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#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in
Martin Bialke1, Christopher Hampf1, Arne Blumentritt2
1Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475 Greifswald, Germany.
International Journal of Medical Informatics
|July 17, 2024
Summary
A new Semantic Consent Code (SCC) standardizes patient data permissions across research networks. This code enables easier querying of consent data, improving data accessibility for research projects.
Area of Science:
- Health Informatics
- Bioethics
- Data Management
Background:
- International research networks use varied patient consent approaches, complicating data usage for new projects.
- Existing consent management is time-consuming and lacks cross-project queryability.
- A need exists for a standardized, queryable patient consent framework.
Purpose of the Study:
- To develop a permission-based (Opt-In) approach for mapping and querying patient consent and withdrawal.
- To create a standardized semantic terminology for consent policies.
- To enhance data accessibility and usability in research networks.
Main Methods:
- Analysis of current research approaches and reusability of consent policies.
- Abstraction of selected process models for consent policy definition.
- Development and expert validation of a standardized semantic terminology for consent policies.
- Evaluation of the developed code for applicability.
Main Results:
- A 3-axis (CLASS, ACTION, PURPOSE) Semantic Consent Code (SCC) was developed and published.
- The SCC demonstrated value using real-world consents from national research associations.
- Successful evaluation of manual and automated consent mapping and interpretation using the SCC.
- A concept for simplifying consent queries in diverse research settings was presented.
Conclusions:
- The Semantic Consent Code (SCC) has shown successful initial evaluations.
- The 3-axis SCC is a foundational step towards standardizing diverse consent texts.
- Iterative extension of the SCC with community input is recommended for broader adoption and functionality.
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