FOCUS-5: Federating Operations and Collaborations Using the Five Safes

This is creating a growing need to conduct data analysis across large populations. This requires doing research across multiple datasets, which remains challenging and something the NHS Secure Data Environment programme and projects like ours are trying to fix. A key part of this difficulty is due to a lack of consistency in the way we document and deliver data analysis across a large network. Details such as: 

• what data you hold, 
• how to manage risks, 
• meet data protection requirements, 
• and do an analysis. 

This bundle of information is called a “Research Object”. 

A lack of standard “Research Objects” affects how we implement security standards and ensure consistency and alignment of decision-making across different platforms. Something we know is critical to maintaining the public’s trust in the use of their health data. Therefore, we need a common language and approach to doing this kind of research. Which is also known as “federated research”. Research conducted across multiple Secure Data Environments (“SDEs”). 

We have a framework called “the Five Safes”, which provides a structure and set of principles to help manage privacy risks when working with sensitive data. It supports the development of multiple layers of protection. Enabling safe and effective use of data. A common language that is increasingly understood by health data researchers and data privacy experts. So we want to build upon this.

To implement this framework more consistently, a project known as TRE-FX introduced “Five Safes Research Object Crates” (5SROCs). These crates track data and analysis history both within and outside secure research settings. Building on that work, our project “FOCUS-5” will explore how these crates can be used in the NHS Secure Data Environments—such as those in Lancashire and South Cumbria and in Wessex—to enable federated analysis. The project will integrate these “Five Safes Research Object Crates” into DataSHIELD. Supporting privacy-focused data analysis across multiple sites and large networks.

Our key aims are:

1. Standardised documentation: FOCUS-5 will enhance and validate 5SROCs for use in NHS Secure Data Environments, ensuring consistent methods for documenting data handling, governance, and risk management.
2. Federated analysis integration: The project will create a blueprint for integrating 5SROCs with DataSHIELD and other similar tools, improving how researchers track and manage data workflows across multiple environments.
3. Public engagement: FOCUS-5 will produce open-access materials that explain federated data access in clear, accessible terms, emphasising privacy-preserving methods rather than simply sharing data.
4. Path to wider adoption: By providing roadmaps for incorporating 5SROCs into more secure environments, FOCUS-5 supports broader adoption of standardised, secure practices in healthcare research.

Project information

Lead organisation: University of Liverpool
Principal investigator: Dr Becca Wilson
Project duration: 14 months
Project partners: Lancashire Teaching Hospitals Trust (Lancashire and South Cumbria Secure Data Environment), Wessex Secure Data Environment, Arjuna Technologies Ltd, Epigeny
Funding provided: £399,960.63
Primary contact email: jamie.o-brien@liverpool.ac.uk  (Cc Paula Irving (PA to Dr Becca Wilson): paula.irving@liverpool.ac.uk)

Relevant links

• DataSHIELD Website
• DataSHIELD LinkedIn
• Wessex SDE
• Lancashire and South Cumbria SDE LinkedIn