clearance from the ethics committee. Given its clear importance, this protocol has just received a small amount of funding from the Congolese government to begin activities while awaiting additional resources.
Discussion group questions
Participants were allocated to breakout rooms, in English and in French, and given a topic to discuss: Trust, implementation, design, and ethics. These topics were selected after a review and knowledge of Ebola clinical trials literature and conversations with people involved in Ebola response and clinical trials in eastern DRC. This is a list of various points made, but they do not necessarily reflect a group consensus.
1. Trust
Question prompts: How does the historical, social, political and economic context of the region shape (mis)trust in the state, researchers, institutions and the products being tested? What are current efforts/ challenges to building participants’ and communities’ trust in the context of the current outbreak, its response and a complex landscape of scientific research?
Trust discussion group notes
- Trials could consider opportunities for supporting local infrastructure or address challenges such as food and water shortages as a way to ‘work along the grain of trust‘ instead of being an extra business that operates in parallel. To address the question of mistrust and concerns around ‘Ebola business‘ (i.e. that people are profiting from the crisis), it is important to attend to how trials become embedded in local political, social, economic and material infrastructures. In practice, this means considering questions of staffing, salary, recruitment processes and networks, supply chains and service provision left over from trials.
- There are challenges in separating science from the Ebola response: Regardless of whether trialists see themselves as separate, populations are likely to view them as connected and/ or as another parallel system. This means needing to consider how the trials are viewed in the context of the response –including (mis)trust in emergency operations, unavailability of local health staff etc.
- There is an urgent need to differentiate between different strains of the Ebola virus, and thus, different trials–this requires careful communication and listening. Differentiating between strains of the Ebola virus is a communication challenge, exacerbated by the simultaneous implementation of vaccine trials for different strains. This may be good for science, but how do we communicate this without breaking trust?
- Speaking openly about uncertainty, including about the possibility of changes to trial design is key. As we learned from anxieties associated with changes for example to inclusion and exclusion criteria (e.g. around the inclusion of pregnant women). In past outbreaks in DRC, the arrival of multiple Ebola vaccines was a source of mistrust. It is important to think about how to have these conversations in honest and transparent ways, discussing openly what decisions were made and why, and being explicit about what uncertainties remain.
- Transparent conversations that engage prospective participants honestly around what we do not know or what might change, are better than unexpected U-turns. Scientific communication can at times underplay uncertainty to ensure authoritative messaging, yet it is important to note that people, especially those who have for many years lived with conflict and other intersecting crises, are very familiar with notions of uncertainty and risk.
- There is a need to co-design trials where possible, and include prospective participants in discussions about trial design to identify factors that may be important for effective implementation, ethical considerations and recruitment
- There may be different levels of trust in local and international staff, and local integration is key, including in connecting teams working on trials and different aspects of the response. However, it is also important to be cautious about how we are defining ‘local‘, as this is not straight forward in a context where some health workers may already be supported by international funding and where questions of who belongs and who deserves to get what have been fraught. This also plays into political economy questions around who has access to opportunities in the new ‘Ebola business‘ created by the influx of emergency-related funds.
2. Implementation
Question prompts: What challenges exist around recruitment and retention into different therapeutic/ vaccine/ diagnostic trials? How can these be addressed? What are opportunities/ challenges for community engagement and communication (including around multiple trials)?
Implementation discussion group notes
- There is a need for tailored communication during a trial. Experience from 2019, challenges were more around explaining why people could not take part in a trial, or skip the line to enter a trial, rather than difficulties in recruitment. Communication around who is invited to take part or not in a trial is challenging.
- Inclusion and exclusion criteria can be constrained operationally including considering access to health structures. Overcoming barriers can be costly. See paper on the perspectives of women who became pregnant during an Ebola vaccine trial in Boende, DRC in 2019–22 (this paper was shared by participants).
- Major issues in recruitment when local communities are not included. Example of an mpox trial which was meant to recruit children over 12 but on the ground children under 5 were the one suffering most from mpox and protocols had to be changed.
- WHO pre-established protocols in Bunia need to be adapted with local communities. Currently in Eastern DRC, a key concern is the bandwidth of local leaders/representatives to tackle mistrust issues considering conflict and displacement. In Ituri at the moment, some community leaders have left the area due to conflict.
- However, we need to consider community in their diversity and challenges coming with relying on perceived leaders. Power mapping is one useful way to do this (this was shared by a participant).
