1. Biobanking and Data Linkage
in Scotland
Pamela Linksted

2. Use of Human Tissue and Data
Scientists and doctors have been collecting and studying tissue and information about health and lifestyle for many years.
Readily available supply is invaluable in
advancing understanding of health and disease
advancing development of healthcare & treatments such as stratified/precision medicine through
basic and discovery research
development of innovative diagnosis and treatments

3. What is in a NAME? tissue Biorepository biological material
Tissue Bank
Biobanking
Biosample
Biospecimens
Bioresource
Cancer bank

4. What are Biobanks Collections of human biological material (and data)
Types of collections
clinical - pathology archive, surplus surgical
diagnostic – surplus blood, urine, biopsy
research – drug trial, health surveys
Therapeutic – stem cells
Patient or population based
Population - large scale prospective studies – range of conditions
Patient/clinical – focus on specific disease categories e.g. cancer
Annotation/Data
e.g. Sample history, patient information, clinical data, pathology, pedigree
For future use - not project specific - Research Tissue Banks (generic ethical approval)?
Appropriate governance mechanisms
Biobank are also overarching organisation/management structures or research group who oversee, manage and coordinate collection of human samples (UKCRC)

5. Requirements Research requires
Readily available resource of the right material &/or data
Associated data & metadata
Operating under appropriate governance
Tissue & data collected, stored, used and disposed of in a responsible manner
Tissue collections
NHS, Universities, private collections …
Infrastructure to maximise the value of biological samples and data from within the NHS Scotland for the research community :
NRS Biorepository (Bioresource) Network and
Federated Network of Safe Havens

6. NHS Research Scotland (NRS) Nodes
Aberdeen: also includes NHS Highland, NHS Orkney & NHS Shetland
Glasgow: also includes
The Golden Jubilee Hospital. NHS Lanarkshire,
NHS Ayrshire & Arran, NHS Dumfries & Galloway
Dundee: also includes NHS Fife and NHS Forth Valley
Collaboration between Chief Scientist Office
and 14 unified Health Boards.
Pan-Scotland working with hub and spoke model
of 4 main Boards with smaller NHS Boards
Edinburgh: also includes
NHS Borders

7. NHS Research Scotland (NRS) Operational units
Clinical Research
Facilities
Bio-repositories
Tissue acquisition
service
‘Safe Havens’
Health informatics
research
Project management
Quality & Facilitation
Research imaging
platform

8. Legislation relating to tissue
Applicable legislation:
Human Tissue (Scotland) Act (2006) – doesn’t regulate tissue from the living
Human Tissue Act (2004) - Section 45 (DNA)
No compulsory licencing system in Scotland!
Key element is consent for collecting and storing tissue for research use
Need reassurance that the highest possible professional
governance standards are in place around
the use of human tissue
Accreditation:
Non-statutory Scheme for collection and storage of NHS tissue in Scotland
Introduced by Scottish Government 2011, developed and delivered by HIS
Adapted HTA Codes of Practice to meet Scottish requirements
Accreditation focuses on:
Governance, Access, Data/Audit Trail and Consent
ACCREDITED

9. -----------------ACCREDITED
Responsibilities
Health Board responsibility to:
ensure collection, storage and use of tissue for research meets required standards
identify/catalogue all collections for which they are responsible
Undergo accreditation for collection and storage of NHS tissue in Scotland
4 NRS Biorepository nodes have led way in establishing
Governance and support infrastructure for researchers
Register of collections within Health Board area
Centralised approach with shared good practice, policies, technology
Ensuring appropriate consent for storage and future use
All have REC RTB generic (delegated) ethical approval
Accredited
Provide governance oversight of collections within NHSS
ACCREDITED

10. NRS Biorepositories provide support
Feasibility of studies
Grant costs
Establishing
clinical
collaborations
Acquire and store tissue that best
reflects research requirements
Governance
Legal
Ethics
Range of tissue services and techniques

11. What is available Collections reflecting local specialities & demand
Pathology Archive
Pre-existing collections
Prospective (bespoke) collection
Surplus diagnostic samples
Tissue Micro Array
Services:
Sectioning and staining
Immunohistochemistry
DNA/RNA extraction
Preparation of material for molecular analysis
TMA construction

12. Prospective collections
Collection of fresh surgical surplus material to meet specific research need
Collection protocols can be standardised (where possible) in all sites
Material used in experiments such as in vitro pharmacology, functionality testing, cell culture and nucleic acid extraction
Seek
consent
Surgery
performed
Tissue
Examined and trimmed
Any surplus
removed
Frozen
Fresh
Fixed

