Previous months have witnessed a growth of clinical research in response to the COVID19 crisis. This brief sets out social science considerations that can inform clinical and vaccine trials for COVID-19. It was developed for SSHAP by London School of Hygiene and Tropical Medicine (LSHTM) by Rose Burns, Alex Bowmer, Luisa Enria, Samantha Vanderslott (University […]
Clinical Research
The conduct and ethics of medical research during, before, and after epidemics, and the experiences and implications of community participation in such research.
9 documents
“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
The 2014–2016 Ebola epidemic presented a challenging setting in which to carry out clinical trials. This paper reports findings from social science research carried out in Kambia, Northern Sierra Leone during first year of an Ebola vaccine trial (August 2015–July 2016). The social science team collected data through ethnographic observation, 42 in depth interviews; 4 […]
Controversial Ebola Vaccine Trials in Ghana: A Thematic Analysis of Critiques and Rebuttals in Digital News
Communication is of paramount importance in responding to health crises. The authors studied the media messages put forth by different stakeholders in two Ebola vaccine trials that became controversial in Ghana. These interactions between health authorities, political actors, and public citizens can offer key lessons for future research. Through an analysis of online media, the […]
Implementation of an Ebola Virus Disease Vaccine Clinical Trial during the Ebola Epidemic in Liberia: Design, Procedures, and Challenge
The index case of the Ebola virus disease epidemic in West Africa is believed to have originated in Guinea. By June 2014, Guinea, Liberia, and Sierra Leone were in the midst of a full-blown and complex global health emergency. The devastating effects of this Ebola epidemic in West Africa put the global health response in […]
Ethical Challenges for International Collaborative Research Partnerships in the Context of the Zika Outbreak in the Dominican Republic: A Qualitative Case Study
The establishment of international collaborative research partnerships in times of infectious disease outbreaks of international importance has been considered an ethical imperative. Frail health research systems in low- and middle-income countries can be an obstacle to achieve the goal of knowledge generation and the search for health equity before, during and after infectious disease outbreaks. […]
Ethical Considerations in the Conduct of Research on Therapies for the Prevention and Treatment of Ebola Virus Disease in Developing Countries
The devastating toll of the Ebola epidemic in West Africa necessitates considerations of new approaches to research into new prevention technologies and treatments for Ebola Virus Disease (EVD). Research must be planned and delivered in consultation with civil society from the epicentre to prevent mistrust and misunderstanding. Ethical considerations include development of local research and […]
Power, Fairness and Trust: Understanding and Engaging with Vaccine Trial Participants and Communities in the Setting Up the EBOVAC-Salone Vaccine Trial in Sierra Leone
This paper discusses the establishment of a clinical trial of an Ebola vaccine candidate in Kambia District, Northern Sierra Leone during the epidemic, and analyses the role of social science research in ensuring that lessons from the socio-political context, the recent experience of the Ebola outbreak, and learning from previous clinical trials were incorporated in […]
Beating the Odds: Successful Establishment of a Phase II/III Clinical Research Trial in Resource-Poor Liberia during the Largest-Ever Ebola Outbreak
It has been argued that a country such as Liberia, not fully recovered from the devastation of decades of civil unrest, lacked the appropriate ethical and regulatory framework, basic human and health care services, and infrastructure to carry out clinical trials according to international standards of quality during a public health emergency. However, as Liberia, […]
Community Perception and Beliefs About Blood Draw for Clinical Research in Ghana
Clinical research participants often express concerns about blood draw because of misconceptions about the uses to which the blood will be put. Their comments can generate rumours in their communities, thereby affecting rates of recruitment to research studies and increasing losses to follow-up. This study sought to identify community perceptions about blood draw for clinical […]