3. Design
Question prompts: What challenges/ opportunities exist for co-production of trial design with affected populations? What aspects of local social, political and economic realities might affect the effectiveness of different trial designs? What considerations need to be made for equitable participation and around exclusion/ inclusion criteria?
Design discussion group notes
- When these trials start, there are usually a number of actors involved and the first goal is response – to save lives and control the outbreak, whereas research is often the second priority.
- Question how much local researchers have been involved in the design of trials.
- There were concerns that health care workers were going to be randomized to receive a placebo – but HCWs are exposed, they’re on the frontline, anytime they’re getting the disease, how are they getting placebos? That was a big concern reported amongst frontline health workers. See paper on placebo use (this was not mentioned, but added after).
4. Ethics
Question prompts: What key ethical questions are emerging from establishing trials in the context of this outbreak? What are specific challenges around use of placebos, randomisation, and the rollout of different trials (e.g. of different vaccines)?
Ethics discussion group notes
- ‘Between-trial‘ ethics is under-addressed: Individual trials get ethics approval, but there’s no clear framework for when multiple trials run simultaneously, over time, or alongside the broader health system. This includes recruitment/consent overlap risks and the danger that uncoordinated trials undermine each other’s data validity.
- Defining ‘trial‘ itself is contested: Where does legitimate research end and exploitative experimentation begin?
- Consent and communication are historically weak: The 2018–20 outbreak showed consent processes were often inadequate and community-facing information wasn’t fit for purpose – especially confusing when vaccine availability differs between outbreaks or trial phases. Previous vaccines/trials need to be explained to communities in relation to new ones – another ‘between-trial‘ issue.
- Trust is built (or broken) between crises, not during them: Communities often only see health interventions during emergencies, breeding distrust; stronger health systems pre-crisis would improve acceptance of measures when outbreaks hit.
- Unresolved ethical questions get settled politically: Without proactive frameworks, decisions about competing trials end up shaped by power and influence rather than principle.
Plenary discussion
Trials as integrative social-political processes
Trials need to be understood as embedded in existing local systems, not as neutral, separate operations. Key open questions include: how are local health staff with existing authority recruited into trial roles? How do trial staffing relationships interact with pre-existing ones?
Participants raised the issue of material infrastructure that trials leave behind (or don’t) – food provision, water stations – and how these can either build trust (if integrated with existing community trust-infrastructure) or read as an ‘outside business‘ operating in parallel.
Trials vs. the wider Ebola response
It is hard to separate ‘the trial‘ from ‘the response‘ in practice, even though trial designers often see themselves as neutral/separate. Communities experience it as another parallel health system regardless of how it’s officially categorised.
Multiple virus species and vaccines
With two virus species (Bundibugyo ebolavirus (BDBV) and Ebolavirus) potentially both being tested for in the same outbreak, plus multiple vaccine candidates (up to four), there’s a clear communication challenge: how to explain this without undermining trust, especially given past community reactions to multiple vaccines in prior outbreaks.
Communicating uncertainty
Communities generally already understand uncertainty as part of daily life – the challenge is not whether uncertainty can be communicated, but how. Problems arose historically when decisions were presented as fixed/black-and-white and then reversed (e.g., inclusion/exclusion criteria changes), causing concern. Participants argued for explicit, transparent conversation about what has been decided and why, especially with several things happening in parallel this time. Participants also flagged that automatic community reactions to new vaccine trials making press were sometimes suspicion.
Local vs. international trial teams and trust
A question was asked whether there’s evidence that trust is higher when trials are run by local research teams rather than international ones.
Response: success is highly contingent on local integration – including the relationship between trial teams and epidemiological/contact-tracing teams (historically often separate, non-interacting groups). Also flagged that existing international actors (e.g., NGOs already subsidising healthcare workers) shape the ‘ecology of trust‘ a new trial enters into – the local/foreign distinction isn’t clean.
This was then linked to who gets included in the response and benefits materially (employment, cash injection) – ‘who counts as local‘ can become a site of power struggle, requiring careful unpacking rather than treating ‘local‘ as self-evident. See paper by Myfanwy James on what ‘local‘ means.
There is a powerful example from Sierra Leone – very local staff (from the trial’s town) built more trust than international funding/scientific authority, because ‘if something goes wrong, you can leave, but they can’t.‘ There is ethical complexity – e.g., when local staff themselves weren’t eligible for the vaccine they were helping administer to others’ families.
Community engagement in practice – vaccine design stage
There was a strong call for community and social scientists to be involved at the point of vaccine trial design, not brought in afterward to ‘help deliver.‘ Cited current trials where ethical/social science considerations weren’t built into the design.
