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Updated: May 24, 2026
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Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
A FHIR Consent Profile for European Research Biobanks
Alessandro Sulis1, Cecilia Mascia1, Giovanni Delussu1
1CRS4, Center for Advanced Studies, Research & Development in Sardinia, Pula, Italy.
Studies in Health Technology and Informatics
|May 23, 2026
Summary
We developed a digital dynamic consent profile using HL7 FHIR standards to integrate participant preferences for biobanked samples. This approach supports data reuse without significant performance impact, enhancing research participation.
Area of Science:
- Health Informatics
- Biobanking Research
- Data Management
Background:
- Digital dynamic consent is crucial for participant engagement in research.
- Standardized information models are needed to facilitate data reuse in biobanking.
- Integrating consent preferences into research infrastructure is complex.
Purpose of the Study:
- To present the HL7 FHIR Consent Profile for integrating individual consent preferences into the BBMRI-ERIC infrastructure.
- To enable better participant involvement and data reuse in biobanking.
- To validate the effectiveness and performance of the developed consent profile.
Main Methods:
- Developed an HL7 FHIR Consent Profile based on the official FHIR Consent Resource.
- Utilized Common Condition of Use Elements (CCE) terminology to represent participant consent.
- Conducted a preliminary performance evaluation on a minimally optimized setup.
Main Results:
- The HL7 FHIR Consent Profile effectively integrates consent preferences for biobanked samples and related information.
- Preliminary evaluation indicates no significant performance overhead when using the profile's attributes in queries.
- The profile is available online with demonstrative tools for broader adoption.
Conclusions:
- The HL7 FHIR Consent Profile is a viable solution for managing digital dynamic consent in biobanking.
- This approach supports data reuse and enhances participant engagement in research.
- The profile is set for validation in a larger pilot project within BBMRI-ERIC.
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