14 October 2016
Prenumerera på information från Nationella Kvalitetsregister

Decision on disclosure of data for research

It is always a healthcare authority that is responsible for personal data processing on the central level in a National Quality Registry.

Decisions on the disclosure of personal data from a quality registry must be made by the CPUA authority. However, it may be the registrar or another party who makes the decision, upon delegation in writing by the CPUA.

Where the registrar has delegation to decide on disclosure and is unsure or intends to deny the request for disclosure or to draft confidentiality clauses regarding use of the data, he or she should always contact the CPUA authority (personal data representative or legal council). Confidentiality clauses are enacted for disclosure to parties not covered under the Public Access and Secrecy Act.

If the decision is made to deny disclosure or stipulate restrictive provisions, the applicant for disclosure must be given the opportunity to obtain a formal decision from the CPUA authority, which can be appealed. That the research is expected to be of low quality or that there are research projects dealing with the same topic are not grounds for denial; this should instead be communicated to the researcher in another way.

Prior to disclosure, an agreement may be entered between the party authorized to make decisions on behalf of the CPUA (the registrar, for example) and the researcher concerning the disclosure. Another way to do this is to clarify the terms and conditions of disclosure in the decision on disclosure and have this document signed by both parties (see template: Application for Registry Data from Quality Registries for Research Purposes).

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

The agreement usually specifies the time frame within which data may be used, and certain registries require that the research must have achieved certain results within a specified period of time for the researcher to be permitted to continue with the project. If the researcher would like to continue working with data in a continuation project, possibly supplemented with new data, a new application must be filed with the Ethical Review Board and a new decision concerning disclosure must be made.

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