Inter-trial coordination question
One participant asked whether there is any intent to coordinate/share consent processes across trials and studies, so people aren’t going through different ethics review processes for essentially similar things. Response: No known mechanism currently exists; flagged as a good potential idea, though would need to be iterative and resourced given trials don’t all start consent processes at the same time. Raised whether this might be part of the vision for an INRB platform.
Consent and placebo design
The plenary discussion included a point that while scientific rigor requires certain design choices (e.g. placebo control groups, blinding), consent is the mechanism through which the community exercises agency over what they don’t control directly – participants aren’t told who receives the product vs. placebo, but they do consent to the study knowing this and can refuse.
Community engagement across the full chain
From over 10 years of experience implementing trials during outbreaks (Guinea 2015, DRC 2018–20), community engagement must start at the political level, then move to community leaders, then to those eligible – not just the eligible group. Face-to-face communication was critical – cited the Guinea Ebola vaccine trial (2015), where community and national-level resistance predicted ‘disaster,‘ but a humble, responsive approach (clear explanation for both eligible and ineligible people, explaining side effects, returning to update communities whenever messaging changed, following up on participant calls/needs even in hard-to-access areas) led to success, including in DRC 2018–20s most difficult access areas – via local representatives when direct access wasn’t possible.
See Annexe 2 for key questions and comments from the Zoom chat and additional key SBS resources.
Closing remarks
In her closing remarks, Professor Clare Chandler (FCDO) emphasised that gathering social and behavioural science (SBS) insights is clearly important but must be done with depth and rigor rather than anecdotally – a challenge given the many languages and communities involved; she noted the group doesn’t need to start from scratch given existing research and pointed to the annotated bibliography as a useful resource (see Annexe 3). She stressed that the work is sensitive, high-stakes, and ongoing rather than a one-off, and highlighted the discussion’s key insight that ethics must be considered between studies and not just within them, flagging Professor Esaie Kindombo’s (INRB) proposed platform as an important initiative to track and encouraged updates on next steps, and closed by underscoring that those working with communities also need to coordinate with one another.
Annexe 3: Annotated Bibliography: Social Science, Community Engagement and Clinical Trials during Ebola Epidemics
Social science and community engagement in clinical trials
- Enria, L. et coll.(2016) ‘Power, fairness and trust: understanding and engaging with vaccine trial participants and communities in the setting up of the EBOVAC-Salone vaccine trial in Sierra Leone’. Santé publique BMC, 16, 1140.
A discussion of the process of integrating social science research in the Ebola vaccine trials in Sierra Leone. The article focuses on how considerations of local norms of fairness, power dynamics within communities and dynamics of mistrust that emerged from social science research were addressed in collaboration with community engagement and trial operations teams to build confidence and improve recruitment. It describes the establishment of a rapid feedback system between social science and community engagement teams for evidence-based communications and dialogue.
- Dada, S., McKay, G., Mateus, A., and Lees, S. (2019) ‘Lessons learned from engaging communities for Ebola vaccine trials in Sierra Leone: reciprocity, relatability, relationships and respect (the four R’s)’. BMC public health, 19(1), 1665.
A study of barriers and facilitators to community engagement (CE) in the Ebola vaccine trials in Sierra Leone through interviews with trial staff and focus group discussions with community members. The article identifies four principles for trust-building for effective CE the trials: reciprocal communication (facilitated by a feedback system between CE and social science teams), relatability (e.g. using examples that made sense to people locally), building on interpersonal relationships, and showing respect to prospective and current participants.
- Vanderslott, S., Van Ryneveld, M., Marchant, M., Lees, S., Nolna, S.K. and Marsh, V. (2021) ‘How can community engagement in health research be strengthened for infectious disease outbreaks in Sub-Saharan Africa? A scoping review of the literature’. BMC public health, 21(1), p.633.
Scoping review on how CE has been conceptualised in the context of research in/on infectious disease outbreaks, and its effectiveness. The review suggests more research specifically on effectiveness is required. Key themes emerging from the literature on what matters for CE include: accurate and culturally-sensitive communication (this has both intrinsic and instrumental value); formative contextual social science research to inform CE; learning lessons over-time (e.g. incorporating feedback into future plans).
- Mansaray, A. et coll. (2024) ‘Engaging the public in decisions about emergency vaccine deployment strategies: Lessons from scenario-based discussions in Sierra Leone’. Santé publique mondiale, 19(1), p.2334887.
