Relevant legislation

The Health Research Act

The Act on medical and health research (the Health Research Act) was passed on 20 June 2008. The Act entered into force on 1 July 2009. The Regulations on the organisation of medical and health research were passed on the same date. The bill that was submitted in Proposition No. 74 (2006–2007) to the Odelsting was based on Official Norwegian Report 2005:1 Good research – better health, and the objective was to revise and simplify the regulatory framework for medical and health research. The regulations pertaining to this area have now been largely compiled into a single Act, and researchers now have to relate mainly to one authority when applying for approval of research projects. This authority consists of the Regional Committees for Medical and Health Research Ethics (REK).

The Personal Data Act

The Personal Data Act (Lov 15. juni 2018 om behandling av personopplysninger) incorporates the European Data Protection Regulation (GDPR) to Norwegian law. The Act also contains national special rules in certain areas where the GDPR allows it.