Procedures related to the Regional Committee for Medical and Health Research Ethics (REK)
All health research projects involving humans, biological material, or health information must be pre-approved by REC.
- In its decisions on pre-approval, REC shall not explicitly address the project's legality under privacy regulations or other legal requirements.
- REC shall refine its research ethics assessments.
General procedures for applying to REC
Electronic applications are sent to REC (Regional Committees for Medical and Health Research Ethics).
To submit an application, you must create your own user account in the portal. You can find information about application deadlines and forms under New application.
The Act on Medical and Health Research (the Health Research Act) shall promote "good and ethically sound" medical and health research. In the Regulations on the organisation of medical and health research, you will find information on requirements for applications, on advance approval and requirements for research protocols, see §§ 7 and 8.
The project manager is the applicant and contact person, and must have a doctoral degree. Check with your faculty/center how this should be filled out in the application.
Complaint about decision
Decisions made by the REC can be appealed to the National Committee for Medical and Health Research Ethics (NEM), cf. the Research Ethics Act § 6 last paragraph. The decision is final and cannot be appealed further.
Register NVA-ID on project manager in REK
Registration of NVA-ID takes place in connection with the submission of project applications via REK-portalen. NVA-ID is used to identify and archive publications and research results. The NVA-ID can be linked to the project description or the results to be registered in NVA.
In case of significant changes to the project
The project change form should be used when a project manager wants to apply for continued approval from REC under new project conditions. You must apply for continued approval when you want to make significant changes to the project's purpose, method, duration or organization (Health Research Act § 11).
The application form for approval of project changes and more information about the application can be found on REC's website.
Upon completion of the project
When the project is completed, you must send a final notification to REC on a separate form. Information about the form can be found on REC's website. You must also send a final notification if the project is not completed as planned.
Archiving the project in VID's case archive
Applications to REK and all correspondence must be archived in Public 360. The project manager sends the relevant documentation to arkiv@vid.no.
Archiving project data after project completion
It is possible to have your research data stored long-term, see the website about archiving research data. For questions, please contact forskningsdatahandtering@vid.no, personvernforskning@vid.no or personvernombud@vid.no.
Resources
Web pages
- The Norwegian Biotechnology Advisory Board
- Health Research (Directorate of Health)
- Medicine and Health Sciences (Research Ethics Committees)
- Guidelines for the processing of personal data in research and student assignments at VID Specialized University