Open AccessThe informed consent in clinical trials in school dental units: Impact analysis
Author(s) -
Cristian Funieru,
Ruxandra Sfeatcu,
Silviu Pițuru
Publication year - 2017
Publication title -
romanian journal of stomatology
Language(s) - English
Resource type - Journals
eISSN - 2069-6078
pISSN - 1843-0805
DOI - 10.37897/rjs.2017.3.1
Subject(s) - informed consent , medicine , clinical trial , family medicine , discernment , minor (academic) , alternative medicine , law , pathology , philosophy , epistemology , political science
. The informed consent is a very important and needful issue for any medical procedure, treatment or clinical trial. In case of minor patients or those without capacity of discernment, the legal owners must sign the informed consent. Materials and methods. The present study is an analysis of the informed consent forms used in 3 studies conducted between 2006 and 2016 in the schools dental units in Bucharest, which had as main objective the examination of the oral health status of schoolchildren aged between 11 and 14 years, as well as many various correlations related to it. Results. The parents approved (69%), refused (17%) their children being part of these studies and others put some conditions. The main reason for the parents’ refusal regarding the clinical trials was the lack of confidence in dental tools’ sterilization process. Conclusions. The informed consent has some limits when dealing with minor patients. It is very important for school dentists, for those who work in private dental clinics or for the examiners in clinical trials that parents always sign the informed consent.