Biobanking, Data and ELSI

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We address topics related to biobanking, ELSI questions, and biodata management as a basis for molecular epidemiology.

We address topics related to biobanking, ELSI questions, and biodata management as a basis for molecular epidemiology.

Our research group consists of experts in all topics related to biobanking such as ELSI (ethical, legal and social issues), biosample acquisition, processing and storage, data management and access to biosamples.

Quality management and data and quality standards are important aspects in all of these topics. Therefore, we are partner in a number of biobanking projects.

Portrait Bettina Lorenz Depiereux (jpg)

Dr. Bettina Lorenz-Depiereux

Head of Research Group 'Biobanking, Data and ELSI', Senior Scientist

View profile

Porträt Jonathan Adam

Jonathan Adam

Scientist

Porträt Hans Demski

Hans Demski

IT and Data Manager

Dr. Therese Feiler

Scientist, Helmholtz Munich

Porträt Bärbel Fösel

Dr. Bärbel Fösel

Senior Scientist, Project Manager

Porträt Julia Groth

Dr. Julia Groth

Senior Scientist, Project Manager

Kathrin Hill

Technician

Porträt Monika Kraus

Dr. Monika Kraus

Senior Scientist, Deputy Head of Research Group "Biobanking, Data and ELSI"

Lilia Lang

Documentalist

Marc Müller

Project Manager

Ewelina Parchanska

Scientist, Project Manager

Manuela Scheuner

Scientist, Project Manager / Quality Management (QMB)

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.

DZIF / Translational Infrastructure Bioresources, Biodata & Digital Health (TI BBD)

We are part of the Translational Infrastructure Bioresources, Biodata & Digital Health (TI BBD) of the German Center for Infection Research (DZIF) and host important DZIF registries and hubs at Helmholtz Munich.

DZIF Central Biosample Registry (DZIF-ZBR)
DZIF Metadata Repository (DZIF-MDR)
DZIF Data & Tools-Hub (DZIF DT-HUB)

cyber security concept, data protection and secured internet access, cybersecurity

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 / DZHK

We support a wide variety of DZHK funded clincal studies

Integration of the Clinical Research Platform and the DZHK Heart Bank in Patient Information and Consent Documents
Maintenance of the ethics concept of the clinical research section
Support of Use & Access processes of DZHK Heart Bank
Support for the public relations team in the area of patient participation

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.

We have longstanding expertise in the collection of biosamples (blood specimen, urine, feces, saliva and swabs) and in setting up the workflow for (multicenter) studies.

We provide long-term storage at -80°C (chest freezer) and in N2 (liquid nitrogen and in gas phase; quality controlled) as well as picking, aliquoting and delivery of samples stored at our facilities upon your order, and campus wide temperature monitoring.

Blood testing and taking sample for research and examination tiny person concept. Microbiological

We provide SOPs for their collection and processing as well as advice on consumables and workflow design. And we give support with all processes “from needle to freezer”, incl. cost calculation.

We also provide SOPs and information on appropriate transport conditions to observe the necessary safety standards and national laws and guidelines. We hold the ICAO/IATA transport permission according to UN3373 and UN1845.

File Folder Labeled as Guidelines.

The Helmholtz Munich Biobank provides a high qualitiy level for all steps of the biobanking process from needle-to-freezer, which are performed in accordance with standard operating procedures (SOPs) or working protocols and documented (time stamps, deviations) in databases.

Safety measures like access control and temperature devices are installed for the assurance of appropriate storage conditions and the protection of the valuable biosamples. These measures are essential to maintain the high quality of biosamples during long-term storage.

We provide conduction and advice on internal audits, quality control and proficiency tests. We also keep detailled information (e.g. forms and guidelines) available. Our quality management system is based on ISO 20387 and certified according to DIN ISO 9001:2015.

Dartscheibe mit Pfeilen über einer Hand schwebend

We have expertise with appropriate ethics documents and can provide support with broad consent solutions for biomaterial collections and design of ethics documents (patient information, informed consent) for biobanks or for data and biomaterial collections within clinical studies.

The Helmholtz Munich Biobank (ethics and data protection concept) was approved by the ethical commission of Bayerische Landesärztekammer in March 2020.

Examine and study ethics, showed as a magnify glass and word ethics to symbolize process of analyzing, exploring, learning and taking a closer look at ethics, 3d illustration

Biobanking involves management of data on collecting, processing and transport of biosamples as well as on storage, usage and performed analysis (incl. analysis results).

Due to the large number of biosamples and the quantity of data stored in the Helmholtz Munich biobank, the data management is very important for successful project work. We operate various IT systems, e.g. LIMS (Laboratory Information Management System), eCRF (electronic Case Report Forms), issue tracking and temperature monitoring.

We can provide advice on local and individual IT solutions that assist biobanking processes. Provisioning of the biobank information management systems for the administration of decentralised sample storage facilities is possible. Moreover, we are experts in data exchange (e.g. data imports into LIMS) and can give support for data integration.

KPI Dashboard Data Analytics On Business Laptop

Together with the biobanks of the Ludwig Maximilians University of Munich and the Technical University of Munich we form the Joint Biobank Munich and are partner in the German Biobank Alliance (GBA). JBM serves as network for joint projects of the Munich partners with relation to biobanking.

Group of people United Hands to built teamwork together with Spirit - teamwork concepts.

Bialke M, Hampf C, Blumentritt A, [...], Kraus M.

#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research

Devaux Y, Zhang L, Lumley AI, [...], Lorenz-Depiereux B et al.

Development of a long noncoding RNA-based machine learning model to predict COVID-19 in-hospital mortality

Hopff SM, Appel KS, Miljukov O, [...], Lorenz-Depiereux B et al.

Comparison of post-COVID-19 symptoms in patients infected with the SARS-CoV-2 variants delta and omicron-results of the Cross-Sectoral Platform of the German National Pandemic Cohort Network (NAPKON-SUEP)

Steinbeis F, Thibeault C, Steinbrecher S, [...], Lorenz-Depiereux B et al.

Analysis of acute COVID-19 including chronic morbidity: protocol for the deep phenotyping National Pandemic Cohort Network in Germany (NAPKON-HAP)

Tilch K, Hopff SM, Appel K, Kraus M, Lorenz-Depiereux B et al.

Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany

Yusuf KO, Chaplinskaya-Sobol I, Schoneberg A, [...], Lorenz-Depiereux B et al.

Impact of Clinical Study Implementation on Data Quality Assessments - Using Contradictions within Interdependent Health Data Items as a Pilot Indicator

Krefting D, Anton G, Chaplinskaya-Sobol I, [...], Kraus M, Lorbeer R, Lorenz-Depiereux B et al.

The Importance of Being FAIR and FAST - The Clinical Epidemiology and Study Platform of the German Network University Medicine (NUKLEUS)