What is a Trusted Research Environment?

Users of a TRE need a consistent way to request access to data and view the status of those requests. Data owners must, where required, be involved in the approval process – and that process must support multiple parties, often geographically dispersed. An orchestrated Data Access Request system will present programmatic request forms to users, automate the approval process, provide consistent feedback to all parties and ensure end-to-end governance.

A TRE must provide owners and researchers the ability to work with complex multi-modal data, such as genomic data, pharma data, medical imaging and structured clinical data. Access to that data must be supported in various ways, either by transfer, secure access to repositories or read-only database access. An enterprise scale TRE provides access to all modalities of data, regardless of mechanism, to the same secure compute environment.

The realities of data sharing across geographical boundaries necessitate the need for the use of federated data platforms. A TRE needs to provide the facility for data owners for controlled federated access to their data, and for researchers, an easy to use and programmatic way of accessing and working with that federated data.

A Trusted Research Environment is a platform designed to provide researchers with a means to collaborate on data analysis securely across their project team. As such, a key component of any TRE is the out-of-the-box-tooling with which users can complete their desired analytical tasks. A Trusted Research Environment is a platform designed to provide researchers with a means to collaborate on data analysis securely across their project team. As such, a key component of any TRE is the out-of-the-box tooling with which users can complete their desired analytical tasks.

Some of the tools available in the Aridhia DRE include data table analytics, with a curated collection of biomedical R modules, R, Python and SQL tooling, such as RStudio and Jupyter Notebook and real-time collaborative Office tools, supporting Excel, Word and Powerpoint. All of these are supported by Git for version management.

Besides out-of-the-box tooling, a Trusted Research Environment must provide the computational resources required to run a range of dedicated complex modelling and analytical pipelines. As such, the TRE must support multi-user access to virtual machine compute capabilities and scalable storage to support high volume multi-modal data analysis.

A TRE must audit user activity, to ensure use of data is aligned with agreed terms and conditions. The audit provides a clear trail of data use, including:

• Dataset creation and upload
• User data request and approval/rejection
• Time of access or transfer to a compute environment
• Acceptance of data use conditions
• Data edit or file creation
• Airlock requests

The entire data journey must be visible via a secure audit mechanism available to platform administrators.

Security is an integral part of all Trusted Research Environments and as such, a TRE and any supporting services must demonstrate that they conform to strict security standards, such as ISO27001 and ISO27701. To provide the peace of mind to data owners and users that their data is safe and secure, audits against these standards must take place frequently and certificates readily available.

The Ardihia DRE is fully compliant with ISO27001, ISO27701, HITRUST standards, making it a globally certified and truly trusted research environment. You can learn more about the security policies of the Aridhia DRE here.