14 October 2016

Quick Guide for researchers to quality registry data disclosure

Are you a researcher interested in using one or more quality registries in your research? Here is a simple guide describing how to apply for permission to use Swedish quality registry data.

The full version of this guide, Guidance and Recommendations for the Disclosure of Quality Registry Data for Research, provides more detailed descriptions of how to use quality registry data for research, who can receive access to data, and what applies for most registries.'

1. Review the legal aspects and laws

For further reading:

Guidance and information on the disclosure of Quality Registry Data for research

Transfer of personal data to third countries for research

Application for registry data from Quality Registries for research purposes (Word document)

Web addresses to authorities and agencies of importance:

Ethics committee review board

The Swedish Data Protection Authority (DPA)

Statistics Sweden

The National Board of Health and Welfare

The following laws and regulations should be reviewed:

  • Swedish Personal Data Act (PUL, 1998:204)
  • Personal Data Act (1998:204)
  • The regulations by the National board of health and Welfare

Legislation on Biobanking in English

See also below.

2. What variables are collected in what registry?

Please find a list of the Swedish National Quality registries on our website. Here you can also find web addresses of the different registries including a list of variables for each registry:

List of all Swedish National Quality Registries

The National Board of Health and Welfare holds national health data registries such as the medical birth, causes of death, hospital discharge and prescribed drug register. Data from these registries can be jointly processed with data from the national quality registries. For more information contact the National Registry Service at The National Board of Health and Welfare:

The National Board of Health and Welfare, contact

Examples of other government agencies that have registries for research purposes include:

Statistics Sweden, Guidance for researchers and universities

The Swedish Social Insurance Agency

The Swedish National Council for Crime Prevention (Brå)

3. Establish contact with the registry

Contact the registrar or a member of the steering committee to discuss definition of variables or the contents further to ensure it will be possible to use the quality registry data for your purposes. You might also consider discussing matters such as:

  • Population, geographic coverage and completeness, validity, comparability and handling of missing data
  • Overlapping and/or previous experience of similar projects
  • If the data extraction is consistent with costs
  • Registry Procedures and processes including timelines to be expected
  • Application and forms

4. Establish contact with the national board of health and welfare (national registry service)

Contact the National board of health and welfare or Statistics Sweden to discuss whether or not it would be possible to use their registries for comparisons to the national registry data. Example of registries at National Board of health and welfare are birth-, death-, drug registries and from Statistics Sweden data on demographics could be received.

You can also find out if any similar projects are underway elsewhere and if the data extraction is consistent with costs and timelines to consider. How to apply for data extraction, if this information is not provided on the registry website.

5. Apply to EPN

Apply for permission to conduct research with the Regional Ethical Review Board (EPN). Your application must be detailed enough for the registry to determine what the Ethical Review Board has approved in terms of what data may be used and how the personal data should be processed through a detailed description of how to process personal identification numbers, coding, encryption, etc.

Also assure that a patient information and consent form is available for the project and that all important areas are covered (such as variables and time periods to be included in the analysis , if data is planned to be transfer to third country etc., if activities will be delegated to third party, contact details of investigator responsible for the study).

If biobank samples are included in the research projects this should be explained and be part of the ethics committee application. To maximize usability of collected samples and to get advice and information about filling in forms and applications it is recommended that contact is taken with the biobank coordinator or the relevant biobank prior to submission to EPN.

The Ethical Review Board (EPN)

6. Apply for data extraction from the registry using the form

Apply for permission to have data released from the quality registry using the form provided by the registry and/or its personal data holding authority (CPUA). If no form is available, use the form Application for Registry Data from the Quality Registry for Research Purposes, which you will find on the registry centre and regional cancer centre websites. The form can be sent to the registrar or the recipient of the form designated by the CPUA for the relevant registry.

Application for registry data from Quality Registries for research purposes (Word document)

If data from several registers are to be used, separate applications must be submitted to the relevant registers/authorities.

7. Processing of application

Applications are processed by the designated representative for CPUA, often the registrar and the steering committee/research council.

8. Decision on disclosure and agreement drafted

A) A decision on disclosure is made and an agreement drafted. The agreement regulates terms such as:

  • Any costs for extraction
  • What variables will be disclosed
  • How long the researcher will have access to data for the project

See examples of templates for Application for Registry Data from Quality Registries for Research Purposes, which also functions as an agreement.

Application for registry data from Quality Registries for research purposes (Word document)

B) The decision is made to deny the application.

The researcher will be notified of this decision and provided information on how to appeal the decision.

9. Disclosure

Data is released in accordance with agreement.

10. Results reported to the registry

The research results are reported to the registry within the agreed time and in the specified manner.

11. Archiving and destruction of copies

The researcher archives their work in accordance with the principal investigator’s guidelines and all working copies are destroyed.

12. Publications

The researcher follow the signed agreement on publication procedures, co-authors etc. For information on defining the role of authors and contributors see:

Guidelines for Authors: Editorial Policy and Manuscript Preparation (PDF, new window)opens in new window

13. New research topic

A new research topic always requires a new application, even if the data has already been provided. Disclosed data may only be used for the research topic the application applies to and data may only be kept as long as needed for this purpose. A new research topic therefore requires a new ethical permit and a new application to the registry/CPUA.

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