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A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative

Hampf, Christopher ; Bialke, Martin ; Geidel, Lars ; Vass, Albert ; Bahls, Thomas ; Blasini, Romina ; Blumentritt, Arne ; Boeker, Martin ; Bruns, Christian ; Jandrig, Burkhard ; Fünfgeld, Maximilian ; Heinrich, Philipp ; Leddig, Torsten ; Michel-Backofen, Achim ; Pirkl, Anna ; Rautenberg, Michael ; Simons, Fabian ; Stahl, Dana ; Prokosch, Hans-Ulrich ; Hoffmann, Wolfgang

Translational medicine communications, 2021-03, Vol.6 (1), p.1-11, Article 7 [Periódico revisado por pares]

London: BioMed Central

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Título:
A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
Autor: Hampf, Christopher ; Bialke, Martin ; Geidel, Lars ; Vass, Albert ; Bahls, Thomas ; Blasini, Romina ; Blumentritt, Arne ; Boeker, Martin ; Bruns, Christian ; Jandrig, Burkhard ; Fünfgeld, Maximilian ; Heinrich, Philipp ; Leddig, Torsten ; Michel-Backofen, Achim ; Pirkl, Anna ; Rautenberg, Michael ; Simons, Fabian ; Stahl, Dana ; Prokosch, Hans-Ulrich ; Hoffmann, Wolfgang
Assuntos: Consent management ; Consortia ; Documentation ; GDPR ; General data protection regulation ; Health informatics ; Informed consent ; Medical informatics initiative ; Medical research ; Medicine ; MIRACUM ; Open source software ; Patients ; Questionnaires ; Research data management ; Working groups
É parte de: Translational medicine communications, 2021-03, Vol.6 (1), p.1-11, Article 7
Descrição: Abstract Background The consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved. Methods We used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary. Results The results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes. Conclusions A release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.
Editor: London: BioMed Central
Idioma: Inglês

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A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative

London: BioMed Central

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