Application of the Biotechnology Act

The Biotechnology Act applies to research projects where carrier status for hereditary diseases can be detected, or where information derived from genetic studies is planned to be returned to the participants.

Genetic studies can be defined as research where all types of human genetic analysis, both at the nucleic acid and chromosome levels, as well as gene products and their function, will be conducted. This must be stated in the Regional Committees for Medical and Health Research Ethics (REK) application, and REK assesses whether or not the planned studies are covered by the Biotechnology Act.

The National Committee for Medical and Health Research Ethics (NEM) adopted on 30.03.2016 Guidelines for the use of genetic studies on humans in medical and health science research (in Norwegian).