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

Abstract

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

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

“…The consent management is an essential component in supporting the realisation of the patient's rights. At present consents or withdrawals are still paper-based, which makes automated processing difficult [8]. Consents are also often customised for a specific study, which limits the comparability [8].…”

“…At present consents or withdrawals are still paper-based, which makes automated processing difficult [8]. Consents are also often customised for a specific study, which limits the comparability [8]. A digitalised consent management enables a research institution to organise consents centrally and allows easy searches for patients with a specific consent state [9].…”

“…Within MIRACUM, various available open-source tools are orchestrated in a collection called Medical Informatics ReusAble eCosystem of Open source Linkable and Interoperable software tools (MIRACOLIX) [1,11]. The generic Informed Consent Service (gICS®) [8] is one part of this collection. gICS follows the principles of "privacy by design" [10,12] and supports the digital-and paperbased management of consents.…”

“…The gICS provides the actual status of each consent policy for every patient at any given point in time. The status is updated if the patient changed parts of their consent forms or completely withdraws from their participation in a study [8]. The digital collection of consents is supported by the opportunity to sign electronically and store relevant information to reproduce signatures.…”

“…The gICS recognizes the templates automatically and documents the contents with the respective study [9]. Rau et al already compared gICS with several approaches for consent management in terms of advantages and disadvantages [8].…”