Rechtliche Aspekte der Nutzung und Aufbewahrung von Proben aus einem (genomischen) Neugeborenen-Screening
摘要
This article discusses the legal challenges associated with the use and storage of blood samples collected as part of newborn screening programs. A key question is whether these samples can or must be stored and used beyond their immediate purpose for further medical analysis or research.
ArgumentsIn principle, newborn blood samples can be used and stored for the intended purpose of screening, as they were collected for this purpose. For use and storage beyond this, German law requires either parental consent or a legal basis, either for further medical purposes or for research. Parental consent must always be given in the best interest of the child, with particular regard to its fundamental rights. For further research purposes, there are national laws that legitimize use for these purposes if research interests predominate.
ConclusionThe handling of blood samples from newborn screening for purposes other than screening has many legal and ethical implications. These issues would remain with the introduction of genomic newborn screening.