MAGIC: once upon a time in consent management—a FHIR® tale

Abstract

BackgroundThe use of medical data for research purposes requires an informed consent of the patient that is compliant with the EU General Data Protection Regulation. In the context of multi-centre research initiatives and a multitude of clinical and epidemiological studies scalable and automatable measures for digital consent management are required. Modular form, structure, and contents render a patient’s consent reusable for varying project settings in order to effectively manage and minimise organisational and technical efforts.ResultsWithin the DFG-funded project “MAGIC” (Grant Number HO 1937/5-1) the digital consent management service tool gICS was enhanced to comply with the recommendations published in the TMF data protection guideline for medical research. In addition, a structured exchange format for modular consent templates considering established standards and formats in the area of digital informed consent management was designed. Using the new FHIR standard and the HAPI FHIR library, the first version for an exchange format and necessary import-/export-functionalities were successfully implemented.ConclusionsThe proposed exchange format is a “work in progress”. It represents a starting point for current discussions concerning digital consent management. It also attempts to improve interoperability between different approaches within the wider IHE-/HL7-/FHIR community. Independent of the exchange format, providing the possibility to export, modify and import templates for consents and withdrawals to be reused in similar clinical and epidemiological studies is an essential precondition for the sustainable operation of digital consent management.

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

“…Since the modular approach of gICS provides a high level of granularity, partial withdrawals of single modules and even single policies are possible. As exemplarily shown for the NAKO project in Bialke et al [25] research studies benefit from partial compared to full withdrawals. By providing the participant with the possibility of withdrawing his/her consent partially, analyses based on other policies can still be conducted.…”

“…gICS only supports the management of consent documents as well as permissions and prohibitions (regarding policies) stated by the participant. Using an IC is the responsibility of data management units and study sites [25]. The content of the informed consent and the resulting policies and modules have to be developed by the researcher-support, guidelines and requirements are provided in the literature [29] or at websites from institutions working in data protection.…”

“…However, Table 2 List of requirements for a comprehensive informed consent management (see Table 1) and respective solutions using gICS No. Requirement and/or use case gICS solution 1 Support of a general consent form for a research project By design gICS facilitates to create general as well as project-specific templates for informed consents [25] 2…”

“…This can lead to time-consuming and costly developments in early study phases. Using templates for consents and versioning them as supported by gICS simplifies processes and can reduce the burden on study staff [25]. Furthermore, policies and consent templates tend to be added, edited or even deleted during the duration of long-term studies, e. g. the NAKO project.…”

Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative

“…The same applies to the status codes used by the open source software gICS [27,28], which was developed by the University Medicine Greifswald, Germany and is part of the technical tools used by the MIRACUM consortium to manage informed consents and/or withdrawals. gICS supports the documentation of the required data items and allows to define the necessary validity period of consents.…”