title: [Analysis of regulatory-ethical framework of clinical trials].
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia. Andrijanam@pharmacy.bg.ac.rs
authors.forename: Andrijana Milosević
authors.initials: AM
authors.lastname: Georgiev
authors.affiliation: Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
authors.forename: Dusanka
authors.initials: D
authors.lastname: Krajnović
authors.affiliation: School of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Srdjan
authors.initials: S
authors.lastname: Milovanović
authors.affiliation: Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Ignjatović
authors.affiliation: School of Medicine, University of Kragujevac, Kragujevac, Serbia.
authors.forename: Dusan
authors.initials: D
authors.lastname: Djurić
authors.affiliation: Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
authors.forename: Valentina
authors.initials: V
authors.lastname: Marinković
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D006801:Humans; D028662:Principle-Based Ethics; D055771:Serbia