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The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial
Author(s) -
Nimmer Mark,
Czachor Jason,
Turner Laura,
Thomas Bobbe,
Woodford Ashley L.,
Carpenter Karli,
Gonzalez Victor,
Liem Robert I.,
Ellison Angela,
Casper T. Charles,
Brousseau David C.
Publication year - 2016
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.26013
Subject(s) - medicine , intervention (counseling) , institutional review board , guardian , clinical trial , informed consent , randomized controlled trial , legal guardian , family medicine , intensive care medicine , alternative medicine , psychiatry , pathology , political science , law
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.