Section 1. Purpose of the Act
This Act seeks to ensure that research carried out by public and private institutions is conducted in accordance with recognised ethical standards.
Section 2. Autonomy
Committees and commissions appointed pursuant to this Act shall be state bodies that are autonomous in professional matters.
Section 3. National research ethics committees
National research ethics committees that collectively cover all disciplines shall be established. These committees shall serve as advisory bodies on research ethics. The Ministry will establish such committees, determine the committees’ fields of responsibility and appoint members.
The committees shall have expertise in relevant research disciplines, ethics and law. They shall also have lay members.
Section 4. Regional committees for medical and health research ethics
Regional committees for medical and health research ethics shall be established. The Ministry will establish such committees, determine the committees’ fields of responsibility and appoint members. Members shall be appointed on the basis of proposals from relevant bodies. The committees shall have expertise in relevant research disciplines, ethics and law. They shall also have lay members.
Research projects in Norway that involve experiments on human subjects shall be submitted to the committee for approval. Research projects conducted outside Norway shall be submitted to the committee for approval if the research is being carried out by a researcher employed by a Norwegian employer or if a substantial portion of the funding comes from Norway.
Appeals against decisions made by the committees may be lodged with the National Committee for Medical and Health Research Ethics. The decision of the National Committee is final and may not be further appealed.
Section 5. The National Commission for the Investigation of Scientific Misconduct
A national commission for the investigation of scientific misconduct shall be established. The commission shall give a statement as to whether scientific misconduct has occurred in research conducted in Norway. The commission shall also give a statement on research conducted outside Norway if the research has been carried out by a researcher employed by a Norwegian employer or if a substantial portion of the funding comes from Norway.
Scientific misconduct is defined as falsification, fabrication, plagiarism and other serious breaches of good scientific practice that have been committed wilfully or through gross negligence when planning, carrying out or reporting on research.
The members of the commission shall be appointed by the Ministry. The commission chair shall have judicial experience. The composition of the commission shall ensure that the commission has the necessary expertise in the field of research and research ethics.
The commission may in individual cases decide that the documents relating to a case shall not be made public until a final statement has been pronounced.
The Ministry is the administrative appeals body for appeals regarding the administrative procedures of the commission. Appeals regarding the content of the statement shall be dealt with by a specially appointed commission. A special commission shall be appointed for each appeal and shall comprise members with the necessary professional or technical, research ethics and legal expertise. The decision of the special commission is final.
Section 6 Regulations
The Ministry may make supplementary regulations regarding the appointment and administrative procedures of committees and commissions pursuant to this Act.
Section 7 Commencement
This Act shall enter into force from the date decided by the King.