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

Sarah Cunningham-Burley; Daniel L McCartney; Archie Campbell; Robin Flaig; Clare E L Orange; Carol Porteous; Mhairi Aitken; Ciaran C Mulholland; Sara Davidson; Selena McCafferty; Lee Murphy; Nicola Wrobel; Sarah McCafferty; Karen Wallace; David St Clair; Shona Kerr; Caroline Hayward; Andrew M McIntosh; Cathie L M Sudlow; Riccardo E Marioni; Jill Pell; Zosia Miedzybrodzka; David John Porteous

doi:10.1038/s43856-022-00189-2

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

Sarah Cunningham-Burley, Daniel L McCartney, Archie Campbell, Robin Flaig, Clare E L Orange, Carol Porteous, Mhairi Aitken, Ciaran C Mulholland, Sara Davidson, Selena McCafferty, Lee Murphy, Nicola Wrobel, Sarah McCafferty, Karen Wallace, David St Clair, Shona Kerr, Caroline Hayward, Andrew M McIntosh, Cathie L M Sudlow, Riccardo E MarioniJill Pell, Zosia Miedzybrodzka, David John Porteous

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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.

Original language	English
Article number	126
Number of pages	8
Journal	Communications Medicine
Volume	2
DOIs	https://doi.org/10.1038/s43856-022-00189-2
Publication status	Published - 6 Oct 2022

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10.1038/s43856-022-00189-2

s43856-022-00189-2Final published version, 659 KBLicence: Creative Commons: Attribution (CC-BY)

Genetics Core, Edinburgh Clinical Research Facility
Lee Murphy (Manager), Angie Fawkes (Other), Katarzyna Hafezi (Other), Richard Clark (Other), Amanda MacCallum (Other), Emma Aitken (Other) & Louise Macgillivray (Other)
Deanery of Clinical Sciences
Facility/equipment: Facility

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Cunningham-Burley, S., McCartney, D. L., Campbell, A., Flaig, R., Orange, C. E. L., Porteous, C., Aitken, M., Mulholland, C. C., Davidson, S., McCafferty, S., Murphy, L., Wrobel, N., McCafferty, S., Wallace, K., St Clair, D., Kerr, S., Hayward, C., McIntosh, A. M., Sudlow, C. L. M., ... Porteous, D. J. (2022). Feasibility and ethics of using data from the Scottish newborn blood spot archive for research. Communications Medicine, 2, Article 126. https://doi.org/10.1038/s43856-022-00189-2

@article{09947b4e6c0148caa139090ccfb2a704,

title = "Feasibility and ethics of using data from the Scottish newborn blood spot archive for research",

abstract = "BackgroundNewborn 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.MethodsWe conducted a Citizens{\textquoteright} 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.ResultsJurors 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.ConclusionsThrough the Citizens{\textquoteright} 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.",

author = "Sarah Cunningham-Burley and McCartney, {Daniel L} and Archie Campbell and Robin Flaig and Orange, {Clare E L} and Carol Porteous and Mhairi Aitken and Mulholland, {Ciaran C} and Sara Davidson and Selena McCafferty and Lee Murphy and Nicola Wrobel and Sarah McCafferty and Karen Wallace and {St Clair}, David and Shona Kerr and Caroline Hayward and McIntosh, {Andrew M} and Sudlow, {Cathie L M} and Marioni, {Riccardo E} and Jill Pell and Zosia Miedzybrodzka and Porteous, {David John}",

note = "{\textcopyright} The Author(s) 2022.",

year = "2022",

month = oct,

day = "6",

doi = "10.1038/s43856-022-00189-2",

language = "English",

volume = "2",

journal = "Communications Medicine",

issn = "2730-664X",

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}

Cunningham-Burley, S , McCartney, DL , Campbell, A , Flaig, R, Orange, CEL, Porteous, C, Aitken, M, Mulholland, CC, Davidson, S, McCafferty, S, Murphy, L, Wrobel, N, McCafferty, S, Wallace, K, St Clair, D, Kerr, S , Hayward, C , McIntosh, AM , Sudlow, CLM , Marioni, RE, Pell, J, Miedzybrodzka, Z & Porteous, DJ 2022, 'Feasibility and ethics of using data from the Scottish newborn blood spot archive for research', Communications Medicine, vol. 2, 126. https://doi.org/10.1038/s43856-022-00189-2

TY - JOUR

T1 - Feasibility and ethics of using data from the Scottish newborn blood spot archive for research

AU - Cunningham-Burley, Sarah

AU - McCartney, Daniel L

AU - Campbell, Archie

AU - Flaig, Robin

AU - Orange, Clare E L

AU - Porteous, Carol

AU - Aitken, Mhairi

AU - Mulholland, Ciaran C

AU - Davidson, Sara

AU - McCafferty, Selena

AU - Murphy, Lee

AU - Wrobel, Nicola

AU - McCafferty, Sarah

AU - Wallace, Karen

AU - St Clair, David

AU - Kerr, Shona

AU - Hayward, Caroline

AU - McIntosh, Andrew M

AU - Sudlow, Cathie L M

AU - Marioni, Riccardo E

AU - Pell, Jill

AU - Miedzybrodzka, Zosia

AU - Porteous, David John

PY - 2022/10/6

Y1 - 2022/10/6

N2 - BackgroundNewborn 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.MethodsWe 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.ResultsJurors 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.ConclusionsThrough 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.

AB - BackgroundNewborn 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.MethodsWe 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.ResultsJurors 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.ConclusionsThrough 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.

U2 - 10.1038/s43856-022-00189-2

DO - 10.1038/s43856-022-00189-2

M3 - Article

C2 - 36210800

SN - 2730-664X

VL - 2

JO - Communications Medicine

JF - Communications Medicine

M1 - 126

ER -

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

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Genetics Core, Edinburgh Clinical Research Facility

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