All DZHK studies are capturing data and biological materials from their study participants in accordance with harmonised and standardised rules, transferring the ownership and the rights of use of the collected data and biological materials to the DZHK to reach their intended study purpose and usually to also allow for potential secondary use across studies. The DZHK can thus increase the scientific value of the collection of biological materials and data and contribute to medical progress.
The collection of the patient data and biological materials captured in a standardised manner in the DZHK studies is summarised by the DZHK Transfer Office in a Data Catalogue to facilitate usage requests. The Transfer Office processes usage applications and notifications and supports the work of the DZHK Use and Access Committee (U&AC) by means of availability statements on data and biological materials and by providing counselling services regarding the DZHK IT infrastructure. After release, the Transfer Office provides the data and biological material to requesters and later on reintegrates the results from secondary use projects into the DZHK data handling. Patients can obtain information on the research results of secondary use projects on the DZHK study participant information platform.
To ensure the high scientific value of the collection of biological materials and data and to meet the special requirements for the protection of patients’ rights, usage requests are subject to an evaluation process assessing their objective and their value for the scientific community. The impartial U&AC performs these tasks in accordance with stringent and transparent criteria in compliance with the DZHK Use and Access Policy. The retention period for data and samples from DZHK projects / clinical studies (DZHK Use and Access Policy § 4 paragraph 5, 6) is of course respected. For the U&AC to meet all requirements, the committee consists of experts for biobanking, ethical aspects, and statistics as well as an external counsellor, in addition to representatives of each DZHK site.
Usage requests and notifications may be submitted to the DZHK continuously. Submissions received within less than two weeks prior to a counselling appointment with the U&AC cannot be discussed during that specific counselling session.
Members of the Use & Access Committee (U&AC)
Representatives from the DZHK partner sites
Mahir Karakas (Hamburg/Kiel/Lübeck)
Marcus Dörr (Greifswald) (deputy speaker)
Benjamin Meder (Heidelberg/Mannheim)
Vera Regitz-Zagrosek (Berlin)
Anja Sandek (Göttingen) (speaker)
Dirk Sibbing (München)
Philipp Wild (RheinMain) (deputy speaker)
Matthias Nauck (Greifswald)
Geraldine Rauch (Hamburg/Kiel/Lübeck)
Tim Friede (Göttingen)
Monika Kraus (München)
Folkert Asselbergs (Utrecht)
Representative of the Technology Transfer Units
Volker Cleeves (Heidelberg)
Representatives of the DZHK Transfer Office
Thomas Franke (Göttingen)
Thorsten Rottmann (Göttingen)