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Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent. The willingness to inform patients of all risks and constraints related to research may be in contradiction with the need to write informative and concise documents that are understandable to research participants. As a result, consent forms are long, contain a lot of information and are complicated to understand.
The objective of this study is to evaluate the impact of the readability of the information and consent forms on the understanding of the information received by participants in clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research participants | Experimental | Each participant of a clinical trial completed the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) about its understanding of the information received. This questionnaire was retrieved immediately on the day of consent, with no possibility of referring to the content of information letter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire of understanding | Other | The study involved 12 clinical trials conducted in the Clinical Research Center Paris Est. Twenty participants per trial were offered to answer the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) at the inclusion visit after receiving the information by the investigator and signed or refused to sign the form of consent. Participants filled out the questionnaire in an isolated location, with no possibility of re-reading the information contained in the consent form. The questionnaire was immediately retrieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the overall comprehension score and the readability index of Flesch | Immediate evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the overall comprehension score and the level of education | Immediate evaluation | |
| Correlation between the overall comprehension score and the status of volunteer | Immediate evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Funck-Brenta, MD, PhD | Centre d'investigation clinique Paris Est | Study Director |
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| ID | Term |
|---|---|
| D007802 | Language |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
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| Correlation between the overall comprehension score and the type of study | Immediate evaluation |