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Uniform Consent: Revolution in Medical Research!
The JLU Giessen and the UKGM are introducing Broad Informed Consent for data protection-compliant research, funded by the BMBF.
Uniform Consent: Revolution in Medical Research!
On March 12, 2025, the Justus Liebig University of Giessen (JLU) and the University Hospital of Giessen (UKGM) took a significant step in medical research. They introduce a uniform declaration of consent, Broad Informed Consent (BIC). This new model aims to make the use of patient data and biosamples for medical research standardized and data protection compliant. The BIC replaces the previous consent models that were used in the clinic and cooperating hospitals. The initiative is funded by the Federal Ministry of Education and Research (BMBF) and is part of the Medical Informatics Initiative (MII), which has been setting up data integration centers at 29 university hospitals nationwide since 2018.
Those responsible, including Prof. Dr. Till Acker from MIRACUM and Prof. Dr. Kurt Marquardt of the UKGM, underline the importance of the BIC for medical research. Standardized consent makes patient data more available, which not only accelerates the research process but also promotes innovative therapies. It is particularly important to work closely with existing biobanks that store biosamples in order to develop targeted diagnostic and therapeutic approaches.
Data protection and cooperation
The development of the BIC involved experts such as Dr. Clemens Ruppert from the UGMLC biobank and Prof. Dr. Andreas Günther from eurILDbank. A central element of the process is the data protection review, which ensures the protection of sensitive patient data. Specialized biobanks such as the UGMLC biobank, CCC biobank, cardio biobank and neuro biobank are organized in the FB11 biobank. The clear division of tasks enables efficient management of consent and patient data.
The Charité – Universitätsmedizin Berlin also plays a central role in the MII. This institution works to optimize digital networking to combat disease. During their stay, patients receive comprehensive information about the declaration of consent, which can be revoked at any time without affecting their treatment. The data generated is collected over five years and may be stored for research purposes for up to 30 years.
Future of medical research
MII's innovation strategies aim to advance individualized medicine. By specifically characterizing patients, tailor-made therapies are to be developed that increase treatment success and reduce side effects. There are also efforts to link biosample information with patient data to further support research. The networked project “Aligning Biobank and DIC efficiently” (ABIDE_MI) has been tasked with implementing these connections since May 2021.
The creation of a sustainable data infrastructure at university hospitals is also considered very important. ABIDE_MI participates in the coordination of the medical informatics initiative and aims to build a central online portal for the management of biosamples in the healthcare sector. This is intended to serve as a contact point for researchers and make it easier to apply for research projects.
In summary, it is clear that the introduction of the BIC and the work of the MII make an important contribution to improving patient data availability and promoting medical research in Germany. The collaboration between universities and clinics will be the basis for future-oriented developments in the health sector and expand access to innovative therapeutic approaches internationally.