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Bialke, M.* ; Hampf, C.* ; Blumentritt, A.* ; Moser, F.M.* ; Lang, S.* ; Stehn, A.* ; Sargsyan, E. ; Hoffmann, W.* ; Kraus, M.

#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research.

Int. J. Med. Inform. 190:105545 (2024)
Verlagsversion DOI PMC
Open Access Hybrid
Creative Commons Lizenzvertrag
INTRODUCTION: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries. MATERIALS AND METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability. RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented. CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Consent Management ; Consent Registry ; Eu Gdpr ; Fhir ; Informed Consent ; Medical Data Management ; Opt-in ; Opt-out ; Patient Rights ; Semantic ; Terminology
Sprache englisch
Veröffentlichungsjahr 2024
HGF-Berichtsjahr 2024
ISSN (print) / ISBN 1386-5056
e-ISSN 1872-8243
Quellenangaben Band: 190, Heft: , Seiten: , Artikelnummer: 105545 Supplement: ,
Verlag Elsevier
Begutachtungsstatus Peer reviewed
Institut(e) Institute of Epidemiology (EPI)
POF Topic(s) 30202 - Environmental Health
Forschungsfeld(er) Genetics and Epidemiology
PSP-Element(e) G-504091-004
Scopus ID 85198501351
PubMed ID 39018708
Erfassungsdatum 2024-07-25