International Journal of Clinical Trials | October-December 2016 | Vol 3 | Issue 4 Page 180
International Journal of Clinical Trials
Buken NO. Int J Clin Trials. 2016 Nov;3(4):180-186
http://www.ijclinicaltrials.com pISSN 2349-3240 | eISSN 2349-3259
Review Article
Clinical trial ethics in Turkey in the context of some
expectations and predictions
Nuket Ornek Buken*
INTRODUCTION
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 out 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
ABSTRACT
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.
Keywords: Clinical trial, Ethics, Turkey, Biological material of human origin
Department of Medical Ethics, Hacettepe University, Faculty of Medicine, Ankara, Turkey
Received: 10 August 2016
Accepted: 10 September 2016
*Correspondence:
Dr. Nuket Ornek Buken,
E-mail: nuketbuken@hotmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: http://dx.doi.org/10.18203/2349-3259.ijct20163954