The Implementation of Broad Consent at University Hospitals

The provision and use of patient data for research and precision medicine purposes is a key prerequisite for evidence-based and patient-centered medicine. As a result of the digitalization in the healthcare sector, many routine data are available now in digital form. These data can be used for research purposes once patient consent has been obtained in accordance with the General Data Protection Regulation (GDPR). As part of the German Medical Informatics Initiative, which was initiated by the German Federal Ministry of Education and Research (BMBF, Bundesministerium für Bildung und Forschung), IT infrastructures and data processing concepts were established that enabled the provision of these data for medical research purposes in a user-friendly, quality-assured and data protection-compliant manner via Data Integration Centers (2). This led to the development of the Broad Consent (BC) which enables patients to decide on the use of their treatment data, health insurance data and biomaterials (such as tissue and body fluids) in future, not yet defined research projects, as well as on whether they agree to be potentially contacted (3). Independent Trusted Third Party (TTP) offices were set up at the University Medicine sites for possible revocations and the administration of these BCs. In this evaluation study, we retrospectively examined the integration of BC into the regular in-patient stay setting at the Dresden, Erlangen, Halle, and Magdeburg University Hospitals. The findings of our study are intended to facilitate the introduction of BC at other sites and make BC available to patients nationwide.

Methods

The consent process for the BC was implemented at the four sites in stages and has continuously been advanced since then. Depending on the site, the BC is obtained either paper-based or digitally, either in the central patient admission unit or directly in the departments. For an accelerated consent process, at one site, patients are sent information material by mail in advance or have it available in the waiting areas or online. In some hospitals, the BC is already sent when an appointment is made together with the usual documents. The consent status is recorded in the hospital information system (HIS), enabling easier administration and targeted patient contact for studies. At several sites, staff were recruited to streamline the process and prevent delays in patient admission (Table 1). The current BC version (version 1.7.2) (4) consists of four modules: patient data, health insurance data, biomaterials, and consent to recontacting for follow-up studies.

Table 1

Process for obtaining and processing Broad Consent (BC) at the four university hospital sites Dresden, Erlangen, Halle, and Magdeburg

Results and discussion

At the four sites, a total of 24 875 valid BCs were obtained in the period from March 2021 to August 2024, of which 90% were from in-patients. The processes, particularly those relating to digitalization, were further developed over this period. As of August 2024, the monthly rates of obtained BCs were 766, 175, 387, and 740 at the Dresden, Erlangen, Halle, and Magdeburg sites, respectively. Table 2 shows the approval and rejection of consent by the respondents combined for all four sites. The mean approval rates were higher than 80% for all submodules, except for the submodules 1.3 and 3.4, which focus on the transfer of BC data to third countries and are not recorded at all sites. Overall, the proportion of BC revocations was 0.4% over the entire period. At the four sites, relatively similar approval rates were found for submodule 1.1 (consent in principle to the collection, storage and further processing of medical data) as well as the health insurance data (2.1 and 2.2) und recontacting (4.1 and 4.2) modules. Major differences were noted between module 1.2 and module 1.3. The submodules 3.3 and 3.4 were only recorded in Erlangen where BCs are also already obtained from outpatients, albeit to a minor extent.

Table 2

Distribution of consents to the individual modules of the BC, summarized for the four university hospital sites Dresden, Erlangen, Halle, and Magdeburg

BC implementation is complex and time-consuming. Many university hospitals and data integration centers started implementation of the BC several years ago. Our study is intended to add data on procedural effects and site-related differences to the findings published by Zenker et al. (5), presenting cumulative BC findings for 27 university medicine sites. So far, the goal of making the BC available to all patients has neither been achieved at any of the four evaluated sites nor at any German university hospital, as far as we know. At the various sites, the BC was implemented at different time points and using varying processes. In our evaluation study, the BC rates at the investigated sites ranged between 5% and 24% of in-patient admissions; outpatient admissions were not taken into account due to their insignificance. At the Marburg site, the switch to a digital process resulted in optimized staff utilization and an increased consent rate. Consent to the use of biomaterials and pseudonymized data was high, as was consent to being recontacted for follow-up studies, whereas the consent rates were significantly lower for third country data modules. Our results are intended to help with optimizing the process of obtaining BC, especially in the context of the German Health Data Utilization Act (GDNG) which aims to facilitate the utilization of patient data on the national and European levels.

Acknowledgement

We would like to thank Stefan Krötki (technical support), Giulia Pelz, Prof. Daniela Dieterich and Yannic Zeller (support with patient information), Diana Hartmann and Stefanie Conrad (administrative tasks in the Independent Trustee Office [THS]).

Funding

This publication was supported by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) as part of NUM: “NaFoUniMedCovid19“ funding code: 01KX2021 Project: [COVID-19 Data Exchange Platform—NUM-CODEX+] and by the MIRACUM and SMITH projects as part of the Medical Informatics Initiative (Medizininformatik-Initiative, MII) funding codes: 01ZZ1801H and 01ZZ1803N.

Tim Herrmann, Johannes Mallow, Markus Plaumann, Rüdiger Lehmann, Sebastian Baecke, Jakob Berger, Marko Rak, Martin Franke, Philipp Heinrich, Daniel Tiller, Anna Pirkl, Johannes Bernarding, Christian Bruns

Institute of Medical Data Science (Herrmann, Mallow, Baecke, Berger, Bruns), Institute for Biometry and Medical Informatics (Plaumann, Lehmann, Bernarding), Otto-von-Guericke-University Magdeburg, Magdeburg, Germany, [e-mail]

IT and Medical Technology Division (ITMT), University Hospital Magdeburg, Magdeburg, Germany (Rak, Franke)

Independent Trustee Office, Department of Medicine and University Hospital
Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany (Heinrich)

University Hospital of Halle (Saale), Zentraler Dienst 1—Information and Communication, Data Integration Center, Halle, Germany (Tiller)

Independent Trusted Third Party Office of the Universitätsklinikum Erlangen, Erlangen, Germany (Pirkl)

Conflict of interest statement
The authors declare that no conflicts of interest exist.

Manuscript received on 24 September 2024, revised version accepted on 28 April 2025.

Translated from the original German by Ralf Thoene, M.D.

Cite this as:
Herrmann T, Mallow J, Plaumann M, Lehmann R, Baecke S, Berger J, Rak M, Franke M, Heinrich P, Tiller D, Pirkl A, Bernarding J, Bruns C: The implementation of broad consent at university hospitals. Dtsch Arztebl Int 2025; 122: 338–9. DOI: 10.3238/arztebl.m2025.0078

References

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