Inconsistencies in institutional review board decisions: A proposal to regulate the decision-making process

Abstract

Medical sciences and medical technologies are developing in an enormous pace. The number of multi-site and multi- cultural clinical trials is increasing in line with this development. Yet, the increase in number brought about a problem, namely that of inconsistencies in institutional review board (IRB) decisions. The efforts to develop a comprehensive and systematic framework for the decision-making procedure of IRB members were ineffective and ended up in form of lists containing general principles of research ethics. The increase in multi-site, multi-cultural clinical research together with the initiation of new institutional review boards in countries involved in these researches emphasize the importance of defining the sine qua non criteria for considering a proposed research study to be ethical, as well as for avoiding inconsistencies in institutional review board decisions. The aim of this study is to prepare a toolkit for IRB members to regulate the ethical decision-making process while minimizing inconsistencies in institutional review board decisions. The objective is to minimize the effect of subjective factors and to ensure that all issues in key international documents and guidelines are covered prior to the point of reaching a conclusion for the proposed research protocol. By providing a comprehensive review of the Declaration of Helsinki, Council For International Organizations of Medical Sciences Guidelines, International Conference on Harmonization Guidelines, Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants of World Health Organization, and Medical Ethics Manual of the World Medical Association, this study aims at developing a standard evaluation sheet for institutional review board members to evaluate the ethical appropriateness of proposed trial protocols (Tab. 1, Ref. 35). Keywords: clinical research, ethics review committee, human subjects, informed consent, institutional review board, research ethics.