How does the ethical review process work in Norway and which are the designated ethics committees?
There are seven regional ethics committees in Norway, which correspond to the National Health Service organization: Eastern, Southern, Western, Central and Northern. In the Eastern and Southern regions there are two committees for each region.
The remit of the committees includes the entire health area (not only medicine) and includes research on health information and biological material as long as the purpose of the research is to gain new knowledge in medicine and health care.
As of 2009 health care research is regulated by the Health Research Act. It aimed at regulating medical research by one law and allow for only one review of projects. This task was given to REK. It means that it also reviews issues of privacy, secrecy and establishment of biobanks. The only exception is clinical trials that also need permission from the Medicinal Health Authority.
REK is regulated by a separate Act (not available in English). The main thrust is that the committees are independent committees which cannot be instructed by anyone. The composition of nine members of the committee: interdisciplinary professional background (medicine, psychology, nursing, law, ethics) and two lay representatives (of which one should be recruited from a patient association). The term is four years with a possibility for one extension.
Administratively REK is organized under the medical faculties at the four large universities in Norway. REK North under the University of Tromsø, REK Mid under the University of Trondheim, REK West under the University of Bergen, and REK South-East under the University of Oslo. Decisions by REK can be appealed to NEM.
Networking between RECs:
The National Committee for Medical Research Ethics (NEM). NEM is an advisory and appeal body for the seven regional committees for medical and health research ethics (REK). NEM has developed a Research Ethics Library in cooperation with the universities in Norway. It is meant as an educational resource for research institutions as well as for members of research ethics committees.
REK is organized through a common national web portal for electronic submission of projects for review. The portal distributes projects evenly between the 7 REC, though it follows a main rule assigning projects to the region of origin. The portal offers common application forms and standard operating procedures. It also has functions for search and for archive. REK organizes one national conference per year for all members of all committees for networking purposes and for addressing issues of common interest. REK also organizes coordination meetings twice a year between the chairs of the committees and respective secretariats.
The secretariates of the REK are organized in a forum consisting of the heads of the secretariates.