Since their creation in 2016, the FAIR (Findability, Accessibility, Interoperability and Reusability) principles for data management have become the standard for ensuring that research data can be shared with confidence. 

But, good as it is, FAIR cannot, by itself, ensure trust and reproducibility, says Dr. Daniel Burgwinkel, a partner of KRM, the Swiss Information Governance Competence Center. “Recent scandals about tampered or incomplete data have shown that the life science industry has to improve their processes and systems in order that all stakeholders can trust the data,” he says.

Data integrity is ever more important with the growing use of AI/Machine Learning in data retrieval and analysis and of cloud-based platforms that allow scientific collaboration, speed up the R&D process and open new opportunities for safety assessment. This technology offers scope, scale and speed in research that would be humanly impossible. On the other hand, data must be formatted to be “understandable” and “actionable” for machines. Without the ability to share data and to trust in data integrity, the promise of this new technology could be compromised. 
 
But Dr. Burgwinkel sees a solution: combine FAIR principles with blockchain technology. “By providing metadata management solutions linked to workflow sub-task processing of datasets, blockchains can ensure privacy, access, provenance, integrity and completeness,” he explains.

Evidence = trust

At OpenTox Euro (October 29-31) in Basel, Dr. Burgwinkel will demonstrate a case study of how this combination can work. “Our case study builds on preliminary work by Edelweiss Connect, in collaboration with regulatory experts, to create best practices for trusted, reproducible scientific workflows. These workflows create evidence to be used in future regulatory evaluation.”

"The EdelweissData™ platform can offer functionalities to increase the trust level for research data”

The case study makes use of Edelweiss Connect’s EdelweissData™, a software solution that offers seamless sharing of data and metadata. The cloud-based platform prepares, curates, harmonises, standardises and brings together data from different formats, different sources and different labs. “The EdelweissData™ platform can offer functionalities to increase the trust level for research data,” says Dr. Burgwinkel.