title: Taking the bull by the horns: Ethical considerations in the design and implementation of an Ebola virus therapy trial.
abstract: Ebola virus is categorized as one of the most dangerous pathogens in the world. Although there is no known cure for Ebola virus, there is some evidence that the severity of the disease can be curtailed using plasma from survivors. Although there is a general consensus on the importance of research, methodological and ethical challenges for conducting research in an emergency situation have been identified. Performing clinical trials is important, especially for health conditions that are of public health significance (including rare epidemics) to develop new therapies as well as to test the efficacy and effectiveness of new interventions. However, routine clinical trial procedures can be difficult to apply in emergency public health crises hence require a consideration of alternative approaches on how therapies in these situations are tested and brought to the market. This paper examines some of the ethical issues that arise when conducting clinical trials during a highly dangerous pathogen outbreak, with a special focus on the Ebola virus outbreak in West Africa. The issues presented here come from a review of a protocol that was submitted to the Global Emerging Pathogens Treatment Consortium (GET). In reviewing the proposal, which was about conducting a clinical trial to evaluate the safety and efficacy of using convalescent plasma in the management of Ebola virus disease, the authors deliberated on various issues, which were documented as minutes and later used as a basis for this paper. The experiences and reflections shared by the authors, who came from different regions and disciplines across Africa, present wide-ranging perspectives on the conduct of clinical trials during a dangerous disease outbreak in a resource-poor setting.
authors.affiliation: KEMRI-Wellcome Trust Research Programme (KWTRP), P.O Box 230, Kilifi, Kenya. Electronic address: Fkombe@kemri-wellcome.org.
authors.forename: Francis
authors.initials: F
authors.lastname: Kombe
authors.affiliation: Department of Child Dental Health, Obafemi Awolowo University, Ile-Ife, Nigeria; Global Emerging Pathogens Treatment Consortium (GET), 1 Mainland Hospital Road, Yaba, Lagos, Nigeria.
authors.forename: Morenike O
authors.initials: MO
authors.lastname: Folayan
authors.affiliation: Global Emerging Pathogens Treatment Consortium (GET), 1 Mainland Hospital Road, Yaba, Lagos, Nigeria.
authors.forename: Jennyfer
authors.initials: J
authors.lastname: Ambe
authors.affiliation: Global Emerging Pathogens Treatment Consortium (GET), 1 Mainland Hospital Road, Yaba, Lagos, Nigeria.
authors.forename: Adaora
authors.initials: A
authors.lastname: Igonoh
authors.affiliation: Global Emerging Pathogens Treatment Consortium (GET), 1 Mainland Hospital Road, Yaba, Lagos, Nigeria; Division of Haematology, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg Hospital, Private Bag X3, Parow Valley, 7505 Cape Town, Cape Town, South Africa.
authors.forename: Akin
authors.initials: A
authors.lastname: Abayomi
mesh_terms: D000354:Africa, Western / Q000453:epidemiology; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D004196:Disease Outbreaks; D019142:Hemorrhagic Fever, Ebola / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D012107:Research Design
keywords: Africa; Ebola virus disease; Emergency health situation; Emerging infectious diseases; Ethics