Quality of Informed Consent in Phase III Clinical Trials in Portugal: The Participants' Perspective

被引:1
作者
Ferreira, Pedro L. [1 ]
Barradas, Ana [1 ]
Ribeiro, Ines [1 ]
机构
[1] Univ Coimbra, Ctr Hlth Studies & Res, Coimbra, Portugal
关键词
Informed Consent; Clinical Trials; Phase III as Topic; Comprehension; Patient Reported Outcome Measures;
D O I
10.20344/amp.20570
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction: Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials. Methods: The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center. Results: The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition. Conclusion: The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants' understanding of the ICF. In this study, we found that some concepts, like 'study protocol' or 'randomization', were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.
引用
收藏
页码:601 / +
页数:10
相关论文
共 26 条
[1]  
[Anonymous], 2016, Guideline for good clinical practice E6
[2]  
Atal Shubham, 2018, HRB Open Res, V1, P12, DOI 10.12688/hrbopenres.12811.1
[3]   Informed Consent: Its History, Meaning, and Present Challenges [J].
Beauchamp, Tom L. .
CAMBRIDGE QUARTERLY OF HEALTHCARE ETHICS, 2011, 20 (04) :515-523
[4]   Exploring Understanding of "Understanding": The Paradigm Case of Biobank Consent Comprehension [J].
Beskow, Laura M. ;
Weinfurt, Kevin P. .
AMERICAN JOURNAL OF BIOETHICS, 2019, 19 (05) :6-18
[5]   Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing [J].
Cohn, Elizabeth Gross ;
Jia, Haomiao ;
Smith, Winifred Chapman ;
Erwin, Katherine ;
Larson, Elaine L. .
ONCOLOGY NURSING FORUM, 2011, 38 (04) :417-422
[6]  
Comissao de Etica para a Investigacao Clinica, 2022, Dados estatisticos globais do ano 2022
[7]   Children's Understanding of Informed Assents in Research Studies [J].
Cotrim, Hortense ;
Granja, Cristina ;
Carvalho, Ana Sofia ;
Cotrim, Carlos ;
Martins, Rui .
HEALTHCARE, 2021, 9 (07)
[8]   Informed Consent in Biomedical Research [J].
Dankar, Fida K. ;
Gergely, Marton ;
Dankar, Samar K. .
COMPUTATIONAL AND STRUCTURAL BIOTECHNOLOGY JOURNAL, 2019, 17 :463-474
[9]  
Direcao-Geral da Saude, 2017, Programa Nacional para as Doencas Cerebro-Cardiovasculares
[10]   Interventions to improve research participants' understanding in informed consent for research - A systematic review [J].
Flory, J ;
Emanuel, E .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2004, 292 (13) :1593-1601