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Staged informed consent for a randomized clinical trial in childhood leukemia: Impact on the consent process
Author(s) -
Angiolillo A.L.,
Simon C.,
Kodish E.,
Lange B.,
Noll R.B.,
Ruccione K.,
Matloub Y.
Publication year - 2004
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.20010
Subject(s) - informed consent , medicine , randomized controlled trial , family medicine , clinical trial , pediatrics , alternative medicine , surgery , pathology
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. © 2004 Wiley‐Liss, Inc.