The Regional Committees for Medical and Health Research Ethics, REK, must pre-approve medical and health-related research projects and research biobanks.
If you are unsure whether your project falls under the Health Research Act, see the section on Categorisation – Do you need to apply to the REK? above.
REK does not provide a legal basis for processing personal data. Projects that fall under the Health Research Act must also be reported to Sikt if personal data will be used.
Applications to REK and Sikt should be submitted simultaneously to minimise processing time. Once the project manager receives a decision from REK, the notification of the decision must be uploaded as an attachment to the notification form to Sikt. Sikt will then conduct a data protection assessment and issue a recommendation on whether the project may commence.
Tips for completing the REK application:
- It is important to design a good consent form. Refer to the separate point below regarding consent.
- Ensure that information is user-friendly and easy to understand. Consider the target group(s) when drafting information sheet(s).
- Pay attention to who will do what and the distribution of project responsibilities. Be especially clear about who will recruit participants and how this will be done. The principal investigator can provide information about the research project, but REK recommends that someone else on the project obtain consent from participants. The procedure for recruiting participants must be described in the REK application.
- Include a detailed follow-up plan of, and responsibility for, vulnerable individuals and groups, specifying what contact information is to be provided to these participants.
- Specify who will assess the participants’ ability to consent when their ability to consent is reduced or missing.
- Significant changes: If there are major changes to a project, the project manager must submit a change notification to REK. See Changes and Extensions.
Right of Appeal:
It is possible to appeal REK’s decision, cf. the Public Administration Act Section 28 ff. Appeals must be submitted on a separate form through the REK portal. The deadline for appeal is three weeks from receipt of the REK’s decision. If REK upholds its decision, the appeal is forwarded to the National Committee for Medical and Health Research Ethics (NEM) for final assessment, cf. the Research Ethics Act paragraph 10 and the Health Research Act paragraphy 10.
Resources related to REK:
- For more information about REK applications and what the research protocol must include, consult the REK portal
- For more information about consent and role understanding, see the National Research Ethics Committees’ text on Consent and Sikt’s text on Researching in your own workplace (Norwegian only).