Abstract
A Working Group of the Joint Commission National Committee of Bioethics and National Committee for Biosafety Biotechnologies and Life Sciences has recommended a National Network of Regional Newborn Screening Repositories the for collection of residual dried blood samples, coordinated by the Italian National Institute of Health.
Highlights
After newborn screening has been completed many screening laboratories retain the residual dried blood samples (DBS) for various purposes, including program evaluation, quality assurance, and biomedical research
State newborn screening programs are essential to protect the health of children
Guidelines and policy documents from national (e.g.: National Bioethics Committees), international and supranational (e.g.: OECD, UNESCO, WHO, WMA, European Union, Council of Europe) institutions are available. These documents give important guidance but clear-cut national policies are needed for the inclusion of children’s biological specimens in population biobanks: lack of openness may lead to the loss of public trust in research
Summary
After newborn screening has been completed many screening laboratories retain the residual dried blood samples (DBS) for various purposes, including program evaluation, quality assurance, and biomedical research. Storage and use of residual newborn screening dot blood samples in Italy Paediatric biobanks raises unique ethical issues: parental authorization, assent and consent of the child when he will mature the capacity to make independent decisions, degree of communication required with the parents and the child, new use of data and/or samples collected previously, potentially lengthy period of storage, long-term studies, withdrawal from storage and/or research, return of results, and others.
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