Staged informed consent for a randomized clinical trial in childhood leukemia: impact on the consent process

Pediatr Blood Cancer. 2004 May;42(5):433-7. doi: 10.1002/pbc.20010.


Background: Children Cancer Group (CCG) 1991 is the first childhood acute lymphoblastic leukemia trial within CCG that allowed the utilization of a staged approach to the consent process.

Methods: One hundred and forty subjects participated in the Project on Informed Consent which compared the primary outcome measures in the consent process of patients enrolled in CCG-1991 with those enrolled in other CCG leukemia studies.

Results: The parents' trust scores were higher for the CCG-1991 compared with other protocols. Eighty percent of parents enrolled in CCG-1991 understood the distinction between the randomized clinical trial and the standard treatment arm, compared with 62.5% in the other studies, P = 0.05. Multiple other outcome measures suggested a positive impact from staged informed consent.

Conclusions: Our results suggest that a consent process with a staged approach can help investigators obtain a more truly informed consent. Future research is needed to confirm the benefits of the staged approach to the informed consent process.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Child
  • Child, Preschool
  • Comprehension
  • Decision Making
  • Female
  • Humans
  • Informed Consent / psychology*
  • Male
  • Parents / psychology
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma*
  • Professional-Patient Relations
  • Randomized Controlled Trials as Topic / ethics*
  • Randomized Controlled Trials as Topic / methods
  • Trust