1. Permission form synopses to improve parents’ understanding of research: a randomized trial
- Author
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Hongyue Wang, Gloria S. Pryhuber, Carl T. D'Angio, J. E. Hunn, Patricia R. Chess, and Satyanarayana Lakshminrusimha
- Subjects
Adult ,Male ,Health Knowledge, Attitudes, Practice ,medicine.medical_specialty ,Pediatrics ,New York ,Pilot Projects ,Permission ,0603 philosophy, ethics and religion ,Article ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Intervention (counseling) ,Humans ,Medicine ,Maternal fetal ,Parental Consent ,Single-Blind Method ,030212 general & internal medicine ,Standard form ,business.industry ,Research ,Infant, Newborn ,Obstetrics and Gynecology ,06 humanities and the arts ,Comprehension ,Family medicine ,Multivariate Analysis ,Pediatrics, Perinatology and Child Health ,Linear Models ,Female ,Observational study ,060301 applied ethics ,business - Abstract
Author(s): D'Angio, CT; Wang, H; Hunn, JE; Pryhuber, GS; Chess, PR; Lakshminrusimha, S | Abstract: 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 Pg0.50).ConclusionA simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
- Published
- 2017
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