Operating parameters

According to the mandate conferred by the Act, NEM, REK and the Investigation Commission are decision-making bodies while NENT and NESH are advisory bodies. The Act establishes the professional autonomy of the committees. The authorities cannot issue instructions to the committees and the Commission on matters within their purview.

The Norwegian National Research Ethics Committees shall have 12 members with expertise in "relevant research disciplines", ethics and law, as well as lay representation. The Regional Committees for Medical and Health Research Ethics (REK) shall have nine members with expertise in "relevant research disciplines", ethics and law, as well as lay representation.

The committees are appointed by the Ministry of Education and Research.

Obligation to submit research projects for approval

Research projects that entail trials on humans must be submitted to REK for approval, and may not be initiated before approval is given. This also applies to projects in other countries if the project has ties to Norway through a project manager having a Norwegian employer, or the project being funded from Norway. (See also Section 10 of the Health Research Act).

There is no obligation to submit projects in the respective disciplines to NENT or NESH, and if they are submitted nonetheless, the statements of these committees are purely advisory.

National Commission for the Investigation of Research Misconduct

The Investigation Commission shall have seven members, at least one of whom should be associated with a research community in another country. The Commission members are appointed by the Ministry of Education and Research. The Commission chairman must have experience as a judge, and the Commission must have members with expertise in research and research ethics.

The Investigation Commission shall issue statements as to whether research has been subject to scientific misconduct, and if appropriate also deal with cases of alleged scientific misconduct.

The Research Ethics Act defines "scientific misconduct" as "falsification, fabrication and plagiarism, and other serious breaches of good scientific practice". For misconduct to apply, the act must as a minimum have been wilful or due to gross negligence.

The Investigation Commission's conclusion must be that the subject of the complaint either is or is not guilty of scientific misconduct, and there must be a "clear" preponderance of evidence for a conclusion of misconduct to be reached.

A statement from the Commission may be appealed to a commission that is appointed by the ministry to deal with the appeal in question. The decision of this commission is final.

Decisions

Decisions adopted by the committees are administrative decisions, and the committees shall comply with the Public Administration Act with respect to impartiality, access to documents, grounds for decisions and administrative proceedings generally.

The committees reach decisions at meetings and according to the standard rules of majority voting. Decisions must be delivered in writing together with the reasons for reaching them and whether they were unanimous.

Decisions reached by the REKs may be appealed to NEM. NEM's decision is final.

The Health Research Act and the Act on ethics and integrity in research can be found at http://app.uio.no/ub/ujur/oversatte-lover/english.shtml.