Not trial specific but discusses strategies for engaging the public in debates about optimal emergency vaccine deployment scenarios. The paper describes a scenario-based methodology where participants in group discussions were asked to discuss different vaccination strategy in an Ebola-like and a Covid-like scenario. The discussion surfaced key, context-specific, logisictal, ethical and livelihoods issues that might make different strategies for vaccination more or less feasible/ acceptable. This paper can be useful to think about how to structure community consultations around trial designs and emergency vaccine/treatment deployment options.
- Doe-Anderson, J. et coll. (2016) Beating the Odds: Successful Establishment of a Phase II/III Clinical Research Trial in Resource-Poor Liberia during the Largest-Ever Ebola Outbreak. Contemp Clin Trials Commun.
The article describes the establishment of an Ebola vaccine trial in Liberia during the West African outbreak, with a particular focus on the processes of setting up research collaborations, as well as barriers and successes. One section discusses community engagement and social mobilisation as a key component of the trial. Of particular interest is a discussion of how changes were made to study procedures in response to community feedback– e.g. an expansion of the informed consent process and the inclusion of participant trackers to help maintain confidentiality.
Participants decision-making and grounded/practical ethics
- Tengbeh, A.F. et coll. (2018). ‘We are the heroes because we are ready to die for this country‘: Participants’ decision-making and grounded ethics in an Ebola vaccine clinical trial. Social science & medicine, 203, pp.35-42.
This article interrogates why, despite an atmosphere of mistrust and individual and collective concerns, participants in the EBOVAC trial in Sierra Leone decided to take part. Key reasons included: altruism, curiosity and hope, health-seeking and beliefs about vaccines powers, and expectations linked to participation. The article focuses on dimensions of decision-making as a key component for understanding ‘acceptability’. It makes a case for thinking about ‘grounded ethics’ that considers context and participants’ assessment and ethical deliberations.
- James, M. et coll. (2023) ‘Protection, health seeking, or a laissez-passer: Participants’ decision-making in an EVD vaccine trial in the eastern Democratic Republic of the Congo’. Sciences sociales et médecine, 323, p.115833.
The article explores reasons for joining a second experimental vaccine trial in North Kivu, DRC, in the context of controversies surrounding both the epidemic and the establishment of a second trial during the 10th Ebola outbreak in the country. It highlights that some reasons may not be captured by trialists because they go beyond medical reasoning and are situated in context. Taking these motivations seriously is key for bioethics in clinical research. Motivations included: protection, health-seeking, a belief that vaccination cards would be essential for travel,
- Nguyen, D., Arnaert, A., Pringle, J., Ponzoni, N., Kouyaté, S., Fansia, N. and Nouvet, E., (2021) ‘Nurses’ experiences of their decision‐making process when participating in clinical trials during the 2014–2016 West African Ebola crisis’. Public Health Nursing, 38(1), pp.40-46.
A study of nurse’s decision-making in various clinical studies in Liberia, Guinea and Sierra Leone. Facilitators of participation included concerns related to working in a dangerous environment, but distrust in authorities, concerns about stigma, conflicting opinions and perceived hypocrisy of some members of research teams being unwilling to take the interventions themselves, worked against participation.
- Nouvet, E., Chénier, A., and Kouyaté, S. (2018) Participants’ perceptions of Ebola research: Report to participants. Hamilton: Humanitarian Health Ethics.
The report outlines lessons learned from people who participated/ refused participation in a range of different clinical and observational studies during the West African Ebola outbreak. It is based on research in Guinea, Liberia and Sierra Leone. The article covers reasons for participating (e.g. wanting to find a cure), the experience of seeking information on the studies (highlighting role of trust in those giving information); experiences of participation; informed consent (e.g. challenges in distinguishing research and health-care).
- Marí Sáez, A. et coll. (2020) ‘The Plasma Mobile,’A gift from heaven’: The impact of health technology transfer on trial perceptions and expectations during the Ebola-Tx Trial, Conakry’. PLoS neglected tropical diseases, 14(4), e0008206.
The article discusses the introduction of a mobile plasma collection centre (‘plasma mobile’) for the convalescent plasma trials in Guinea during the West African Ebola outbreak and specifically the effect that the transfer of this technology had on participants’ experiences. For example, it helped people understand the separation of blood and plasma, efforts were made to render the space relaxing and communal, staff felt empowered by being able to learn a new technology in the plasma mobile itself, and the process generated hope amongst survivors that they could help others.
