{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T13:43:23Z","timestamp":1762004603806},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2014,7,14]],"date-time":"2014-07-14T00:00:00Z","timestamp":1405296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Developing World Bioethics"],"published-print":{"date-parts":[[2015,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 (<jats:styled-content style=\"fixed-case\">DNDi<\/jats:styled-content>), 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 <jats:styled-content style=\"fixed-case\">A<\/jats:styled-content>frican Trypanosomiasis (<jats:styled-content style=\"fixed-case\">HAT<\/jats:styled-content>). The project involved the implementation of a novel \u2018pre\u2010review\u2019 process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from <jats:styled-content style=\"fixed-case\">A<\/jats:styled-content>frican and <jats:styled-content style=\"fixed-case\">E<\/jats:styled-content>uropean countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.<\/jats:p>","DOI":"10.1111\/dewb.12068","type":"journal-article","created":{"date-parts":[[2014,7,15]],"date-time":"2014-07-15T17:01:55Z","timestamp":1405443715000},"page":"241-247","source":"Crossref","is-referenced-by-count":9,"title":["Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative \u2018Pre\u2010Review\u2019 Mechanism for a Study of Fexinidazole for Human <scp>A<\/scp>frican Trypanosomiasis"],"prefix":"10.1111","volume":"15","author":[{"given":"Carl H.","family":"Coleman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chantal","family":"Ardiot","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00e9verine","family":"Blesson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yves","family":"Bonnin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francois","family":"Bompart","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Colonna","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ames","family":"Dhai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julius","family":"Ecuru","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Edielu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Herv\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fran\u00e7ois","family":"Hirsch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bocar","family":"Kouyat\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie\u2010France","family":"Mamzer\u2010Bruneel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dionko","family":"Maound\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Martinent","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Honor\u00e9","family":"Ntsiba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G\u00e9rard","family":"Pel\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gilles","family":"Qu\u00e9va","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie\u2010Christine","family":"Reinmund","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samba Cor","family":"Sarr","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdoulaye","family":"Sepou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antoine","family":"Tarral","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Djetodjide","family":"Tetimian","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olaf","family":"Valverde","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Van Nieuwenhove","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathalie","family":"Strub\u2010Wourgaft","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,7,14]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"xi","volume-title":"Standards and Operational Guidance for Ethics Review of Health\u2010Related Research with Human Participants","author":"World Health Organization (WHO)","year":"2011"},{"key":"e_1_2_7_3_1","unstructured":"14"},{"key":"e_1_2_7_3_2","unstructured":"World Medical Association 2008.Declaration of Helsinki.Available at:http:\/\/www.wma.net\/en\/30publications\/10policies\/b3\/ [Accessed 16 May 2014];"},{"key":"e_1_2_7_3_3","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.Good Clinical Practice. Available at:http:\/\/ichgcp.net\/[Accessed 16 May2014]."},{"key":"e_1_2_7_4_1","first-page":"107","volume-title":"The Ethics of Research Related to Healthcare in Developing Countries","author":"Nuffield Council on Bioethics","year":"2002"},{"key":"e_1_2_7_5_1","first-page":"5","volume-title":"Registering New Drugs: The African Context","author":"The George Institute for International Health","year":"2010"},{"key":"e_1_2_7_6_1","first-page":"771","article-title":"Beyond Informed Consent","volume":"72","author":"Bhutta Z.A.","year":"2004","journal-title":"Bull World Health Org"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1086\/381709"},{"key":"e_1_2_7_8_1","unstructured":"Networking for Ethics on Biomedical Research in Africa (NEBRA).2006.Final Report. Available at:http:\/\/elearning.trree.org\/file.php\/1\/NebraReport\/FinalReport\u20102006\u2010english.pdf[Accessed 16 May 2014]."},{"key":"e_1_2_7_9_1","unstructured":"E.g.European and Developing Countries Clinical Trials Partnership.Ethics Review Boards. Available at:http:\/\/www.edctp.org\/?id=659[Accessed 16 May2014]."},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040003"},{"key":"e_1_2_7_11_1","unstructured":"Ibid."},{"key":"e_1_2_7_12_1","unstructured":"Drugs for Neglected Diseases Initiative (DNDi).Human African Trypanosomiasis: Global View. Available at:http:\/\/www.dndi.org\/diseases\u2010projects\/diseases\/hat.html. [Accessed 16 May2014]."},{"key":"e_1_2_7_13_1","unstructured":"Further information about the study is available atClinicalTrials.gov available at:http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01685827?term=fexinidazole&rank=3. 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