ANALYSIS OF THE NEW REGULATORY BIOETHICAL REVIEW FRAMEWORK FOR CLINICAL TRIALS IN TURKEY.

We conducted a descriptive study of the existing research ethics committee (REC) review structure in Turkey with respect to clinical trials and discuss what can be expected in the future under the new regulation that came into effect in April 2013. We identified 78 RECs in Turkey under the Ministry of Health (MOH) as of September 2012, categorised under geographic location, type and institution. We identified REC member lists from the MOH in the same month and further characterize them under: membership number, gender, and speciality. MOH, universities, national nongovernmental organizations such as the Turkish Medical Association and the Turkish Bioethics Association, as well as clinical research and pharmaceutical bodies are intensively interested in the enhancement of the current system of research ethics review in the country. The European Union and Council directives have been important sources that have guided new developments. Proper evaluation of the existing system and introduction of new regulatory framework are expected to further clarify the obstacles and offer opportunities for institutions, researchers, REC members and administrators.