Governance
Digital Governance
The PRANA registry is hosted within the Wessex sub-national secure data environment, developed and maintained utilising ‘BC Insight’ software on the Microsoft Azure cloud by the University of Southampton’s Clinical Informatics Research Unit (CIRU).
Data is stored in an auditable, permission-controlled database system. Data transformation and linkage is performed using Python within the secure data environment.
The University of Southampton Clinical Informatics Research Unit meets the standards required of the NHS data and security protection toolkit (organisation number EE133879-CIRU) and the ISO 27001 standard.
Information Sharing Governance
The University of Southampton Research Innovation Service (RIS) legal team and the PRANA team in collaboration with stakeholders have developed the information sharing agreements that enable the data described above to flow in accordance with the UK General Data Protection Regulation (GDPR). The structure and content of these data sharing agreements will be used to expand governed data sharing with all the NHS ambulance services and CQC registered pre-hospital critical care providers in the UK. Collaboration with each of the services nationally to enable this expansion will be achieved by the PRANA research nurse and principal investigator with the support of the University of Southampton RIS legal team.
Research Ethics Committee opinion
PRANA applied for independent review by the Health Research Autho Research Ethics Committee (HRA REC) regarding the ethics of data collection, linkage and analysis. The PRANA programme has received a 'favourable ethical opinion'. The reference number for this REC support is 24/SW/0007.
The PRANA submission for Research Ethics can be found on the HRA website:
https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/
PRANA will apply for independent REC review again in 2028.
Use of personally identifiable data
For PRANA to process personally identifiable data for the purposes of service evaluation, audit and research on a national level an application to the Health Research Authority Confidentiality Advisory Group (HRA CAG) has been made. This application is under Section 251 of the NHS Act 2006.
Minutes of the HRA CAG's review of the PRANA submission (page 18-22) are available at the following link:
Following consideration of this application. The HRA CAG provided full support for PRANA from 5th March 2024. This support is provided under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 (’section 251 support’). The support provides a lawful basis for PRANA to collect specific information without incurring a breach of the common law duty of confidence.
The HRA CAG reference numbers for the non-research and research support are respectively: 24/CAG/0012 and 24/SW/0007.
This permission must be reapplied for annually.
The PRANA outcome from the HRA CAG is available at:
Finances
PRANA is financially supported or has received support in kind by:
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Southampton Academy of Research
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Wessex sub-national Secure Data Environment programme
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Clinical Informatics Research Unit, University of Southampton
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Centre for Healthcare Analytics, University of Southampton