13. How to find it Single point of contact to the network Or Or
Approach to individual biorepositories

14. How to find it Catalogue of collections and capabilities
Find biobanks based on capabilities e.g. samples collected or capacity to collect and additional services
Find samples based on aggregate data i.e. disease, gender, sample type & quality & SOP information

15. Importance of data Characterisation of patients and samples
Identification of suitable patients and/or tissue for studies
Facilitate research & clinical trials
Improved access to information - actionable data - at the point of decision-making for healthcare

16. Routine collected Data Birth to Death

17. Policy developments around how data is governed
Scottish Government’s Data Linkage Framework and Joined up date for better decision: Guiding Principles for Data Linkage
Introduction of the Public Benefit and Privacy Panel –this makes decisions on National and cross regional projects for secondary care data
Thomas and Walport Data Sharing Review (2008):
“environments for population based research and statistical analysis
in which the risk of identifying individuals is minimised”
SHIP Blueprint highlights:
Safe Projects, Safe People, Safe Data,
Safe Setting, Safe Outputs

18. -----------------ACCREDITED
Safe Setting
Safe havens are specialised secure environments supported by trained, specialist staff where data in ePR can be processed and linked with other health data (and/or non-health-related data) to facilitate research while protecting patient identity and privacy.  
Accreditation in line with accreditation policy framework for NHS
ACCREDITED

19. Federated Network of Safe Havens
Electronic Data Research and Innovation Service (eDRIS)
Glasgow Safe Haven
Lothian Safe Haven

20. Scottish Health Datasets
National Datasets cohort of ~5m
Other Datasets across Scotland
SCI-Store (lab test)
PACs GP
etc
Vital statistics
Birth certificates
Marriage certificates
Death certificates
Administrative data
Outpatient attendances (SMR00)
Hospital admissions: acute (SMR01), psychiatric (SMR04)
Maternity (SMR02)
Primary care
Prescribing Information System (PIS)
Scottish Immunisation Recall System (SIRS)
Child Health Systems Programme (CHSP): preschool, school
Support Needs System
Disease registries
Cancer registrations (SMR06)
Bowel screening system (BoSS)
Scottish Renal Registry (SRR)
Scottish Stillbirth & Infant Death Enquiry (SSIDE)
Scottish Stroke Care Audit
SCI-CHD
SCI-Diabetes
Population surveys
Scottish Health Surveys (SHS)
Scottish Schools Adolescent Lifestyle and Substance Use Survey (SALSUS)
Growing Up in Scotland (GUS)
Health Behaviour in Scottish Children (HBSC)
Scottish Longitudinal Study (SLS)
Regional/local Datasets
Heart failure
ECG data
Stroke clinic data
Rheumatology
Parkinson
PsyCIS
Cohort 1950
Aberdeen Maternity & Neonatal database
Local copies of national data
Research Datasets
etc
Enriched by
Administrative data
Education
Social work
Transport
Police
DWP
etc

21. What is available

22. Safe Haven offerings
Range of services include (varies across the network)
Guidance on access and approvals required
Specialist datasets
Data Linkage Service
Secure analytic platform
Facilitate study recruitment
Data analytics
Research Data Management
Application development
etc

23. How to Find it Each Safe Haven
has its own Website with a catalogue and details on how to access data
Plans for a central catalogue

24. Activity supported Supporting - NHS, Academia & Industry
Researcher-led provision of material from within the NHS
Basic & discovery Research
Clinical studies - case/control, cohorts, epidemiology studies …
Clinical trials
efeasibility, eRecruitment, follow-up, safety, samples
UK & Scottish Strategic partnerships
CRUK Stratified Medicine program (ECMC)
lung tissue – extracting DNA for NGS – clinical record – pre-screening for UK Matrix clinical trial
Scottish Stratified Medicine Innovation Centre - Exemplar projects
Phenotype and genotype
Biopta COPD & IBD (fresh lung and bowel) – network provisioning of tissue
Translational SCOTRRCC – annotated collection renal cancer

25. The way forward Stronger links between Biorepositories and Safe havens
Coordinated provision of data and tissue
Enhance interoperability of Safe havens
Greater Integration genomics and eHR for discovery science and precision medicine.
Intelligent clinical trials
Health Data Science -> Learning Health Systems – actionable analytics for health systems - data & research to inform patient care decision
Strategic research activities of Farr Institute…

26. Thank You