[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 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.

journal_name

Srp Arh Celok Lek

authors

Georgiev AM,Krajnović D,Milovanović S,Ignjatović S,Djurić D,Marinković V

doi

10.2298/sarh1310659m

subject

Has Abstract

pub_date

2013-09-01 00:00:00

pages

659-66

issue

9-10

eissn

0370-8179

issn

2406-0895

journal_volume

141

pub_type

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