CN39Quality of informed consent in clinical trials patients

Abstract Background One of the critical ethical requirements of conducting clinical research regardless of the study setting is to obtain informed consent before enrolling subjects’ participants. It is crucial to ensure quality and validity of the informed consent of study’s participants. Methods We used a quantitative survey design using the Italian validated version of the Quality of Informed Consent (QuIC) questionnaire. We included 7 Italian cancer sites and 300 clinical trials patients. Results All the patients invited accepted to fill the questionnaire. Most of them were male (N = 130), and the mean age was 60 (sd 10). Most of them were satisfied with the information received, and they considered themselves to be well informed. The average score for objective understanding was 62.2 and for subjective understanding was 74.6 (p  Conclusions Our results suggest that investigators should invest more effort to improve clinical trials subjects reach a safer understanding of the informed consent. The clinical trials nursing role is crucial to protect the clinical trial participants rights. Legal entity responsible for the study Gianluca Catania. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.