1. Research ethics
The principle objective of research ethics is to raise the awareness of researchers in particular, and society by large, with respect to the ethical challenges of research in terms of research results and the research process. As well as ensuring that research conforms to the moral values and demands of society, research ethics is important for the protection of individuals and participants in research projects. Sound research ethics will also increase confidence in research results, individual researchers and the research community in general. The confidence of society in researchers and their results is a prerequisite for research funding and, in addition, is likely to affect the recruitment of new researchers. In other words, ethical reflection and sound research ethics are a prerequisite for freedom of research and the possibilities researchers have to realize their aims. Breaches of sound ethical practice are likely to damage the status of research and decrease support for research in society.

2. Misconduct and fraud in biomedical and health care research
In recent years several cases of fraud within biomedical research have been unveiled, e.g. the exposure of Sudbø in Norway (January 2006) and Woo-suk Hwang in South Korea (July 2006). In the wake of the Sudbø case, a commission of inquiry was set up at UiO/ Rikshospitalet-Radiumhospitalet Health Trust (www.rikshospitalet.no/content/res_bibl/6621.pdf). The debate on co-authorship in scientific journals has thus become even more relevant, focusing on what qualifies a researcher for authorship and the responsibilities which co-authorship entails.

In 2006 the government presented a proposition to the "Odelsting" on ethics and integrity in research ("Om lov om behandling av etikk og redelighet i forskningen", Ot.prp. nr. 58 2005-2006) www.odin.no/kd/norsk/dok/regpubl/otprp/070001-050004/dok-bn.html.

Fraud in biomedical and health care research can have far-reaching consequences. In addition to affecting the reputation of medical research, it can cause injury or expose groups of patients to added risk as a result of new principles of treatment being implemented on an incorrect basis.

In practice, a qualitatively poorly executed research project and outright research fraud may be on the same sliding scale which includes everything from unconscious mistakes and actions, such as incorrect observations and analytical errors, missing credits to actual plagiarism, false correction or exclusion of "inappropriate" data, as well as fabrication of data.

One definition of the difference between fraud and error is as follows: fraud entails a deliberate intention to cheat and deceive. In the Government proposal "Om lov om behandling av etikk og redelighet i forskningen" academic fraud is defined as "falsifying, fabrication, plagiarism and other serious breaches of academic practice carried out with intent or with gross negligence in the planning, carrying out or reporting of research". The authors of the Research Handbook are of the opinion that "gross negligence" in this context includes breaches of standard internal or external scientific norms or regulations which researchers, by way of their skills and position, ought to be acquainted with and comply with.

It is impossible to determine the exact extent of fraud within biomedical and health care research. This is partly because the definition of fraud is somewhat unclear and partly because the legal definitions do not necessarily correspond exactly to judgments based on research ethics. By its very nature, research fraud is based on factors that are concealed and denied, as in other forms of fraud and breaches of trust. It is uncertain whether scientific fraud is more frequent than previously and whether there is any variation between disciplines. There have been attempts to establish the extent of scientific fraud via questionnaires to researchers. Such questionnaires in Norway in the 1990s indicated that many researchers were aware of actual cases of scientific fraud, but very few indeed declared that they were involved in fraudulent research themselves.

3. Possible causes of misconduct and fraud in research

Lack of awareness of extensive regulations
One of the problems of current research control in Norway is that the regulations are extremely fragmentary and are therefore inaccessible and over-complex. The Report of the Nylenna Committee on research and health care (NOU 2005: 01 God forskning - bedre helse) identified approximately 25 different general laws regulating medical and health care research in some form or other, including the Patients' Rights Act ("Pasientrettighetsloven"), the Biobank Act ("Biobankloven") and the Data Protection Act ("Personopplysningsloven") (www.regjeringen.no/nb/dep/hod/dok/NOUer/2005/NOU-2005-01.html?id=389605). The Committee proposed that these laws should be coordinated into one coherent law on medical and health care research and that institutional responsibility for research should be reinforced, including providing for improved and more explicit sanctions for those who break the law. In 2008, the Storting passed the Health Research Act (see Chapter 10), which will come into effect in 2009.

