首页 | 本学科首页   官方微博 | 高级检索  
   检索      


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
Authors:Carl H Coleman  Chantal Ardiot  Sverine Blesson  Yves Bonnin  Francois Bompart  Pierre Colonna  Ames Dhai  Julius Ecuru  Andrew Edielu  Christian Herv  Franois Hirsch  Bocar Kouyat  Marie‐France Mamzer‐Bruneel  Dionko Maound  Eric Martinent  Honor Ntsiba  Grard Pel  Gilles Quva  Marie‐Christine Reinmund  Samba Cor Sarr  Abdoulaye Sepou  Antoine Tarral  Djetodjide Tetimian  Olaf Valverde  Simon Van Nieuwenhove  Nathalie Strub‐Wourgaft
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.
Keywords:Africa  clinical trials  research ethics  international justice  committees  research  informed consent
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号