- Ronse, M. et coll. (2018) ‘What motivates Ebola survivors to donate plasma during an emergency clinical trial? The case of Ebola-Tx in Guinea’. PLoS neglected tropical diseases, 12(10), p.e0006885.
Based on the same convalescent plasma trial discussed in the previous article, this one discusses motivations for donating plasma. The authors highlight some hesitation including due to concerns of potential effects of donation on theirhealth, especially as it was difficult to differentiate it from blood donation (no local word for plasma), and fears of reinfection. Factors like trust in other survivors were key for participation.
Ethics of inclusion and exclusion
- James, M. (2025) ‘Rumor as ethical vernacular: Ebola and the politics of the womb in eastern Congo’. Anthropologie médicale trimestrielle, 39(3), e70015.
Drawing on experiences from the 10th Ebola outbreak in DRC, the article discusses the effects of a policy reversal in 2019, which allowed pregnant women to take part in vaccine trials, after having previously been excluded. It discusses both how this was discussed in Goma and how it influenced pregnant women’s participation in the trial. It highlights the political context that shaped rumours. Pregnant women weighed the benefits (e.g. of receiving healthcare in the trial and protection from Ebola) and the potential risks. The article argues that, especially in a context of scientific uncertainty, rumours became a vehicle of ethical debate (‘ethical vernacular’), for example to determine what constituted ‘acceptable risk’.
- Schwartz, D.A. (2020) ‘Being pregnant during the Kivu Ebola virus outbreak in DR Congo: the rVSV-ZEBOV vaccine and its accessibility by mothers and infants during humanitarian crises and in conflict areas’. Vaccins, 8(1), 38.
An in-depth discussion of the process leading to the inclusion of pregnant women in the Ebola vaccine trials in the 10th Ebola outbreak in DRC.
Stigmate
- Alenichev, A. (2021) ‘We will soon be dead’: stigma and cascades of looping effects in a collaborative Ebola vaccine trial. Critical public health, 31(1), 55-65.
The paper discusses stigma experienced by participants in an Ebola vaccine trial in Liberia. Despite extensive community engagement and mobilisation embedded within the trial, stigma persisted, with participants being viewed as infected, or as desperate for money. It identifies two processes that reinforced stigma: association of Ebola trials with Ebola and the conflation of trial participants with marginalised populations. A key argument is that community engagement efforts can struggle to deactivate long-standing socially embedded and contextual knowledge that underpins situated interpretations of biomedical research.
Challenges of communicating multiple trials/vaccines
- James, M.V., and Lees, S.S. (2022) ‘‘Are you sure It’s not the Corona vaccine?‘ an Ebola vaccine trial during Covid-19 in DRC’. Anthropologie médicale, 41(5), 503-517.
A discussion of the challenges of implementing an Ebola trial during the Covid-19 pandemic. It highlights rumours and concerns as the trial offered opportunities to comment on global inequality and medical colonialism. These included concerns that perhaps participants were secretly being given the Covid vaccine. As the trial had to make changes to respond to pandemic conditions, fresh concerns emerged, showing the challenges of maintaining trust throughout a trial as circumstances change.
- James, M., Kasereka, J.G., and Lees, S. (2021) ‘The politics of the second vaccine: debates surrounding Ebola vaccine trials in eastern Democratic Republic of the Congo’. Journal des affaires humanitaires, 3(3), 4-13.
The article describes local debates about the establishment of two different Ebola vaccine trials during the 10th Ebola outbreak in DRC. These included concerns about whether this was a form of ‘Ebola business’, questions around selection criteria (e.g. research taking place in predominantly Nande neighbourhoods), and anxieties that people were being used as ‘guinea pigs’.
- Monrad, J.T. (2020) ‘Ethical considerations for epidemic vaccine trials’. Journal of medical ethics, 46(7), 465-469.
A discussion of ethical dilemmas arising from conducting vaccine trials in epidemic contexts., including the testing of other candidates when one has been found effective.
Politics and ethics of clinical trials in emergencies
- Kelly, A.H. (2018) ‘Ebola vaccines, evidentiary charisma and the rise of global health emergency research’. Économie et société, 47(1), pp.135-161.
The article discusses the unprecedented fast-tracking of Ebola vaccine trials during the West African outbreak and how standards of clinical research were influenced by claims of emergency and a moral imperative to act in times of crisis. It discusses for example the introduction of ring vaccination in the Ebola ça suffit trial in Guinea and the effect that this and other deliberations around the evidence requirements in emergency situations has had on subsequent outbreaks,
- Street, A. and Kelly, A.H. (2025) ‘Tolerable tests: Regulating diagnostic innovation in a global health emergency, lessons from Ebola’. Science, Technology, & Human Values, 50(4), pp.744-771.
