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

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Outcome Assessments (Health Care); Comprehension; Language

Treatments: Other: Questionnaire of understanding

Study type: Interventional

Funder types: Other

Identifiers

NCT03105752

CIC-1421-14-02

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Every volunteers included in a study in a french clinical research center
• Ability to read and write in French

Exclusion criteria

• Refusal of participation

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

Research participants

Experimental group

Description:

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.

Treatment:

Other: Questionnaire of understanding