5579 - Quality of informed consent in clinical trials patients

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 < 0.001). Subjects responded correctly to questions about the general understanding of participation in research. Only 33% understood which procedures were experimental, and 40% of respondents knew foreseeable risks or discomfort from the research. In ANOVA analysis, an increased understanding was associated with a higher level of education.

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.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Gianluca Catania.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.