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Permission form synopses to improve parents' understanding of research: a randomized trial.
- Author(s): D'Angio, CT;
- Wang, H;
- Hunn, JE;
- Pryhuber, GS;
- Chess, PR;
- Lakshminrusimha, S
- et al.
Published Web Locationhttps://doi.org/10.1038/jp.2017.26
ObjectiveWe hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control).
Study designThis pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.
ResultsThirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).
ConclusionA simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
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