Mæland, Silje
Holmås, Tor Helge
Øyeflaten, Irene
Husabø, Elisabeth
Werner, Erik L.
Monstad, Karin
Article History
Received: 30 April 2021
Accepted: 8 February 2022
First Online: 26 February 2022
Declarations
:
: The Norwegian Regional Ethical Committee (REK nr. 2015/560) assesses research proposals covered by the Health Research act and declared the project as exempt from review. The reason was that the main aim of the study was to evaluate the effect of IME on RTW. Work participation is not viewed as a health outcome by the Norwegian Health research act. As a result, the study was instead covered by the Personal Data Act. This trial was performed as part of NAV’s follow up of sick listed employees and therefore regulated by The Insurance Law Act 1997-02-28-19-§25–13 § 4 and a specific regulation for testing IME in Norway [CitationRef removed]. This Act authorizes NAV to summon sick listed employees receiving sickness benefits from the national social security insurance scheme to consultations. Therefore, an ethical approval was not required for this study. Importantly, as this was a trial and not implemented practises for all sick listed employees in Norway, there were no economical or treatment sanctions for not attending. The Norwegian Labour and Welfare Administration gave administrative permissions to access data and records from their registries for this specific study.The study is registered in the international register ClinicalTirals.gov (trial number NCT02524392, 14.08.2015). All methods were carried out in accordance with relevant guidelines and regulations.
: Not applicable.
: None declared.