Research Ethics Acts: 2017 & 2006
Law on organization of ethical research work (Research Ethics Act)
Date LOV-2017-04-28-23
Department Ministry
Last changed
Published
Commencement 01.05.2017
Changing LOV-2006-06-30-56
Promulgated 28.04.2017
Korttittel Research Ethics law
§ 1. Purpose
The law will help ensure that research in the public and private sector takes place in accordance with recognized ethical standards.
§ 2. Scope
The Act applies to researchers and research in Norway. On Svalbard and Jan Mayen Act applies if the research is undertaken by researchers employed by a Norwegian employer or if a substantial portion of the funds coming from Norway.
Investigation Committee may further comment on the research abroad if research is undertaken by a researcher employed by a Norwegian employer or if a substantial portion of the funds coming from Norway.
§ 3. Independence
Committees appointed pursuant to this Act shall be professionally independent.
§ 4. Investigators duty of care
Researchers should act with due care to ensure that all research is done in accordance with recognized ethical standards.This is also under preparation for research, reporting on research and other research-related activities.
§ 5. Requirements for research
Research institutions are public or private institutions that have research as one of its main tasks.
Research institutions should ensure that research at the institution takes place in accordance with recognized ethical standards. The institution is responsible for:
§ 6. Treatment of cases of fraud in research institutions
Research institutions have a responsibility to deal with cases of possible violations of recognized ethical standards. Administration Chapters IV and V apply to these cases.
Research institutions should have an integrity committee. The committee shall have the necessary expertise in research, ethics and law. The committee shall have at least one member who is not employed by the institution.
Research institutions should establish guidelines for dealing with cases of possible violations of recognized ethical standards.The guidelines shall also specify when that part of the handling of such cases should be obtained a statement from the integrity committee.
Research institutions are required to report cases of possible serious violations of recognized ethical standards to the review board.
Statements which conclude that a researcher has performed scientific fraud, can be appealed by the researcher to the review board, ref. § 7,. Public Administration Chapter VI shall apply with the limitations imposed by this law.
§ 7. Investigation Committee
The Ministry shall appoint a national commission for the investigation of research misconduct. Investigation Committee shall have the necessary expertise in research and research ethics. The chairman shall have a law degree or master's degree in jurisprudence.
Investigation Committee appealed statements which concludes that a researcher has acted scientifically fraudulent. The committee may also consider cases of possible violations of recognized ethical standards on their own initiative. Administration Chapters IV and V apply to these cases. Investigation Committee statements are final and can not be appealed further.
The investigation committee will guide the research on the treatment of cases involving possible breaches of recognized ethical standards.
§ 8. Statements in cases of fraud
In statements from research organizations under § 5, probity selection under § 6, second paragraph and Investigation Committee under § 7 in cases involving possible breaches of recognized ethical norms must always be decided:
§ 9. National Research Ethics Committees
Ministry appoints national research ethics committees which cover all disciplines, and determines each Committee's area of responsibility. The members are appointed by the Ministry on the proposal of the relevant bodies. Each committee to be skilled in the relevant fields of research, ethics and law, and should have at least one lay representatives.
The committees shall be advisory bodies on research ethics.
§ 10 Regional Committees for Medical and Health Research
Ministry appoints regional committees for medical and health research. Each committee to be skilled in the relevant fields of research, ethics and law, and should have at least one lay representatives.
The committees' responsibilities included the Health Research Act and other legislation that adds tasks to committees.
The National Research Ethics Committee for Medical and Health appealed to the committees' decisions, also for decisions under Freedom of Information Act. The national committee's decision is final and can not be appealed further.
§ 11. Exemption from public
Freedom of Information Act § 24 subsection applies to cases involving possible breaches of recognized ethical standards under this Act.
§ 12. Regulations
The Ministry may issue regulations with further provisions regarding the appointment and procedures of committees under the Act.
§ 13. Entry into force
This Act comes into force on the date decided by the King. 1
From the same date the Act 30 June 2006 no. 56 on ethics and integrity in research.
1 From May 1 2017 acc. Res. April 28, 2017 no. 505.
§ 14. Amendments to other Acts
From the time the law comes into force the following amendments to other Acts - - -
Date LOV-2017-04-28-23
Department Ministry
Last changed
Published
Commencement 01.05.2017
Changing LOV-2006-06-30-56
Promulgated 28.04.2017
Korttittel Research Ethics law
§ 1. Purpose
The law will help ensure that research in the public and private sector takes place in accordance with recognized ethical standards.
§ 2. Scope
The Act applies to researchers and research in Norway. On Svalbard and Jan Mayen Act applies if the research is undertaken by researchers employed by a Norwegian employer or if a substantial portion of the funds coming from Norway.
Investigation Committee may further comment on the research abroad if research is undertaken by a researcher employed by a Norwegian employer or if a substantial portion of the funds coming from Norway.
§ 3. Independence
Committees appointed pursuant to this Act shall be professionally independent.
§ 4. Investigators duty of care
Researchers should act with due care to ensure that all research is done in accordance with recognized ethical standards.This is also under preparation for research, reporting on research and other research-related activities.
§ 5. Requirements for research
Research institutions are public or private institutions that have research as one of its main tasks.
