Ethical issues of dried blood spot storage and its secondary use after newborn screening programme in Hong Kong

Abstract

The advances in high-resolution tandem mass spectrometry led to a paradigm shift in expanded newborn screening, based on the dried blood spot (DBS). At the time of DBS collection, the quantity of blood collected is always more than sufficient for initial and repeated testing to validate screening results. Thus, the residual DBS for secondary use is almost always available. Current applications of residual DBS for various purposes, including quality assurance and test validation, new screening programme development and evaluation, biomedical research and public health epidemiological studies. However, because of the sensitive information that can be derived from the DBS, the storage and secondary use of residual DBS for research purposes raise several ethical considerations. This paper discusses some issues about the storage and secondary use of residual DBS in newborn settings, including informed consent, privacy and confidentiality concerns, the need for returning research results and public transparency.