Ethics Committee
25 Haziran 2020

Ankara Keçiören Educational Research Hospital Clinical Research Ethics Committee, T.C. The Ministry of Health published in the Official Gazette No. 28617 dated April 13, 2013, under the regulation on Clinical Research, T.C. Ministry of Health Turkish medicines and medical devices Authority 22 / 12 / 2011 it was established with the date and approval of No. 100623. T.C. Ministry of Health Turkish medicines and Medical Devices Agency "published by the Ethics Committee standard operating Method according to the principles of pursuing his studies, kecioren training and Research Hospital Clinical Research Ethics Committee of our hospital and from other institutions need to be made from the application to bioavailability and bioequivalence (BA/BE) studies for biosimilar products, cosmetic products or raw materials, except for the drugs and preparations be made with the authorization or consent has been obtained, even if any medicine interventional clinical research on humans (Phase I, Phase II, Phase III and Phase IV), observational studies observational studies medical device; Medical Devices, advanced therapy medicinal products, traditional herbal medicinal products, including products that may be subject to testing in humans and clinical studies on humans to be done all other materials to be made with stem cell research, organ and tissue transplantation research, considers the scientific and ethical aspects of Surgical Research and gene therapy research.

Researchers who wish to study in any of the areas mentioned above should submit their files prepared according to the 'Ethics Committee Application Form' reported on our website to the Secretariat of the Ethics Committee.

Applications made up to at least five business days before the meeting date are placed on the agenda of the next week's meeting. The missing files are taken to the next agenda after the missing files are completed.The scientific and ethical relevance of the Applied Studies is evaluated at the meeting to be held on the second and fourth Wednesdays of each month if it does not coincide with the public holidays and the majority is provided. The decision letter of the ethics committee is delivered from the secretariat.

According to the provisions of the regulation on clinical trials, which has received scientific and ethical approval phase I, Phase II, Phase III and Phase IV clinical drug trials and observational studies observational medical device studies, which is made with advanced therapy medicinal products, Clinical Research, Clinical Research, Medical Devices, Industrial Products and industrial advanced medical non-medical products to be done with the Advanced Research, Clinical Research, gene therapy, stem, stem cell research, organ and tissue transplantation research, and research a new surgical method, clinical trials with traditional herbal medicinal products and all other substances and products that may be tested in humans, including cosmetic raw materials or products, cannot be started without the permission of the Ministry. To get a ministry permit, T.C. The Ministry of health should refer to the Turkish medicines and medical devices Authority.

For the studies mentioned above, researchers primarily located on our web site in accordance with The Shape of reference of the Ethics Committee the Ethics Committee of our hospital and received eligibility to apply to the decision prepare by considering examples of current application forms and the address and reference letter must submit files to the ministry. For non-interventional clinical trials for Academic Purposes and/or specialization thesis which have received scientific and ethical approval, the approval of the ethics committee is sufficient and there is no need for ministerial permission.