Case 2: Data From Patient Records
Case 2: Health data from patient records Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration. A researcher wanted access to data from patient health records. However, they had doubts regarding the required approvals and whether the project should be reported to the Danish Data Protection Agency. Therefore, the researcher contacted the Guidance Function. In the project, the researcher planned to collect visual acuity data from patient medical records and supplement the dataset using data from Danish health registers, e.g. the National Patient Register from the Danish Health Data Authority. There were no plans to use diagnostic imagining or to collect patient samples in the project. The project would not be using sensitive bioinformatics data, such as genomic data or diagnostic imaging, and would not be collecting patient samples. For these reasons, the project should not be reported to the National Committee on Health Research Ethics. However, it was planned to collect data from patient records, which does require approval. Up until June 1st, 2020, this permission was granted by the Danish Patient Safety Authority, but the responsibility has since then been passed to the Regional Councils. The researcher must submit their application to their domiciled Regional Council. Research projects are no longer required to apply for permission for the transfer of personal information with the Danish Data Protection Agency unless the transfer occurs under specific circumstances. However, it is required to register the project on the regional research record. In this case, the Guidance Function supported the researcher in identifying the required approvals for their research project and referred them to the regional research records. In addition to this, we outlined the process for data access and we provided information about wait times in the application process. Feel free to contact us if you need guidance in your research project. Our services are completely free. The Guidance Function offer first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects Call us on tel. +45 2494 7969 Monday – Thursday 09:00-16:00 Friday 09:00-15:00 Or send us an email by clicking info@vejledningsfunktionen.dk
