(Letzte Aktualisierung: 12.07.17)
Biobanking and molecular medicine
Facilitating analysis
Molecular medicine issues are a central challenge for patient-oriented medical research and thus an important common field of activity for TMF researchers.
Studies at molecular level are playing an ever-growing role in biomedical research and are also becoming increasingly important for the diagnosis and treatment of individual patients. In the long term basic research and clinical practice in this field will mesh to a greater extent: results from basic research together with clinical findings from well characterized patient cohorts will result in an improved understanding of different diseases.
Comprehensive biobanking forms the basis for the linkage of cell biology data and clinical data. And indeed a wide range of such biobanking structures are currently being developed by the medical research networks of the TMF. However, their increasing importance and widespread use means that the questions, requirements and need for regulation in connection with these collections have also grown.
Numerous factors have contributed to this:
- Modern molecular high-throughput analysis techniques that make it possible to obtain an increasing amount of "more individual" data from human sample material.
- Increased networking of cross-institutional medical research, which brings with it new organizational forms for data and sample collection and consolidation.
- The data protection legislation in Germany that has been in place since the 1990s and the associated enhanced awareness among the population which, in turn, requires precise and transparent regulations to protect and guarantee the rights of patients and volunteers.
The members of the TMF recognized at an early stage that this issue is one of the key challenges for networked medical research and is thus an important common field of activity. Following the first appraisals in 2003 and 2004, as of 2005 a major project was carried out within the TMF in order to clarify the legal, ethical and organizational infrastructure for biobanking development and operation. Documentation in the form of expert opinions, action checklists and specimen texts on the various aspects is now available to researchers:
- Categorization and modeling of biobanking projects
- Legal framework
- Data protection concepts
- Informed consent declaration
- Biobanking quality assurance
Today, it is becoming more and more common for medical research network projects to go beyond national boundaries. For this reason, last year the TMF biobanking working group initiated a project to clarify the legal framework for the forwarding of material from German donors to cooperative biobanking centers in, to start with, European partner countries. Another ongoing project aims to create a German medical biobanking register.
In another research process, high-dimension molecular data is being created that is being linked with clinical data in a patient, trial and center context. Within the TMF as the umbrella organization, researchers are working together to ensure the quality control of molecular data in terms of creation, interpretation, storage and validation. The unique data protection requirements that result in conjunction with the storage, management and forwarding of molecular and, in particular, genetic data constitute part of these comprehensive activities.
Contact person at the TMF Office
Sebastian C. Semler
Phone: +49 30 31 01 19 50
E-Mail