Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual. (December 2017)

• Record Type: Journal Article
• Authors: Garrett, Sarah B.; Murphy, Marie; Wiley, James; Dohan, Daniel
• Is Part Of: Journal of empirical research on human research ethics. Volume 12:Number 5(2017)
• Page Start: 326
• Page End: 334
• Publication Date: 2017-12
• Subjects: informed consent -- biobanks -- biorepositories -- Common Rule -- tissue donors -- enhanced consent form -- patient comprehension -- accrual; Medical ethics -- Research -- Periodicals; Research -- Moral and ethical aspects -- Periodicals; 174.205
• DOI: 10.1177/1556264617731869
• Languages: English
• ISSNs: 1556-2646

Abstract

Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.