Amendments
Significant changes in research projects must be submitted to the Regional Committees for Medical and Health Research Ethics (REK). Examples of changes that may require reporting are:
- Changes in study design, inclusion and exclusion criteria, recruitment procedures or consent forms
- Changes in sample size or diagnosis
- New knowledge of risks, disadvantages or benefits
- Change of project manager/PI, research manager or person responsible for research biobank
- Postponement or extension of the project period
In the change report to REK it is sufficient that the specific changes and the reasons for these are explained. At OUS, a guideline on the notification of significant changes in health research projects has been established.
The project manager/PI is responsible for sending change notification to REK. On REK's website you will find information about when a change notification is required. Significant changes to a clinical drug trial or testing of medical devices should, as a general rule, also be submitted to the Norwegian Medicines Agency (SLV).
Correspondence with REK, both submissions and decisions, should be sent to godkjenning@ous-hf.no.
Change notification to the Data Protection Officer and Chief Information Security Officer is only necessary if the change concerns storage location or disclosure of data. If this is the case, the electronic notification form must be submitted, select the option "Endringsmelding" (change notification).