The use of individual-level health and welfare data requires a permit. The permit application process will be helped by a comprehensive preliminary analysis of the available data and a carefully prepared research plan.
The sections below give further information about the important details of research.
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Research questions and preliminary analysis of the available data
In the planning stage, it is important to phrase the research questions clearly. The research questions will determine the type of data needed for the research. The research data can be compiled by collecting the data yourself, using data from existing sources, or by combining the two.
Rich data is available from multiple sources
In Finland, a great deal of individual-level data on people’s health and welfare are recorded when public authorities perform their service tasks. There are five main groups of health and welfare data sources:
- patient documents and social welfare customer documents
- hospital district data lakes
- biobank samples and data
- data collected in population studies
There are many ways to utilise registers and other data sources in different types of research. If the research will utilise health and welfare data sources, do the following:
Study data sources with due care
The preliminary analysis of available data is particularly important for biobank samples and data. Specific availability information may be scarce, and the availability of samples and data may need to be negotiated with the biobank. The use permit can only be applied for after a preliminary assessment is completed with the biobank.
A single study may use one or more data sources. In practice, single registers will often prove insufficient for obtaining enough data for the purposes of a research. Thus, particular attention should be paid to the possibility to combine data from different sources so that the desired dataset can be be compiled.
Preparing the research plan
Scientific research is always based on a research plan. The structure of a research plan may vary quite significantly, as different parties may have different requirements. In general, the research plan should define at least the following:
A research plan is also required to apply for the use permits for health and welfare data. Individual-level health and welfare data is personal data and hence, according to section 14 of the Finnish Personal Data Act, its use must be based on an appropriate research plan. Use permits are only granted for the purpose described in the research plan. Only data that is necessary to carry out the research and achieve its objectives may be disclosed. The research plan must clearly state why and how the data being sought is necessary for the research.
Below are some perspectives that should be taken into account when planning research that will use health and welfare data.
Sufficient time must be reserved for acquiring health and welfare data. Although the data can be compiled relatively quickly, the various statements and permits may take several weeks to come through, depending on the type of research. A long wait is particularly likely when the use permit can only be granted after a preliminary ethical assessment of the research is obtained, a separate research permit is granted, or consent is obtained from the research subjects.
Financial planning should take into account the fact that research permits and statements, as well as the collection of health and welfare data from data sources, are typically subject to a charge. The pricing depends on the data source, the extent of the data and the author of the research. For example, students may be eligible for a discount. The research environments to which the data is delivered may charge fees.
According to section 14 of the Personal Data Act, when personal data is used in research, a person or a group of persons responsible for the research must be nominated. Section 5 of the Finnish Medical Research Act stipulates that a person with sufficient professional and scientific qualifications must be nominated as responsible for the research in question for any medical research as defined by section 5 of the Act.
“Data management” refers to how the collection, use, storage and further handling of the research data is carried out. The planning of data management is part of drawing up the research plan. The importance of data management is particularly great when sensitive data is used. Sponsors are also increasingly demanding a separate data management plan in addition to the research plan.