Strand, Bjørn Heine
Skirbekk, Vegard
Langballe, Ellen Melbye
Bergh, Sverre
Landmark, Brynjar
Wangensteen, Sigrid
Selbæk, Geir
Kirkevold, Øyvind
Article History
Received: 19 August 2021
Accepted: 15 November 2021
First Online: 8 December 2021
Declarations
:
: All participants has given a written informed consent. NORSE was assessed by the Norwegian Regional Ethics Committee for medical research (REC), which in a decision of 25.06.2015 (2015/970/REK south-east) concluded that the treatment involves the establishment of a health register and that the project therefore falls outside the scope of the Health Research Act. An application was therefore made for a license pursuant to section 7 of the Health Register Act, cf. section 33 of the Personal Data Act. This license was granted 18.10.2016, and NORSE was then officially defined as a health registry, and the study, including all experimental protocols, were approved by the Norwegian data inspectorate (Reference number 16/00929–2/GRA). All methods were carried out in accordance with relevant guidelines and regulations.
: All participants has given a written informed consent for publication.
: None declared for all authors.