Many essential considerations need to be taken into account prior to starting a collaboration with biobanks and registers. How to navigate the country dependent access rules, different country terminology, requirements for obtaining data for cost-benefit analysis, are just a few. In these pages you will find many useful facts which are good to know when develop your study plan and starting up your successful collaboration.
National entry points and umbrella organisations
Countries normally have a strategic plan which addresses how to provide better access to their valuable research infrastructures, such as biobanks and registers. Usually there is one national entry point (i.e. National Node) or umbrella organisation, which provides information about the local resources and provides assistance to find suitable collaboration partners. The umbrella organisations in Estonia, Denmark and Sweden are shown in the fact box.
Not only do the access routes and legislation change between countries but the national terminology can also vary. In Sweden for example you meet the term “quality registers” and in Denmark “national and regional health registers”.
Different services and types of sample collections
Sample collections in biobanks vary in both size, characteristics and the degree of related information. In some biobanks samples can already be analyzed and it can sometimes be possible to gain access to the analysis result (genome data, NMR data, clinical biochemistry results etc). This accelerates the start of your project and reduces your R&D costs.
Some biobanks have even linked their samples with national health registers to provide a quick overview of the disease and treatment history of sample donors, and provide statistics on disease or biomarkers prevalence on the population level. A number of biobanks also have strong science teams to provide their expertise for new R&D activities in the frame of the collaboration projects. Some biobanks have even already developed algorithms for disease risk prediction. Understanding what the individual biobanks have available and what is possible based on the individual country’s legal conditions is therefore important when selecting which biobank to join a collaboration with. More information on the biobanks associated with EIT Health is available on the Biobank factsheets pages:
Support in data analysis
In situations where the biobank can not provide the required previously generated data from biological samples, it is recommended to involve the biobanks core facility in the planning to extrapolate the data from the samples. Support in data analysis can also be obtained via the universities in the EIT Health community, who have competence in areas such as biostatistics and bioinformatics:
You can find relevant contact persons such as experts in big data analysis, health economists, as well as contacts to the core facilities, the national entry points to the biobanks and registers, and the contact persons to the EIT Health connected biobanks here:
Registers: individual but anonymous data
The data released from registers is not normally personalised.. To combine health register’s data and sample data it should be linked via a personal code in a secured way to protect participants rights. Some biobanks have therefore where legally possible, linked together with registers to combine together health data and omics data, to advance scientific studies and provide health and omics data on an individual level, while remaining anonymous. This for example enables an overview of the disease and treatment history of sample donors for discovering new biomarkers for particular diseases.
A cost-benefit analysis is a pre-requisite to obtain reimbursement for a new product or service from healthcare payers in a particular country. When health data is required to perform cost-benefit analysis a collaboration with a health economist in that particular country should be established, as information is normally in the local language, and they know how to navigate quickly through the requirements and processes.
Navigating access rules
In general, to obtain access to biobank samples and data, or registers data, it is required to first obtain ethical approval, which might take several months. Often, cooperation with a partner in the country in question is also required to gain access to samples and/or data.
In different countries there are slight differences in processes and legislation. Further information can be found in the “How To Access” section (add link https://www.eithealth-scandinavia.eu/biobanksregisters/access/)
In the majority of cases access is not free of charge as there are direct costs for the biobank or register. In order to agree the cost, a detailed study plan providing a clear overview of required samples and data sets is a prerequisite.
Estonia: Estonian National Biobanks
Denmark: The Danish Biobank
Sweden: Biobank Sweden
- The Estonia Health Insurance Fund
- National Institute for Health Development
- The Estonia Ministry of Social Affairs
Denmark: National Patient Register
Sweden: Nationella Kvalitetsregister
The "Registers and Biobanks in Transition” strategic initiative is funded by EIT Health