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RESEARCH PRODUCT

Parental informed consent in pediatric cancer trials: A population-based survey in Germany

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In Germany, nearly every child afflicted by a malignant dis-ease or a central nervous system tumor is enrolled in a clinicaltrial during treatment. Many of these children are under the age of5 years when they are first diagnosed [1]. The decision whether ornot to participate in a clinical trial is normally made by theparents on behalf of their child. Therefore, ensuring adequatelyinformed parental consent is essential to ethical practice in pedi-atric oncology.However, many empirical studies have revealed difficultieswith the informed consent process when parents are faced withthe decision to enroll their child in a clinical trial. Previous studyfindings have indicated that recalling signing the consent docu-ment and understanding the information given about the plannedresearch are particular challenges of the consent process. Parentsmay, for example, mistakenly understand that the research projectwas designed to benefit their child directly [2]. They may alsomisunderstand key concepts of research designs such as randomi-zation [3,4], or they may even be unaware that they have giventheir consent to enroll their child in a clinical trial [5].Confronted with a severe diagnosis, parents’ understandingand memory are influenced by high levels of emotional distressat the time they are asked for consent [6–9]. Although parentsmay receive appropriate information about the purposes, risks,and benefits of a clinical trial, they may not be able to understandor recall it correctly. In this context, the impact of education andmigration is discussed in the literature [10–15]. There is someempirical evidence that parents with low educational status andthose belonging to minority groups are at greater risk than othersof enrolling their child in a clinical trial without fully understand-ing the implications [13,15]. However, common pediatric cancerssuch as acute leukemia require immediate treatment and an im-mediate parental decision as to whether or not their child shouldbe enrolled in a clinical trial [16].As the existing empirical studies have mainly been conductedin the United States and Canada, we examined the process ofparental consent in pediatric cancer trials in Germany. We presenthere the first population-based survey on parents’ memory andexperience of the consent process. In order to evaluate parents’perception and recollection of the written consent process, wewanted to know how well the decision regarding enrollmentwas stored in parents’ memory. Therefore, we first asked theparents whether or not they had consented to their child’s partici-pation in a clinical trial. If the answer was yes, we wanted toknow how well they remembered the informed consent processitself; we then evaluated the parents’ subjective satisfaction withthe consent process by asking whether they felt adequately in-formed at the time they made their decision.