Mandatory Ethical issues for the projects which conducted by Trials-Network

Respect for individual rights has become a constant concern, and its principles have become quasi-universal in research. These rights are protected by international agreements. Trials-Network gives special respect for the dignity of individuals, the integrity of their persons, their personal autonomy through the rule of informed consent, their privacy and their private life.
Research carried out on data from the usual management of the patient is not considered as biomedical research, but as observational research. This involves data obtained retrospectively (e.g. from medical records), post hoc analyses from data obtained for another goal (i.e. data obtained from patient usual care or from another research), or new prospective data. A questionnaire is not considered as an intervention on a person, with the exception of some questionnaires which could jeopardize psychological integrity.
If situation refers particularly to so-called observational studies, such as data collected retrospectively or prospectively, or data obtained without any additional therapy or monitoring procedures, universal principles such as the Helsinki Declaration will apply to all these kinds of “non-pharmacological” researches. With regard to pharmacological research, important standardization work is carried out under the auspices of, in addition to Helsinki Declaration, the protection of human subjects, good clinical practise guide, nurenberg code, and  The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (http://www.ich.org/home.html).

All clinical trials performed via Trials-Network will be obligated to obey the guidelines of “Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy” with respect to their quality.
Related Documents

ICH