Please use this identifier to cite or link to this item: https://hdl.handle.net/20.500.11851/1871
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dc.contributor.authorEkmekci, Perihan Elif-
dc.date.accessioned2019-07-10T14:39:33Z-
dc.date.available2019-07-10T14:39:33Z-
dc.date.issued2016-12-
dc.identifier.citationEkmekci, P. E. (2016). Main ethical breaches in multicenter clinical trials regulations of turkey. Medicine and Law, 35(4), 491-508. Retrieved from www.scopus.comen_US
dc.identifier.issn0723-1393-
dc.identifier.urihttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5370078/-
dc.identifier.urihttps://hdl.handle.net/20.500.11851/1871-
dc.description.abstractTurkey has been a growing market for multicenter clinical trials for the last ten years and is considered among the top ten countries in terms of potential study subject populations. The objective of increasing the share of Turkey in multicenter clinical trials is strongly supported. This ambitious goal of Turkey raises the need to have regulations in compliance with other leading countries conducting clinical trials. The latest published Turkish regulations on clinical trials are structured in compliance with the International Conference on Harmonization (ICH) Guidelines and in harmony with the regulations of other leading countries in clinical research, such as the US. There are still flaws in Turkish regulation with the risk of violating human subjects' rights and issues with responsible conduct of research. The aim of this article is to compare Turkish clinical trials regulations with those of the US, to determine if there exists any incompatibility between the countries' regulations and, if so, how to ameliorate these. The main flaws in Turkish clinical trials regulations are identified as follows: lack of definition of the term "human subject; absence of explicit referral to the unacceptability of Conflict of Interest (COI) and taking measures to avoid it; exiguity of emphasis on plurality of the IRB members; nonexistence of a clear expression that this is research; and clinical equipoise, regarding the treatment of the existing clinical problem and lack of integration with international accreditation systems for Institutional Review Boards.en_US
dc.language.isoenen_US
dc.publisherYozmol Heiligeren_US
dc.relation.ispartofMedicine and Lawen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectClinical Trialsen_US
dc.subjectRegulationsen_US
dc.subjectMulticenteren_US
dc.subjectInstitutional Review Boarden_US
dc.subjectResearch Ethics Committeeen_US
dc.subjectTurkeyen_US
dc.titleMain Ethical Breaches in Multicenter Clinical Trials Regulations of Turkeyen_US
dc.typeArticleen_US
dc.departmentFaculties, School of Medicine, Department of Basic Medical Sciencesen_US
dc.departmentFakülteler, Tıp Fakültesi, Temel Tıp Bilimleri Bölümütr_TR
dc.identifier.volume35-
dc.identifier.issue4-
dc.identifier.startpage491-
dc.identifier.endpage508-
dc.authorid0000-0002-0777-3861-
dc.identifier.wosWOS:000447800100002en_US
dc.identifier.scopus2-s2.0-85028684325en_US
dc.institutionauthorEkmekci, Perihan Elif-
dc.identifier.pmid28360454en_US
dc.authorwosidO-7742-2016-
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.relation.otherFIC NIH HHS [R25 TW009248]en_US
dc.identifier.scopusqualityQ3-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.languageiso639-1en-
item.openairetypeArticle-
item.cerifentitytypePublications-
crisitem.author.dept03.14. Department of Internal Medicine-
Appears in Collections:PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection
Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection
Temel Tıp Bilimleri Bölümü / Department of Basic Medical Sciences
WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection
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