Case 5: Inquiry from foreign researcher

Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration.

A researcher from abroad reached out to the Guidance Function to ask about the Danish declarations of consent rules. The researcher’s project investigated the outcome after 12 months for patients treated with a specific medical device during an operation. Besides the outcome information, the project collected information about incidents as well as the patients’ baseline information.

As the project only collects its data from the patients’ medical records, it is classified as a register research project. Cf. the Danish Komitélov §14, part three, it is not required to report register research projects to the regional scientific ethics committees. It is also not required to obtain a research permission from the Danish Scientific Ethical Committee.

Despite the fact that the project examines the outcome after treatment with a specific medical device, a separate declaration of consent must be obtained as the project is considered separate from the treatment. The researcher is therefore obligated to draw up a written declaration of consent as the researcher must be able to document the date of signature as well as the information given to the patients. The signature can be either digital or on a physical copy of the consent form, but all consent forms must be dated. The Danish Scientific Ethical Committee has various documents to assist researchers when writing the declaration of consent. Please see på https://www.nvk.dk/forsker/forskertjeklister (in Danish). The five Danish regions also have standardized consent forms researchers can use as inspiration, e.g. from the Central Denmark Region: https://www.rm.dk/sundhed/faginfo/forskning/de-videnskabsetiske-komiteer/hjalpemidler/samtykkeerklaring-og-deltagerinformation/ (in Danish).

In this case, we informed the foreign researcher about the Danish declarations of consent rules and the rules for when to obtain permission from the Danish Scientific Ethical Committee. We also passed along examples of standard consent forms the researcher could draw inspiration from.

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.

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