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
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 unwar...
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| Veröffentlicht in: | Developing world bioethics 2015-12, Vol.15 (3), p.241-247 |
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| creator | 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 Mamzer-Bruneel, Marie-France Maoundé, Dionko Martinent, Eric Ntsiba, Honoré Pelé, Gérard Quéva, Gilles Reinmund, Marie-Christine Sarr, Samba Cor Sepou, Abdoulaye Tarral, Antoine Tetimian, Djetodjide Valverde, Olaf Van Nieuwenhove, Simon Strub-Wourgaft, Nathalie |
| description | 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. |
| doi_str_mv | 10.1111/dewb.12068 |
| format | Article |
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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.</description><identifier>ISSN: 1471-8731</identifier><identifier>EISSN: 1471-8847</identifier><identifier>DOI: 10.1111/dewb.12068</identifier><identifier>PMID: 25039421</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Africa ; African trypanosomiasis ; Antiprotozoal Agents - therapeutic use ; Bioethics ; Biomedical Research - ethics ; clinical trials ; Collaboration ; Committees ; Constraints ; Developing Countries ; Disease ; Drugs ; Ethical Review ; Ethics ; Experts ; Humans ; Implementation ; informed consent ; International ; International Cooperation ; international justice ; International organizations ; LDCs ; Medical research ; Nitroimidazoles - therapeutic use ; Oversight ; Public sector ; research ethics ; Reviews ; Treatment programs ; Trypanosomiasis ; Trypanosomiasis, African - drug therapy ; Vector-borne diseases</subject><ispartof>Developing world bioethics, 2015-12, Vol.15 (3), p.241-247</ispartof><rights>2014 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.</rights><rights>Copyright © 2015 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdewb.12068$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdewb.12068$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27843,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25039421$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Coleman, Carl H.</creatorcontrib><creatorcontrib>Ardiot, Chantal</creatorcontrib><creatorcontrib>Blesson, Séverine</creatorcontrib><creatorcontrib>Bonnin, Yves</creatorcontrib><creatorcontrib>Bompart, Francois</creatorcontrib><creatorcontrib>Colonna, Pierre</creatorcontrib><creatorcontrib>Dhai, Ames</creatorcontrib><creatorcontrib>Ecuru, Julius</creatorcontrib><creatorcontrib>Edielu, Andrew</creatorcontrib><creatorcontrib>Hervé, Christian</creatorcontrib><creatorcontrib>Hirsch, François</creatorcontrib><creatorcontrib>Kouyaté, Bocar</creatorcontrib><creatorcontrib>Mamzer-Bruneel, Marie-France</creatorcontrib><creatorcontrib>Maoundé, Dionko</creatorcontrib><creatorcontrib>Martinent, Eric</creatorcontrib><creatorcontrib>Ntsiba, Honoré</creatorcontrib><creatorcontrib>Pelé, Gérard</creatorcontrib><creatorcontrib>Quéva, Gilles</creatorcontrib><creatorcontrib>Reinmund, Marie-Christine</creatorcontrib><creatorcontrib>Sarr, Samba Cor</creatorcontrib><creatorcontrib>Sepou, Abdoulaye</creatorcontrib><creatorcontrib>Tarral, Antoine</creatorcontrib><creatorcontrib>Tetimian, Djetodjide</creatorcontrib><creatorcontrib>Valverde, Olaf</creatorcontrib><creatorcontrib>Van Nieuwenhove, Simon</creatorcontrib><creatorcontrib>Strub-Wourgaft, Nathalie</creatorcontrib><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</title><title>Developing world bioethics</title><addtitle>Developing World Bioeth</addtitle><description>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.</description><subject>Africa</subject><subject>African trypanosomiasis</subject><subject>Antiprotozoal Agents - therapeutic use</subject><subject>Bioethics</subject><subject>Biomedical Research - ethics</subject><subject>clinical trials</subject><subject>Collaboration</subject><subject>Committees</subject><subject>Constraints</subject><subject>Developing Countries</subject><subject>Disease</subject><subject>Drugs</subject><subject>Ethical Review</subject><subject>Ethics</subject><subject>Experts</subject><subject>Humans</subject><subject>Implementation</subject><subject>informed consent</subject><subject>International</subject><subject>International Cooperation</subject><subject>international justice</subject><subject>International organizations</subject><subject>LDCs</subject><subject>Medical research</subject><subject>Nitroimidazoles - therapeutic use</subject><subject>Oversight</subject><subject>Public sector</subject><subject>research ethics</subject><subject>Reviews</subject><subject>Treatment programs</subject><subject>Trypanosomiasis</subject><subject>Trypanosomiasis, African - 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| identifier | ISSN: 1471-8731 |
| ispartof | Developing world bioethics, 2015-12, Vol.15 (3), p.241-247 |
| issn | 1471-8731 1471-8847 |
| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; PAIS Index |
| subjects | Africa African trypanosomiasis Antiprotozoal Agents - therapeutic use Bioethics Biomedical Research - ethics clinical trials Collaboration Committees Constraints Developing Countries Disease Drugs Ethical Review Ethics Experts Humans Implementation informed consent International International Cooperation international justice International organizations LDCs Medical research Nitroimidazoles - therapeutic use Oversight Public sector research ethics Reviews Treatment programs Trypanosomiasis Trypanosomiasis, African - drug therapy Vector-borne diseases |
| 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 |
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