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

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.