Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States.
Mayo Clin Proc
; 96(8): 2095-2101, 2021 08.
Article
in English
| MEDLINE | ID: covidwho-1253365
ABSTRACT
OBJECTIVE:
To assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States. PATIENTS ANDMETHODS:
English consent forms were used for patients in phase 3 COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Using Microsoft Word tools, we analyzed the readability (ie, the ease of reading) of written consent forms and informational documents from phase 3 COVID-19 vaccine clinical trials in the United States from the following manufacturers AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax.RESULTS:
Owing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Comprehension
/
Consumer Health Information
/
Health Literacy
/
COVID-19 Vaccines
/
Informed Consent
Type of study:
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Mayo Clin Proc
Year:
2021
Document Type:
Article
Affiliation country:
J.mayocp.2021.05.025
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