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Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations

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dc.contributor.author Ekmekci, Perihan Elif
dc.contributor.author Güner, Müberra Devrim
dc.date.accessioned 2019-12-30T07:28:20Z
dc.date.available 2019-12-30T07:28:20Z
dc.date.issued 2018
dc.identifier.citation EKMEKCİ, P. E., & GÜNER, M. D. (2018). Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. Turkiye Klinikleri Journal of Medical Ethics-Law and History, 26(1), 6-22 en_US
dc.identifier.issn 1303-4332
dc.identifier.uri http://www.trdizin.gov.tr/publication/paper/detail/TWprek5qUTBOQT09
dc.identifier.uri http://hdl.handle.net/20.500.11851/3251
dc.description.abstract All research on human subjects should go through objective and independent ethical review. However, there are huge inconsistencies in the decisions of the review boards, which lead the investigators to question the validity and the objectivity of the decisions. We aim to develop a standard evaluation tool to regulate the ethical decision-making process for the board members’ review and to minimize the effect of subjective factors. All international and national guidelines on clinical research ethics were reviewed and relevant criteria identified to prepare a comprehensive evaluation tool. Turkish laws and legislations regarding clinical research were also evaluated in order not to exclude any item that will affect the well-being of human subjects and investigators’ conduct of clinical research. Ethical evaluation criteria are grouped under six headlines, and Turk- ish Ethical Evaluation of Clinical Research Protocols on Human Participants Sheet (TR-EGES) was developed and is offered for use by Institutional Review Boards as a general template for decision- making process. TR-EGES will ensure that all issues in national and international documents and guidelines are covered before reaching a conclusion for the proposed research protocol and will make the decision-making process as rational and standard as possible. en_US
dc.language.iso eng en_US
dc.rights info:eu-repo/semantics/openAccess
dc.subject Clinical research en_US
dc.subject institutional review boards en_US
dc.subject research ethics en_US
dc.subject ethics committee en_US
dc.subject human subjects en_US
dc.subject standardization of ethical review criteria en_US
dc.title Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations en_US
dc.type article en_US
dc.relation.journal Turkiye Klinikleri Journal of Medical Ethics-Law and History en_US
dc.relation.journal Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi tr_TR
dc.contributor.department TOBB ETÜ, Tıp Fakültesi, Temel Tıp Bilimleri Bölümü tr_TR
dc.contributor.department TOBB ETU, Faculty of Medicine, Department of Basic Medical Sciences en_US
dc.identifier.volume 26
dc.identifier.issue 1
dc.identifier.startpage 6
dc.identifier.endpage 22
dc.contributor.tobbetuauthor Ekmekci, Perihan Elif
dc.contributor.tobbetuauthor Güner, Müberra Devrim
dc.identifier.doi 10.5336/mdethic.2017-58536
dc.contributor.wosresearcherID O-7742-2016
dc.contributor.wosresearcherID Q-1305-2015
dc.relation.publicationcategory Makale - Ulusal Hakemli Dergi - Kurum Öğretim Elemanı tr_TR
dc.identifier.TRDizin https://trdizin.gov.tr/publication/paper/detail/TWprek5qUTBOQT09


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