An increasing number of international directives and conventions also affect the regulation of medical research, for example the EU Directive on Medicinal Products (GCP: Guideline for Good Clinical Practice, www.ich.org/LOB/media/MEDIA482.pdf) and the European Council Convention on Biomedicine and Human Rights (Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research conventions.coe.int/treaty/en/treaties/html/195.htm

In addition, there are a number of written and unwritten professional norms which affect how research is conducted, as well as the criteria for authorship in academic journals, e.g. the Helsinki Declaration (www.etikkom.no/REK/skjemaer/2005/veiledning/Etikkom/retningslinjer/helsinkideklarasjonen and www.wma.net/e/policy/b3.htm) and the CIOMS (The Council for International Organizations of Medical Sciences, www.cioms.ch).

Personal motives
There is an increasing pressure to publish ("publish or perish"), particularly within biomedical disciplines in which it is crucial for researchers to be the first to publish important findings. Publications also function as a system of merit, both in terms of personal careers and with respect to allocation of research grants. However, the pressure to publish cannot fully explain why a few researchers deliberately choose to commit fraud in research, for example fabricating data. It is likely that personal characteristics of the individual researcher also play a role as some fraudsters who have been exposed have shown repeated fraudulent behavior (in research). The desire for "honor and glory" may also be a motivational factor that can lead to research fraud.

4. What can be done to prevent research fraud?

Existing measures
A number of quality assurance systems are already in place to minimize research errors and improve the quality of research within research institutions. In reality, the most important elements of the quality assurance system are the research groups and the researchers themselves. Systematic errors can be prevented through sound research design and random errors can be corrected for by statistical analyses.

All research institutions are required to have internal control routines so that they can carry out their activities in a responsible manner (cf. Health Personnel Act, "Helsepersonellovens" § 16). In addition, a number of public agencies have auditing and supervisory functions with respect to research, see Chapter 10. Advance audits are the most comprehensive, e.g. REK and the Data Inspectorate (applications for licenses). Audits of ongoing research and of completed research projects are likely to be more fragmentary, both at the level of research institution and levels above. The Data Inspectorate has passed advance audits prior to approval of processing of sensitive personal information in research projects to a locally nominated Data Protection Inspector (see Chapter 10), for example, while they themselves now undertake a greater number of audits of ongoing projects. Many research institutions also have their own bodies and routines for monitoring ethical and quality aspects of ongoing research projects.

Once a research project has been completed, publishing mechanisms become an important factor in revealing errors or deficiencies. Often preliminary findings are presented as lectures or posters and manuscripts are revised according to the feedback received on these before submission to an academic journal. Methodological, ethical and presentational aspects of the study are evaluated through the peer review system of academic journals and, as a rule, articles have to be revised a number of times before they are published. The underlying assumption is that peer review improves the academic quality of published work, but there is general agreement that the system cannot guarantee exposure of fraudulent research. Peer reviewers are not close enough to data sources to be able to check the validity of results, although they do sometimes discover irregularities which may lead to suspicions of fraud. Editors may then request further information. It is a matter of some debate among editors of leading medical journals how the peer review process may be improved and also the degree of responsibility editors have for articles they publish. It has become increasingly common for journals to require authors to declare the exact nature of the contribution they have made to the study and the publication. If a journal suspects there is something dubious about the research, they have the option of rejecting the article or sending out a "warning".

Citation and ethics
Correct use of references shows academic integrity and avoids plagiarism. Presentation of others results, thoughts, ideas or formulations as your own, is plagiarism (www.sokogskriv.no/norsk/basis/sitering-etikk/index.html). Plagiarism is intellectual theft, and is regulated by "Lov om opphavsrett til åndsverk m.v. (åndsverkloven)" and "Lov om universiteter og høgskoler".

