Are Well-Informed Potential Trial Participants More Likely to Participate?

Bearing in mind the importance of the informed consent, flaws in this process may be a barrier to participants’ recruitment. Our objective was to determine the relationship between the degree of comprehension of the informed consent document plus the importance given to individual elements by potent...

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Bibliographic Details
Published in:Journal of empirical research on human research ethics 2017-12, Vol.12 (5), p.363-371
Main Authors: de Oliveira, Lucas Lentini Herling, Vissoci, Joao Ricardo Nickenig, de Lara Machado, Wagner, Rodrigues, Clarissa G., Limkakeng, Alexander T.
Format: Article
Language:English
Subjects:
Adult
Bioethics
Clinical trials
Comprehension
Consent Forms
Empirical Perspectives on Informed Consent Processes
Female
Health informatics
Health Knowledge, Attitudes, Practice
Humans
Informed Consent
Male
Patient Selection
Polls & surveys
Reading
Self evaluation
Surveys and Questionnaires
Young Adult
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Summary:Bearing in mind the importance of the informed consent, flaws in this process may be a barrier to participants’ recruitment. Our objective was to determine the relationship between the degree of comprehension of the informed consent document plus the importance given to individual elements by potential participants of a hypothetical trial and their willingness to participate in such trials. We performed an Online Survey simulating an emergency department trial recruitment, posteriorly evaluating participants’ ratings of importance and self-assessed comprehension of specific topics of the informed consent document. Only 10% of the sample read the entire document. Some specific topics were associated with willingness to participate in the hypothetical trial, but simple composite additive scores of comprehension and importance were not. We concluded that participants in general do not read the entire informed consent document and that importance given to specific topics may influence willingness to participate.
ISSN:1556-2646
1556-2654
DOI:10.1177/1556264617737163