{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T16:06:38Z","timestamp":1773158798550,"version":"3.50.1"},"reference-count":30,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2016,3,11]],"date-time":"2016-03-11T00:00:00Z","timestamp":1457654400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"DOI":"10.1371\/journal.pntd.0004531","type":"journal-article","created":{"date-parts":[[2016,3,11]],"date-time":"2016-03-11T18:31:33Z","timestamp":1457721093000},"page":"e0004531","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":19,"title":["Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment"],"prefix":"10.1371","volume":"10","author":[{"given":"Henok","family":"Negussie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Addissie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adamu","family":"Addissie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gail","family":"Davey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2016,3,11]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"1448","DOI":"10.1136\/bmj.313.7070.1448","article-title":"The Nuremberg Code (1947)","volume":"313","year":"1996","journal-title":"BMJ"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World medical association declaration of helsinki: Ethical principles for medical research involving human subjects","volume":"310","year":"2013","journal-title":"JAMA"},{"key":"ref3","article-title":"The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research","year":"1979"},{"key":"ref4","unstructured":"Council for International Organization of Medical Sciences (CIOMS):International Ethical Guidelines for Biomedical Research Involving Human Subjects. Avenue Appia 20, CH1211 Geneva 27, Switzerland: CIOMS, c\/o WHO: 2002."},{"key":"ref5","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH harmonized tripartite guideline. Guideline for good clinical practice E6. ICH 1996. <italic>Avialable<\/italic>: <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/wwwichorg\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R1_Guidelinepdf\" xlink:type=\"simple\">http:\/\/wwwichorg\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R1_Guidelinepdf<\/ext-link>"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"306","DOI":"10.1191\/1740774506cn150oa","article-title":"Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa","volume":"3","author":"MT Krosin","year":"2006","journal-title":"Clin Trials"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"186","DOI":"10.2471\/BLT.14.141390","article-title":"Participants\u2019 understanding of informed consent in clinical trials over three decades: systematic review and meta analysis","volume":"93","author":"NT Tam","year":"2015","journal-title":"Bull World Health Organ"},{"key":"ref8","first-page":"26","article-title":"Informed consent in an antiretroviral trial in Nigeria","volume":"4","author":"O Manafa","year":"2007","journal-title":"Indian J Med Ethics"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"e482","DOI":"10.1371\/journal.pntd.0000482","article-title":"Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting","volume":"3","author":"F Tekola","year":"2009","journal-title":"PLoS Negl Trop Dis"},{"key":"ref10","first-page":"33","article-title":"Developing Cultural Competence and Overcoming Ethical Challenges in the Informed Consent Process: An Experience from Egypt","volume":"39","author":"IA Abdel-Messih","year":"2008","journal-title":"Journal of Research Administration Fall"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"399","DOI":"10.1186\/1745-6215-15-399","article-title":"Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities","volume":"15","author":"P Bower","year":"2014","journal-title":"Trials"},{"key":"ref12","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/1472-6939-10-13","article-title":"Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study","volume":"10","author":"F Tekola","year":"2009","journal-title":"BMC Med Ethics"},{"key":"ref13","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1525\/jer.2012.7.1.37","article-title":"Tailoring information provision and consent processes to research contexts: the value of rapid assessments","volume":"7","author":"SJ Bull","year":"2012","journal-title":"J Empir Res Hum Res Ethics Int J"},{"key":"ref14","unstructured":"Bull SJ:Consent to research in a Gambian context: legal, social and ethical issues <italic>PhD Thesis Kings College<\/italic>, <italic>London<\/italic> 2007,"},{"issue":"Supp. 1","key":"ref15","article-title":"FEASIBILITY OF RAPID ETHICAL ASSESSMENT FOR THE ETHIOPIAN HEALTH