Reusing Biomedical Data as Agreed - Towards Structured Metadata for Data Use Agreements.

Abstract

Introduction: With increasing availability of reusable biomedical data - from cohort studies to clinical routine data, data re-users face the problem to manage transferred data according to the heterogeneous data use agreements. While structured metadata is addressed in many contexts including informed consent, contracts are to date still unstructured text documents. In particular within collaborative and active working groups the actual usage agreement's regulations are highly relevant for the daily practice - can I share the data with colleagues from the same university or the same research network, can they be stored on a PHD student's laptop, can I store the data for further approved data usage requests?

Methods: In this article, we inspect and review seven different data usage agreements. We focus on digital data that is copied and transferred to the requester's environment.

Results: We identified 24 metadata items in the four main categories data usage, storage, and sharing, as well as publication of results.

Discussion: While the topics are largely overlap in the data use agreements, the actual regulations of the topics are diverse. Although we do not explicitly investigate trusted research environments, where data is offered within an analytics platform, we consider them a as subgroup, where most of the practical questions from the data scientist's perspective also arise.

Conclusion: With a limited set of structured metadata items, data scientists could have information about the data use agreement at hand along with the transferred data in an easily accessible way.