Parental perceptions of the informed consent process in pediatric oncology clinical trials

Yvonne D Hastings, Natalie K Bradford, Liane R Lockwood, Robert S Ware, Jeanine Young


Background: The integrity of good clinical practice in clinical trials is underpinned by the informed consent process; however the stress of a life threatening diagnosis challenges the absorption of information and may affect the parent’s ability to understand diagnosis, treatment plans and the consent process.

Aims: The aim of this study was to explore and describe parental perceptions of the informed consent process in pediatric oncology clinical trials.

Methods: A cross-sectional survey was used to collect responses from 50 parents of children aged 8-16 years, enrolled on a clinical trial, one month after diagnosis at an Australian tertiary pediatric oncology centre.

Results: The majority of parents (47, 94%) agreed that they understood the diagnosis and information regarding the purpose of the clinical trial. Parents relied primarily on their Oncology consultant for this information. Parents discussed the diagnosis with their children although only 60% (n=30) felt that their child understood the treatment and trial process.

Conclusions: Parents indicated that the current process of providing information regarding the clinical trial process met their needs and that they were able to provide informed consent. They were unsure however, of how involved they wanted their children to be in treatment decisions.

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Journal of Nursing Education and Practice

ISSN 1925-4040 (Print)   ISSN 1925-4059 (Online)

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