Author/Authors :
SOMER, Pervin Medipol Üniversitesi - Hukuk Fakültesi - Medeni Hukuk Anabilim Dalı, Turkey , VATANOĞLU, E. Elif Yeditepe Üniversitesi - Tıp Fakültesi, Turkey
Title Of Article :
Ethics Committees Within The Scope of the Regulation of Clinical Research
شماره ركورد :
20739
Abstract :
The first step to the research in order to promote scientific development and to generate knowledge in the field of medicine is laboratory research. After this step, there are experiments on animals. If this result is positive, we start experimenting on humans. Both experiments on animals and humans are supervised by the ethical committee according to laws and ethical principles. By its purpose and scope, the new Regulation on Clinical Research, which has entered into force in August 2011, brings out regulations parallel with the European Union Practices and it also fills an important gap about the issue. However, like seen on most of the similar regulations and legislations, there are found loopholes among the articles which have been adopted by means of translation and it is probable that some legal and ethical problems may occur because of the conspicuous deficiencies. As a matter of course, the Regulation has been based on the relationship between “the clinical research”, “the volunteer” and “The Ethical Committee”. In this work, the role of the ethical committee in the supervision of experiments on humans has been examined, from permission stage to its completion.
From Page :
381
NaturalLanguageKeyword :
Ethical Committee , Clinical research , Experiment , Clinical research advisory committee
JournalTitle :
Hukuk Araştırmaları Dergisi
To Page :
396
Link To Document :
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