If you have concerns you should definitely familiarize yourself with the Health Research Act (Act on medical and health research). This act was approved in 2008 (1 July 2009), and was more recently updated in 2017. Below you will find a short introduction to the act.

§2 defines the aim with medical and health research as research on human beings, human biologic material and health related information. In addition, the act is applicable for pilot studies and exploring treatments. The act also defines the geographical area where research is conducted (in § 3), and relates to Norwegian territory or when research is conducted under the leadership of Norwegian scientists.

§4 involves who is the responsible institution and normally this is the place where the responsible scientist is employed. In addition, we get a definition of the project leader as a person who should have the competence both to topic and science for a responsible performance. The supervisor is normally the project leader and should then have a PhD or corresponding merits.

The project leader has the responsibility for the daily conduct of the project and should oversee: that ethical, health related, scientific and individual concerns are taken; that the institution is informed before the project is started; that applicable ethical approval from REK is at hand; that the project is conducted according to the original plan; as well as appropriate communications to public institutions have been done.

Who must apply at REK? All who conduct research with an aim of novel knowledge about health and disease.

Who does not need to apply? Activities concerned with quality assurance. In addition, there are borderline areas, for example health service research, explorative treatments and methodological developments.

If you have questions/concerns? Use the application template “Remit Assessment”.  By this you will get a quick response from REK.

And please note – you will never obtain ethical approval after a project has been started!

How do I apply? You find the Web portal here.  There is full electronic handling of applications.  The decision is sent to the responsible institution. There are different forms for remit assessment, project application, project amendments, and reports.

If you still have questions and concerns – contact the administration at REK. You find them in the second floor of Armauer Hansen Building.

Roland
Acting Head