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:

  1. In Turkey ethics education for researchers is far from being adequate. There are a few certificate programs for ethics committee members, but when taking the dimensions of research endeavor for the entire country into consideration, it is not adequate either. Without a comprehensive research ethics education, any kind of regulation, whether restraining or more permissive, is subject to be ineffective.
  1. The relationship between the government and the university is a little complex in Turkey, when biomedical research is in question. The Ministry of Health is the central regulating body and the major employer for the medical professionals. It is also the legislator who put statutes on research ethics into force and execute the follow-up. All the ethics committees in the country are either directly or indirectly depended on the Ministry. On the other hand, universities in Turkey are claimed to be autonomous in their scientific endeavor and they are the main medium of biomedical research. With the last legislation, the Ministry of Health came into a position which controls the universities scientific activities. According to Turkish Bioethics Association, it is against the autonomy of the university and unacceptable. In addition, Ministry of Health has no legal right to apply sanctions on the university members, so the legal outcomes of unethical research remain uncovered. 
  1. The new Statute authorizes the supporter, which is mostly a drug company in Turkey, to apply to ethics committee. As the ethics committees are located at the universities and application for a biomedical research is generally directed to the ethics committee at the university where it will be executed, an ethically doubtful situation exists. Ethics committees have to address drug companies instead of researchers, who are their actual staff.
  1. The number of bioethicists and medical ethicists is not enough to take part in all the ethics committees. According to the Statute,  member of an ethics committee can not participate in another one.  As a natural consequence there are ethics committees without any ethicists or any professional with legitimate ethics education on board. The backfires of this situation were mentioned and real life examples were provided by the members of our Association.    

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