Browsing by Author "Djurić, Dušan (35589783700)"

Introduction Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. Objective The aim of the study was to analyse clinical cases with the outcomes leading to the changes in regulatory-ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the introduction of the ethical principles into clinical trials. Methods This was a descriptive research (methods of analysis and documentation; desk analysis of the secondary data). Results By analysing the cases from the secondary sources as well as clinical and ethical outcomes, it may be noticed that the codes, declarations and regulations have been often preceded by certain events that caused their adoption. Moral concern and public awareness of the ethical issues have initiated not only the development of numerous guidelines, codes, and declarations, but also their incorporation into the legislative acts. Conclusion It is desirable that ethical instruments become legally binding documents, because only in this way will be possible to control all phases of the clinical trials and prevent abuse of the respondents.

Introduction Since inception of the alexithymia construct in 1970's, there has been a continuous effort to improve both its theoretical postulates and the clinical utility through development, standardization and validation of assessment scales. Objective The aim of this study was to validate the Serbian translation of the 20-item Toronto Alexithymia Scale (TAS-20) and to propose a new method of translation of scales with a property of temporal stability. Methods The scale was expertly translated by bilingual medical professionals and a linguist, and given to a sample of bilingual participants from the general population who completed both the English and the Serbian version of the scale one week apart. Results The findings showed that the Serbian version of the TAS-20 had a good internal consistency reliability regarding total scale (α=0.86), and acceptable reliability of the three factors (α=0.71-0.79). Conclusion The analysis confirmed the validity and consistency of the Serbian translation of the scale, with observed weakness of the factorial structure consistent with studies in other languages. The results also showed that the method of utilizing a self-control bilingual subject is a useful alternative to the back-translation method, particularly in cases of linguistically and structurally sensitive scales, or in cases where a larger sample is not available. This method, dubbed as 'forth-translation', could be used to translate psychometric scales measuring properties which have temporal stability over the period of at least several weeks.