RESEARCH ETHICS REVIEW SYSTEM","volume":"53","author":"A Addissie","year":"2015","journal-title":"Ethiop Med J"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1016\/0035-9203(76)90078-X","article-title":"The association of endemic elephantiasis of the lower legs in East Africa with soil derived from volcanic rocks","volume":"4","author":"EW Price","year":"1976","journal-title":"Transactions of the Royal Society of Tropical Medicine & Hygiene"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"148","DOI":"10.4269\/ajtmh.14-0446","article-title":"Epidemiology and individual, household and geographical risk factors of podoconiosis in Ethiopia: results from the first nationwide mapping","volume":"92","author":"K Deribe","year":"2015","journal-title":"Am J Trop Med Hyg"},{"key":"ref18","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1016\/j.trstmh.2009.07.021","article-title":"Health professionals&apos; attitudes and misconceptions regarding podoconiosis: potential impact on integration of care in southern Ethiopia","volume":"104","author":"B Yakob","year":"2010","journal-title":"Transactions of the Royal Society of Tropical Medicine & Hygiene"},{"key":"ref19","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1186\/s13063-015-0818-7","article-title":"Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial","volume":"16","author":"H Negussie","year":"2015","journal-title":"Trials"},{"key":"ref20","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1371\/journal.pntd.0001744","article-title":"Podoconiosis in East and West Gojam Zones, Northern Ethiopia","volume":"6","author":"YB Molla","year":"2012","journal-title":"PLoS Negl Trop Dis"},{"key":"ref21","unstructured":"Central Statistical Agency:Population and Houseing Census Report. CSA Addis Ababa Ethiopia, 2007."},{"key":"ref22","unstructured":"Federal Democratic Republic of Ethiopia:Health Sector Strategic Plan (HSDP-III) <italic>Planning and Programming Department<\/italic>, <italic>Federal Ministry of Health<\/italic>, <italic>Addis Ababa; 2009\/10<\/italic>"},{"key":"ref23","article-title":"Ethiopia Demographic and Health Survey (2011)","year":"2012"},{"key":"ref24","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1186\/1472-6939-15-35","article-title":"A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting","volume":"15","author":"A Addissie","year":"2014","journal-title":"BMC Medical Ethics"},{"key":"ref25","unstructured":"Denney L, Kassaye D:Securing communities for development: community policing in Ethiopia&apos;s Amhara National Regional State 2013,"},{"key":"ref26","first-page":"7","article-title":"Contextualizing the Informed Consent Process in Vaccine Trials in Developing Countries","volume":"4","author":"Y Saidu","year":"2013","journal-title":"Clinical Research & Bioethics"},{"key":"ref27","article-title":"The Ethics of Research Related to Healthcare in Developing Countries","year":"2002"},{"key":"ref28","unstructured":"(OPRS) OftPoRS:Informed Consent in Human Subjects Research. <italic>University of Southern California<\/italic>,<ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/oprsuscedu\/files\/2013\/04\/Informed-Consent-Booklet-4413pdf\" xlink:type=\"simple\">https:\/\/oprsuscedu\/files\/2013\/04\/Informed-Consent-Booklet-4413pdf<\/ext-link> 2013,"},{"key":"ref29","doi-asserted-by":"crossref","first-page":"1026","DOI":"10.1186\/1471-2458-14-1026","article-title":"Perceptions of consent, permission structures and approaches to the community: a rapid ethical assessment performed in North West Cameroon","volume":"14","author":"J Kengne-Ouafo","year":"2014","journal-title":"BMC Public Health"},{"key":"ref30","unstructured":"Commission USNBA:Ethical and policy issues in international research: clinical trials in developing countries: Volume I: Report and Recommendations of the National Bioethics Advisory Commission. 2001,"}],"container-title":["PLOS Neglected Tropical Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/dx.plos.org\/10.1371\/journal.pntd.0004531","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T12:46:18Z","timestamp":1589028378000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pntd.0004531"}},"subtitle":[],"editor":[{"given":"Patrick J.","family":"Lammie","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2016,3,11]]},"references-count":30,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2016,3,11]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pntd.0004531","relation":{},"ISSN":["1935-2735"],"issn-type":[{"value":"1935-2735","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,3,11]]}}}