Abstract 5579
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.
Resources from the same session
3349 - Interplay between miR-17-5p and MALAT-1 Shapes The Cytokine Storm in Triple Negative Breast Cancer (TNBC) Tumor Microenvironment
Presenter: Raghda Soliman
Session: Poster Display session 3
Resources:
Abstract
4014 - Clinical verification on the relationship between lipid metabolism and the immune microenvironment of breast cancer
Presenter: Wataru Goto
Session: Poster Display session 3
Resources:
Abstract
4158 - The clinical and transcriptional signatures of human CD204 reveal an applicable marker for tumor associated macrophage in breast cancer
Presenter: Yunjie He
Session: Poster Display session 3
Resources:
Abstract
5392 - Activated effector T cells co-expressing multiple inhibitory receptors (IRs) are enriched in the tumor immune microenvironment in high grade serous ovarian cancer (HGSOC)
Presenter: Alice Bergamini
Session: Poster Display session 3
Resources:
Abstract
2617 - Oncolytic reovirus as a new anti-tumor strategy in castration resistant prostate cancer
Presenter: Yunlim Kim
Session: Poster Display session 3
Resources:
Abstract
2995 - Dysregulation of helper T lymphocytes in esophageal squamous cell carcinoma (ESCC) patients is highly associated with aberrant production of miR-21
Presenter: Ali Memarian
Session: Poster Display session 3
Resources:
Abstract
3597 - Myeloid derived suppressor cells but not regulatory T cells are associated with adaptive immunity and clinical outcomes in anal squamous cell carcinoma
Presenter: Christophe Borg
Session: Poster Display session 3
Resources:
Abstract
3430 - Evaluation of immune responses among responders (R) and non-responders (non-R) in a humanized mouse model with colorectal cancer (CRC) xenografts treated with combination immunotherapy
Presenter: Juan Marín Jiménez
Session: Poster Display session 3
Resources:
Abstract
1995 - ¬¬Advanced melanoma patients with high CD16+ macrophages have better response and survival to anti-PD-1 based immunotherapy
Presenter: Hansol Lee
Session: Poster Display session 3
Resources:
Abstract
3988 - Basal NK activity and early Treg function inhibition predicts Nivolumab responsiveness in metastatic renal cancer patients (REVOLUTION) trial.
Presenter: Sara Santagata
Session: Poster Display session 3
Resources:
Abstract