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

Mark Nimmer*, Jason Czachor, Laura Turner, Bobbe Thomas, Ashley L. Woodford, Karli Carpenter, Victor Gonzalez, Robert I. Liem, Angela Ellison, T. Charles Casper, David C. Brousseau, for the sickle cell working group of the Pediatric Emergency Care Applied Research Network (PECARN)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1649-1652
Number of pages4
JournalPediatric Blood and Cancer
Volume63
Issue number9
DOIs
StatePublished - Sep 1 2016

Keywords

  • consent
  • preconsent, pediatric hematology/oncology
  • sickle cell disease

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Pediatrics, Perinatology, and Child Health

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