In the event of significant changes in the purpose, method, time course or organization of a research project, a detailed explanation must be sent to REK (and the Norwegian Medicines Agency (Statens legemiddelverk,if applicable). This could be, for example:
- Change of project manager, research manager or person responsible for the research biobank
- Changes in the number of participants in projects or the inclusion of new groups
- Changes in study design, inclusion and exclusion criteria or written consent
- Postponement or extension of the project period
For intervention studies with pharmaceuticals, it is the sponsor's responsibility to assess whether a change is significant. See
legemidelverket.no for more information on what is considered a significant change.
Proposed changes must be reported and approved before the changes are implemented. For example, an application for the extension of the project must be made in good time before the approval from REK has expired.
- Application for change is sent to REK using a separate form Project change (see
the REK portal for more information)
- Changes must also be reported to the PVO for all UNN projects using the update link for the project in
the UNN research and reporting register
- If the change to the research project is sufficiently substantial that it must be considered a completely new project, the project manager must apply for new approval from REK and report the project to the PVO.
- The project manager must send all relevant documents via an update link for the project to
UNN's research and reporting register (PVO), this includes correspondence with REK and other bodies
In the notification of change to REK, it is sufficient that the specific change and justification for this are explained. When you want to apply for changes, go to the case under the menu tab "My portfolio"[«Min portefølje»], "Active projects"[«Aktive prosjekter»] in the REK portal. The necessary forms can be found on the right of the screen.
Relevant routines in DOCMAP (only available via the intranet):
Notice of change in medical and healthcare research projects