The generic Informed Consent Service gICS®: implementation and benefits of a modular consent software tool to master the challenge of electronic consent management in research

• DOI: 10.1186/s12967-020-02457-y
• Publication Date: 2020-07-29T12:02:39Z
• Authors: Henriette Rau; Lars Geidel; Martin Bialke; Arne Blumentritt; Martin Langanke; Wenke Liedtke; Sandra Pasewald; Dana Stahl; Thomas Bahls; Christian Maier; Hans-Ulrich Prokosch; Wolfgang Hoffmann
• Keywords: Informed Consent; Research; General data protection regulation; R; Research Personnel; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Medizinische Fakultät; Research Design; Consent management; Medicine; Humans; ddc:610; Informed consent; GDPR; Electronics; Software

Abstract Background Defining and protecting participants’ rights is the aim of several ethical codices legal regulations. According to these regulations, Informed Consent (IC) an inevitable element research with human subjects. In era “big data medicine”, aspects IC become even more relevant since becomes complex rendering compliance regulations increasingly difficult. Methods Based on literature practical experiences gathered by Institute for Community Medicine (ICM), University Greifswald, requirements digital consent management systems were identified. Results To address requirements, free-of-charge, open-source software “generic Service” (gICS ® ) was developed ICM provide a tool facilitate enhance usage ICs international community covering various scenarios. gICS facilitates based modularisation supports workflows within research, including (1) electronic depiction paper-based consents (2) fully consents. Numerous projects applied documented over 336,000 2400 withdrawals 2014. Discussion Since consent’s content prerequisite securing rights, application no guarantee compliance. However, fine-granular accommodation differentiated states, which can be directly exchanged between systems, allowing automated processing. Conclusion simplifies sustained as major key successfully conduct studies build trust in Therefore, interested researchers are invited use feedback further improvements.