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Publications

Journal Article Epublish

PubMed: 42647251 DOI: 10.3390/ijns12030064

Features and Legal Practice of Dried Blood Spot Card Biobanking in Europe: Balancing Research Potential with Parental and Children's Rights.

Int J Neonatal Screen 12(3)

Authors: Sophie Ter Braak, Mette Nyegaard, Christian Munch Hagen, Marie Bækvad-Hansen, Madara Auzenbaha, François Boemer, James R Bonham, Patricia Borde, Ian Brincat, David Cheillan, Vera Frankova, Leifur Franzson, Ksenija Fumić, Urh Groselj, Tom L G M van den Kerkhof, Riikka Kurkijärvi, Giancarlo la Marca, Tatjana Milenković, Olve Moldestad, Vyacheslav Mitkin, Florentina Moldovanu, Marios Vogazianos, Jürgen G Okun, Lene Sörensen, Gulnara Svyatova, Ildikó Szatmári, Maja Raičević, Karit Reinson, Trine Tangeraas, Alma Toromanović, Laura Vilarinho, Svetlana Vorslova, Raquel Yahyaoui, Maximillian Zeyda, Dianne Webster, Peter C J I Schielen

Affiliations

  • International Society for Neonatal Screening, Reigerskamp 273, 3607 HP Maarssen, The Netherlands.
  • Department of Congenital Disorders, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen, Denmark.
  • Children's Clinical University Hospital, Riga Stradiņš University, LV-1007 Riga, Latvia.
  • CHU Liege, 4000 Liège, Belgium.
  • Sheffield Children's Hospital, Sheffield S10 2TH, UK.
  • Laboratoire National de Santé, 3555 Dudelange, Luxembourg.
  • Mater Dei Hospital, TAL-QROQQ Msida, Malta.
  • University Hospital of Lyon, 69500 Lyon, France.
  • First Faculty of Medicine, Charles University, 128 08 Prague 2, Czech Republic.
  • Department of Genetics and Molecular Medicine-Newborn Screening, Landspitali University Hospital, 101 Reykjavik, Iceland.
  • University Hospital Centre Zagreb, 10000 Zagreb, Croatia.
  • Faculty of Medicine, University of Ljubljana, SI-1000 Ljubljana, Slovenia.
  • Reference Laboratory for Neonatal Screening, Center for Health Protection, National Institute for Public Health and the Environment (RIVM), 3720 BA Bilthoven, The Netherlands.
  • Finnish National Newborn Screening Centre (Saske), Turku University Hospital, 20521 Turku, Finland.
  • Newborn Screening, Clinical Biochemistry and Clinical Pharmacy Lab Meyer Children's Hospital IRCCS, 50139 Florence, Italy.
  • Department of Experimental and Clinical Biomedical Sciences, University of Florence, 50139 Florence, Italy.
  • Mother and Child Healthcare Institute of Serbia "Dr Vukan Cupic", 11070 Belgrade, Serbia.
  • Norwegian National Unit for Newborn Screening, Division of Pediatric and Adolescent Medicine, Oslo University Hospital, 0424 Oslo, Norway.
  • Laboratory Genetics, Neonatal Screening Center, 115580 Moscow, Russia.
  • National Institute for Mother and Child Health "Alessandrescu-Rusescu", 050474 Bucharest, Romania.
  • Center for Preventive Paediatrics "Americos Argyriou", 3022 Limassol, Cyprus.
  • Center for Pediatric and Adolescent Medicine, Department I, Division of Metabolic Diagnostics and Newborn Screening, Medical Faculty Heidelberg, Heidelberg University, 69120 Heidelberg, Germany.
  • Centre for Inherited Metabolic Diseases, Karolinska University Hospital, 171 76 Stockholm, Sweden.
  • Center for Molecular Medicine, Almaty 050020, Kazakhstan.
  • Pediatric Centre, Semmelweis University, 1083 Budapest, Hungary.
  • Institute for Children's Diseases, Clinical Centre of Montenegro, 81000 Podgorica, Montenegro.
  • Department of Clinical Genetics, Genetics and Personalized Medicine Clinic, Tartu University Hospital, 50406 Tartu, Estonia.
  • Genetics and Personalized Medicine Clinic, Tartu University Hospital, 51014 Tartu, Estonia.
  • Department of Pediatrics, University Clinical Center Tuzla, 75000 Tuzla, Bosnia and Herzegovina.
  • National Institute of Health Doutor Ricardo Jorge, Rua Alexandre Herculano, 321, 4000-055 Porto, Portugal.
  • Laboratorio de Metabolopatías y Cribado Neonatal, Hospital Regional Universitario de Málaga, 29011 Málaga, Spain.
  • Departamento de Biomedicina y Odontología, Universidad Europea de Andalucía, 29130 Málaga, Spain.
  • Austrian Newborn Screening, Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, A-1090 Vienna, Austria.
  • National Newborn Screening Laboratory, LabPlus, Health New Zealand Te Whatu Ora, Auckland 1023, New Zealand.

Abstract

Neonatal screening using Dried Blood Spot (DBS) cards is an important and successful public health facility in Europe, enabling early detection of congenital disorders for early treatment and prevention of overt disease. Biobanks of stored DBS cards offer significant potential for biomedical research. Biobanking and secondary use of DBS cards also raise ethical and legal issues, particularly concerning the rights of parents and children. This study provides a comprehensive overview of legislation and legal practices governing DBS biobanking across 29 European countries, based on a survey conducted in collaboration with the International Society for Neonatal Screening. Findings reveal a highly heterogeneous landscape: 15 countries have national legislation, five have regional guidelines, and nine lack formal regulations. Only four countries require explicit parental consent for DBS storage, with considerable variation in approval processes for research use. A harmonization of practices, with the European General Data Protection Regulation (GDPR) as a basis for future regulation, supplemented by clearer guidance on 'public interest' and robust safeguards for individual rights may lead to more transparent and consistent governance, which is essential to balance scientific progress with the protection of parental and children's rights in DBS-based research across Europe.

MeSH

Blood, Informed Consent, Research, Child