The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial.

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.

journal_name

Pediatr Blood Cancer

journal_title

Pediatric blood & cancer

authors

Nimmer M,Czachor J,Turner L,Thomas B,Woodford AL,Carpenter K,Gonzalez V,Liem RI,Ellison A,Casper TC,Brousseau DC,sickle cell working group of the Pediatric Emergency Care Applied Research Network (PECARN).

doi

10.1002/pbc.26013

subject

Has Abstract

pub_date

2016-09-01 00:00:00

pages

1649-52

issue

9

eissn

1545-5009

issn

1545-5017

journal_volume

63

pub_type

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