Premium
Consent for participating in clinical trials ‐ Is it really informed?
Author(s) -
AlexaStratulat Teodora,
Neagu Marius,
Neagu AncaIulia,
Alexa Ioana Dana,
Ioan Beatrice Gabriela
Publication year - 2018
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/dewb.12199
Subject(s) - informed consent , confidentiality , clinical trial , psychology , population , good clinical practice , research design , family medicine , clinical research , medical education , medicine , alternative medicine , law , political science , environmental health , pathology , sociology , social science
The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north‐eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (Qu IC ) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF , few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants’ decision‐making is meaningful and that their interests are protected.