Norway - RECs and Medical Research

History

Ethical review of biomedical research was organised in Norway during the late 80s but there was legal review of research before then. This was carried out by the Secretariat for Data Protection Affairs which was established in 1981. The National Committee for Medical Research Ethics was set up in 1990 by the Ministry of Education, Research and Church Affairs. It is an advisory and coordinating body for the regional committees but not an appeal body. Its main tasks are to inform and advise scientific communities, governmental authorities and the general public. It is one of three national committees covering all types of research - the others being The National Committee for Research Ethics in Science and Technology and The National Committee for Research Ethics in the Social Sciences and the Humanities.

There are 5 regional committees in Norway, which correspond to the National Health Service organisation: Eastern, Southern, Western, Central and Northern. These were established in 1985 and operate under terms of reference issued by the Ministry of Education and Research. They carry out the actual review of research projects.

Summary of Norwegien RECs

Type of REC	National Committee for Medical Research Ethics	Regional (RRECs)
Where situated?	Centrally	University medical faculties
Who applies to them?		Researchers
Formal/Informal	Formal	Formal
National/Regional	National	Regional
Laws Involved		Biobank law Freedom of Information Act Public Administration Act
Guidance Involved	The mandate of the National Committee for medical research ethics, laid down on 16 May 1990 by the Ministry of Education, Research and Church Affairs.	Terms of reference from Ministry of Research & Education Declaration of Helsinki Council of International Organizations of medical Sciences guidelines
Membership requirements	12 members with different professional backgrounds, including those with competence in medicine, ethics, law, psychology and genetics	8 members: 2 medical professionals -1 from regional faculty of medicine and 1 from regional health authority a member with psychology qualifications a member with nursing qualifications a representative of the regional hospital owners a member with professional expertise in ethics a lawyer a lay representative
Responsible/accountable to whom?	Ministry of Education & Research	Independent - not answerable to any body
Approval or Advisory powers	Advisory	Formally only advisory although in practice approval from a RREC is necessary for research to go ahead.

Not submitting research or failing to follow review

The committees have no power of sanction but there may be other consequences such as withdrawal of funding, lost prestige and status.
The Ministry of Research & Education is at present evaluating the system of RRECs and this may involve giving them a legal basis.

Which body, if not the REC itself takes this action, and how do they proceed?

The Data Inspectorate may stop the project if it involves processing of personal information.

Impact of Directive 2001/20 EC

This may change the system of review in that it recommends that drug trials be reviewed at least once a year.

Legal action that can be taken against RECs

No legal action may be taken at present but as before the system is currently being evaluated and this may give RRECs a legal basis.

Links section

Norwegian Medical Association (in Norwegian & English)
Norwegian Biotechnology Advisory Board (in Norwegian & English)
Norwegian Laws (in Norwegian & English)
National Committee for Research Ethics in Science & Technology (in Norwegian & English)
The National Committees for Research Ethics (in Norwegian & English)

See the REC bibliography section for more links and papers