What standards are we adopting?

These standards have been selected based on relevance and prevalence to the research data infrastruture domain. Included below is a brief description of what these standards are and why they have been adopted.

Five Safes

A set of principles to describe how decisions about granting access to data should be made. Covering Safe People, Data, Project, Outputs, Settings it is a set of interlocking principles
HDR UK have been a major proponent of the adoption of these principles across the UK health data eco-system. It has become the default mechanism across most domains and is the governance framework in which access decisions are made for HDR UK and DARE UK.

Findable Accessible Interoperable Reusable (FAIR)

A set of principles that describes guidelines to improve transparency, reproducibility, and reusability of data, metadata and infrastructure.
Defines what information should be provided about the data in order to help that reuse, called metadata (data that describes data)
Significant adoption with the open life sciences community
Becoming the default requirement in all research programmes to ensure data is FAIR

For both HDR UK and DARE UK, FAIR is a key principle and both organisations are promoting FAIR as an essential requirement in the eco-system. They are funding programmes to understand what metadata is appropriate and possible to collect across secure data environments.

At first glance it may seem challenging to implement the FAIR principles for sensitive data under access control, however the FAIR principles permit access control for data, but with a primary goal of the metadata being openly available.

In particular, within HDR Federated Analytics, we are collaborating with DARE TREvolution in a series of requirement and capability gathering exercises, working with TREs to build a joint understanding and common approach, guidelines and tooling to implementing “just enough” FAIR within the constraints of secure TRE operations.

Global Alliance for Genomics and Health (GA4GH)

A joint academic and industry programme
Health Data Research UK and GA4GH have a strategic partnership
Pre-competitive work to enable global analysis of genomic data
Produced international standards

HDR UK and DARE UK have funded programmes to understand if the standards developed in GA4GH can be used in wider data environments, and especially within secure data environments for sensitive data.

The Federated Analytics programme in HDR UK and the TREvolution programme in DARE UK have MVPs to demonstrate the utility of these standards beyond health.

Task Execution Service (TES)

Provides a standard mechanism for orchestrating complex analyses across different compute environments

Research Object Crate (RO-Crate)

A collaborative approach to use Web standards for packaging data with structured metadata
Rich support for describing provenance (e.g. attribution, workflow executions)
Support FAIR principles with programmatic consumption/generation of metadata and content
Platform-independent and Archivable for long-term storage
Extensible with domain-specific metadata profiles
Used and supported by a large range of international research projects, open source tools and data repositories

We are using (and further developing) RO-Crate in HDR UK and DARE UK to achieve:

Transparency of internal TRE processes (e.g. evidence of disclosure control)
Records of TRE use as part of Information Governance, e.g. to populate data usage registry or aggregate into a TRE dashboard
Reproducibility of computational analysis, if captured as an embedded workflow
Interoperability across disparate existing systems, in particular as a common format between different TRE implementations

In particular, we have developed the Five Safes RO-Crate profile as a FAIR approach to document and support Five Safes principles, initially in the context of computational workflows. We are working further, in collaboration with our FAIR engagement work, to expand this profile to evidence any computational execution and data extract, as well as a new profile (TRE Crate) to document TRE datasets (e.g. linking to OMOP specifications of variables, and populating the HDR Gateway).

Related publications:

Observational Medical Outcomes Partnership (OMOP)

A standard that describes how health data should be grouped together in a set of common tables (a common data model)
Created and maintained by Observational Health Data Sciences and Informatics (OHDSI)
Adopted by NHS England Secure Data Environment programme
Used as a global standard for real world data studies

HDR UK have supercharged the UK efforts in the adoption of OMOP, by funding the conversion of data to OMOP, helping to establish OHDSI UK, and by the establishment of the real-world evidence framework.

The Federated Analytics programme in HDR UK have open-source tools in production that support the conversion of data to OMOP and the discovery of OMOP datasets globally. These are being developed further in DARE UK to demonstrate how they can be deployed across multiple secure data environments.