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Article History

Received: 16 September 2024

Accepted: 29 May 2025

First Online: 1 July 2025

Declarations

:

: The project has followed the normal process for General Data Protection Regulation (GDPR) [] and ethics self-assessment. For any research involving collection of personal data the Data controller must keep records according to GDPR legislation []. For research projects, The University of South-Eastern Norway (USN) does this by registering the project with the Norwegian Agency for Shared Services in Education and Research (Sikt, until 2022 called The Norwegian Centre for Research Data (NSD). Sikt carries out an assessment based on descriptions of research, plans for processing of personal data and data management, consent forms, and questionnaires. The Data Protection Officer at USN monitors projects researchers at USN have registered with Sikt, together with USN’s Ethics Officer. A preliminary form describing the study was filled out on the NSD website in February 2018, stating that the study would not involve personally identifiable nor any other sensitive data, and that the focus groups would be audio-recorded. This was prior to the GDPR [] being implemented in Norway in July 2018. Before this, data privacy in Norway was regulated by the Personal Data Act of 2000 [], which nationally implemented EU Directive 95/46/EC []. At this time there was no consensus as to whether audio recordings were considered a form of personal data. As such the response to the preliminary form on the NSD website was that the project did not need to be registered within NSD. However, all the data in the project was stored according to university guidelines and legal rules for anonymity. The participants were informed both verbally and in writing to secure informed consent and that the students could withdraw from the study at any time without consequences for their study situation. The students who chose to participate provided written consent prior to enrolment. In Norway, there is no requirement for ethics approval for most research, either by a national committee, regional committee, institutional review board (IRB) or by a university ethics board. USN complies with The Norwegian Research Ethics Act of 2017 []. The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) has written a statement regarding the Norwegian system for ethical evaluation []. The statement is in relation to requests for ethics approval for EU-funded projects, but also applies in this case. One exception for this are projects covered in The Act on medical and health research (2008) []. In the case of medical and health research, the Regional Committees for Medical and Health Research Ethics (REK) evaluates projects. However, the scope of The Act on medical and health research in Norway is quite narrow, covering medical research involving human subjects, biological materials, or health data. It also defines health research as: “activities carried out with scientific methodologies aimed at gathering new knowledge about health and disease” [] (§ 4a). As this project dealt with education and students’ perspectives on electronic documentation systems, rather than health outcomes or health data, the project fell outside the scope of The Act on medical and health research []. The REK website provides more information about what kind of projects that are covered by their mandate: . The study project was approved in writing by the departmental dean. Information about the study was communicated to the students in class and in writing via the university’s digital learning platform. The students were informed that they could withdraw from the study at any time without any impact on their academic status. Those who opted for participation provided written informed consent before enrolment. The study was conducted in accordance with the Declaration of Helsinki and ethical guidelines for research [].

: Not applicable.

: The authors declare no competing interests.