Regional Committees for Medical and Health Research Ethics (REK)
It is the task of the Regional Committees for Medical and Health Research Ethics (REK) to assess whether research projects are ethically justifiable.
For all medical and health research involving humans, human biological material or health data, prior approval must be applied for from REK. The obligation of disclosure also applies to pilot studies and experimental treatment. Approval from REK is required before the project can start.
From September 2020, VHP+ has been initiated as a trial scheme to practise an overall assessment from ethics committees and medicines agencies. It can be used for clinical trials of medicinal products to be conducted in two or more EU/EEA countries. It should be preferred over VHP.