TY  - JOUR
TI  - Standardizing Decision-Making Processes in Institutional Review Boards in Accordance with International Guidelines and Turkish Regulations
AB  - 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.
AU  - ekmekci, perihan elif
AU  - Güner, Müberra Devrim
PY  - 2018
JO  - Türkiye Klinikleri Tıp Etiği-Hukuku Tarihi Dergisi
VL  - 26
IS  - 1
SN  - 1303-4332
SP  - 6
EP  - 22
DB  - TRDizin
UR  - http://search/yayin/detay/293644
ER  -