Case 4: Inquiry from a researcher in a privately owned company   Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration. A researcher from a privately owned Danish company approached the Guidance Function and asked for help with identifying where a certain type of laboratory data was stored. The researcher didn’t know how to locate the laboratory data or which permits were required. Since the researcher represents a privately owned company, there are specific conditions and rules for data extractions. The rules and conditions differ depending on the data provider, who owns the laboratory data. The law does not specify which persons can conduct research in the Danish health data, but common practice in Denmark is that a publicly employed researcher is in charge of the research project. The research can, however, be conducted by other parties in the research group. Access to laboratory data from Statistics Denmark: Before access to laboratory data can be permitted, an authorization must be obtained. Privately owned companies can apply for authorization if the research environment falls into one of the following categories: Nongovernmental organization Consultancy – these companies cannot access micro-data, which contain corporate data. The head of Government Statistical Services can grant an exemption if a consultancy conducts analysis or research on behalf of a public authority or a nongovernmental organization, assuming that the public authority or nongovernmental organization acts as the data controller Other companies can beautorized but cannot access micro-data containing corporate data Privately owned research environments cannot obtain authorization if less than one year old. Read more about Statistics Denmark and their offered services here (in English): https://www.dst.dk/en/TilSalg/Forskningsservice Access to laboratory data from the Danish Health Data Agency: Privately owned companies can apply for authorization with Forskningsservice (“Research service”) at the Danish Health Data Agency and hereafter access to laboratory data. A privately owned company can only obtain authorization, if the company conducts analysis and research for a public authority. Pharmaceutical companies cannot obtain access to laboratory data due to conflict of interest. Read more about the Danish Health Data Agency here (in English): https://sundhedsdatastyrelsen.dk/da/english Access to laboratory data from Bio- and Genome Bank Denmark: Depending on which information the privately owned company needs, there are different rules for obtaining laboratory data from Bio- and Genome Bank Denmark: if the company needs data, e.g. social security number or diagnosis codes, it is required that the company has a research partner who is employed somewhere in the public health system in Denmark. If the company does not require data about the samples stored at the Bio- and Genome Bank Denmark, e.g. samples for quality analysis, no external collaborator is needed. Reed more about the Bio- and Genome Bank Denmark here (in English): https://www.regioner.dk/rbgben/research-development-rd The laboratory data can also be found in the patient records, which is stored in each of the five Danish regions. This means that the researcher must apply each region for an extraction of the laboratory data from the medical records. Normally, a privately owned company cannot obtain access to the Danish patient records unless the company collaborate with a researcher from a researcher employed in a public research facility. In this case, the Guidance Function helped the researcher from the privately owned company to localize the specific laboratory data the researcher needed. We also provided information about the specific rules and conditions a research from a privately owned company is subject to when accessing laboratory data. Please 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