Regional Committees for Medical and Health Research Ethics
All medical and health research projects must be pre-approved by the Regional committees for medical and health research ethics (REK). Approval must be obtained before the project can start.
All medical and health research on human beings, human biological material or personal health data must seek pre-approval from REK. This also applies for pilot studies and experimental treatments.
When the Health Research Act came into force in July 2009, the "one mailbox" principle was introduced. The researchers would only have to apply for pre-approval to one body – REK. At the same time, the processing of applications for exemption from the duty of confidentiality in research was transferred from the Norwegian Directorate of Health to REK.
REK must also approve the establishment of research biobanks, but the Health Research Act does not apply to the establishment of health registers.
In 2020, the first REK KULMU was established. These committees will handle pre-approval applications under the Medical Device Regulation, Clinical Trial Regulation and In-vitro Diagnostic Medical Device Regulation. REK KULMU works closely with the Norwegian Medicines Agency.
The committee system has its legal base under the Research Ethics Act and the Health Research Act. The committees are professionally independent state bodies.
Each committee shall have expertise in relevant research disciplines, ethics and law, and shall have at least one lay representative. The committees are appointed by the Ministry of Education and Research for four years at a time. The regional committees reflect the regional health authorities: Helse Nord, Helse Midt-Norge, Helse Vest and Helse Sør-Øst.
The committees are:
Regional Comittee for Medical Research Ethics Northern Norway, REK North
Regional Comittee for Medical Research Ethics Central Norway, REK Central
Regional Comittee for Medical Research Ethics Western Norway, REK West
Regional Comittees for Medical Research Ethics South East Norway, REK South East
For more information, go to REKs website.
The appeal body for decisions made by REK pursuant to the Research Ethics Act and the Health Research Act is The National Committee for Medical and Health Research Ethics (NEM).