NEW_LIVES: Genomic NEWborn screening programs – Legal Implications, Value, Ethics and Society

Subproject 1 ethics, society, genetics, medicine (Heidelberg University)

Subproject 2 law (University of Mannheim)

Newborn screening (NBS) programs for treatable congenital disorders are the most effective measures to save lives and prevent disabilities through early diagnosis and pre-symptomatic treatment. Genomic NBS (gNBS) would allow early identification of individuals with genetic diseases undetectable in current NBS programs. Although gNBS is about to become technically feasible, an addition of this new technology to NBS programs comes with multiple challenges: medical, but even more importantly ethical, legal, societal, and psychological. These challenges are addressed in the project NEW_LIVES. Focus is put on the child’s best interest and on the family’s and public health interests. NEW_LIVES aims at, firstly, evaluating ethical, legal, and social criteria for adding diseases to a gNBS panel for a gNBS program in Germany; secondly, evaluating the reasons in favour of or against long-term storage of genomic data; thirdly, evaluating the information needs for informed consent and value assessment of parents. Fourthly, the final outcome will be a normative framework and practical recommendations for a gNBS program in Germany, which will be discussed and presented publicly and scientifically. The scientific investigation of the gNBS is complemented by the perspective of society. Patient representatives and international experts are included within a project advisory board.

Subproject 1 at Heidelberg University investigates the ethical, societal, genetic, and medical parameters of gNBS. Translational medical ethics, medical psychology, human genetics, and pediatrics and adolescent medicine are involved.

In subproject 2 at the University of Mannheim, the legal framework of gNBS will be analysed. In cooperation with Translational Medical Ethics, Medical Psychology, Human Genetics and Pediatric and Adolescent Medicine of subproject 1, a normative framework and best practice recommendations for the implementation of a gNBS program will be developed.

 

Contact

 

See also “Project group” below with the contact details of all project partners (Medical Ethics; Human Genetics; Pediatrics & Youth Medicine from Heidelberg University, and Law from Mannheim University/IMGB).

Funding

German Federal Ministry of Education and Research (BMBF), Health Research Framework Program, Funding of research projects on ethical, legal and social aspects in the life sciences (2022 – 2025; 36 months)

Subproject 1 ethics, society, genetics, medicine (Heidelberg University):

Subproject 2 law (University of Mannheim):

Representatives of patient groups:

  • Tobias Hagedorn (Patient Representative German Interest Group Phenylketonuria and Related Metabolic Disorders, DIG PKU);
  • Henriette Högl, Annette Mund (Patient Representatives, German Children's Network, Kindernetzwerk e.V.)

Partner project U.S.:

  • Jonathan Berg (UNC School of Medicine, NC NEXUS)

Affiliated researchers:

  • Vincent Heuveline (Head of Engineering Mathematics and Computing Lab, Heidelberg University; Chief Information Officer of Heidelberg University; Director of the Computing Centre);
  • Georg F. Hoffmann (Medical Director of Department of General Pediatrics, Neuropediatrics, Metabolism, Gastroenterology, Nephrology, Heidelberg University; Spokesperson of Screening Commission, German Society for Pediatrics and Adolescent Medicine);
  • Gerrit Hornung (Head, Department of Public Law, IT Law and Environmental Law, University of Kassel);
  • Josephine Johnston (Director of Research, The Hastings Center);
  • Jan Korbel (Head, Data Science, Group Leader, European Molecular Biology Laboratory);
  • Maximilian Muenke (CEO, American College of Medical Genetics and Genomics, Newborn Screening Translational Research Network);
  • Christian Netzer (Head, Clinical Human Genetics, Molecular Genetic Diagnostics, University Cologne, Spokesperson Commission for Basic Positions and Ethical Issues, German Society of Human Genetics);
  • Christoph Rehmann-Sutter (Deputy Director, Institute for History of Medicine and Science Studies, University of Luebeck)
  • Jochen Taupitz (Director, Institute for German, European and International Medical Law, Health Law and Bioethics, Universities of Heidelberg and Mannheim)