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Comparison of the Informed Consent Process for Randomized Clinical Trials in Pediatric and Adult Oncology

From the Department of Bioethics and the Rainbow Center for Pediatric Ethics, Department of Pediatrics, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, Case Western Reserve University School of Medicine, Cleveland, OH

Address reprint requests to Christian M. Simon, PhD, Department of Bioethics/Oncology, Case Western Reserve University School of Medicine, 10900 Euclid Ave, Cleveland, OH 44106; e-mail: cxs66{at}po.cwru.edu

PURPOSE: To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent.

PATIENTS AND METHODS: A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using ² statistics and t tests.

RESULTS: Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments.

CONCLUSION: Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.

This is original, previously unpublished work supported by grants from the Rainbow Board of Trustees, NIH RO1 CA83267 (E.D.K.), and NCI R01-CA78210 (L.A.S.).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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