Medical and health research must be carried out in a safe manner. In order to ensure that health research projects are organized in a sound way, approvals are required.
External approval is required from the Regional Committees for Medical and Health Research Ethics (REK). For testing of drugs or medical devices, approval from the Norwegian Medicines Agency (SLV) is also required.
Internal approval comprises the hospital’s routines for registering research activities, assigning legal basis for data processing and ensuring compliance with internal routines. Approval requirements may vary between hospitals.