Consent for participating in clinical trials ‐ Is it really informed?

Abstract

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 (QuIC) 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.

Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies

“…Even so, most authors agree that there are more common characteristics than differences, and that the differences identified are not categorical. Most studies that analysed differences in the understanding of informed consent in clinical trials by gender found no differences [ 4 , 6 , 20 ]. Indeed, the few studies that identified differences mostly found a better understanding by women [ 21 – 24 ].…”

“…Patient information and consent forms are increasingly long and difficult to understand. They are usually written in complex language (above the recommended grade 8 reading level) and often omit significant information [ 2 , 3 ].Several studies have reported a lack of understanding of some content [ 4 , 5 ], and no significant advances have been made in recent decades [ 6 ].…”

Assessment of knowledge and awareness about clinical trials of patients participating in cancer trials

“…Therefore, according to the Alexa�Stratulat et al survey, despite the patients understanding of the general principles of conducting a clinical trial as described in the informed consent form, the researchers efforts should be focused on the patients to help them better understand con� sent, in particular the meaning of the trial and protection of their interests. 13 The factor that determined the participa� tion in a clinical trial to the greatest extent (36%) was the greater access to innovative therapy. A higher number of im� aging tests encouraged almost half of the respondents (48%) to participate in the trial.…”

Mortality among involuntary inpatients of psychiatric hospital

“…In the hanging cases, death leading self-induced external and internal traumatic injuries were found at the cervical region, without other injuries with significance of an attack-defence action. The in-hospital suicide rate can be reduced by developing strategies to combat the phenomenon, with the application of educational measures for medical staff involved in patient care (Xue et al 2020;Alexa-Stratulat et al 2018).…”