Analysis of regulatory-ethical framework of clinical trials

Abstract

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.

Uvod. Svako kliničko ispitivanje, pored naučnih, mora da zadovolji i etičke kriterijume. Osnovni etički principi u kliničkim ispitivanjima su: neškodljivost, dobročinstvo, poštovanje autonomije i princip pravednosti. Cilj rada. Cilj rada je bio da se analiziraju klinički slučajevi čiji su ishodi doveli do promena u regulatorno­etičkom okviru u vezi s kliničkim ispitivanjima i ishodi kliničkih ispitivanja koja su uticala na uvođenje etičkih principa. Metode rada. Istraživanje je bilo deskriptivno, a primenjene su metoda dokumentacione analize i desk­analiza sekundarnih podataka. Rezultati. Analizom slučajeva iz sekundarnih izvora, te kliničkih i etičkih ishoda, može se primetiti da su kodeksima, deklaracijama i pravilima prethodili događaji koji su uzrokovali njihovo donošenje. Moralna briga i svest javnosti o etičkim problemima pokrenule su razvoj brojnih smernica, kodeksa i deklaracija i njihovo uvrštavanje u zakonska akta. Zaključak. Ukoliko se regulativa svih faza kliničkih ispitivanja zasniva na etičkim postavkama, kontrola i ishod su bazirani na humanim osnovama i prava su mera dobrobiti društva i pojedinca.