Nüket ÖRNEK BÜKEN*,o, Erhan BÜKEN**

*Hacettepe University, Faculty of Medicin Department of Deontology, 06100Ankara, TURKEY. **Başkent Üniversitesi, Tıp Fakültesi, Adli Tıp Anabilim Dalı, Eskişehir Yolu 20. Km. Bağlıca kampusü, Ankara, TURKEY.
oCorresponding author

Summary:
It is a reality that the ethical problems existing in scientific research, particularly in biomedical research, can reach considerable limits. In order to be acceptable at an international level, the related ethical principles as well as the harmonization of methodology and semantics, must be specified in scientific research activities. In various countries in which the production of scientific knowledge has become possible, the existence of different cultural characteristics can be observed. Nevertheless, to whatever extent their culture and the level of their social and economic development may differ from each other, there should be “universal ethical principles” which would be binding for scientists living in different geographies. In medical research activities, accordingly, the concept of “universality” has come to the fore in recent times. And there is a need now for a consensus about the fundamental values, which govern these activities. Only in such a way would it be possible to have common ethical principles in terms of research carried out in different countries. In clinical drug trials in medicine, the principal element is the human component. This concept covers the investigator himself as well as the patient-subject, who is the research material. The aim of the biomedical research involving human subjects is to develop the diagnostic, therapeutic and/or preventive procedures or to explain the etiology and pathogenesis of disease. This research may involve the diagnosis and treatment of a patient; or may be carried our on experimental subject solely for pure scientific purposes. Thus, while the patient in the first category is both an object or end and a means or tool, the experimental subject in the latter is only. In clinical drug trials, to distinguish between the ends and means thus becomes of utmost significance from an ethical point of view. And the limits of the rights of the voluntary health subjects become more comprehensive.
The physician involved in drug trials on patients is not just a physician but a researcher-physician. And it is due to this role that he becomes the subject of the Declaration of Helsinki, of the guide for “Good Clinical Practice”, and national and international regulations as regards drug trials. The activities of the physician, governed by the rules therein, stem for his identification and role as a “researcher”, with no ensuing intervention with his function as a physician. And whether his research is therapy-oriented or not, a medical doctor conducting a clinical drug trial should not consider himself as a physician with his “ordinary” function. Nor should a patient presume that the research or trial activity is integrated part of his treatment; otherwise, his decision, made upon such a consideration, and his informed consent given accordingly, will be invalid.

Keywords:
Experimental subjects rights, Patient’s rights, Clinical drug trials, Medical ethics