This article discusses negotiations surrounding the development and testing of Ebola diagnostics during the West African outbreak, in a context where standard norms for evidence were confronted with urgency of humanitarian crisis.
Tools, guidance and operational recommendations
- Schmidt-Sane, M., Vanderslott, S., Rohan, H., et Enria, L. (2025). Utiliser les sciences sociales et comportementales pour éclairer l'utilisation de vaccins expérimentaux dans les situations d'urgence sanitaire. Plateforme des sciences sociales dans l'action humanitaire (SSHAP). doi.org/10.19088/SSHAP.2025.013
A SSHAP brief on operational lessons from SBS research for vaccine deployment during emergencies with practical recommendations for roll-out. Key dimensions highlighted: how experience of health services affects vaccine confidence; engaging with community-specific dynamics for effective engagement; and the importance of community consultations for design of trials and vaccination campaigns rollout.
- Vanderslott, S. et Rohan, H. (2025). Considérations clés pour l'introduction de vaccins expérimentaux dans les situations d'urgence sanitaire. Sciences sociales dans l'action humanitaire (SSHAP). doi.org/10.19088/SSHAP.2025.024
A SSHAP brief offering a review of different strategies for rolling out experimental vaccines (e.g. ring vaccination, post-exposure prophylaxis, human challenge trials etc), regulation and ethics for different types of experimental vaccine deployments. It then proposes key practical SBS and community engagement considerations associated with different types of deployment strategies, including the use of formative SBS research and power mapping, participant consultations on study design, etc.
- Joint Workshop in and for ethical research for infectious diseases and other humanitarian crises
A report from a workshop bringing together survivors, policymakers, practitioners and researchers to discuss community engagement in biomedical research, with reflections drawn particularly from experiences during the West African Ebola outbreak. It highlights the values underpinning CE as well as offering practical recommendations for thinking about embedding CE in research, including identifying OMS the community is, recognising community agency, complementing SBS research and CE and the potential for community input in study design.
Not Ebola specific, but a useful set of tools to engage with prospective participants and communities about clinical research processes and the rights of research participants. The tools are designed specifically for implementation with low-literacy populations in Sub-Saharan Africa but can be adapted for different settings. Detailed tools include all aspects of workshop planning (from budgeting to post-workshop surveys) as well as picture aides and posters.
- Nouvet, E. (2023) Strengthening ethics in Ebola research: a toolbox developed with and for limited literacy adults in Ebola-affected countries. Population Medicine, 5 (Supplement).
This article outlines the participatory development of the Participants’ Research Ethics Toolbox (PRET). It was developed with Ebola survivors and other stakeholders in Ebola-affected countries. Its accessible, multilingual resources aim to improve communication, support meaningful consent, and strengthen ethical research during public health emergencies.
Global guidelines for people involved in the design and implementation of prevention and treatment trials in the context of (re-)emerging pathogens. The guidelines specifically address how to engage stakeholders in the design, conduct and conclusion of trials. It outlines the values of respect, fairness, integrity, transparency, accountability and autonomy and traces how these can guide different stages and types of trial implementation.
Not trial specific but discusses practical methodological tools for collecting and prioritising community concerns through feedback mechanisms to inform emergency operations. This tool can be useful as a way to track rumours and concerns surrounding a trial and determining, with affected communities, how to prioritise and address them.
Contributors
This report was written by Megan Schmidt-Sane (Institute of Development Studies and Case Western Reserve University) and Luisa Enria (The London School of Hygiene & Tropical Medicine).
Remerciements
This brief has been produced for the Multi-Hazard Research Network (MHRN). This project is funded by the UK Government’s Foreign, Commonwealth & Development Office (FCDO) through the Science for Emergencies Centre (SEC), under the Global Research and Technology Development (GRTD) portfolio. The views expressed in this brief are those of the authors and do not necessarily reflect the official policies or positions of the FCDO, the UK Government, or its partners.
First published by the Institute of Development Studies in September 2026.
Citation suggérée : Schmidt-Sane, M. and Enria, L. (2026) MHRN Roundtable Report: Social and Behavioural Science Priorities for Ebola Clinical Trials in DRC, Multi-Hazard Research Network (MHRN), Brighton: Institute of Development studies, DOI: 10.19088/MHRN.2026.003
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