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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 A frican Trypanosomiasis
Author(s) -
Coleman Carl H.,
Ardiot Chantal,
Blesson Séverine,
Bonnin Yves,
Bompart Francois,
Colonna Pierre,
Dhai Ames,
Ecuru Julius,
Edielu Andrew,
Hervé Christian,
Hirsch François,
Kouyaté Bocar,
MamzerBruneel MarieFrance,
Maoundé Dionko,
Martinent Eric,
Ntsiba Honoré,
Pelé Gérard,
Quéva Gilles,
Reinmund MarieChristine,
Sarr Samba Cor,
Sepou Abdoulaye,
Tarral Antoine,
Tetimian Djetodjide,
Valverde Olaf,
Van Nieuwenhove Simon,
StrubWourgaft Nathalie
Publication year - 2015
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/dewb.12068
Subject(s) - psychological intervention , research ethics , political science , public relations , engineering ethics , business , medicine , nursing , engineering
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 A frican 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 A frican and E uropean countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.