Approval from REC for health research
It is the purpose of the project that determines whether a project will need approval from REC (Regional Committees for Medical and Health Research Ethics) according to the Health Research Act or if it is subject to notification to us according to The Personal Data Act/Personal Health Data Filing System Act. If a project is approved by REC, it will normally not be necessary to get an assessment from The Data Protection Official.
What should be approved by REC?
- The Health Research Act applies only to research that aims to generate new knowledge about health and disease. If you are in doubt, you can send a Remit Assessment form to REC
What should be notified to us (NSD)?
- Research on patient and health information for other purposes, is regulated by the Personal Data Act and should be notified to us. This also applies even if the project involves collecting health data or if it will be carried out at a health enterprise
- Quality assurance within the health sector (page in Norwegian)
What should be sent both to REC and NSD?
- When using data from the pseudonymous health registries (IPLOS and NorPD (Reseptregisteret)), it is necessary to send a notification to us, get a license from the Data Protection Authority and an approval from REC.