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.
The formal project implementation steps described here are taken from the Research Procedure at Oslo University Hospital, and apply to:
- Employees with project manager responsibility. The project manager is the researcher who formally applies for prior approval from REK, and who has the everyday responsibility for the study
- Employees who are responsible for the implementation of a health research project at Oslo University Hospital (OUS), but where the project has an external project manager at another hospital, for example in a multicenter study
- Researchers, with or without formal employment, who are subject to the hospital's instructional authority, for example by being a project employee
If the project is led by an employee at the University of Oslo (UiO), but involves patients, health information or human biological material from OUS patients, the Research Procedure must also be followed.