Klinik Araştırmalar Yönetmeliği’ne Bakış

Authors : Cumhur İZGİ, Yeşim Işıl ÜLMAN

Pages : 161-167

View : 29 | Download : 19

Publication Date : 2013-12-01

Article Type : Other Papers

Abstract :The history of clinical research on human subjects, which created the opportunity for the current scientific achievements in medicine, has a longstanding past. However, this period of time has witnessed numerous examples that cost human life, such as war crimes and withdrawal of due treatment. In order not to experience those horrible events anymore, and to regain confidence of the society, clinical research has been structured all over again. The establishment of multidisciplinary ethics committees meant to safeguard volunteer rights for granted by necessitating the ethical evaluation of a research project prior to its initiation. The first legal text in Turkey, regulating clinical research specifically on human volunteers ever was the “Regulation on Pharmaceutical Researches” issued in 1993. Yet this regulation proved to be inadequate to enact the actual needs of clinical research and it was renewed two times in 2008 and 2011. Nevertheless, the Regulation was amended once again on April 13, 2013, which caused critical debates due to its controversial content. The reason lies in the fact that the natural stakeholders, such as the representatives of the health professional institutions, medical specialty societies, bioethics institutions are not incorporated enough into the process of preparation and legislation; and it is mostly left to the bureaucratic authorities outside the academy. This ultimately causes lack of due attention requisite to development of ethical awareness of healthcare professionals and all the parties concerned. This paper aims to evaluate the latest Regulation and to emphasize the role of ethics committees as an ideal academic ground by functioning multidisciplinary, which is needed for a pluralistic and participatory democratic society guided by the universal values and human rights law
Keywords : ethics committees, research ethics, clinical research, volunteers