Changes to Health Research Projects
Significant changes to health research projects should be reported to REK
Examples of changes that may require notification to REK (the Regional Committees for Medical and Health Research Ethics) include:
- Changes in study design, inclusion and exclusion criteria, recruitment procedures, or consent forms
- Changes in sample size or diagnosis
- New knowledge about risks, disadvantages, or benefits
- Changes in project manager/PI, research responsible, or person responsible for the research biobank
- Delays or extensions of the project period
In the notification of changes to REK, it is sufficient to explain the specific change and the justification for it. OUS has a guideline concerning notifications of changes in medical and health research projects.
The project manager is responsible for submitting the notification of changes to REK. On REK’s website, you will also find information on when a notification of changes is required.
Changes in a clinical drug trial should be submitted via the CTIS portal, whereas for trials concerning medical devices, the changes should be submitted to the Norwegian Medical Products Agency (DMP). In industry-sponsored trials, the sponsor usually handles the submission.
Correspondence with REK, both submissions and decisions, should be sent to godkjenning@ous-hf.no.
Notification to the Data Protection Officer is only necessary if the change concerns the storage location and/or disclosure of data. In such cases, an electronic notification form must be completed, selecting the option "Endringsmelding" (Notification of Changes).