14 October 2016

What data is disclosed for research, and to whom?

Under current legislation, all research projects approved by the Ethical Review Board can access the variables in a quality registry that are warranted by the topic, provided there are not confidentiality obstacles under the Public Access and Secrecy Act (2009:400).

Normally only anonymous data is disclosed to researchers, but joint processing with other data can be performed at the individual level if legal and ethical research requirements are met.

Joint processing is usually performed by an authority and anonymous information is provided to the researcher. Only variables relevant for the research topic are disclosed. It is important that it is clear to the disclosing authority (CPUA) and the registry organization which data has been approved for research by the Ethical Review Board.

How do I gain access to data from a quality registry?

A researcher who is interested in gaining access to aggregate data or personal data from a quality registry is recommended to make contact at an early stage (before application to the Ethical Review Board) with those responsible for the registry to discuss their project and determine if the quality registry contains data that can be used to answer the question. The researcher can also determine if there are other tangential or overlapping projects they can collaborate with.

Under current legislation, all researchers who have approval from the Ethical Review Board must be treated equally. For researchers engaged in research where the university (state) or county is not the responsible principal investigator, it must be taken into account that they are not covered by the Public Access and Secrecy Act in the same way as universities or county councils, which means that confidentiality clauses must be drafted and formalized with agreements before the data can be disclosed.

What research needs to be approved by the Ethical Review Board (EPN)?


All research, i.e. studies that are intended to be published in scientific journals and which will be performed on personal data in the quality registry must be approved by an Ethical Review Board. The law concerning ethical review of research encompasses research on living and deceased persons, human biological material and research involving the handling of sensitive personal data.

Following an amendment to the law in 2008, an ethical review must be performed on all research involving the processing of sensitive personal data. This applies whether research subjects have given their informed consent or not.

Third-party agreement

If it is a research project involving the private sector, a third-party agreement must be established between the registry, university/college and company, in accordance with the national agreement between the health authorities and private sector representatives concerning the National Quality Registries. A quality registry can, under the agreement, refuse cooperation if the registry does not have sufficient resources to carry out the work.

Registry organizations and researchers not affiliated with any university are recommended to contact a registry centre and/or CPUA for support in dealing with issues involving the business community. The registry centres recommend clear cooperation agreements between the registry and its CPUA, university/college and the company, and that people involved with the registry have a role in the research project. If it is a matter of only simple analysis of data ordered from the registry, the procedure may be of a simpler nature.

Further information

Quick Guide for Researchers on the Disclosure of Quality Registry Data for Research

Personal Data in Research — what rules apply? Information booklet that can be downloaded or ordered from the following authorities’ websites:

Ethics Committee Review Board

The Swedish Data Protection Authority

Statistics Sweden (SCB)

The National Board of Health and Welfare

Agreement concerning cooperation between the Swedish Association of Local Authorities and Regions (SKL) and private sector representatives regarding National Quality, entered in March 2012.

Collaboration with private sector representatives (in Swedish)

Among other things, this agreement stipulates principles for cooperation, and terms and conditions for documentation, agreements, and the disclosure of personal data.

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