Biobanking, Data and ELSI

DZIF / Unit Liquid Biobanking

​The German Centre for Infection Research (DZIF) Liquid Biobanking is located at Helmholtz Munich and responsible for all issues related to the collection of liquid biosamples. Our goal is to provide safe, high-quality, authenticated and standardised biospecimens for DZIF projects and external partners.

DZIF / Transplant Cohort​ (Tx)

​At Helmholtz Munich we are responsible for long-term storage of the biosamples collected at the two Munich Tx partner clinics LMU and MRI as well as for the harmonized, quality-controlled collection of biosamples at all five partner sites by providing joint SOPs and conducting annual audits. Moreover, we host the DZIF Central Biosample Register (DZIF-ZBR), for central data storage and administration of the DZIF Tx-cohort sample collection and further DZIF studies.

ELSI (Ethical, Legal and Social Issues) / Ethics Coordination (EC)

Clinical studies, registers and cohorts, collect a wealth of quality-assured health data and biosamples. Participants’ consent provided, using this data for secondary research projects efficiently utilizes existing resources and is increasingly encouraged.

Ethics coordination as part of research data infrastructures

We accompany clinical studies and dedicated infrastructures from project planning onwards and are responsible for the integration of infrastructural, ethical and data protection aspects of the processing and use of patient data and biosamples by the research infrastructure into patient documents. We further provide ELSI consultation to ensure that applicable regulatory frameworks allow secondary use of data collected as part of and additional to clinical studies and managed by large national research data infrastructures.

To support Interoperability, consent contents are translated into machine-readable code enabeling the implementation of automated processes, such as bulk consent querying as part of secondary research requests. We further provide Consulting for ethical and regulatory aspects of (emerging) topics in clinical research such as OMICS, record linkage, health insurance data, new legislation, patient involvement, among other.

These topics were adressed as part of the research data infrastructures of the German Centre for Cardiovascular Research (DZHK) and the NUM Clinical Epidemiology and Study Platform (NUKLEUS) of the German Network University Medicine (NUM) in a continuously changing environment over the past 10 years and counting.

ELSI / NUM NUKLEUS

NAPKON 1.0/2.0: The National Pandemic Cohort Network (NAPKON) was initiated in July 2020 during COVID pandemic conditions within the framework of the University Medicine Network (NUM) and bundles previously decentralized national research activities in a common framework of cohorts and infrastructures.

NAPKON-TIP (NAPKON Therapeutic Intervention Platform): The project aims to establish an infrastructure for adaptive clinical platform studies in Germany. Using the recruitment network established in NAPKON and the NUKLEUS infrastructure, successful concepts from international study platforms are to be integrated and adapted to the national and NUM legal contexts.

RACOON FADEN (NUM Radiological Cooperative Network - Early detection of adenomyosis): The clinical trial investigates validated radiological features after MRI examination for the early detection of adenomyosis in young patients and aims to establish an infrastructure for the extraction of imaging biomarkers of the uterus for scalable use. For this purpose, the two NUM infrastructures RACOON and NUKLEUS joined forces.