Research institutions should ensure that research at the institution takes place in accordance with recognized ethical standards. The institution is responsible for:
- a) necessary training of candidates and employees of recognized ethical standards and
- b) that anyone who performs or participates in research, familiar with recognized ethical standards.
§ 6. Treatment of cases of fraud in research institutions
Research institutions have a responsibility to deal with cases of possible violations of recognized ethical standards. Administration Chapters IV and V apply to these cases.
Research institutions should have an integrity committee. The committee shall have the necessary expertise in research, ethics and law. The committee shall have at least one member who is not employed by the institution.
Research institutions should establish guidelines for dealing with cases of possible violations of recognized ethical standards.The guidelines shall also specify when that part of the handling of such cases should be obtained a statement from the integrity committee.
Research institutions are required to report cases of possible serious violations of recognized ethical standards to the review board.
Statements which conclude that a researcher has performed scientific fraud, can be appealed by the researcher to the review board, ref. § 7,. Public Administration Chapter VI shall apply with the limitations imposed by this law.
§ 7. Investigation Committee
The Ministry shall appoint a national commission for the investigation of research misconduct. Investigation Committee shall have the necessary expertise in research and research ethics. The chairman shall have a law degree or master's degree in jurisprudence.
Investigation Committee appealed statements which concludes that a researcher has acted scientifically fraudulent. The committee may also consider cases of possible violations of recognized ethical standards on their own initiative. Administration Chapters IV and V apply to these cases. Investigation Committee statements are final and can not be appealed further.
The investigation committee will guide the research on the treatment of cases involving possible breaches of recognized ethical standards.
§ 8. Statements in cases of fraud
In statements from research organizations under § 5, probity selection under § 6, second paragraph and Investigation Committee under § 7 in cases involving possible breaches of recognized ethical norms must always be decided:
- a) if the researcher has acted scientifically fraudulent or not,
- b) whether there is any system failure at the institution and
- c) about the scientific work should be corrected or withdrawn.Scientific misconduct is defined as falsification, fabrication, plagiarism and other serious violations of recognized ethical norms that are committed intentionally or through gross negligence in the planning, implementation or reporting research.
§ 9. National Research Ethics Committees
Ministry appoints national research ethics committees which cover all disciplines, and determines each Committee's area of responsibility. The members are appointed by the Ministry on the proposal of the relevant bodies. Each committee to be skilled in the relevant fields of research, ethics and law, and should have at least one lay representatives.
The committees shall be advisory bodies on research ethics.
§ 10 Regional Committees for Medical and Health Research
Ministry appoints regional committees for medical and health research. Each committee to be skilled in the relevant fields of research, ethics and law, and should have at least one lay representatives.
The committees' responsibilities included the Health Research Act and other legislation that adds tasks to committees.
The National Research Ethics Committee for Medical and Health appealed to the committees' decisions, also for decisions under Freedom of Information Act. The national committee's decision is final and can not be appealed further.
§ 11. Exemption from public
Freedom of Information Act § 24 subsection applies to cases involving possible breaches of recognized ethical standards under this Act.
§ 12. Regulations
The Ministry may issue regulations with further provisions regarding the appointment and procedures of committees under the Act.
§ 13. Entry into force
This Act comes into force on the date decided by the King. 1
From the same date the Act 30 June 2006 no. 56 on ethics and integrity in research.
1 From May 1 2017 acc. Res. April 28, 2017 no. 505.
§ 14. Amendments to other Acts
From the time the law comes into force the following amendments to other Acts - - -
Norway's Research Ethics Act: 2006 [repealed]
(Source: http://app.uio.no/ub/ujur/oversatte-lover/data/lov-20060630-056-eng.pdf or iLOV-2006-06-30-56)
(Source: http://app.uio.no/ub/ujur/oversatte-lover/data/lov-20060630-056-eng.pdf or iLOV-2006-06-30-56)
Act of 30 June 2006 No. 56 on ethics and integrity in research
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 committee’s 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 given.
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.
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 committee’s 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 given.
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.
Norwegian Ministry of Education and Research
The Norwegian Ministry of Education and Research (Kunnskapsdepartementet) issued a "Consultation paper" regarding the proposed amendments to Norway's Research Ethics Act No. 56 of 30 June 2006 (since repealed). This "Consultation paper" is included below via titles and URL links for the English and Norwegian versions, which helps to explain how the Research Ethics Act 2017 came into existence.
The Norwegian Ministry of Education and Research (Kunnskapsdepartementet) issued a "Consultation paper" regarding the proposed amendments to Norway's Research Ethics Act No. 56 of 30 June 2006 (since repealed). This "Consultation paper" is included below via titles and URL links for the English and Norwegian versions, which helps to explain how the Research Ethics Act 2017 came into existence.
- Consultation paper – Research Ethics in Norway
- Høring om revisjon av forskningsetikkloven Høring
Høring| Dato: 09.07.2015
"Kunnskapsdepartementet sender med dette forslag til endringer i lov 30. juni 2006 nr. 56 om behandling av etikk og redelighet i forskning (forskningsetikkloven) på alminnelig høring. Høringsnotatet tar særlig opp spørsmål knyttet til forskningsinstitusjoners forskningsetiske ansvar.
Status: Under behandling
Høringsfrist: 31.10.2015 (Source: Regjeringen.no)