NCT03105752

Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers

Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Outcome Assessments (Health Care)
• Comprehension
• Language

Interventions

Type	Name	Description
OTHER	Questionnaire of understanding	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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2017-04-10
• Last updated: 2017-04-10