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

ABSTRACT 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. Access through your institution Buy or subscribe This is a

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PERSPECTIVES ON A TRIAL USING WAIVED INFORMED CONSENT AT BIRTH Article 21 December 2023 EXPERIENCES AND PREFERENCES FOR LEARNING ABOUT NEONATAL RESEARCH: INSIGHTS FROM PARENT INTERVIEWS

Article 25 November 2023 INTEGRATING PARENT VOICES INTO RESEARCH AT THE EXTREMES OF PREMATURITY: WHAT ARE WE DOING AND WHERE SHOULD WE GO? Article Open access 15 November 2024 REFERENCES *

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ACKNOWLEDGEMENTS This research was supported in part by NICHD Bioethics Supplement 3U10HD068263-01S1, and is listed on clinicaltrials.gov, NCT01704560. We wish to thank the study

coordinators, Elizabeth Werner, MPH, Tanya Scalise, RN, BSN, and Deanna Maffett, RN, the neonatal faculty and fellows and Christine Trahms, BS for their help. We thank the ‘Randomized

Controlled Trial of the Effect Of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22–26 Months of Age in Intubated Infants <30 Weeks

Gestation Age’ (‘Hydrocortisone’) subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network (NRN), which agreed to the

use of the modified consent forms. We similarly thank the Rochester center investigators of the National Heart Lung and Blood Institute’s Prematurity and Respiratory Outcome Program (PROP)

for allowing modified consent forms. We also thank the families who agreed to participate, without whom the work would not have been possible. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS *

Department of Pediatrics, University of Rochester Medical Center, Golisano Children’s Hospital, Rochester, NY, USA C T D’Angio, J E Hunn, G S Pryhuber & P R Chess * Department of

Biostatistics, University of Rochester, Rochester, NY, USA H Wang * St Francis Hospital and Medical Center, University of Connecticut, Hartford, CT, USA J E Hunn * Department of Pediatrics,

University at Buffalo, Buffalo, NY, USA S Lakshminrusimha Authors * C T D’Angio View author publications You can also search for this author inPubMed Google Scholar * H Wang View author

publications You can also search for this author inPubMed Google Scholar * J E Hunn View author publications You can also search for this author inPubMed Google Scholar * G S Pryhuber View

author publications You can also search for this author inPubMed Google Scholar * P R Chess View author publications You can also search for this author inPubMed Google Scholar * S

Lakshminrusimha View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to C T D’Angio. ETHICS DECLARATIONS COMPETING

INTERESTS The authors declare no conflict of interest. ADDITIONAL INFORMATION Supplementary Information accompanies the paper on the _Journal of Perinatology_ website SUPPLEMENTARY

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permissions ABOUT THIS ARTICLE CITE THIS ARTICLE D’Angio, C., Wang, H., Hunn, J. _et al._ Permission form synopses to improve parents’ understanding of research: a randomized trial. _J

Perinatol_ 37, 735–739 (2017). https://doi.org/10.1038/jp.2017.26 Download citation * Received: 22 August 2016 * Revised: 17 January 2017 * Accepted: 19 January 2017 * Published: 30 March

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