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

A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
Research
Christopher Hampf, Martin Bialke, Lars Geidel, Albert Vass, Thomas Bahls, Romina Blasini, Arne Blumentritt, Martin Boeker, Christian Bruns, Burkhard Jandrig, Maximilian Fünfgeld, Philipp Heinrich, Torsten Leddig, Achim Michel-Backofen, Anna Pirkl, Michael Rautenberg, Fabian Simons, Dana Stahl, Hans-Ulrich Prokosch, Wolfgang Hoffmann
Translational Medicine Communications, 8 March 2021; 6(7)
Open Access
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.

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