Permission form synopses to improve parents’ understanding of research: a randomized trial

• Published in: Journal of perinatology Vol. 37; no. 6; pp. 735 - 739
• Main Authors: D’Angio, C T, Wang, H, Hunn, J E, Pryhuber, G S, Chess, P R, Lakshminrusimha, S
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01.06.2017; Nature Publishing Group
• Subjects: 692/308/409; 706/648/179; Adult; Comprehension; Confidentiality; Design standards; Female; Health Knowledge, Attitudes, Practice; Humans; Infant, Newborn; Informed consent; Informed consent (Medical law); Intervention; Legal documents; Linear Models; Male; Medicine; Medicine & Public Health; Multivariate Analysis; Neonatal intensive care; Neonates; New York; Observational studies; original-article; Parental Consent - psychology; Parents; Parents & parenting; Participation; Pediatric research; Pediatric Surgery; Pediatrics; Pilot Projects; Premature babies; Premature birth; Psychological aspects; Single-Blind Method; Young Adult; United States
• ISSN: 0743-8346; 1476-5543; 1476-5543
• DOI: 10.1038/jp.2017.26

Objective: We 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 Design: This 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. Results: Thirty-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). Conclusion: A simplified permission form cover sheet had no effect on parents’ understanding of studies for which their newborns were being recruited.