Case 6: FAIR Principles and Research Data

May 31, 2022

Case 6: FAIR Principles and Research Data Cases are examples of questions and inquiries we receive in the Guidance Function, which we would like to share for inspiration. A researcher contacted the Guidance Function with an inquiry regarding information about the FAIR principles. The FAIR principles aim to act as a guideline to increase the availability and reusability of data and metadata. The FAIR principles are divided into four categories: Findability: Principles, which must be fulfilled to ensure the findability of the data. Data must have descriptive metadata, as metadata is essential to be able to find datasets and any supplementary information. Accessibility: Principles, which must be fulfilled to ensure the availability of the data. As data must be readable by both humans and machines, data and metadata must be organized in a way that makes it easy to obtain the (meta)data and any supplementary information. Interoperability: Principles, which must be fulfilled to ensure that data is integrable with other data, i.e. interoperability. Additionally, these principles ensure that data can interact with applications and tools for analysis, storage, and processing. The variables of metadata and data must therefore be described in accordance with international standards, terminologies, and classifications so that data can be used with other data sources. Reuse: Principles, which must be fulfilled to ensure reusability. This is ensured through well-described metadata and data, which can be replicated and combined in other contexts. Metadata can describe the terms of reusing the data, how the dataset has been processed, and data quality, among other things. The FAIR principles are suitable to support the administration of data and metadata, but also to support the processes surrounding sharing and reusing health data. In this case, we assisted the researcher in gaining a better understanding of the FAIR principles and referred them to material that explained the FAIR principles in more detail. Please feel free to contact us if you need guidance in your research project. Our services are completely free, and we aim to reply to any inquiries within 2-4 working days. The Guidance Function offers 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 Learn more about the FAIR principles from the “FAIR across” project: https://forskningsdata.dk/fairytale/ Learn more about the FAIR principles and the tools developed for implementation: https://www.deic.dk/en/data-management/instructions-and-guides/FAIR-for-Beginners

Case 5: Inquiry from foreign researcher

May 10, 2022

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). 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. 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

Case 6: FAIR Principles and Research Data

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Case 5: Inquiry from foreign researcher

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