Is Ethics Approval Necessary for all Trials? A Clear But Not Certain Process

All researchers want to do well planned study and their trial to be published and globally read. However, most of researchers feel there is generally a lack of guidance on how to prepare good papers and what the rules of ethics at the beginning of study. Thus, they seek to learn medical publication rules and find out the advices of the Helsinki Declaration which is prepared in line with WHO policies and also guidelines on publication ethics (international and /or national) (1-7). They define that good planning, design, management of the study and safely recording of all study data are main principles for good publication. Looking at good publication principles in detail, ethics approval and informed consent seem to be as important beginning procedures for a study. The Helsinki Declaration, lastly published on Oct 2008, declares that ethical approval for all interventional studies is required (1,2) and the Committee on Publication Ethics (COPE) provides valuable advices to researchers on publication ethics (3). Here, ethics approval will be mainly discussed rather than informed consent because of some confusions arising due to ethics directives recently published in our country (4,5). The requirement for ethics approval during submission to publish is depended on the local and international publication guidelines, some international and national journals ask it for all submitting papers, even retrospective studies, but some of them not. Many journals generally present to authors whether ethics approval is necessary or not. However, sometimes clear explanation cannot be achieved and authors raised the question which frequently occurs for the retrospective studies and case reports. In this paper, we wish to discuss this controversial issue and to share last codes published by government in our country and international guidelines such as Consolidated Standards of Reporting Trials (CONSORT) and Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) which state the ethical principles in the conduct and reporting of research and provide recommendations relating to specific parts of publishing (6,7).