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(1) Documents provided by the Ministry are in Turkish. No official English translation is available. Unofficial English translations could be provided by Turkish Clinical Research Infrastructure Network (TUCRIN - tucrin.deu.edu.tr) upon request.

(2) An ethics committee is defined as 'a body established with the approval of the Agency to protect the rights, safety and wellbeing of human subjects by, among other things, expressing their scientific and ethical opinion on the methods and documents to be used to inform trial subjects and obtain their informed consent' (Regulation on Clinical Trials of Medicinal and Biological Products 2014).

Clinical Trial Ethics Committees whose structure, operating principles and procedures have been set out in the Regulation on Clinical Trials of Medicinal and Biological Products and who have taken approval from the Agency shall evaluate all the medical device clinical investigations that are subject to the provisions of the Regulation On Medical Device Clinical Trials. No separate ethics committee shall be constituted to evaluate the medical device clinical investigations.

In addition to the relevant provisions in the Regulation on Clinical Trials of Medicinal and Biological Products, the specialized persons or consultants in the relevant branch or in side branches from whom written opinion is taken by ethics committees may not be elected from amongst the persons who take part in the investigated research.

A standard operating procedure for ECs is available (Standard Operating Procedure for Clinical Trials and Bioavailability-Bioequivalence Studies 2014).