THE EVOLUTION OF RESEARCH ETHICS IN TURKEY AND TURKISH BIOETHICS ASSOCIATION’S PERSPECTIVES
The necessity for ethics education and regulations on research activities was continuously stated by bioethicists in Turkey for more then a decade, starting from 1980. Although the Medical Deontology Charter which was issued in 1960, has mentioned research on patients to a certain extent; its main concern was regulating the relation between research and treatment. The very first legal document on research ethics in the modern sense in Turkey was issued in 1993, namely Statute on Drug Research. The Statute’s scope was limited to drug research and short after coming into force serious criticisms were directed to it. After numerous unsuccessful efforts to enhance the scope and the ethical competence of the Statute, an overall renovation was realized on the regulations of medical research in 2009. This year the Statute is revised according to the pressures put on the legislator by drug industry.
The last revision on the legislation mainly reduced the time allocated for ethical assessment of research protocols, broadened the set of exempted research and left the research on the biological specimens out of the scope of the Statute. One of the criticisms towards the new regulation is that it leaves huge pitfalls for unethical conducts while trying to shorten the time for ethical analysis. Another serious issue which raised with the last version of the Statute is that, there are no regulation for the recruitment of the biological specimens for research purposes anymore in Turkey.
The new legislation was widely discussed on the Turkish Bioethics Association’s online network Bioethics Platform. Some of the main topics from the correspondence is as follows:
These criticisms and some others were listed by the Board of Directors of the Association and brought to the attention of the legislator. We are looking forward receiving some feedback. In Turkey, it takes time to revise and change the legal texts, especially when they come into force.
The ethics education and regulations about the research involving animals has been much more competently executed in Turkey. The first ethics committee for animal research was established in 1996. The Statute on the Working Procedures and Principles of Animal Research Ethics Committees was issued in 2006. This Statute obliged researchers to attend to and receive a certificate from a specific program on animal research which provides ethics education on the relevant field as well as theoretical and practical education. We hope that biomedical research on human subjects will reach to the ethically justifiable level of animal research, despite all the pressures and conflicts of interests.
Neyyire Yasemin YALIM M.D., Ph.D.
Professor of Bioethics at Ankara University Faculty of Medicine Department of Medical History and Ethics
President of the Turkish Bioethics Association