دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Coleman CH, Ardiot C, Blesson S, Bonnin Y, Bompart F, Colonna P, Dhai A, Ecuru J, Edielu A, Hervé C, Hirsch F, Kouyaté B, Mamzer-Bruneel MF, Maoundé D, Martinent E, Ntsiba H, Pelé G, Quéva G, Reinmund MC, Sarr SC, Sepou A, Tarral A, Tetimian D, Valverde O, Van Nieuwenhove S, Strub-Wourgaft N |
| المصدر: | Developing world bioethics [Dev World Bioeth] 2015 Dec; Vol. 15 (3), pp. 241-7. Date of Electronic Publication: 2014 Jul 14. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: John Wiley & Sons Ltd Country of Publication: England NLM ID: 101120122 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-8847 (Electronic) Linking ISSN: 14718731 NLM ISO Abbreviation: Dev World Bioeth Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2014- : Abingdon : John Wiley & Sons Ltd. Original Publication: Oxford ; Malden, MA : Blackwell, c2001- |
| مواضيع طبية MeSH: | Ethical Review*, Antiprotozoal Agents/*therapeutic use , Biomedical Research/*ethics , Nitroimidazoles/*therapeutic use , Trypanosomiasis, African/*drug therapy, Developing Countries ; Humans ; International Cooperation |
| مستخلص: | 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. (© 2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.) |
| فهرسة مساهمة: | Keywords: Africa; clinical trials; committees; informed consent; international justice; research; research ethics |
| المشرفين على المادة: | 0 (Antiprotozoal Agents) 0 (Nitroimidazoles) 306ERL82IR (fexinidazole) |
| تواريخ الأحداث: | Date Created: 20140722 Date Completed: 20170111 Latest Revision: 20170112 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1111/dewb.12068 |
| PMID: | 25039421 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1471-8847 |
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| DOI: | 10.1111/dewb.12068 |