gms | German Medical Science

Background: Based on various legal and ethical aspects, e.g. the Declaration of Helsinki and the EU General Data Protection Regulation (GDPR), an informed consent (IC) is required when processing and using sensitive personal data, e.g. health data. Additionally, patients and study participants are sensitized to data protection aspects and expect to be informed and to give their (expressed) consent in order to participate in a research project. Integrating the collection of ICs in existing (clinical) workflows and managing them effectively is becoming an increasingly challenging task. To help meet this challenge, electronic consent management tools are available.

Objective:

1.

Can general requirements for an electronic consent management tool be deducted from literature and practical experience of researchers?

2.

Do existing electronic consent management tools meet the requirements?

3.

Can an electronic consent management tool support (clinical) workflows of planned (e.g. in cohort studies) and unplanned visits (e.g. in registries)?

Method:

• For 1. An interdisciplinary team consisting of researchers from different specialist disciplines, clinicians, ethicists and computer scientists, listed requirements for IC management. This list was complemented by requirements identified by a literature search.
• For 2. An open-source, in-house developed tool as well as various electronic consent management tools from literature were considered. It was assessed whether they met the requirements.
• For 3. Different workflows regarding the un-/planned visits of patients or study participants and, thus, the use of fully electronic or paper-based IC collection were analyzed. The in-house electronic consent management tool was evaluated regarding the adaptability to the resulting workflows.

Results:

1.

The resulting list of requirements regarding electronic consent management tools comprises 18 requirements based on use cases such as the possibility to create, edit and update a fine-granular consent.

2.

An analysis of existing tools for consent management revealed that such tools are a) not always freely available to the scientific community or b) do not cover most of the stated requirements regarding IC management. Regarding a): Some of the considered tools are commercial and, consequently, not applicable for small-scale research projects with limited resources. In addition, applications retrieved from literature are often customized to the specific infrastructure and not accessible from outside the research institute they originated from.
In consequence, a free-of-charge, open-source, customizable electronic consent management tool was developed in-house and made available for download (e.g. via GitHub and Docker). The evaluation showed that this in-house developed tool met all the listed requirements.

3.

This developed electronic consent management tool is used since 2014, and optimized for research and routine care. It supports all clinical workflows: un-/planned visits, fully digital IC collection using signpads as well as paper-based IC collection with the possibility to digitally map and upload scans of the paper-based IC form. To enable the digital mapping of patient’s or study participant’s consent on a fine-granular level, a modular, policy-based approach was used. Each policy represents an aspect, which a patient or study participant can consent to or not as well as withdraw at any time. Consequently, the information about which respective health data a patient or study participant chose to allow for processing and usage is accessible in a digital form. This enables the usage of automated queries for Use and Access as well as facilitates automated data processing and exchange between systems, e.g. for electronic health records.

Discussion: Most electronic consent management tools for research are specifically customized solutions. The arising main problem is the end of tool support after a project’s finalization. Providing a generic, highly customizable electronic consent management tool as open-source, free of charge and, due to Docker, easy to install software tool, ensures reusability in new projects as well as a widespread provision of a consent management tool for the scientific community. Consequently, it supports the collection of Informed Consents and workflows even in small and researcher-driven studies and registries with only a minimum of IT resources.

Practical implications: The developed electronic consent management tool is successfully used to manage more than 250,000 ICs and 1,400 withdrawals in several complex research projects since 2014. For example, it is used within the German National Cohort (NAKO), the Baltic Fracture Competence Centre (BFCC) as well as the German Centre for Cardiovascular Research (DZHK). Furthermore, it will be used within the MIRACUM consortium (Medical Informatics in Research and Care in University Medicine) as part of the medical informatics initiative.