Case 3: Extraction of patient addresses
Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration.
Which approvals are required to obtain an extraction of contact information from the Danish Health Data Agency in order to recruit participants to form a cohort?
The question above came from a researcher who approached the Guidance Function.
If the project only sends questionnaires to its participants, it is not necessary to obtain prior approval from the National Committee on Health Research Ethics since questionnaires are excempt from the duty of notification. If so, the project can proceed directly to the Danish Health Data Agency and apply for a data extraction after being registered on the regional research record and approved by the data controlling organization.
If the project collects e.g. biological material or sensitive bio informative data, the project is required to notify the National Committee on Health Research Ethics. The approval from the committee must be attached to the extraction application sent to the Danish Health Data Agency. The extraction application must also contain the approval from the data controlling organization. The project is also required to be registered on the regional research record.
Both the Danish Health Data Agency and the National Committee on Health Research Ethics have specific requirements for the recruitment material. Therefore, this material must also be included in the project’s applications. The researcher is obligated to ensure the quality of the information in the recruitment material and to ensure that the material is neither offensive nor misleading. The material must also contain adequate information about the project.
In this case, we helped the researcher obtain an overview of which applications were necessary for the researcher’s project and referred the researcher to different guides from the National Committee on Health Research Ethics on how to write good and satisfactory recruitment material and information for participants.
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
