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

Area of Science:

• Biomedical Informatics
• Data Governance
• Research Ethics

Background:

• Increasing availability of reusable biomedical data from cohort studies and clinical routine data.
• Data re-users struggle to manage transferred data according to heterogeneous data use agreements (DUAs).
• Current DUAs are unstructured text documents, complicating compliance and daily research practice.

Purpose of the Study:

• To analyze and review existing data use agreements for digital data transfer.
• To identify essential metadata for managing data use, storage, sharing, and publication regulations.
• To propose a structured metadata approach for improved data governance and accessibility.

Main Methods:

• Inspection and review of seven different data usage agreements.
• Focus on digital data that is copied and transferred to the requester's environment.
• Identification of metadata items across key categories: data usage, storage, sharing, and publication.

Main Results:

• Identified 24 essential metadata items across four main categories: data usage, storage, sharing, and publication of results.
• Demonstrated significant overlap in topics covered by DUAs but diversity in specific regulations.
• Highlighted the practical relevance of these regulations for daily research activities and data sharing.

Conclusions:

• A limited set of structured metadata items can significantly improve data accessibility and compliance.
• Structured metadata provides data scientists with crucial information about DUAs alongside transferred data.
• This approach facilitates easier management of data use agreements, even considering trusted research environments.