Current sanctions against fraudulent researchers
Current Norwegian regulations for dealing with fraud and misconduct in research are inadequate, although sanctions may have a preventative effect and thereby reduce misconduct and fraud in research environments. Sanctions include censure by colleagues and exclusion from academic circles, as well as withdrawal of funding. In addition, researchers may face administrative, disciplinary, civil or criminal action. They may be given notice by their employer and sentenced to pay compensation to parties who have been duped or injured. Researchers who also work in the health care system risk receiving a warning from the Norwegian Board of Health Supervision ("Helsetilsynet"), and in extreme cases authorization may be withdrawn. In 2006 one researcher was deprived of the PhD title ("dr.med.") and approval of his/her doctoral thesis at the University of Oslo was withdrawn. Criminal action may also be taken, potentially resulting in fines or a prison sentence if someone has been deceived or duped and has suffered a loss as a result.

5. How to prevent fraud in research environments in future

Can fraud be prevented by more research bureaucracy?
The opinion of the authors of this Handbook is that more bureaucracy and control could easily lead to research being paralyzed by over-regulation and may result in many researchers giving up their careers. On the other hand, the culture of research must be based on a fundamental ethos of integrity, openness and honest work of high quality in all parts of the research process, as well as an awareness on the part of research institutions of their responsibility for the system.

In practice, the integrity of researchers themselves and internal social control are probably more significant than external control, which is chiefly designed to expose the most serious cases of fraud. The opinion of the authors of this Handbook is that research institutions must continue to be the cornerstone of initiatives promoting sound research ethics and prevention of misconduct. Internal and external control systems must be improved and existing rules and regulations must be clarified, simplified and made more effective. Continued promotion of sound principles in research environments and an increased awareness of the moral, professional and legal responsibilities of researchers are also important. Open communication in research groups about ongoing research projects, in addition to discussions on sound research practice and research ethics, should contribute to the promotion of sound research and help prevent misconduct and fraud.

Presentation of research data and methodology not only provides opportunities for improving the scientific quality of projects, but also ensures openness in the research environment which, in turn, makes fraud more difficult. Any fraud would soon be discovered if large amounts of data appeared after only a brief period of time since other researchers in the group are fully aware that data collection can take several years. Sound research behavior and a sound research culture require openness, honesty, trust and fruitful collaboration and are thus likely to contribute to reducing conflicts, misconduct and fraud. It is also important that a greater number of researchers in any research group have access to original data so that the data material, calculations and presentation of results may undergo a greater degree of quality control.

Some of the possible avenues for research institutions to explore in this context include further development of research training with greater emphasis on research ethics and improved supervision procedures, as well as a closer follow-up of candidates and researchers.

The practical role of supervisors in research projects varies considerably. The opinion of the authors of this Handbook is that supervisors should, as a rule, be well acquainted with all aspects of a project, including quality control of data collection, electronic data processing and statistical analyses, in addition to contributing to the publication process itself.

Protection of "whistleblowers" in the workplace
It is often difficult for a person who discovers or suspects fraud to know how best to deal with the situation. The closer the "fraudster" is to one's own research group, the more difficult it can be. In practice, inexperienced researchers should be able to discuss the matter with their supervisor, who can then take the matter further. If this is not possible, advice should be sought from another senior researcher in whom one has confidence.

An institutional research system founded on sound ethical and research principles should reduce the need for "whistleblowers". Since 2007 a new Working Environment Act (www.regjeringen.no/nb/dep/aid/tema/andre/Arbeidsmiljoloven/Varsling.html?id=448305) has afforded protection to whistleblowers against retaliation ("Retaliation against an employee who reports irregularities in accordance with regulations is prohibited"/"Det er forbudt med gjengjeldelse mot arbeidstaker som varsler i henhold til reglene"). Employers are to develop routines for internal reporting of irregularities or put into place other measures which enable internal reporting of censurable conditions in the workplace. This law also applies to research.

