The Trusted Research Environment (TRE) is a controlled, protected and GDPR-compliant computer environment in which registered researchers are given access to the requested data set of NAKO participants. “The aim is to make the data from the baseline study and the 5-year follow-up accessible for scientific questions, especially for research companies, via this data processing environment. Collaboration with research-based companies is an important addition to academic NAKO research to better utilize the potential of the study. The pilot phase that is now beginning offers research companies an opportunity to get to know the NAKO database. The aim is to realize innovative research projects in the field of disease prevention, early diagnosis and treatment using NAKO data,” says Prof. Annette Peters, Chair Board of Directors of the NAKO e.V. and Director of the Institute of Epidemiology at Helmholtz Munich Peters and the Institute of Epidemiology play a key role in the study’s design, management, and implementation.
A Digitally Sovereign Solution
The Neckarsulm-based company Honic has developed its research data platform exclusively with European technology in close cooperation with data protection authorities and patient organisations. Based on the requirements of NAKO, a digitally sovereign TRE was designed that fully complies with the high German and European data protection and data security requirements. This means that the data is protected in the best possible way and always remains within the European legal framework. At the same time, Honic’s experience with comparable research projects enables efficient utilization. “NAKO e.V. has always focused on the protection of participant data. With the TRE developed for NAKO, we ensure the strictest data protection requirements while fulfilling the scientific and social purpose of NAKO, to enable the most extensive research with this data. The data provided via the TRE remains within the environment and only the results can be exported by the researchers,” explains Dr. Henrik Matthies, CEO of Honic.
Applications for Data Use and Access
Research companies who would like to analyze NAKO data as part of the TRE pilot project can submit their use and access applications via the application portal ‘TransferHub’. In line with NAKO’s aims, the research projects should serve the health-related public interest. In addition to the study design, the methods used and the project objectives, the application must provide a clear justification for the selected variables. The Use & Access Committee and Board of Directors of NAKO e.V. will review the content of the applications received and recommend revisions if necessary.
There are costs associated with using the TRE, which are communicated at the time of application and charged to the research companies. The usage fee enables secure access to sensitive data within the responsible and contract-based cooperation between NAKO e.V. and the applicant companies. The number of applications for use during the pilot phase is limited. It is therefore recommended to submit applications as soon as possible. Participating companies have the unique opportunity to provide early input on the further development of the TRE and individual feedback to develop the platform for future use.
To NAKO TransferHub
About the German National Cohort (NAKO Gesundheitsstudie)
The German National Cohort (NAKO is the largest long-term population study in Germany. Since 2014, over 205,000 randomly selected people have been medically examined and asked about their lifestyle habits in 18 study centres. At the beginning of the study, the participants were aged between 20 and 69. The German National Cohort (NAKO) is a prospective epidemiological cohort study. The researchers observe a large group, a so-called cohort, of healthy, ill or formerly ill people over a long period of time. The aim is to use scientific analyses of the participants’ data to investigate the frequency and causes of common diseases such as cancer, diabetes or cardiovascular diseases, to identify risk factors and to show ways of effective prevention and early detection. The research project is supported by 26 organisations. Scientists from universities, the Helmholtz Association, the Leibniz Association and other research institutes in Germany are working together in a nationwide network. The study is being carried out by the NAKO e.V. association. It is financed by public funds from the Federal Ministry of Research, Technology and Space (BMFTR), the Helmholtz Association and the participating federal states.www.nako.de/en
