title: Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.
abstract: Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.
authors.forename: Carl H
authors.initials: CH
authors.lastname: Coleman
authors.forename: Chantal
authors.initials: C
authors.lastname: Ardiot
authors.forename: Séverine
authors.initials: S
authors.lastname: Blesson
authors.forename: Yves
authors.initials: Y
authors.lastname: Bonnin
authors.forename: Francois
authors.initials: F
authors.lastname: Bompart
authors.forename: Pierre
authors.initials: P
authors.lastname: Colonna
authors.forename: Ames
authors.initials: A
authors.lastname: Dhai
authors.forename: Julius
authors.initials: J
authors.lastname: Ecuru
authors.forename: Andrew
authors.initials: A
authors.lastname: Edielu
authors.forename: Christian
authors.initials: C
authors.lastname: Hervé
authors.forename: François
authors.initials: F
authors.lastname: Hirsch
authors.forename: Bocar
authors.initials: B
authors.lastname: Kouyaté
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Mamzer-Bruneel
authors.forename: Dionko
authors.initials: D
authors.lastname: Maoundé
authors.forename: Eric
authors.initials: E
authors.lastname: Martinent
authors.forename: Honoré
authors.initials: H
authors.lastname: Ntsiba
authors.forename: Gérard
authors.initials: G
authors.lastname: Pelé
authors.forename: Gilles
authors.initials: G
authors.lastname: Quéva
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Reinmund
authors.forename: Samba Cor
authors.initials: SC
authors.lastname: Sarr
authors.forename: Abdoulaye
authors.initials: A
authors.lastname: Sepou
authors.forename: Antoine
authors.initials: A
authors.lastname: Tarral
authors.forename: Djetodjide
authors.initials: D
authors.lastname: Tetimian
authors.forename: Olaf
authors.initials: O
authors.lastname: Valverde
authors.forename: Simon
authors.initials: S
authors.lastname: Van Nieuwenhove
authors.forename: Nathalie
authors.initials: N
authors.lastname: Strub-Wourgaft
mesh_terms: D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D035843:Biomedical Research / Q000941:ethics*; D003906:Developing Countries; D026724:Ethical Review; D006801:Humans; D007391:International Cooperation; D009593:Nitroimidazoles / Q000627:therapeutic use*; D014353:Trypanosomiasis, African / Q000188:drug therapy*
chemical_list: D000981:Antiprotozoal Agents; D009593:Nitroimidazoles; C038307:fexinidazole
keywords: Africa; clinical trials; committees; informed consent; international justice; research; research ethics