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

ekmekci, perihan elif; Güner, Müberra Devrim

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

Perihan Elif EKMEKCİ, (TOBB Economy and Technology University Faculty of Medicine, Department of History of Medicine and Ethics, Ankara, TURKEY)

Müberra Devrim GÜNER (TOBB Economy and Technology University Faculty of Medicine, Department of Medical Pharmacology, Ankara, TURKEY)

Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi

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Yıl: 2018 Cilt: 26 Sayı: 1 Sayfa Aralığı: 6 - 22 Metin Dili: İngilizce İndeks Tarihi: 21-03-2019

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

Öz:

All research on human subjects should go through objective and independent ethicalreview. However, there are huge inconsistencies in the decisions of the review boards, which leadthe investigators to question the validity and the objectivity of the decisions. We aim to develop astandard 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 onclinical research ethics were reviewed and relevant criteria identified to prepare a comprehensiveevaluation tool. Turkish laws and legislations regarding clinical research were also evaluated inorder 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) wasdeveloped 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 andguidelines are covered before reaching a conclusion for the proposed research protocol and willmake the decision-making process as rational and standard as possible.

Anahtar Kelime:

Konular: Tıbbi Etik Bilim Felsefesi ve Tarihi

Uluslararası Rehberler ve Türk Mevzuatı Çerçevesinde Klinik Araştırmalar Etik Kurullarında Karar Verme Sürecinin Standardizasyonu

Öz:

Gönüllü katılımcılar üzerinde yapılan klinik araştırmalar, araştırmaya başlanmadan önce ob- jektif ve bağımsız klinik araştırmalar etik kurulları tarafından değerlendirilmektedir. Ancak, etik kurul kararlarındaki tutarsızlıklar araştırmacıların kurul kararlarının geçerliliği ve objektifliğini sorgulamalarına yol açmaktadır. Bu çalışmanın amacı, standart bir değerlendirme aracı geliştirerek etik kurul üyelerinin karar verme sürecini düzenlemek ve verilen kararlarda sübjektif faktörlerin etkisini en aza indirgemektir. Kapsamlı bir değerlendirme aracı oluşturmak üzere insan denekler üzerinde yapılan araştırmalar ile ilgili uluslararası rehberler ve yönergeler incelenmiş ve değerlen- dirmeye alınması gereken kriterler belirlenmiştir. Daha sonra, belirlenmiş kriterler klinik araştır- malara ilişkin Türk mevzuatı ile uyumlu olacak şekilde revize edilmiştir. Klinik araştırmalar etik kurul üyelerinin araştırma protokolünü değerlendirirken incelemeleri gereken kriterler altı başlık altında toplanmış ve etik kurul üyelerinin kullanımına sunulmuştur. Bu değerlendirme aracının kullanılması, etik kurul kararlarının verilmeden önce geçerli uluslararası ve ulusal mevzuatta yer alan tüm maddeler uyarınca gözden geçirilmiş olmasını sağlayacaktır.

Anahtar Kelime:

Konular: Tıbbi Etik Bilim Felsefesi ve Tarihi

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık

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APA	ekmekci p, Güner M (2018). Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. , 6 - 22.
Chicago	ekmekci perihan elif,Güner Müberra Devrim Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. (2018): 6 - 22.
MLA	ekmekci perihan elif,Güner Müberra Devrim Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. , 2018, ss.6 - 22.
AMA	ekmekci p,Güner M Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. . 2018; 6 - 22.
Vancouver	ekmekci p,Güner M Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. . 2018; 6 - 22.
IEEE	ekmekci p,Güner M "Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations." , ss.6 - 22, 2018.
ISNAD	ekmekci, perihan elif - Güner, Müberra Devrim. "Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations". (2018), 6-22.

APA	ekmekci p, Güner M (2018). Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi, 26(1), 6 - 22.
Chicago	ekmekci perihan elif,Güner Müberra Devrim Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi 26, no.1 (2018): 6 - 22.
MLA	ekmekci perihan elif,Güner Müberra Devrim Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi, vol.26, no.1, 2018, ss.6 - 22.
AMA	ekmekci p,Güner M Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi. 2018; 26(1): 6 - 22.
Vancouver	ekmekci p,Güner M Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations. Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi. 2018; 26(1): 6 - 22.
IEEE	ekmekci p,Güner M "Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations." Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi, 26, ss.6 - 22, 2018.
ISNAD	ekmekci, perihan elif - Güner, Müberra Devrim. "Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations". Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi 26/1 (2018), 6-22.