This article is the first in a series of articles about trusted research environments (TREs), and their uses and benefits.
Successful precision medicine efforts require population-level data volumes to build robust models, help discover associations, and develop insights that ultimately impact patients. Collecting data at this scale is often done in collaboration with multiple sites and researchers. To enable these teams, a Trusted Research Environment (TRE), also known as a Secure Data Environment (SDE) or a Data Safe Haven, ensures researchers can access, analyze, and collaborate with the data in a protected and secure environment.
TREs are secure digital spaces where sensitive data can be accessed, analyzed, and shared without compromising privacy or security. It acts as a fortress, safeguarding the data while enabling researchers to collaborate on projects that require access to confidential or proprietary information. By setting stringent access controls and using advanced technologies such as data loss prevention systems and anomaly detection tools to monitor data usage, TREs ensure that only authorized personnel can view or manipulate the data.
TREs are not just about data security. They are about building a collaborative research community. As data volumes grow, TREs provide a framework for collaboration, trust and accountability, spanning different organizations and jurisdictions. TREs offer a harmonized approach to data governance, ensuring all collaborators adhere to the same standards and protocols for data security and privacy.
The Architectural Essentials of Trusted Research Environments
At its core, a TRE includes physical and virtual layers of protection: secure servers, encrypted data transfer, and robust user authentication. Data access, and usage, and export are strictly regulated through role-based access control, ensuring users only interact with the data necessary for their research.
Moreover, TREs should incorporate audit trails and real-time monitoring to trace data access and use, providing transparency and accountability. Figure 1 below illustrates how DNAnexus has worked with organizations to develop TRE solutions; the architecture of any specific TRE will depend on the needs of the host and the collaborators. These architectural essentials not only protect against external threats, but also prevent internal misuse or accidental exposure of sensitive data, maintaining research integrity.
Figure 1: DNAnexus TRE architecture
Enhancing Data Privacy and Security in Collaborative Research
In research collaboration, protecting participant privacy and securing data against breaches are paramount. TREs address these issues by implementing strict protocols that comply with legal and regulatory standards, such as ISO 27001, GDPR and HIPAA. TRE data is anonymized or pseudonymized to protect individual identities, and security measures are constantly updated to combat evolving cyber threats.
Watch the video below to learn more about what makes a TRE useful.
Case Studies: Successful Implementations of Trusted Research Environments
Examples of successful TRE implementation underscore their value in diverse research domains. For instance, the UK Biobank TRE, which uses the DNAnexus Platform, allows groundbreaking studies in public health by providing a secure TRE for researchers to access population health data. Similarly, the YODA Project, a TRE initiative from Yale University, provides access to clinical trial data from pharmaceutical companies, ensuring external researchers can contribute to medical advancements while maintaining patient confidentiality. These are just a few examples of how TREs are being used in real-world research settings, in our following blog posts we will take a closer look at some individual TREs, how they serve their individual research collaborators, and how we expect the landscape of TREs to evolve over time.
These examples demonstrate that TREs are not just about security and privacy. They are about fostering innovation. By enabling access to high-quality, sensitive datasets, TREs open doors to new research possibilities. The success of these environments in facilitating research that informs policy changes and advances scientific knowledge stands as a testament to their potential. This potential should excite you about the future of research and the role TREs can play in driving innovation.
