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Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.
- Source :
-
Journal of empirical research on human research ethics : JERHRE [J Empir Res Hum Res Ethics] 2017 Dec; Vol. 12 (5), pp. 326-334. Date of Electronic Publication: 2017 Oct 16. - Publication Year :
- 2017
-
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.
Details
- Language :
- English
- ISSN :
- 1556-2654
- Volume :
- 12
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Journal of empirical research on human research ethics : JERHRE
- Publication Type :
- Academic Journal
- Accession number :
- 29037106
- Full Text :
- https://doi.org/10.1177/1556264617731869