New systems of awarding merit?
Some consider that reducing the pressure to publish would affect the motivation underlying research fraud. However, it is not conceivable that biomedical and health care research environments in Norway would choose other academic systems of merit and funding arrangements than the rest of the world.

New national panel for misconduct in research
In 2006 the Norwegian government decided that the National Committee for Medical and Health Research Ethics ("Den nasjonale forskningsetiske komité for medisin og helsefag", NEM) has the responsibility for initiatives for prevention of misconduct and fraud in biomedical and health care research. NEM is to act at a national level providing advice and support to research institutions, but is not to deal with individual cases of suspected fraud. Instead, the Research Ethics and Integrity Act ("Lov om behandling av etikk og redelighet i forskningen") (Proposition to the Odelsting, Ot.prp. nr. 58 2005-2006; the Act itself came into force as of 1.7.2007) proposed that a new committee be set up, the National Panel for Inquiry into Fraudulent Research ("Nasjonalt utvalg for gransking av uredelig forskning"): www.odin.no/kd/norsk/dok/regpubl/otprp/070001-050004/dok-bn.html.

The Inquiry Panel deals with reported cases or may open a case by their own initiative. There is no statutory requirement for research institutions to submit serious cases to the committee, but the Ministry of Education and Research expects information to be passed to the panel if an institution is dealing with a case of misconduct/fraud. The Inquiry Panel is not to mete out penalties or impose sanctions. This is to be left to the employer or, indirectly, to funding agents. Under the same Act, research institutions are given primary responsibility for prevention of and dealing with fraudulent research, including primary responsibility for good research ethics training of candidates, as well as investigation into and dealing with specific cases of fraud.

The National Committee for Medical and Health Research Ethics (NEM) has since 2007 in its revised mandate (from the Department of Education and Research) been given the responsibility to prevent fraud in biomedical and health research. NEM is not supposed to process individual cases where there is a suspicion of fraud, this responsibility is given to the newly established "Granskingsutvalget" ("Nasjonalt utvalg for gransking av uredelig forskning").

The cases can be notified by institutions or individuals or by the committee. The Norwegian Act on research ethics ("Lov om behandling av etikk og redelighet i forskningen", "Forskningsetikkloven", Ot.prp. nr. 58 2005-2006, www.odin.no/kd/norsk/dok/regpubl/otprp/070001-050004/dok-bn.html) was put forward by the Department of Education and Research, and effectuated 1.7.2007.

Background literature

International links:

The Helsinki Declaration www.etikkom.no/REK/skjemaer/2005/veiledning/Etikkom/retningslinjer/helsinkideklarasjonen

The Vancouver Rules (see also chapter 8)
www.icmje.org

The EU Directive on Pharmaceuticals (GCP: Good Clinical Practice) http://www.ich.org/LOB/media/MEDIA482.pdf

National links:

The National Committee for Medical and Health Research Ethics (Den nasjonale forskningsetiske komité for medisin og helsefag, NEM)
www.etikkom.no

The Ethics and Integrity in Research Act (Om lov om behandling av etikk og redelighet i forskningen, Ot.prp. nr. 58 2005-2006)
www.odin.no/kd/norsk/dok/regpubl/otprp/070001-050004/dok-bn.html

Nylenna Committee Report (NOU 2005: 01 God forskning - bedre helse) www.regjeringen.no/nb/dep/hod/dok/NOUer/2005/NOU-2005-01.html?id=389605

Report by the Inquiry Commission ("Sudbø case") appointed by Rikshospitalet - Radiumhospitalet Hospital Trusts and the University of Oslo
www.rikshospitalet.no/content/res_bibl/6621.pdf

