Clinical trial ethics in Turkey in the context of some expectations and predictions


  • Nüket Örnek Büken Department of Medical Ethics, Hacettepe University, Faculty of Medicine, Ankara, Turkey



Clinical Trial, Ethics, Turkey, Biological Material of Human Origin


Why is so much attention now being given to the ethics of clinical trial? Why does debate continue over the ethics and regulation of research involving human subjects? Are there societal duties to support the conduct of clinical research? Why was this protocol good enough for X, or Y, or Z, but not good enough for this university or institution? What is the rationale for public bioethics? As shown even though all the rights and obligations of all parties of clinical trial – the researching physician, the volunteering patient, the industry, research institution-  have been assured with ethico-legal regulations, there still exist many problems in the world of clinical research, and suggestions of solutions to the said problems. It is obvious that medical trials on human beings, on the one hand, accelerate developments in medicine and offer benefits for the present and future generations, but on the other hand, they can lead to acts that may endanger human dignity and human value. The objective of this paper is to discuss the rights of human subjects  in clinical drug trials; to review the researcher-physician/subject-patients relationship from several aspects; to consider the dynamics which exist in this relation; and to reach some practical solutions that might be conveyed to the applications in the context of medical ethics in Turkey.


Büken NÖ. Büken E: The Legal Grounds Regarding Clinical Trial in Turkey. A Glimpse of National Legislation, Medicine and Law, December 2011.

Association of clinical research organisation. Available at

Globalization.pdf. Accessed on 12 January 2016.

Buken NO, Buken E. Uluslararası Araştırmalar, Araştırma Etiğinde Temel İkilemler ve Etik Kurullar. International Researches, Fundamental Dilemmas in Research Ethics and Ethics Committees, Sendrom (Syndrom). 2008;20(7-8):37–47.

UNESCO: Division of Ethics of Science and Technology. Establishing Bioethics Committees-Guide No 1 (In Turkish). Ankara, Turkey. Turkish National Commission for UNESCO; 2008.

UNESCO: Division of Ethics of Science and Technology. Educating Bioethics Committees, Guide No 3 (In Turkish). Ankara, Turkey. Turkish National Commission for UNESCO; 2010.

Buken NO, Buken E. The Rights Experimental of Subjects and Patients in Clinical Drug Researches. FABAD J Pharma Sci. 2002;27:173-85.

Buken NO, Buken E. Clinical Drug Research from Medical Ethics and Legal Perspectives. Türk Psikiyatri Dergisi. Turkish J Psych. 2003;14(4):289-99.

Clinical A service of the US National Institutes of Health. Available at https://clinicaltrials.

gov. Accessed on 12 January 2016.

Guide for Research Ethics Committee Members, Steering Committee on Bioethics CDBI, Strasbourg, February, 2011.

Council of Europe. Convention on Huma Rights on Biomedicine- Oviedo, 4.IV.1997. Available at

ices/DisplayDCTMContent?documentId=090000168007cf98. Accessed on 10 February 2016.

Council of Europe Committee of Ministers, Recommendation Rec-2006. Available at Accessed on 10 January 2016.

Vanderpool HY. Introduction and overview; ethics, historical case studies and the research enterprise. In: Vanderpool HY, editor. The Ethics of Research Involving Human Subjects. Maryland: Univ. Publishing Group; 1996: 1-18.

Buken NO. Turkey's Position Regarding Clinical Drug Trials. Clinical Research and Regulatory Affairs. 2003;20(3):349-55.






Review Articles