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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03105752

Enrollment

240

Registered

2017-04-10

Start date

2014-04-30

Completion date

2016-04-30

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comprehension, Language, Outcome Assessments (Health Care)

Keywords

Outcome Assessments (Health Care), Volunteers, Informed consent, Comprehension, Language tests

Brief 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.

Interventions

OTHERQuestionnaire 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Correlation between the overall comprehension score and the readability index of Flesch	Immediate evaluation

Secondary

Measure	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
Correlation between the overall comprehension score and the type of study	Immediate evaluation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026