AI Summary & Key Takeaways
AI InsightIn this work, the role of the ethical committee in the supervision of experiments on humans has been examined, from permission stage to its completion.
📌 3 Key Takeaways
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 Te 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.
Özet
Klinik araştırmalarda laboratuvar çalışmalarının sonuçlanmasını takiben hayvan üzerinde deney aşamasına geçilmektedir. Bu aşamanın olumlu sonuçlar vermesini takiben hasta ve/ veya gönüllü denekler üzerinde deneyler başlar. Hayvan ve insan üzerindeki deneylerin etik ilkelere ve hukuka uygunluğu etik kurullar tarafından denetlenir. Yeni Klinik Araştırmalar Hakkında Yönetmelik 2011 yılının Ağustos ayında yürürlüğe girmiştir. Bu düzenleme AB uygulamalarına paralel hazırlanmıştır. Yönetmelik klinik araştırma gönüllü ve etik kurul ekseni üzerinde hazırlanmıştır. Bu çalışmada insan üzerindeki deney ve denemelerde denetleme görevi yapan etik kurullar ele alınacaktır.