The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial.
Publication/Presentation Date
9-1-2016
Abstract
Enrollment of patients in sickle cell intervention trials has been challenging due to difficulty in obtaining consent from a legal guardian and lack of collaboration between emergency medicine and hematology. We utilized education and preconsent in a pediatric multisite sickle cell intervention trial to overcome these challenges. Overall, 48 patients were enrolled after being preconsented. Variable Institutional Review Board policies related to preconsent validity and its allowable duration decreased the advantages of preconsent at some sites. The utility of preconsent for future intervention trials largely depends on local Institutional Review Board policies. Preeducation may also benefit the consent process, regardless of site differences.
Volume
63
Issue
9
First Page
1649
Last Page
1652
ISSN
1545-5017
Published In/Presented At
Nimmer, M., Czachor, J., Turner, L., Thomas, B., Woodford, A. L., Carpenter, K., Gonzalez, V., Liem, R. I., Ellison, A., Casper, T. C., Brousseau, D. C., & sickle cell working group of the Pediatric Emergency Care Applied Research Network (PECARN) (2016). The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial. Pediatric blood & cancer, 63(9), 1649–1652. https://doi.org/10.1002/pbc.26013
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
27081930
Department(s)
Administration and Leadership
Document Type
Article