In order to use the data contained in the national quality registries, the research question must be clear and concrete, and the data desired must be precisely defined. In addition, approval must be obtained from the Ethical Review Board (EPN). Applications to extract data from a registry for research purposes must be submitted to the registry in question using an application form that can be downloaded from their website.

Normally, only de-identified data are released to researchers, but data at the individual level may be merged if legal and research ethics conditions are met. As a rule, an authority processes the data, and de-identified data are released to the researcher. Only variables pertinent to the research question approved by the Ethical Review Board are released.

All research that uses personal data stored in a quality registry must be approved by an Ethical Review Board. The Act on Ethical Review of Research applies to research on living and deceased persons, human biological material and research that involves handling sensitive personal data. After changes to the law in 2008, all research that involves handling sensitive personal information must be ethically reviewed. This applies whether or not the study participant has given their express permission.

If a research project involves a commercial company, a third-party agreement must be established between the registry in question, the University/University College and the company, in accordance with the national agreement between the healthcare principal and the industry's representative for the national quality registry.

Project applications are reviewed with regard to clarity, objectives and implementability in the respective registry's research group. If the application is approved, a representative from the registry is appointed who is responsible for ensuring that the de-identified database is used only for the purposes of the submitted project.

All publications that use data from a national quality registry must state the source of the data in the methodology section. In general, it is recommended that one person who is highly familiar with the registry is involved in the research project so that they can explain how the data have been collected for entry in the registry. Standard rules apply to authorship.

It is the responsibility of the national quality registry to explain which research results the individual registries have contributed. This means it is important that the registry receives information about the scientific journals in which the results are published.


Back to top