IF THE THESIS STUDY INCLUDES, “Clinical studies, observational drug studies (Regulation on Medicinal and Biological Products Clinical Researches Regulation) of pharmaceuticals, medicinal and biological products and herbal products, including bioavailability and bioequivalence studies, even if licenses or permits are obtained. including all medical device clinical trials (Medical Device Clinical Research Regulation), efficacy studies, safety studies or clinical trials with cosmetic products and raw materials (Regulation on Efficiency and Safety Studies and Cosmetic Researches of Cosmetic Products and Raw Materials), non-pharmaceutical clinical trials. (A new surgical method study, stem cell transplant research, tissue transplant research or organ transplant research to be performed on humans) ” PERMISSION MUST BE OBTAINED FROM THE ETHICS COMMITTEE OF CLINIC RESEARCHES.
Gazi University Clinical Research Ethics Committee
Turkey Pharmaceuticals and Medical Devices Agency, Clinical Research Ethics Committee and the Ethics Committee Bioavailability and Bioequivalence Studies List
World Medical Association Helsinki Declaration, Ethical Principles of Medical Researches on People
Click for the legislation.
IF THE THESIS STUDY INCLUDES,“All observational studies, survey studies, retrospective archive scans such as file and image records, obtained with biochemistry, microbiology, pathology and radiology collection materials such as blood, urine, tissue, radiological image, or during routine examination, examination, analysis and treatment procedures. cell or tissue culture studies; Genetic therapy, which is outside the clinical trials of genetic material, researches within the borders of nursing activities, diet studies with food additives, researches on body physiology such as exercise, studies based on anthropometric measurements, and research on the evaluation of life habits. If it includes researches without direct intervention by the physician, PERMISSION MUST BE OBTAINED FROM THE ETHICS COMMITTEE OF NON-INTERVENTIONAL CLINICAL RESEARCHES.
Gazi University Clinical Research Ethics Committee is structured to evaluate Non-Interventional Clinical Research.
Turkey Pharmaceuticals and Medical Devices Agency, Clinical Research Ethics Committee and the Ethics Committee Bioavailability and Bioequivalence Studies List
Click for the legislation.
IF THE THESIS STUDY INCLUDES, “The ethical committees established in our university are outside the scope of their duties, do not have experimental characteristics on human and animal, biological materials (blood, urine etc. biological fluids and samples) are not used, but for observational purposes, for the permission of the individual in the research. naturally, biological material can be obtained and examined, and does not include any intervention in body, spiritual and social integrity. PERMISSION MUST BE OBTAINED FROM THE ETHICS COMMISSION.
