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,

    Corresponding author
    • Address for correspondence: Carl Coleman, Seton Hall University, School of Law, One Newark Center, Newark, New Jersey 07102 United States. Email: carl.coleman@shu.edu.

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  • Chantal Ardiot,

  • Séverine Blesson,

  • Yves Bonnin,

  • Francois Bompart,

  • Pierre Colonna,

  • Ames Dhai,

  • Julius Ecuru,

  • Andrew Edielu,

  • Christian Hervé,

  • François Hirsch,

  • Bocar Kouyaté,

  • Marie-France Mamzer-Bruneel,

  • Dionko Maoundé,

  • Eric Martinent,

  • Honoré Ntsiba,

  • Gérard Pelé,

  • Gilles Quéva,

  • Marie-Christine Reinmund,

  • Samba Cor Sarr,

  • Abdoulaye Sepou,

  • Antoine Tarral,

  • Djetodjide Tetimian,

  • Olaf Valverde,

  • Simon Van Nieuwenhove,

  • Nathalie Strub-Wourgaft


  • Conflict of interest statement: No conflicts declared

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.

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