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

Ensuring adequate parental consent is a key issue of ethical practice in pediatric oncology. In Germany, however, knowledge about parental comprehension and satisfaction with the informed consent procedure is limited, and representative data on parents' perspectives are still missing. Based on data collected by means of a population-based survey, we evaluated the parental recall of the informed consent process for pediatric clinical trials, and how they rated the consent process retrospectively.

A standardized survey was carried out among 1,465 parents whose children were first diagnosed in 2005 with a disease defined by ICCC-3 in the German Childhood Cancer Registry (response: 55.1%). The survey's primary objective was to assess how well parents were able to recall of the informed consent process. To evaluate the results, we set up a second survey among 581 parents who had given consent recently for their child's participation in a clinical trial (response: 53.5%).

Approximately 81% of the parents in the population-based survey correctly remembered whether or not their child had been enrolled in a clinical trial or treated off-trial. The ability to recall accurately is significantly lower if the parents have a migration background or if their child was not a trial participant. However, parents who recalled the child's trial participation status incorrectly felt as adequately informed as parents who recalled it correctly.

Our results identified weak points and vulnerable subgroups in the parental consent process in pediatric oncology in Germany.