Idland, Siri
Kramer-Johansen, Jo
Bakke, Håkon Kvåle
Hagen, Milada
Tønsager, Kristin
Platou, Hans-Christian Stoud
Hjortdahl, Magnus
Funding for this research was provided by:
The Laerdal Foundation (3623)
OsloMet - Oslo Metropolitan University
Article History
Received: 13 February 2024
Accepted: 22 May 2024
First Online: 28 May 2024
Declarations
:
: The study was registered in clinicaltrials.gov (NCT05121649). We applied to the Regional Committees for Medical and Health Research Ethics (REK) (247264), who appraised the study to not be in need of consent from REK, but from Sikt, the Norwegian Agency for Shared Services in Education and Research (reference number 804294) and data protection officers from all study sites. We followingly applied and received approval from Sikt (804294) and all local data protection officers. As a general rule, research conducted on individuals who cannot consent must be directly beneficial for the group or individuals the research is conducted on, and not be possible to conduct if individuals must consent<sub>1</sub>. In some situations, exemption can be given. In emergency situations, obtaining consent from individuals involved in the events can be challenging. Many may be unconscious, and seeking consent at a later time would be difficult. Consent was not obtained from the individuals in our study before inclusion. This exemption from informed consent was approved by Sikt, however, passive consent was still to be maintained. Passive consent was ensured by ambulance personnel giving included patients written information about the study and how to withdraw if they did not wish to participate, including contact information to project leader. They had the right to access, delete, restrict, and object. A data protection impact assessment (DPIA) was developed according to procedures for passive consent. Due to the exemption from informed consent, dispensation from the duty of confidentiality was given by the Norwegian Directorate of Health to those project members who collected retrospective data from audio logs and journals (21/7455).<sub>1</sub>Forskningsdata (sikt.no)
: Not applicable.
: The authors declare no competing interests.