Clinical testing of other interventions

Studies that do not involve trials of medicinal products

Interventions that do not involve testing medicinal products will, as a general rule, be covered by the Norwegian Act on Medical and Health Research (the Health Research Act) and require prior approval from the Regional Committee for Medical and Health Research Ethics (REK). When planning a medical and health research project, you should familiarise yourself with the requirements that apply to this type of research. A good starting point is to read the following:

• Guideline for interventional and observational studies (PDF)
• The research handbook From Idea to Publication
• Research Ethics Library (FBIB) – relevant topics
• The Norwegian Health Research Act

A protocol template can be found in the “Guideline for interventional and observational studies”. A good approach to protocol writing is also to use published protocols as a starting point:

1. Protocol: Physiotherapy study
2. Protocol: Exercise study
3. Protocol: Diet study