Ethical Practices for Health Research in the Eastern Mediterranean Region of the World Health Organization A Retrospective Data Analysis 英文参考文献.docVIP

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Ethical Practices for Health Research in the Eastern Mediterranean Region of the World Health Organization A Retrospective Data Analysis 英文参考文献.doc

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Ethical Practices for Health Research in the Eastern Mediterranean Region of the World Health Organization A Retrospective Data Analysis 英文参考文献

EthicalPracticesforHealthResearchintheEastern MediterraneanRegionoftheWorldHealthOrganization: ARetrospectiveDataAnalysis MohammadAbdurRab1,MohammadAfzal2,AlaaAbou-Zeid2,HenrySilverman3* 1Country Office, World Health Organization (WHO), Khartoum, Sudan, 2Eastern Mediterranean Regional Office, Research Policy and Cooperation Unit, World Health Organization(WHO),Cairo,Egypt,3UniversityofMarylandSchoolofMedicine,Baltimore,Maryland,UnitedStatesofAmerica Abstract Background:Commentatorshaveexpressedconcernregardingtheexistenceofproperethicsreviewsystemsindeveloping countries. Our aim is to explore the extent with which investigators from countries in the Eastern Mediterranean (EM) Regionconsiderseveralethicalpracticesintheconductoftheirresearch. Methodology/Principal Findings: Investigators from 12 countries in the EM region submitted 143 proposals involving PublicHealthandBiotechnologyGenomicstoagrantschemefundedbytheEasternMediterraneanRegionalOfficeofthe WHOandtheOrganizationofIslamicConferenceStandingCommitteeforScienceandTechnologicalCooperationin2006. Thegrantapplicationincludeda1questionnairethataskedinvestigators1)whetherethicalclearancewasobtained, 2)whethertheyplantoobtaininformedconsent,and3)whetherconfidentialityofhumansubjectdatawouldbeensured. Themethodologiesofthesubmittedresearcheswerecategorizedastowhetheritinvolved1)humansubjectresearch(e.g., theprospective collection ofbiological specimens or theperformance of qualitative research), 2) research thatcould be exempt from ongoing ethics review, and 3) research not involving human subjects. A descriptive analysis was used to analyzetheinvestigators’responsesandachi-squareanalysiswasusedtoanalyzecategoricalvariables.Ofthe79submitted proposalsdeterminedtoinvolve‘‘humansubjects’’,ethicalclearancewasnotobtainedin29%;investigatorsthoughtthat informedconsentwasnotneededin29%;andinvestigatorsdidnotmentionthattheywouldensureconfidentialityofthe obtaineddatain8%ofthestudies.Themagnitudeofthesedeficiencieswassimilar