The member university hospitals of the Medical Informatics Initiative (MII) store and manage their data locally, and retain control, with the assistance of their local use & access committee (UAC), over any decision regarding which research projects their data will be made available for. To ensure scientists do not have to approach each site individually to apply for data use for a new project, a central point of administration for the submission and processing of project applications is needed. Against this background, the MII decided to establish a central office that accepts project applications, manages projects, and provides scientists with an overview of the status of their MII projects. The office should also create transparency for patients by acting as a registry to continuously publish a list of all research projects that have been approved based on the Broad Consent of the MII.
Achievements to date:
To integrate the so-called German Portal for Medical Research Data (FDGP) into MII’s infrastructure, corresponding processes and interfaces have been prepared.
Technical implementation of the portal has been carried out by a company. This involves close cooperation with the MII project ABIDE_MI. In this project, a digital feature has been developed that will enable researchers to send fully automated requests for available data to the MII via the German Portal for Medical Research Data (so-called feasibility inquiries). The aim of these requests is to enable researchers to prepare project proposals.
The FDPG offers researchers the opportunity to request data and biospecimens from MII sites centrally. Requests can be made for data based on the MII core data set. This includes a wide range of datasets regardless of indication. During the test phase only scientists from the MII sites may submit feasibility inquiries and data use requests. Starting in Mai 2023, additional researchers may request access to patient data and biospecimens for medical research purposes and submit feasibility requests. When submitting an application, a positive ethics vote from the researcher's institution for the research project is required.
The FDPG has been accessible online since September 2022 at: forschen-fuer-gesundheit.de.
The work took into account requirements of future user groups, i.e., researchers and patients, but also the MII sites that provide the data.
For the technical and organizational implementation of the German Research Data Portal for Health, formerly ZARS, the Data Sharing AG of the MII has drafted a rough concept in 2019, which has been coordinated within the initiative and decided in the NSG.
Download General concept ZARS
version 0.6 (18/01/2019) [PDF | 256 kb]