Ethische und rechtliche Aspekte der epidemiologischen Forschung mit Kindern und Jugendlichen in Deutschland am Beispiel des Kinder- und Jugendgesundheitssurveys

Definition of the problem: The Health Survey of Children and Adolescents shall produce representative, valid data on this target population in Germany, as an essential prerequisite for the evaluation and improvement of their health. The examinations and blood samplings involve persons not able to give their informed consent. The ethical and legal assessment necessary has to respect national and international recommendations as well as the German relevant laws. According to the German legal situation it appears that parents cannot give their informed consent to blood sampling in their children except if it benefits the individual child. This goes beyond international recommendations that accept a group specific benefit of studies in children if the risk of the measure is minimal. Arguments and conclusion: The blood sampling in the Health Survey certainly has a group specific benefit, but it also benefits the individual participant in that it detects e.g. hidden nutritional deficiencies, allergic sensitization, immunization deficits, or indicators of health risks in adulthood that could not be discovered by other means. In the pretest of the survey, many children were found to have such problems that could be brought to intervention. In more than 90% of the participating children of the pretest, blood sampling was possible after parental informed consent and after respecting informal disagreement of individual children or adolescents in every single case. In a sub-sample the general acceptance was tested anonymously, and was found to be quite good.