Feasibility and ethics of using data from the Scottish newborn blood spot archive for research

Cunningham-Burley, S. et al. (2022) Feasibility and ethics of using data from the Scottish newborn blood spot archive for research. Communications Medicine, 2, 126. (doi: 10.1038/s43856-022-00189-2) (PMID:36210800) (PMCID:PMC9537278)

Abstract

Background: Newborn heel prick blood spots are routinely used to screen for inborn errors of metabolism and life-limiting inherited disorders. The potential value of secondary data from newborn blood spot archives merits ethical consideration and assessment of feasibility for public benefit. Early life exposures and behaviours set health trajectories in childhood and later life. The newborn blood spot is potentially well placed to create an unbiased and cost-effective population-level retrospective birth cohort study. Scotland has retained newborn blood spots for all children born since 1965, around 3 million in total. However, a moratorium on research access is currently in place, pending public consultation. Methods: We conducted a Citizens’ Jury as a first step to explore whether research use of newborn blood spots was in the public interest. We also assessed the feasibility and value of extracting research data from dried blood spots for predictive medicine. Results: Jurors delivered an agreed verdict that conditional research access to the newborn blood spots was in the public interest. The Chief Medical Officer for Scotland authorised restricted lifting of the current research moratorium to allow a feasibility study. Newborn blood spots from consented Generation Scotland volunteers were retrieved and their potential for both epidemiological and biological research demonstrated. Conclusions: Through the Citizens’ Jury, we have begun to identify under what conditions, if any, should researchers in Scotland be granted access to the archive. Through the feasibility study, we have demonstrated the potential value of research access for health data science and predictive medicine.

• Item Type: Articles
• Additional Information: The Citizens’ Jury was funded by a Wellcome Trust Institutional Science Support Fund award to the University of Edinburgh (S.C.B. and D.J.P.). Generation Scotland received core support from the Chief Scientist Office of the Scottish Government Health Directorates [CZD/16/6] and the Scottish Funding Council [HR03006] and is currently supported by the Wellcome Trust [216767/Z/19/Z] award to D.J.P. Baseline DNA methylation was funded by the Wellcome Trust (Wellcome Trust Strategic Award “STratifying Resilience and Depression Longitudinally” (STRADL) Reference 104036/Z/14/Z and Investigator Award 220857/Z/20/Z to A.Mc.I.). The feasibility study was supported in part by HDRI Health Data Research UK substantive hub award (EDIN1) and Chief Scientist Office Scotland (ETM19). C.H. and S.K. are supported by the Medical Research Council University Unit award to the MRC Human Genetics Unit, University of Edinburgh, grant number MC_UU_00007/10, Programme MC_PC_U127592696.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Orange, Miss Clare and Pell, Professor Jill
• Authors: Cunningham-Burley, S., McCartney, D. L., Campbell, A., Flaig, R., Orange, C. E.L., Porteous, C., Aitken, M., Mulholland, C., Davidson, S., McCafferty, S. M., Murphy, L., Wrobel, N., McCafferty, S., Wallace, K., StClair, D., Kerr, S., Hayward, C., McIntosh, A. M., Sudlow, C., Marioni, R. E., Pell, J., Miedzybrodzka, Z., and Porteous, D. J.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Communications Medicine
• Publisher: Nature Research
• ISSN: 2730-664X
• ISSN (Online): 2730-664X
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in Communications Medicine 2: 126
• Publisher Policy: Reproduced under a Creative Commons License

Project Code	Award No	Project Name	Principal Investigator	Funder's Name	Funder Ref	Lead Dept
190082		Generation Scotland	Anna Dominiczak	Office of the Chief Scientific Adviser (CSO)	CZD/16/6	MVLS - College Senior Management