National Research and Ethics Research Training Network
www.etikk.no

Medical Ethics Unit at the University of Oslo
www.med.uio.no/iasam/sme

Bioethical research group at NTNU
www.bioethics.ntnu.no/index.php?id=startside

The Ethics Program at the University of Oslo
www.uio.no/etikkprogrammet

Norwegian books on research ethics:

Nydal R og Solberg B (red). Juks, uredelighet og god forskning. Tapir akademisk forlag 2006. Simonsen S og Nylenna M. Helseforskningsrett: den rettslige regulering av medisinsk og helsefaglig forskning. Gyldendal akademisk 2005.
Ruyter KW (red.). Forskningsetikk: beskyttelse av enkeltpersoner og samfunn. Gyldendal akademisk 2003.
Ruyter KW, Førde R og Solbakk JH. Medisinsk etikk: en problembasert tilnærming. Gyldendal akademisk 2000.

Local suggestions and advice for UUS
There are a number of central and decentralized bodies and resources at UUS whose objective is to ensure ethically sound research at the hospital. Together they promote research of a high ethical standard based on sound research principles, as well as national and international regulations. These bodies are also to reduce the possibility of misconduct and fraud by carrying out preventative measures and audits.

Some of the measures undertaken as of 2007:
· Data Protection Officer, Biobank Support
· The Research Handbook
· Centre for Clinical Research, including clinical monitoring (see Chapter 10)
· A separate research committee in each division and one joint, central research committee, VIRUUS (see Chapter 11 and Chapter 12)
· Separate IT group area for research databases in "Vilje" (see Chapter 10)
· Register of ongoing studies

In addition, there are plans for regular introductory courses for new researchers at UUS. The aims of these courses includes an emphasis on sound research ethics and an introduction to current regulations on research. All researchers have access to a continuously updated electronic edition of the Research Handbook, thereby securing access to updated national regulations, as well as local regulations at UUS. The Research Handbook has been classified as a national resource since 2007 and the general chapters in the handbook can be accessed via a link at the National Health Library (Helsebiblioteket, www.helsebiblioteket.no).

New Research Officer ("ombudsmann") at the University of Oslo and Oslo University Hospitals (Rikshospitalet University Hospital, Ullevål University Hospital, Akershus University Hospital and the Medical Faculty at the University of Oslo)
A new officer for research was appointed in May 2008. The Research Officer shall be a contact person in matters where breach on generally accepted scientific standards related to planning, conduction and termination of a research project is suspected. The Research Officer can be contacted for confidential discussion as to ethical issues related to irregularities or suspected irregularities in research. The Research Officer shall advice and direct scientists or other personnel that get knowledge to circumstances where irregularities in research may be questioned.

Professor emeritus Peter Kierulf is appointed Research Officer. He can be reached at phone 92 28 51 11 or e-mail peter.kierulf@medisin.uio.no

Local suggestions and advice for Helse Bergen
An integral part of the responsibilities of the Health Trust as an employer is to promote development of sound ethics and follow up routines, guidelines, information and training measures in this area.

Sections of the internal control system of the health trust specifically dealing with research activities can be accessed on the Intranet: innsiden.helse-bergen.no/Forskning/rutiner. Researchers are notified via the research news service of any changes in requirements and routines determined by the authorities.

The Research Handbook provides individual researchers a valuable overview of current authority regulations and local guidelines. Chapter 10 provides a useful overview of both legal and ethical aspects, including which bodies must be contacted for advance approval. Helse Bergen arranges one-day courses for employees on authority regulations and also participates in the mandatory teaching of doctoral students at Bergen University.

Helse Bergen's responsibility as an employer is of great importance as far as audits are concerned. The health trust conducts regular internal audits of research projects in order to ensure that established research routines and procedures are followed. Breaches in routine are dealt with under the appropriate regulations at hospital level.

The Clinical Research Unit ("Klinisk forskningspost") also offers a monitoring service.