The collection, processing and use of medical research data usually requires an informed consent of the person concerned, the so-called Informed Consent (IC) (see Art. 6-11 EU-GDPR). In the context of constantly growing national and international research initiatives, a reliable and efficient procedure for the digital administration of consents and revocations is necessary.
The gICS was developed for this purpose by the Trusted Third Party Greifswald. It can be integrated into both paper-based and purely digital workflows, and is used to process consent and revocation in the study context. In practice, it’s a good idea to combine single content- or logically related process steps of data processing (policies like collecting, transferring and storing data) into modules (e.g. module “Data Handling”). In gICS, templates represent an uncompleted but structured consent document. It contains modules that can be agreed to or declined by the participant as well as additional information of the consent (answer options, mandatory modules, free texts, etc.).
Documenting consents
Digital consent can be documented via SOAP and FHIR interface, web interface or as an automatically imported scan. The signature can also be added digitally or attached as a scan.
Managing consents
Digitally documented consents can be checked, processed and evaluated via the SOAP interface and the web interface.
Creating templates
Templates for digital consents consisting of selectable modules, texts and other options can be created via the web interface.
Module system
Due to the modular approach of the gICS, a large number of policies can be combined into comprehensible modules, which are displayed to the participant on consent templates.
Who uses the gICS?
The diagram shows productive (green) and planned projects (light green).
Date: June 2024
You are interested in our gICS? You can either try it out online in our demo or install it via Docker.