doiSerbia

Analysis of regulatory-ethical framework of clinical trials

Milošević-Georgiev Andrijana (Farmaceutski fakultet, Beograd)
Krajnović Dušanka (Farmaceutski fakultet, Beograd)
Milovanović Srđan (Medicinski fakultet, Beograd + Klinički centar Srbije, Klinika za psihijatriju, Beograd)
Ignjatović Svetlana (Farmaceutski fakultet, Beograd + Klinički centar Srbije, Centar za medicinsku biohemiju, Beograd)
Đurić Dušan (Medicinski fakultet, Kragujevac + Institut za rehabilitaciju, Beograd)
Marinković Valentina (Farmaceutski fakultet, Beograd)

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 analyze clinical cases with the outcomes leading to the changes in regulatory­ethical 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 analyzing 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.

Keywords: clinical trials, regulation, ethical principles, ethical norms

Projekat Ministarstva nauke Republike Srbije, br. 175036 i br. 41004