A generalized overview describing the biobanking network P2N can be found in our recent publication (Lieb W. et al., 2019).
If you are interested in the use of data or samples from a P2N biobank, you are required to formally apply for access via the P2N executive board. In the P2N request form, you must describe the planned use of the data or samples in sufficient detail for the P2N supervisory board to be able to judge the quality and success prospects of your project. Please note that, under pending professional regulations for medical doctors in Germany, and following the principles of good scientific practice, you have to search approval of your planned research by an institutional review board (IRB) in advance. No access will be granted to any data or samples in P2N without documented IRB approval.
No! All consent given to P2N biobanks is confined to health-related research. Therefore, use of P2N data or samples for any other purposes is strictly prohibited.
There are no general rules regarding benefit sharing in P2N. If you anticipate any financial profit from using data or samples from P2N, including patents, fees or grants, you are obliged to inform the respective biobank and to seek an amicable agreement for their participation.
The different P2N biobanks have different policies for refinancing their operation costs. None of the biobanks is allowed to commercialize their data or samples, and thus any demands must be limited to the coverage of overheads. For further details, consult the individual biobank homepages.
Yes, provided that the requested data or samples are not themselves commercially exploited. Usually, the biobanks in P2N will expect an academic partner to be involved in a research project for which their data or samples are being used.
The biobanks in P2N take great care to ensure maximum protection of the personal and medical data logged in their databases. Wherever possible, different data categories (i.e. personal, health-related, genetic etc.) are physically stored in separate places. Data are released for scientific use only in anonymized form. The data protection measures taken by PopGen, one of the major P2N biobanks, are based upon a generic concept developed by the TMF (Technology, Methods and Infrastructure for Networked Medical Research) and are formally endorsed by German data protection authorities.
P2N is a project funded by the German Ministry of Education and Research as part of the National Biobank Initiative. Two principal investigators (Wolfgang Lieb, Michael Krawczak) are currently in charge of P2N. This funding will cease at the end of 2016. By that time, P2N will have been transformed into the P2N core facility as part of the permanent research infrastructure of the Medical Faculty of the Christian-Albrechts-University, Kiel. From then on, P2N will be run by personnel nominated and financed by the Kiel Medical Faculty.
The biobanks in P2N cover a broad spectrum of diseases. For a list of collections currently available for scientific research, click here!
There is no general consent among legal experts in Germany as to who owns the samples in a biobank. The majority opinion is that the sample belongs to the donor unless any agreement to the contrary has been made. The samples in PopGen are the property of the University Hospital Schleswig-Holstein because donors have explicitly transferred their property rights to the hospital. For other biobanks in P2N, the situation is de facto the same or similar, because the respective biomaterials have mostly been collected in a clinical health care context. For further details, see the individual biobank homepages.
Rich phenotypic data are available for many samples in P2N. Since these data form an integral part of the respective biobanks, they are available for research purposes as well. The scope of access granted by an individual biobank may be subject to mutual agreements and will likely depend upon the scientific project in question.
Access to additional samples, in particular of family members, is subject to availability and IRB approval. If obtaining additional samples requires re-contact of donors, the respective biobank must have the donors’ explicit consent to do so. Moreover, if the recruitment of family members requires the disclosure of health-related information to the donor or their family, this needs to be communicated by a specially trained medical doctor, usually a human geneticist.